Abivax Hosting Key Opinion Leader Webinar on ABX464 for the Treatment of Ulcerative Colitis

DGAP-News: ABIVAX

/ Key word(s): Miscellaneous

19.04.2021 / 18:11

The issuer is solely responsible for the content of this announcement.

Abivax Hosting Key Opinion Leader Webinar on ABX464 for the Treatment of Ulcerative Colitis

 

The Webinar takes place on Tuesday, April 20, 2021 at 7:30am EDT (1:30pm CEST)

PARIS, France, April 19, 2021 – 6:00 p.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today announced that it will host a key opinion leader (KOL) webinar on ABX464 for the treatment of ulcerative colitis (UC). The webinar takes place on Tuesday, April 20, 2021 at 7:30am Eastern Time (1:30pm CEST), ahead of the data read-out of the Company’s phase 2b clinical induction study in UC that will become available in the second half of next month.

The webinar will feature presentations by KOL Prof. Bruce Sands, M.D., M.S., Icahn Scool of Medicine at Mount Sinai, New York City, NY, who will discuss the current and future treatment landscape and unmet medical needs in treating patients with UC. Dr. Sands will be available to answer questions following the formal presentations.

Abivax’s management team will discuss the drug-candidate, ABX464, and its potential to become a well-tolerated, easily administrable, short, and long-term effective therapy option for patients with moderate-to-severe UC. ABX464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in preclinical trials and in phase 2a induction and maintenance clinical studies to treat UC.

To register for the webinar, please follow the weblink: https://media.rampard.com/20210420/

KOL Biography
Prof. Bruce Sands, M.D., M.S., is the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, New York City, NY. Dr. Sands is widely recognized as an expert in the management of inflammatory bowel diseases (IBD) and for his clinical investigations of new therapeutics. He has published over 250 original manuscripts and was the lead investigator of the landmark studies ACCENT 2, UNIFI and VARSITY, published in the New England Journal of Medicine. Dr. Sands was awarded his B.A. and M.D. from Boston University, and trained in internal medicine at the Hospital of the University of Pennsylvania. After completing GI fellowship at the Massachusetts General Hospital, he joined the faculty of Harvard Medical School and served as the Acting Chief of the Gastrointestinal Unit at MGH before moving to Mount Sinai in 2010 as Chief of the Dr. Henry D. Janowitz Division of Gastroenterology.

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About Abivax (www.abivax.com)
Abivax, a clinical stage biotechnology company, is developing novel therapies that modulate the body’s natural immune machinery to treat patients with chronic inflammatory diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma. More information on the company is available at www.abivax.com.

 

Contacts

Abivax
Communications
Regina Jehle
regina.jehle@abivax.com
+33 6 24 50 69 63
Investors
LifeSci Advisors
Chris Maggos
chris@lifesciadvisors.com
+41 79 367 6254
Press Relations & Investors Europe
MC Services AG
Anne Hennecke
anne.hennecke@mc-services.eu
+49 211 529 252 22
Public Relations France
Actifin
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 6 21 10 49 24
Public Relations France
DGM Conseil
Thomas Roborel de Climens
thomasdeclimens@dgm-conseil.fr
+33 6 14 50 15 84
Public Relations USA
Rooney Partners LLC
Marion Janic
mjanic@rooneyco.com
+1 212 223 4017

 

DISCLAIMER

This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) with respect to certain of the Company’s programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its registration document (Document d’Enregistrement Universel). Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law.
This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction, in particular in France. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgement. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.


19.04.2021 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Medios AG: Deutsche Bank initiates coverage on Medios with a ‘Buy’ recommendation and a price target of €50.00

DGAP-News: Medios AG

/ Key word(s): Study/Research Update

19.04.2021 / 10:08

The issuer is solely responsible for the content of this announcement.

Press Release

Medios AG: Deutsche Bank initiates coverage on Medios with a “Buy” recommendation and a price target of €50.00

Berlin, 19 April 2021 – Deutsche Bank has initiated coverage on Medios AG today and issued a “Buy” recommendation for the shares of the leading provider of Specialty Pharma solutions in Germany. The price target amounts to €50.00 per share, accordingly. The Medios share price currently stands at €36.00 (Xetra closing on 16 April 2021). In addition to Deutsche Bank, Medios continues to be covered by Berenberg, Jefferies, Kepler Cheuvreux, Metzler Capital Markets and Warburg.

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About Medios AG
Medios AG is the leading provider of Specialty Pharma solutions in Germany. As a competence partner and expert, Medios covers all relevant aspects of the supply chain in this field: from pharmaceutical supply to the manufacture of patient-specific therapies including blistering. The focus is on optimal patient care via specialized pharmacies.

Medios AG is Germany’s first listed Specialty Pharma company and member of the SDAX selection index (Prime Standard) (ISIN: DE000A1MMCC8).

www.medios.ag

Contact
Claudia Nickolaus
Head of Investor & Public Relations
Medios AG
Heidestraße 9 | 10557 Berlin | Germany
P +49 30 232 566 800
c.nickolaus@medios.ag
www.medios.ag

Nikolaus Hammerschmidt
Senior Consultant Investor & Public Relations
Kirchhoff Consult AG
Borselstraße 20 | 22765 Hamburg | Germany
P +49 40 609 186 18
nikolaus.hammerschmidt@kirchhoff.de
www.kirchhoff.de

Disclaimer
This notification contains forward-looking statements that are subject to certain risks and uncertainties. Future results may significantly deviate from currently expected results, specifically due to various risk factors and uncertainties such as changes in business, economic, and competitive circumstances, exchange rate fluctuations, uncertainties about legal disputes or investigations, and the availability of financial resources. Medios AG assumes no responsibility whatsoever for updating the forward-looking statements contained in this notification.


19.04.2021 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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Evotec enters partnership with Kazia Therapeutics for clinical development of EVT801

DGAP-News: Evotec SE

/ Key word(s): Miscellaneous

19.04.2021 / 08:31

The issuer is solely responsible for the content of this announcement.

  • EVOTEC GRANTS KAZIA THERAPEUTICS AN EXCLUSIVE WORLDWIDE LICENSE FOR DEVELOPMENT AND COMMERCIALISATION OF ONCOLOGY ASSET EVT801
  • KAZIA INTENDS TO INITIATE A PHASE I CLINICAL TRIAL OF EVT801 MANAGED BY EVOTEC
  • EVOTEC WILL PROVIDE CHEMISTRY, MANUFACTURING AND CONTROLS (“CMC”)
  • EVOTEC RECEIVES A SMALL UPFRONT PAYMENT AS WELL AS RESEARCH FUNDING TO DEVELOP A BIOMARKER, AND IS ELIGIBLE TO RECEIVE CLINICAL AND COMMERCIAL MILESTONES AS WELL AS TIERED ROYALTIES ON THE NET SALES

Hamburg, Germany, 19 April 2021:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that the Company has entered into both a licensing and master service agreement with Kazia Therapeutics Limited (“Kazia”, ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company. Under the contract, Evotec will grant Kazia an exclusive worldwide license for research, development and commercialisation of Evotec’s oncology project EVT801.

EVT801 is a pre-clinical-stage, orally available, small molecule inhibitor of the lymphatic growth factor receptor VEGFR3, originally developed within Evotec’s partnership with Sanofi. The high selectivity of EVT801 for VEGFR3 over other VEGF receptors differentiates the compound from other small-molecule multi-kinase inhibitors that target multiple VEGF receptors, which are associated with significant toxicity. EVT801 provides the potential to specifically antagonise VEGFR3 to combine high efficacy both against the primary tumour and lymphatic-borne metastases with a highly favourable toxicology profile.

Kazia seeks to clinically evaluate EVT801 both as a single agent and in combination with immunotherapy in a set of specific oncology indications. Evotec will manage the Phase I trial under the full sponsorship of Kazia. Kazia will be responsible for any subsequent clinical evaluation and commercialisation of EVT801.

Evotec receives a small upfront payment as well as further payments for continued support progressing EVT801 into the clinic and beyond, e.g. for biomarker development and CMC. Additionally, Evotec is eligible to receive clinical and commercial milestones of more than € 300 m as well as tiered high single-digit royalties on the net sales of EVT801, which will be shared with Sanofi, Evotec’s partner for the discovery and early development of EVT801.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are excited to enter this licensing agreement with Kazia, who have a strong track record of clinical expertise in oncology. EVT801 comes with a comprehensive pre-clinical data package, very well-characterised pharmacology, and a clear mechanistic understanding that can inform rational selection of target populations and therapeutic combinations. In addition to a great asset, Evotec provides Kazia with a world-class team to continue progression into the clinic. We look forward to working with Kazia, to make EVT801 available to patients globally, thus providing a new treatment option for their severe unmet medical needs.”

Dr James Garner, Chief Executive Office of Kazia, said: “We are delighted to add this tremendously exciting new compound to the Kazia pipeline. Evotec have done first-class work in the early development of EVT801, and the preclinical data package is exceptionally strong. Our intention is to fast track a phase I clinical trial of the drug, which we expect to commence in CY2021.”

ABOUT KAZIA THERAPEUTICS LIMITED
Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Seven additional studies are active in other forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020. In March 2021, Kazia licensed Greater China rights for paxalisib to Simcere Pharmaceutical Company. For more information, please visit
www.kaziatherapeutics.com.

ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,500 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women’s health. On this basis, Evotec has built a broad and deep pipeline of more than 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to
www.evotec.com and follow us on Twitter @Evotec.

FORWARD-LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Media Contact Evotec SE:
Gabriele Hansen, SVP Head of Global Corporate Communications & Marketing, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

IR Contact Evotec SE:
Volker Braun, SVP Head of Global Investor Relations & ESG, Phone: +49.(0)40.56081-775, volker.braun@evotec.com


19.04.2021 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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SYNLAB sets price range for its planned IPO at EUR 18.00 to EUR 23.00 per share

DGAP-News: Synlab AG

/ Key word(s): IPO

19.04.2021 / 07:30

The issuer is solely responsible for the content of this announcement.

SYNLAB AG
Moosacher Straße 88
80809 Munich
Germany
Press release
Munich, 19 April 2021

 

  • SYNLAB aims to raise gross proceeds in the amount of EUR 400 million; gross proceeds intended to be used for further reduction of leverage
  • Total size of the offering set to exceed EUR 1 billion including secondary component
  • Free float to amount to up to 26% of outstanding share capital
  • Price range implies a total market capitalisation of between EUR 4 billion and EUR 5 billion
  • Offer period is expected to begin later today and is expected to end on 27 April 2021; first day of trading on the Regulated Market (Prime Standard) of the Frankfurt Stock Exchange is planned for 30 April 2021
  • Prof. Dr. David Ebsworth appointed Chairman of the Supervisory Board of SYNLAB AG

Munich, 19 April 2021. SYNLAB (the “Company”), the largest European clinical laboratory and medical diagnostic services company, has set the price range for its planned initial public offering (the “Offering”) at EUR 18.00 to EUR 23.00 per share. The final offer price will be determined by way of a book building process. The Offering is subject to approval of the prospectus by the German Federal Financial Supervisory Authority (BaFin) and its publication. The period during which investors may submit orders is expected to start later today and to end on 27 April 2021. Trading of the Company’s shares on the Regulated Market (Prime Standard) of the Frankfurt Stock Exchange is expected to begin on 30 April 2021.

“We are very excited about the IPO as a natural next step for SYNLAB and are receiving very positive feedback from the financial community ahead of the upcoming IPO investor roadshow. We are looking forward to deepening the conversations on our successful growth story and the clear opportunity for further growth and value creation ahead of us”, says SYNLAB CEO Mathieu Floreani. “The current COVID-19 pandemic has not only highlighted the importance of medical diagnostic services. It also proved how SYNLAB is generally able to quickly apply both medical and operational leadership based on our position as a European market leader with a unique and growing international footprint.”

Details of the Offering

The Offering comprises up to 22.2 million newly issued ordinary bearer shares from a capital increase as well as 27.5 million ordinary bearer shares from the Pre-IPO shareholders. Cinven, Novo Holdings and Ontario Teachers’ Pension Plan Board (together the “Institutional Shareholders”) can additionally place up to 12.4 million ordinary bearer shares as an upsize option, subject to market demand. The number of shares to be placed with investors will be determined by the Institutional Shareholders in consultation with Goldman Sachs and J.P. Morgan as Joint Global Coordinators on the date of pricing. In addition, the Institutional Shareholders will grant a Greenshoe option over 9.3 million ordinary bearer shares to cover possible over-allotments.

Assuming full exercise of the Greenshoe option and excluding the upsize option, the IPO size will range from EUR 1.03 billion to EUR 1.19 billion, implying a free float range of between 24% and 26% of the outstanding share capital. Assuming full exercise of the upsize option in addition to the Greenshoe option, a total of between 64.5 million ordinary bearer shares (at the upper end of the price range) and 71.5 million ordinary bearer shares (at the lower end of the price range) will be offered, leading to a total IPO size range between EUR 1.29 billion and EUR 1.48 billion, depending on the final issue price, and a free float of up to 32% of the outstanding share capital. Based on the set price range, the total market capitalisation amounts to between EUR 4 billion and EUR 5 billion with a total enterprise value between EUR 5.9 billion and EUR 6.9 billion.

SYNLAB aims to raise gross proceeds of approximately EUR 400 million from the sale of the newly created shares placed in the offering. The Group intends to use the proceeds to repay parts of its outstanding debt obligations, resulting in a further reduction of leverage.

At customary terms and conditions, the Company and the major shareholders, which include the Institutional Shareholders and SYNLAB founder Dr. Bartl Wimmer, have agreed to lock-up periods of 180 days after the Company’s first day of trading. The management board has agreed to a staggered lock-up period of between one and three years.

For the purpose of the planned IPO, SYNLAB AG was created as the new ultimate holding company of SYNLAB Group. Prior to the listing of the shares of the company, SYNLAB’s existing shareholders will contribute their shareholding in the current ultimate holding company SYNLAB Ltd. to SYNLAB AG in exchange for shares in SYNLAB AG.

Prof. Dr. David Ebsworth appointed Supervisory Board chair of SYNLAB AG

In the context of the change in legal structure to a German stock corporation (AG), the Company also established a Supervisory Board. It is chaired by Prof. Dr. David Ebsworth. Prof. Ebsworth has over 40 years of experience in the healthcare industry. He previously served as CEO of Galenica AG, Vifor Pharma AG and global head of the Pharmaceutical Division of Bayer AG. Prof. Ebsworth has chaired numerous private and public healthcare companies and also served on boards as either chairman of the audit, remuneration or nominations and governance committees. Marc Welters, trade union officer of IG Bergbau, Chemie, Energie (IG BCE), is the designated deputy chair of the Supervisory Board.

“SYNLAB is a company with compelling fundamentals and a strong management team which is diligently implementing a proven growth strategy based on medical and operational leadership. As the newly appointed chairman of the Supervisory Board, I am committed to support the company with my experience as we transition to become a listed company”, says Prof. Dr. David Ebsworth.

The new Supervisory Board will consist of twelve members with six shareholder and six employee representatives. The designated shareholder representatives besides Prof. David Ebsworth are Barbara Lambert, supervisory board member of Deutsche Börse and Banque Pictet & Cie SA; Dr. Bartl Wimmer, founder of SYNLAB; Peter Catterall, Partner at Cinven; Anastasya Molodykh, Principal at Cinven; and Christian Salling, Senior Partner at Novo Holdings A/S. Alongside Marc Welters, Karin Bierstedt, Dr. Stefan Graf, Dr. Ute Hasholzner and Rene Schmidt-Ferroud from SYNLAB are the designated employee representatives. They will be complemented by Iris Schopper from IG BCE.

Goldman Sachs and J.P. Morgan are acting as Joint Global Coordinators and Joint Bookrunners. BofA Securities, Deutsche Bank, Barclays, BNP PARIBAS, HSBC, Jefferies and UniCredit Bank AG have been mandated as Joint Bookrunners. Crédit Agricole CIB and Natixis are acting as Co-Lead Managers. Lilja & Co. is the independent advisor to the shareholders and SYNLAB.

About SYNLAB Group

  • SYNLAB Group is the largest European clinical laboratory and medical diagnostic services provider by revenue and number of tests. SYNLAB offers a full range of innovative and reliable medical diagnostics for patients, practising doctors, clinics and the pharmaceutical industry.
  • Providing the leading level of service within the industry, SYNLAB is the partner of choice for diagnostics in human and veterinary medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.
  • SYNLAB operates in 36 countries across four continents and holds leading positions in most markets. More than 20,000 employees (FTE), including over 1,200 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 carries out approximately 500 million laboratory tests per year and achieved Group revenues of EUR 2.6 billion in 2020.
  • More information can be found on www.synlab.com

For more information:

Media contact:
Carolin Amann, FTI Consulting

Florian Brückner, FTI Consulting

+49 (0) 175 299 3048
Carolin.Amann@fticonsulting.com
+49 (0) 160 9192 5265
Florian.Brueckner@fticonsulting.com
Investor contact:
Mark Reinhard, SYNLAB
+49 (0) 170 118 3753
Mark.Reinhard@synlab.com

 

Disclaimer

This release is not for distribution, directly or indirectly, in or into the United States (including its territories and possessions, any State of the United States and the District of Columbia), Australia, Canada or Japan. It does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States, Australia, Canada or Japan. The shares mentioned herein have not been, and will not be, registered under the US Securities Act of 1933, as amended (the “Securities Act”). The shares may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the Securities Act. There will be no public offer of shares of SYNLAB AG (the “Company”) in the United States.

This release constitutes neither an offer to sell nor a solicitation to buy shares of the Company. A public offer in Germany will be made solely on the basis of a securities prospectus which is yet to be published. An investment decision regarding shares of the Company should only be made on the basis of such securities prospectus. The securities prospectus will be published promptly upon approval by the German Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht (BaFin)) and will be available free of charge on the IPO website of SYNLAB AG (https://ag.synlab.com).

In any EEA Member State, other than Germany, this communication is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of Article 2(e) of Regulation (EU) 2017/1129.

This release may in the United Kingdom only be distributed to, and is only directed at, persons who are “qualified investors” within the meaning of Article 2 of Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018, and who are also (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), or (ii) persons falling within Article 49(2)(a) to (d) of the Order (high net worth companies, unincorporated associations, etc.) (all such persons together being referred to as “Relevant Persons”). This release is directed only at Relevant Persons and must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity in shares of the Company is available only to Relevant Persons and will be engaged in only with Relevant Persons.

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares have been subject to a product approval process, which has determined that such shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, distributors should note that: the price of the shares may decline and investors could lose all or part of their investment; the shares offer no guaranteed income and no capital protection; and an investment in the shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the shares and determining appropriate distribution channels.

In connection with the placement of the shares in the Company, Goldman Sachs Bank Europe SE, acting for the account of the underwriters, will act as stabilization manager (the “Stabilization Manager”) and may, as Stabilization Manager, make overallotments and take stabilization measures in accordance with Article 5(4) and (5) of the Regulation (EU) No 596/2014 of the European Parliament and of the Council of April 16, 2014 on market abuse in conjunction with Articles 5 through 8 of Commission Delegated Regulation (EU) 2016/1052) of March 8, 2016. Stabilization measures aim at supporting the market price of the shares of the Company during the stabilization period, such period starting on the date the Company’s shares commence trading on the regulated market (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse), expected to be 30 April 2021, end ending no later than 30 calendar days thereafter (the “Stabilization Period”). Stabilization transactions may result in a market price that is higher than would otherwise prevail. The Stabilization Manager is, however, under no obligation to take any stabilization measures. Therefore, stabilization may not necessarily occur, and it may cease at any time. Stabilization measures may be undertaken at the following trading venues: Frankfurt Stock Exchange, Xetra, BATS Europe, Berlin Stock Exchange, Chi-X Exchange, Dusseldorf Stock Exchange, Equiduct MTF, Eurocac Stock Exchange, Hamburg Stock Exchange, Hanover Stock Exchange, IBIS, Munich Stock Exchange, Stuttgart Stock Exchange, Turquoise MTF, VirtX Exchange.

In connection with such stabilization measures, investors may be allocated additional shares of the Company of up to 15% of the new shares and existing shares sold in the offering (the “Over-Allotment Shares”). The selling shareholders have granted the Stabilization Manager, acting for the account of the underwriters, an option to acquire up to 9,322,916 shares of the Company at the offer price, less agreed commissions (the “Greenshoe Option”). To the extent Over-Allotment Shares were allocated to investors in the offering, the Stabilization Manager, acting for the account of the underwriters, is entitled to exercise this option during the Stabilization Period, even if such exercise follows any sale of shares by the Stabilization Manager which the Stabilization Manager had previously acquired as part of stabilization measures (so-called refreshing the shoe).

This release contains forward-looking statements. These statements are based on the current views, expectations, assumptions and information of the management of the Company. Forward-looking statements should not be construed as a promise of future results and developments and involve known and unknown risks and uncertainties. Various factors could cause actual future results, performance or events to differ materially from those described in these statements, and neither the Company nor any other person accepts any responsibility for the accuracy of the opinions expressed in this release or the underlying assumptions. The Company does not assume any obligations to update any forward-looking statements. Moreover, it should be noted that all forward looking statements only speak as of the date of this release and that neither the Company nor Goldman Sachs Bank Europe SE, J.P. Morgan AG, Barclays Bank Ireland PLC, BNP PARIBAS, BofA Securities Europe SA, Deutsche Bank Aktiengesellschaft, HSBC Trinkaus & Burkhardt AG, Jefferies, UniCredit Bank AG, Crédit Agricole Corporate and Investment Bank and Natixis (together, the “Underwriters”) or their respective affiliates as defined under Rule 501(b) of Regulation D under the Securities Act (“affiliates”) assume any obligation, except as required by law, to update any forward looking statement or to conform any such statement to actual events or developments.

Each of the Company and the Underwriters and their respective affiliates expressly disclaims any obligation or undertaking to update, review or revise any forward-looking statement contained in this release, whether as a result of new information, future developments or otherwise.

Certain sources of market data included in this release were prepared before the renewed outbreak of the COVID-19 pandemic and have not been updated for the potential effects of the ensuing developments. The Company and the Underwriters are not able to determine whether the third parties who have prepared such sources will revise their estimates and projections due to the potential further impact of COVID-19 on future market developments.

The Underwriters are acting exclusively for the Company and the selling shareholders and no-one else in connection with the planned offering of shares of the Company (the “Offering”). They will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than the Company and the selling shareholders for providing the protections afforded to its clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to herein.

In connection with the Offering, the Underwriters and their respective affiliates may take up a portion of the shares offered in the Offering as a principal position and in that capacity may retain, purchase, sell, offer to sell for their own accounts such shares and other securities of the Company or related investments in connection with the Offering or otherwise. Accordingly, references in the international offering memorandum, once published, to the shares being offered, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or acquisition, placing or dealing by, the Underwriters and their respective affiliates acting in such capacity. In addition, the Underwriters and their respective affiliates may enter into financing arrangements (including swaps or contracts for differences) with investors in connection with which the Underwriters and their respective affiliates may from time to time acquire, hold or dispose of shares of the Company. The Underwriters do not intend to disclose the extent of any such investment or transactions, other than in accordance with any legal or regulatory obligations to do so.

None of the Underwriters or any of their respective affiliates or any of their or any of their affiliates’ respective directors, officers, 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 release (or whether any information has been omitted from the release) or any other information relating to the Company or its subsidiaries, 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 release or its contents or otherwise arising in connection therewith.


19.04.2021 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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Cosmo announces the start of trading of its shares on XETRA

Cosmo Pharmaceuticals N.V. / Key word(s): Miscellaneous

19-Apr-2021 / 06:00 GMT/BST

Release of an ad hoc announcement pursuant to Art. 53 KR

The issuer is solely responsible for the content of this announcement.


Dublin, Ireland – 19 April 2021: Shares of Cosmo Pharmaceuticals NV (‘Cosmo’) (SIX: COPN), which have traded on the Swiss Stock Exchange since 2007, will now also trade on XETRA in Frankfurt, Germany. Trading will commence today, Monday, at 9:00am CEST under tickersymbol C43. COSMO PHARMACEUT. EO-,26 ISIN: NL0011832936 | WKN: A2AJ68 | Ric: C43 | Type: Equity. The listing on XETRA, Germany’s most important stock exchange, is aimed at providing easier access to European investors, significantly improving the visibility of the Company on the capital markets and increasing the overall liquidity in the trading of Cosmo’s shares. 

Cosmo has appointed ODDO BHF Corporates & Markets AG, market leader in Germany, as Designated Sponsor. Designated Sponsors provide additional liquidity in the electronic trading system XETRA by obliging themselves to set binding bid and ask limits (so-called quotes) in the order book for the respective managed assets in continuous trading and auctions. 

Cosmo recently announced US Food and Drug Administration (FDA) approval of GI GeniusTM, the first device approved by the FDA that uses artificial intelligence to help detect potential signs of colon cancer. GI GeniusTM is already approved in Europe, Australia, Israel and the United Arab Emirate and will be distributed worldwide under an exclusive distribution agreement with Medtronic. 

In 2020, Cosmo had revenues of €60.9 million, an operating profit of €6.9 million and delivered a cashflow from operating activities of €10.1 million. During 2020, Cosmo received European approval for Methylene Blue MMX(R) for the visualization of colorectal lesions during colonoscopies and received FDA approval for BYFAVO(TM) for use in procedural sedation. The market value of Cosmo’s stake in Cassiopea SpA (SIX: SKIN), equity investments, treasury shares, loans and cash & liquid investments at 31 December 2020 was €624.6 million and equity was €400.1m.

About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius(TM), its artificial intelligence device to help detect signs of colon cancer. Cosmo has licensed Aemcolo(R) to Red Hill Biopharma Ltd. for the US and Relafalk(R) to Dr. Falk Gmbh for the EU and other countries. For additional information on Cosmo and its products, please visit the Company’s website:  www.cosmopharma.com

Calendar  
Annual General Meeting, Amsterdam May 28, 2021
Half-Year 2021 Report July 30, 2021

Disclaimer

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the ‘Order’), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

This press release does not constitute an “offer of securities to the public” within the meaning of Directive 2003/71/EC of the European Union (the “Prospectus Directive”) of the securities referred to in it (the “Securities”) in any member state of the European Economic Area (the “EEA”). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.

Contact
Niall Donnelly, CFO & Head of Investor Relations
Cosmo Pharmaceuticals N.V.                                  
Tel: +353 1 817 03 70
ndonnelly@cosmopharma.com


End of ad hoc announcement


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Relief Comments on Certain Statements Made by NeuroRx, Inc. in the Amended Form S-4 Filing of Big Rock Partners Acquisition Corp.

EQS Group-News: RELIEF THERAPEUTICS Holdings AG

/ Key word(s): Miscellaneous

19.04.2021 / 07:00

Relief Comments on Certain Statements Made by NeuroRx, Inc. in the Amended Form S-4 Filing of Big Rock Partners Acquisition Corp.

Geneva, Switzerland, April 19, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company“), commented today on certain statements made by NeuroRx, Inc., its collaboration partner for the development of RLF-100TM (aviptadil) pursuant to that certain binding collaboration agreement, dated September 18, 2020 (the “Collaboration Agreement”), in Amendment No. 1 to the Form S-4 of Big Rock Partners Acquisition Corp.’s (“BPRA”) that was filed on Friday, April 16, 2021 (the “Amendment”). The Amendment was filed by BRPA with respect to the proposed merger between NeuroRx and BRPA.

NeuroRx has elected to make statements in the Amendment with respect to pending disputes between Relief and NeuroRx under the terms of the Collaboration Agreement. As a result, Relief has concluded that it must inform the public about the nature of the pending disputes and its views regarding the positions regarding these issues taken by its collaboration partner. The issues currently in dispute include the following:

  1. NeuroRx has refused to share clinical trial data from its recently completed Phase 2b/3 trial with Relief, which data are required to be provided to Relief under the Collaboration Agreement. Further, NeuroRx has refused to allow NeuroRx’s contract partners dealing with issues relating to the development of aviptadil to share information with Relief that Relief requires to develop its aviptadil product in its territories (including the E.U. and the U.K.). As a result, Relief believes that NeuroRx is in default under the Collaboration Agreement, and that NeuroRx’s failure to provide this data is impairing Relief’s ability to develop and execute a clinical and regulatory strategy for its territories.
  2. NeuroRx states in the Amendment that Relief owes it approximately $4,000,000 in unpaid invoices. Unfortunately, many of these alleged expenses have not been substantiated by valid, verifiable invoices that support that these expenses are reimbursable under the Collaboration Agreement. Further, there are disputes between the parties over whether expenses exceeding the budget established in the Collaboration Agreement are reimbursable. With respect to this information, Relief has been seeking information from NeuroRx in order to establish what may be due to NeuroRx under the Collaboration Agreement, and, accordingly, Relief intends to exercise its rights under the Collaboration Agreement to conduct a forensic audit of NeuroRx’s books and records in order to determine the accuracy of the expense information that has been provided.
  3. NeuroRx has alleged in the Amendment that Relief has elected not to fund the recently initiated clinical trial evaluating inhaled aviptadil for the treatment of patients with moderate to severe COVID-19. In fact, Relief has requested certain information required for it to determine whether or not to fund this trial, and NeuroRx has refused to provide the requested information that is needed by Relief to make a decision on whether or not to fund this trial. It is Relief’s position that until it is provided with sufficient information to make this decision, NeuroRx cannot bring in another source to specifically fund this trial.
  4. NeuroRx has stated in the Amendment that Relief’s failure to fund expenses may result in a dispute with Relief over whether Relief’s share of the net profits from sales of aviptadil in NeuroRx’s territory should be less than that set forth in the Collaboration Agreement. Relief believes that the net profit splits between Relief and NeuroRx that are set forth in the Collaboration Agreement are not affected by any of these funding issues (including the recent warrant exercise reported in the Amendment by GEM Yield Bahamas Limited, a significant stockholder of Relief).
  5. NeuroRx makes allegations in the Amendment that raise questions about the formulation of aviptadil that Relief has contributed to the parties’ collaboration. Relief notes that while there are stability issues with the formulation that Relief brought to the collaboration, all of these problems were understood by all parties at the time of the execution of the Collaboration Agreement and that efforts to resolve those issues were contemplated by the Collaboration Agreement. In all respects, Relief believes that the version of aviptadil which is in evaluation in NeuroRx’s clinical trials is, in all respects, the drug product covered by the Collaboration Agreement.

Relief intends to continue its efforts to resolve amicably the pending disputes with NeuroRx over the Collaboration Agreement. However, if such disputes are not resolved amicably, Relief intends to take all necessary actions to enforce its rights under the Collaboration Agreement. While there can be no assurance, Relief believes that it will prevail in any such actions to enforce its rights under the Collaboration Agreement.

ABOUT RELIEF THERAPEUTICS HOLDING AG
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.

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CONTACT:
RELIEF THERAPEUTICS Holding AG

Raghuram (Ram) Selvaraju, Ph.D., MBA                                            
Chairman of the Board
Mail: contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
MC Services AG

Anne Hennecke / Brittney Sojeva
Tel.: +49 (0) 211-529-252-14
Mail: relief@mc-services.eu

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, including the outcome of the pending disputes between Relief and NeuroRx if such disputes are not resolved amicably, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.


End of Media Release


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​​​​​​​Eckert & Ziegler Acquires Direct Majority Stake in Drug Developer PENTIXAPHARM

Eckert & Ziegler Strahlen- und Medizintechnik AG / Key word(s): Investment/Strategic Company Decision

​​​​​​​Eckert & Ziegler Acquires Direct Majority Stake in Drug Developer PENTIXAPHARM

16-Apr-2021 / 11:01 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.


Berlin, 16 April 2021 – Eckert & Ziegler Strahlen- und Medizintechnik AG today acquired several share packages from the founders of the drug developer PENTIXAPHARM GmbH. Together with another internal share transfer, Eckert & Ziegler AG will directly hold a total of about 83% of the shares in the Würzburg-based company as of closing of the transactions. The total cost for the three share packages amount to approximately EUR 30 million. About a quarter of the purchase price payments will be made in cash, the remainder in shares of Eckert & Ziegler AG, which the seller has committed to hold at least until the date at which an advanced clinical trial approval is expected. The management of PENTIXAPHARM, which holds the remaining 17% of PENTIXAPHARM shares, has been granted additional options to sell its remaining shares. 

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


Information and Explanation of the Issuer to this News:

PENTIXAPHARM is developing a radiopharmaceutical combination product against lymphoma and a number of related tumors. Depending on whether chelated with Gallium-68 or Yttrium-90, the product will be able to be used both for the diagnosis and the therapy of cancer. For the lead diagnostic PENTIXAFOR, PENTIXAPHARM recently received the green light for advanced clinical trials from the European Medicines Agency in a form of preliminary notification. The management of PENTIXAPHARM expects that it will be able to go through the approval process in approximately three years. Eckert & Ziegler AG intends to raise funds for the approval process through further investments in the aftermath of its acquisition of PENTIXAPHARM.


16-Apr-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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IGEA to secure convertible bond commitment with Negma Group

IGEA Pharma N.V. / Key word(s): Miscellaneous

15-Apr-2021 / 23:34 CET/CEST

Release of an ad hoc announcement pursuant to Art. 18 KR

The issuer is solely responsible for the content of this announcement.


IGEA to secure convertible bond commitment with Negma Group

Hoofddorp, the Netherlands, 15 April 2021. IGEA Pharma N.V. (SIX: IGPH) today announced the signing of a two-year convertible bond commitment with UAE-based Negma Group.

The deal will make available up to EUR 2 million, already extendable up to EUR 10 million once the business with Blue Sky Natural Resources LTD will be combined, for IGEA to use at its discretion, subject to terms, in its pursuit to have the industrial activities on cannabidiol and other vegetable matrices extracts started within the second half of 2021 as well as to immediately boost all efforts to establish and strengthen market acceptance and position for its early-stage combined portfolio of health prevention, nutraceutical, pharma, and cosmeceutical solutions.

Through the convertible bond, structured in tranches then convertible with a one-digit discount on the stock market price, the Company expect to issue within the next coming two-years between 5 and 25 million new shares.

Vincenzo Moccia, CEO of IGEA “This commitment will allow us to definitively improve our commercial efforts and achieve all our medium-term objectives of the two combined businesses.

Rodolfo Galbiati, Fund Manager of Negma Group “At Negma we are always looking for the greatest opportunities in the market and we are glad the management chose us to fund IGEA in these important steps. The merger with Blue Sky Resources will create one of the most important players in the CBD sector in Europe and we will provide the necessary capital to expand and consolidate the company in the next years.
***
About Negma
Negma Group is a specialist financing institution that provides publicly listed companies with the funding required to develop and grow their business. Negma works with companies that meet established and transparent criteria to provide them with structured debt and equity products that meet their specific needs and constraints. Its positioning and the scale achieved allows Negma to offer industry leading terms.

About IGEA
IGEA Pharma N.V. focuses on health-tech and med-tech products and devices. Health-tech products are exclusively preventative. IGEA commercializes an Alzheimer’s prevention set (which includes ‘Alz1’, an at-home lab test kit to measure non-bound copper in the blood and a natural dietary supplement branded ‘Alz1 Tab’ designed to reduce blood heavy metals content) and expects to integrate the non-bound copper detection-based pipeline with a diabetes type II prevention set in 2021. Non-bound copper is an expected Alzheimer’s and diabetes type II associated biomarker. Controlling non-bound copper can contribute to reduce the risk of Alzheimer’s and diabetes type II. IGEA furthermore commercializes a COVID19 rapid test for the detection of IgM and IgG SARSCoV-2 related antibodies. Med-tech products focuses on selected solutions and specialties, among which dry aerosol generators for air and inanimate environmental surfaces sanitization and sterilization and air purification devices.

IGEA is listed on the SIX Swiss Exchange (ticker IGPH) and is headquartered in Hoofddorp, the Netherlands. Find out more at www.igeapharma.nl

Contacts
Vincenzo Moccia, CEO, +39 340 583 09 33, moccia@igeapharma.com

Disclaimer
This document constitutes neither an offer to buy nor to subscribe securities and neither this document nor any part of it should form the basis of any investment decision in IGEA. The information contained in this press release has been carefully prepared. However, IGEA bears and assumes no liability of whatever kind for the correctness and completeness of the information provided herein. IGEA does not assume an obligation of whatever kind to update or correct information contained in this press release whether as a result of new information, future events or for other reasons. This publication may contain specific forward-looking statements and assessments or intentions concerning IGEA and its business. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of IGEA and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties, readers should not rely on forward-looking statements. IGEA assumes no responsibility to update forward looking statements or to adapt them to future events or developments, except as may be required by law.

Additional features:

File: 20210415 igea nv_press release


End of ad hoc announcement


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Relief Reports 2020 Financial Results and Provides Business Update

EQS Group-News: RELIEF THERAPEUTICS Holdings AG

/ Key word(s): Annual Results

15.04.2021 / 07:00

Relief Reports 2020 Financial Results and Provides Business Update

Geneva, Switzerland, April 15, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company“), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat COVID-19 induced lung injury, today announced its 2020 financial results for the year ended December 31, 2020 and provided a business update.

“The past year has been an incredibly productive and rewarding one for all of us at Relief,” said Raghuram (Ram) Selvaraju, Chairman of the Board. “We have had an opportunity to make a true difference in fighting the ongoing COVID-19 pandemic with the development of RLF-100(TM) to treat critically ill patients. With the goal of bringing this potential treatment to patients as expeditiously as possible, we entered into important partnerships and made key hires, adding executives to our team who have strong expertise in important areas such as clinical development, regulatory and commercialization.”

He continued: “Critical for the future growth of our Company, we also have taken a very important first step to broaden our development pipeline. We entered into a collaboration and license agreement for ACER-001, a compound in late-stage development for orphan diseases where patients are in need of better treatment options. We plan to continue to advance the development of our current programs and further grow our pipeline in the year ahead. I am excited about Relief’s future as we work to provide patients with therapeutic relief in serious diseases with high unmet medical need.”

Recent Key Development and Corporate Highlights:

Clinical Development Highlights (RLF-100)

  • In March 2020, a U.S. phase 2b/3 trial of RLF-100(IV) for the treatment of patients with critical COVID-19 with respiratory failure commenced.
  • In June 2020, RLF-100 (IV) was awarded Fast Track designation by the U.S. FDA for the treatment of acute lung injury (ALI) /acute respiratory distress syndrome (ARDS) associated with COVID-19.
  • In July 2020, the FDA granted Expanded Access Protocol (EAP) designation for the treatment of respiratory failure induced by COVID-19 with RLF-100 (IV). Treatment was made available to patients who had exhausted standard therapies and were not eligible for the phase 2b/3 trial due to confounding medical conditions. Data from the first 21 patients in the EAP showed promising results demonstrating that some critically ill patients with COVID-19 experienced substantial clinical improvement when treated with RLF-100.
  • In January 2021, Relief, its partner NeuroRx, and the Quantum Leap Healthcare Collaborative (QLHC) of San Francisco announced that NeuroRx and QLHC had signed a Clinical Trial Participation Agreement for the inclusion of inhaled RLF-100 in the I-SPY COVID-19 Clinical Trial. Quantum Leap is the sponsor of the I-SPY COVID-19 Trial, a platform trial that is assessing multiple drugs for the treatment of patients with critical COVID-19 who are hospitalized or in intensive care units.
  • In January 2021, Relief and AdVita Lifescience GmbH signed a binding term sheet for Relief to acquire all shares of AdVita. Relief will gain access to all AdVita assets including future pending IP rights that may cover RLF-100 inhaled formulation specifications for the potential application of inhaled aviptadil in the treatment of lung diseases such as ARDS and Pulmonary Sarcoidosis.
  • In February 2021, Relief’s partner NeuroRx announced the initiation of a U.S. phase 2b/3 trial evaluating inhaled RLF-100 in patients with moderate to severe COVID-19 in order to prevent progression to respiratory failure.
  • In March 2021, Relief’s partner NeuroRx reported topline results (28-day and 60-day) from the U.S. phase 2b/3 trial evaluating RLF-100 (IV) for the treatment of patients with critical COVID-19 with respiratory failure. On the basis of the findings, NeuroRx plans to apply to the U.S. FDA for Emergency Use Authorization (EUA) and subsequently plans to submit a New Drug Application (NDA).
  • In March 2021, NeuroRx announced that RLF-100 had been selected for inclusion in TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), a phase 3 multicenter clinical trial that will include the United States and multiple foreign countries, that is being sponsored by the U.S. National Institutes of Health (NIH).

Corporate Highlights

  • To match the fast pace at which the Company is developing, Relief strengthened its management team during 2020 and early 2021 with the additions of Jack Weinstein as Chief Financial Officer and Treasurer, Chris L.J.J. Stijnen as Chief Commercial Officer, Gilles Della Corte, M.D. as Chief Medical Officer, J. Paul Waymack, M.D., Sc.D. as development and regulatory consultant and J.J. Scherpbier of Sonsbeek Pharma Consultancy B.V. as manufacturing and supply chain consultant.
  • To strengthen and expand its pipeline, in March 2021, Relief signed a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 for the treatment of Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD).

Financial Highlights

2020

  • Relief reported a strong financial position with CHF 43.1 million in cash on its balance sheet as of December 31, 2020 (CHF 0.1 million at year end 2019).
  • Service expenses were CHF 13.7 million (2019: CHF 0.1 million), primarily for services provided by collaboration partner NeuroRx, Inc. and other third parties related to RLF-100 clinical trials.
  • Personnel expenses were CHF 2.6 million (2019: CHF 0.3 million), as additional human resources were essential to oversee clinical trial activities with RLF-100 and to strengthen Relief’s organization.
  • Other administrative expenses were CHF 3.0 million (2019: CHF 0.6 million), as requirements for legal, consulting and marketing services increased in conjunction with the Company’s activities.
  • Relief recognized a one-time disposal gain of CHF 3.4 million following the divestment of its former subsidiary holding the atexakin alpha compound.
  • EBITDA for 2020 was a loss of CHF 20.3 million (2019: loss of CHF 0.9 million).
  • Net loss in 2020 was CHF 7.8 million (2019: CHF 7.5 million).
  • In July 2020, Relief entered into a binding agreement with Gem Global Yield LLC (GEM) for the redemption of the outstanding CHF 1.7 million debt position in exchange for newly issued Relief shares.
  • Through 2020, Relief successfully closed several capital increases in the amount of CHF 49.2 million pursuant to drawdowns from its Share Subscription Facility (“SSF”) in place with GEM.
  • Financing activities throughout 2020 resulted in the raising of a total of CHF 58 million in new equity financing.

Post reporting period

  • In January 2021, Relief signed a second binding agreement with GEM for the implementation of a new SSF in the amount of up to CHF 50 million.
  • In March 2021, the Company raised CHF 10 million in a private placement with a single healthcare-dedicated U.S. institutional investor.
  • As of April 15, 2021, the Company had available cash of approximately CHF 35 million.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, commented: “Relief is not the same company it was a month ago, let alone a year ago. Through exercising flexible financing tools, which allows the Company to support ongoing clinical development of RLF-100, ACER-001 and its pipeline expansion strategy, we have developed a cash runway that will see us well into 2022. I remain excited about meeting the challenges of growing a biopharmaceutical company with a very bright future.”

Outlook for 2021:

Relief expects to make continued progress with its development programs and in advancing its business in the months ahead.

Pipeline

Looking first to RLF-100 (IV), as our partner NeuroRx executes plans to file for EUA for the treatment of critically ill patients with COVID-19, followed by an NDA, Relief is preparing for clinical assessment and potential commercialization in Europe and other territories. Once Relief has received and analyzed the full data set from the U.S. phase 2b/3 trial, the Company will decide on the best path forward for the development of RLF-100 in Europe and other territories.

Turning to RLF-100 (inhaled), the acquisition of AdVita is expected to close in Q2 2021. Additionally, Relief is hopeful that its partner NeuroRx will have results from the ongoing U.S. phase 2b/3 trial evaluating inhaled RLF-100 in H2 2021.

Our second late-stage program in collaboration with Acer Therapeutics for ACER-001 is expected to progress quickly in 2021. A pre-NDA meeting is scheduled to occur between Acer and the FDA in Q2 2021 to discuss the results of the clinical study of ACER-001 in UCDs. Provided no additional data are requested by FDA during the meeting and ongoing development activities are successfully completed, Acer expects to submit a 505(b)(2) NDA for ACER-001 for the treatment of UCDs in mid-2021, with a potential regulatory decision in H1 2022. Relief plans to initiate discussions with European regulatory authorities regarding ACER-001 in UCDs in Q3 2021. Clinical studies in MSUD could start later in 2021.

Relief plans to continue its strategy to aggressively pursue opportunities to expand its pipeline with attractive late-stage clinical assets that would drive the evolution of the Company into a mature, diversified biopharmaceutical company.

Corporate

Adding expertise by hiring personnel and consultants will continue in an effort to match the Company’s pace of development.

Throughout 2021 Relief will continue to evaluate and take steps to facilitate interest from institutional investors. In addition, the Company expects to “up list” to a major U.S. stock exchange in the coming months.

Relief’s 2020 Annual Report is available for download at https://relieftherapeutics.com/investor-relations.

###

ABOUT RELIEF THERAPEUTICS HOLDING AG
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com.

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CONTACT
RELIEF THERAPEUTICS Holding AG

Raghuram (Ram) Selvaraju, Ph.D., MBA                              
Chairman of the Board
Mail: contact@relieftherapeutics.com
FOR MEDIA/INVESTOR INQUIRIES:
MC Services AG

Anne Hennecke / Brittney Sojeva
Tel.: +49 (0) 211-529-252-14
Mail: relief@mc-services.eu
Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the ongoing clinical trials of Relief’s lead compound, RLF-100(TM) (aviptadil) in advanced clinical development to treat respiratory deficiency due to COVID-19, will be successful. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.


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IGEA and its CFO end collaboration

IGEA Pharma N.V. / Key word(s): Miscellaneous

14-Apr-2021 / 23:41 CET/CEST

Release of an ad hoc announcement pursuant to Art. 18 KR

The issuer is solely responsible for the content of this announcement.


IGEA and its CFO end collaboration

Hoofddorp, the Netherlands, 14 April 2021. IGEA Pharma N.V. (SIX: IGPH) today announced that the collaboration with Patrick Pozzorini is terminated. The formed CFO resigned due to personal reasons.

According to the ongoing business combination with Blue Sky Natural Resources LTD, on which the extraordinary general meeting of IGEA will resolve on 28 April 2021, substantial changes are expected in both shareholding and corporate bodies. The Company therefore decided to postpone a replacement and assigned the role functions ad interim to Vincenzo Moccia, CEO of the Group.

Patrick has been of tremendous help in deploying our project in the past years. His human behavior together with his extraordinary professional skills helped me and the Company in achieving the planned results. I would like to thank Patrick for the excellent work performed and wish him all the best for his new professional challenges” said Vincenzo Moccia, CEO of IGEA.

***

About IGEA
IGEA Pharma N.V. focuses on health-tech and med-tech products and devices. Health-tech products are exclusively preventative. IGEA commercializes an Alzheimer’s prevention set (which includes ‘Alz1’, an at-home lab test kit to measure non-bound copper in the blood and a natural dietary supplement branded ‘Alz1 Tab’ designed to reduce blood heavy metals content) and expects to integrate the non-bound copper detection-based pipeline with a diabetes type II prevention set in 2021. Non-bound copper is an expected Alzheimer’s and diabetes type II associated biomarker. Controlling non-bound copper can contribute to reduce the risk of Alzheimer’s and diabetes type II. IGEA furthermore commercializes a COVID19 rapid test for the detection of IgM and IgG SARS-CoV-2 related antibodies. Med-tech products focuses on selected solutions and specialties, among which dry aerosol generators for air and inanimate environmental surfaces sanitization and sterilization and air purification devices.

IGEA is listed on the SIX Swiss Exchange (ticker IGPH) and is headquartered in Hoofddorp, the Netherlands.Find out more at www.igeapharma.nl

Contacts
Vincenzo Moccia, CEO, +39 340 583 09 33,moccia@igeapharma.com

Disclaimer
This document constitutes neither an offer to buy nor to subscribe securities and neither this document nor any part of it should form the basis of any investment decision in IGEA. The information contained in this press release has been carefully prepared. However, IGEA bears and assumes no liability of whatever kind for the correctness and completeness of the information provided herein. IGEA does not assume an obligation of whatever kind to update or correct information contained in this press release whether as a result of new information, future events or for other reasons. This publication may contain specific forward-looking statements and assessments or intentions concerning IGEA and its business. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of IGEA and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties, readers should not rely on forward-looking statements. IGEA assumes no responsibility to update forward looking statements or to adapt them to future events or developments, except as may be required by law.

Additional features:

File: 20210414 igea nv_press release


End of ad hoc announcement


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