Apogenix to Present New Data on Asunercept at ESMO Immuno-Oncology Congress

Heidelberg, Germany, December 5, 2019 – Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, announced today that new data on its lead immuno-oncology candidate asunercept will be presented in a poster at the ESMO Immuno-Oncology Congress 2019, held from December 11-14, 2019, at the Palexpo in Geneva, Switzerland. The data are the result of a research collaboration with Benoit Van den Eynde and his team from the Ludwig Institute for Cancer Research in Brussels, Belgium.

Poster Title: “The role of asunercept as a selective CD95L inhibitor in cutaneous melanoma: rationale and results from an enhanced TiRP model” (Poster #118P)
Poster Presentation: December 12, 12:15 pm
Presenter: Andriy Krendyukov, M.D., VP Medical Affairs, Apogenix AG

About Apogenix
Apogenix is a private company developing innovative immuno-oncology therapeutics for the treatment of solid tumors and hematological malignancies. The company’s pipeline of immuno-oncology drug candidates targets different tumor necrosis factor (TNF) superfamily-dependent signaling pathways, thereby restoring the immune response against tumors. Checkpoint inhibitor asunercept, the company’s lead immuno-oncology candidate, is in late-stage clinical development with PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of glioblastoma. Based on its proprietary technology platform for the construction of novel TNF superfamily receptor agonists (HERA-ligands), Apogenix develops CD40, CD27, GITR, HVEM, and 4-1BB receptor agonists for cancer immunotherapy. The TRAIL receptor agonist program was outlicensed to AbbVie. AbbVie has initiated a phase I trial with TRAIL receptor agonist ABBV-621 in patients suffering from solid tumors, non-Hodgkins’s lymphoma, or acute myeloid leukemia.

Contacts
Peter Willinger, CFO
Jennifer Mogk, PR Manager
Apogenix AG
Phone: +49 6221 58608-0
E-Mail: contact@apogenix.com
Web: www.apogenix.com

Media Contacts
Katja Arnold
Andreas Jungfer
MC Services AG
Phone: +49 89 210228-0
E-Mail: apogenix@mc-services.eu

New hope for brain tumor patients in Saxony: Paracelsus Clinic Zwickau and MagForce AG open new NanoTherm therapy center for the East German region

• Use of innovative technology in the treatment of brain tumor patients, now also in Zwickau, the central treatment center in East Germany
• Milestone reached for the opening of the mobile NanoTherm treatment center at the Paracelsus Clinic in Zwickau

Zwickau and Berlin, Germany, December 5, 2019 – The Paracelsus Clinic in Zwickau and MagForce AG (Frankfurt, Scale, Xetra: MF6, ISIN: DE000A0HGQF5) received all necessary certifications on November 27, 2019 for the immediate use of the NanoTherm therapy system in the neurosurgery department of the Paracelsus Clinic in Zwickau, located in the German federal state of Saxony. In light of the potential life-prolonging effect of NanoTherm therapy and in the acute interest of patients, this therapeutic option is immediately available to patients in the entire Eastern region of Germany. Since the transportability of critically ill patients with glioblastoma to more distant centers was previously nearly impossible due to the limiting overall health of the patients, all brain tumor patients in this region will now also be able to benefit from the innovative therapy.

“I am glad that my team and I can now offer this highly innovative treatment option to patients with brain tumors. NanoTherm therapy means nothing less than new hope for each and every one of our patients. It complements our broad neurosurgical portfolio with a very important component,” said Prof. Dr. med. habil. Jan-Peter Warnke, Senior Consultant in the Neurosurgical Clinic at the Paracelsus Clinic in Zwickau.

NanoTherm therapy is a relatively new procedure for the focal treatment of solid tumors. In the simplest of terms: Magnetic nanoparticles are introduced either directly into the tumor or into the resection cavity wall. These particles are subsequently heated by an alternating magnetic field, thus destroying the cancer cells. In June of this year, the Paracelsus Clinic Zwickau and MagForce AG entered into a cooperation agreement and announced the planned opening of a mobile NanoTherm treatment center for brain tumor patients. The successful approval of the therapy center is an important milestone.

MagForce AG was granted the European CE certificate (“European Certification”) in 2011 and thus the official approval of NanoTherm therapy for the treatment of brain tumors in Germany and all member states of the European Union.

Paracelsus Clinic Saxony in Zwickau will be the fourth clinic in Europe currently to offer MagForce’s NanoTherm therapy for the treatment of brain tumours. The Paracelsus Clinic in Zwickau is a standard care hospital with 180 patient beds and around 400 employees in the specialist departments of internal medicine and trauma surgery / orthopedics, general, visceral and vascular surgery, pain therapy as well as the focus disciplines of neurology and neurosurgery. The department of neurosurgery cares for approximately 2,200 patients annually and performs an average of 1,500 surgeries per year, of which approximately 300 are primary gliomas.

For more information, please visit: www.paracelsus-kliniken.de and www.magforce.com

Press and investor contact information:

Paracelsus Clinic Sachsen
Isabelle Georgi
Corporate Communications & Marketing
T 037464 85-1504
M isabelle.georgi-barth@paracelsus-kliniken.de

MagForce AG
Barbara von Frankenberg
VP Communications & Investor Relations
T +49-30-308380-77
M bfrankenberg@magforce.com

Disclaimer
This release may contain forward-looking statements and information which may be identified by formulations using terms such as “expects”, “aims”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates” or “will”. Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.

Ad-hoc RELEASE
Announcement according to Article 17 European Market Abuse Regulation (MAR)

Biotest AG increases Guidance

Dreieich, 4 December 2019. Following the evaluation of the current business situation, the Management Board today confirms the revenue guidance for the 2019 financial year in the range of € 420 – 430 million. Although the efforts to find a co-marketing and co-development partner could will not be successfully completed this year, the Management Board increases the guidance for the operating result (EBIT) to € -3 to -13 million, provided that the existing trade conflicts won’t aggravate.

Biotest Aktiengesellschaft
Board of Management

Biotest AG
Landsteinerstr. 5
D-63303 Dreieich
www.biotest.com

About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: investor_relations@biotest.de

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

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

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

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

Contact:
Dr. Michael Ramroth
Chief Financial Officer
Biotest AG
Landsteinerstr. 3
63303 Dreieich
Tel. +40 6103 801 338
Fax: +49 6103 801 347
Michael.ramroth@biotest.com

Pressemitteilung
 

Bad Neustadt a. d. Saale/Basel 4. Dezember 2019
 

Medgate Deutschland established – RHÖN KLINIKUM AG and Medgate sign foundation agreement

On 3 December 2019 RHÖN-KLINIKUM AG and Medgate signed the notarised agreement establishing Medgate Deutschland GmbH, and appointed Verena Weißenseel as the company’s Managing Director. Business operations of Medgate Deutschland are slated to begin in the first half of 2020. The telemedical centre providing the services (Medgate Tele Clinic) will have its registered office in Berlin.

Anyone falling ill can grab their smart phone and get medical advice and treatment by phone or video. Patients can access the services in two ways: either by using the Medgate App or contacting the patient reception of Medgate Tele Clinic by phone. What has been a reality in Switzerland for many years already will soon also be possible in Germany. It is for that purpose that Medgate Deutschland GmbH was officially founded today. RHÖN-KLINIKUM AG holds the majority stake in the company with an interest of 51%, with 49% being held by Medgate.

Verena Weißenseel appointed Managing Director

Verena Weißenseel will take over the management of the newly founded company. Weißenseel was previously Head of Corporate Development at RHÖN-KLINIKUM AG and already a year ago assumed the project management for Medgate’s market entry to Germany. Weißenseel has outstanding knowledge of the German healthcare market as well as extensive experience in developing and establishing new medical services and offerings.

Regarding her new task Verena Weißenseel noted: “I am very much looking forward to the new challenge and am convinced that with our offering in the area of telemedicine and digital health we can make an important contribution towards improving the healthcare system. We are gearing our offering to the requirements of an increasingly digitalised society and its need for efficient, high-quality and fast healthcare provision.”

Stephan Holzinger, Chairman of the Board of Management of RHÖN-KLINIKUM AG, said: “Over the past months Ms. Weißenseel, working together with Medgate, has successfully advanced the preparations for the operative launch of Medgate Deutschland with tremendous commitment. RHÖN-KLINIKUM is expanding its value chain with the telemedicine offer: digital before outpatient before inpatient. In this way we are creating a modern care offer for patients.”

Path cleared for market entry

The most important preparations for market entry were already implemented over the past months: the legal framework conditions for provision of services were clarified, the technological infrastructure for the local application in Germany was developed and the recruiting process for the staff was initiated. Moreover, we have established close and promising contacts with potential customers, having already succeeded in acquiring a reputable private hospital insurance company as a customer. Likewise, we have begun establishing a partner network with community-based service providers so as to offer patients and insured persons comprehensive service going beyond tele-consultation.

In a first step, the offering is addressed to private health insurance companies and self-payers. There are also plans to work together with statutory health insurance funds as well as to expand the offering. The structures for providing telemedical and digital services will be established along the same lines as the Swiss business model, giving due regard to the legislative framework in Germany.

—————————————————————————————————————————————-

RHÖN‐KLINIKUM AG is one of the largest healthcare providers in Germany. The hospital group offers excellent medical care with a direct link to universities and research institutes. More than 850,000 patients are treated every year at the five group hospitals located in Bad Berka, Bad Neustadt, Frankfurt (Oder), Giessen and Marburg where more than 17,000 employees work. With the RHÖN campus concept the Company is currently implementing a new and forward-looking project which raises fully comprehensive healthcare in rural areas to a new level of excellence and is geared to the growing needs of patients.
More information under www.rhoen-klinikum-ag.com

Contact

Elke Pfeifer | Head of Division Corporate Communications and Marketing
RHÖN-KLINIKUM AG, Schlossplatz 1, D-97616 Bad Neustadt a. d. Saale
T. +49 9771 65-1327, elke.pfeifer@rhoen-klinikum-ag.com

About Medgate

Medgate focuses on digital healthcare solutions to bring the physician to where he or she is needed by patients. Emphasis is also placed on the well-being of patients as well as on the benefit for society in general. Medgate was established in 1999 and currently employs over 330 employees in Switzerland, of whom over 100 are physicians. Since 2000 Medgate has been operating its teleclinic which is the largest telemedical centre in Europe. Medgate therefore possesses a large amount of experience and knowledge in the field of telemedicine. Consultations on the patient’s doorstep are carried out in Medgate’s miniclinics where there are also physicians available in clinics by Medgate’s network of partners. Medgate’s well-established concept is also exported abroad where Medgate is active in various countries such as the UAE, Philippines, India and the Czech Republic.

Contact

Cedric Berset | Director Marketing, Communications & Sales
Medgate, Gellertstraße 19, CH-4020 Basel
T. +41 61 377 88 44, cedric.berset@medgate.ch

RHÖN-KLINIKUM AG | Schlossplatz 1 | D-97616 Bad Neustadt a. d. Saale

Ad-hoc release
 

Publication of inside information pursuant to Article 17 of Regulation (EU) No 596/2014

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN OR ANY JURISDICTION IN WHICH SUCH DISTRIBUTION OR DISTRIBUTION IS UNLAWFUL.
 

MOLOGEN AG: Insolvency Filing

Berlin, December 3, 2019 – The Management of MOLOGEN AG (ISIN DE000A2LQ900, WKN A2L Q90) (the Company) today filed for insolvency with the local court of Berlin-Charlottenburg (Amtsgericht Charlottenburg).
 

Important note:

This announcement constitutes neither an offer nor a solicitation to purchase or subscribe for securities in the United States of America, Australia, Canada, Japan or other jurisdictions in which an offer is unlawful. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act. There will be no public offering of the securities referred to in this announcement in the United States of America. Subject to certain exceptions under the Securities Act, the securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan or to or for the account or benefit of persons resident in Australia, Canada or Japan.
 

Contact
Mologen AG
Tel: +49 – 30 – 84 17 88 – 0
Fax: +49 – 30 – 84 17 88 – 50
investor@mologen.com

Risk note on the forward-looking statements

Certain statements in this release contain forward-looking terminology or the corresponding negative terminology, or versions or similar terminology that differ therefrom. These are referred to as forward-looking statements. In addition, all information given here relating to planned or future results of business segments, key financial figures, developments in the financial situation or other financial figures or statistical data contains such forward-looking statements. The Company advises forward-looking investors not to place undue reliance on these forward-looking statements as a guide to future events. The Company does not undertake, and shall not be liable in any manner whatsoever, to update any forward-looking statements, which speak only as of the date of their publication.

• PARTNERSHIP BUILDS ON THE EXISTING EVOTEC-CELMATIX-ALLIANCE IN WOMEN’S HEALTH
• CELMATIX LEVERAGING PROPRIETARY MULTI-OMICS DATA PLATFORM FOR THERAPEUTIC DRUG DEVELOPMENT
• EVOTEC INVESTS IN A FINANCING ROUND ALONGSIDE INVESTORS INCLUDING LIFE SCIENCES INNOVATION FUND AND TOPSPIN FUND

Hamburg, Germany, 03 December 2019: Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced an expansion of the Company’s strategic partnership with Celmatix Inc., the leading precision health company advancing the fields of reproductive medicine and fertility at the intersection of big data and genomics. Furthermore, together with investors including Life Sciences Innovation Fund and Topspin Fund, Evotec participates in a funding round which will allow Celmatix to expand its broader, innovative, therapeutics initiatives.

This alliance builds on Evotec’s existing partnership with Celmatix in women’s health. Under the terms of the agreement announced this October, both Companies would collaborate to develop pre-clinical programmes for highly prevalent, yet underserved conditions affecting women’s reproductive health including endometriosis, polycystic ovary syndrome (“PCOS”), and infertility.

The women’s health therapeutics market is poised for transformation and meaningful growth. More than half a billion women worldwide are impacted by reproductive conditions such as endometriosis and PCOS, but there has been little to no progress in how these and many other related conditions are diagnosed, then treated. Women are having children later in life, leaving a huge unmet need for managing ovarian aging and connecting the dots for women on how certain conditions impact their fertility potential.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: “Over the last 10 years, Celmatix has built the largest, proprietary multi-omics datasets and multidisciplinary expertise in women’s reproductive health. Coupled with our experience developing drugs for hundreds of novel biological targets with top pharmaceutical companies worldwide, we have seen indisputable evidence that data-driven target selection bolsters long-term success for new drug programmes. Celmatix is changing the paradigm for women’s health, and we are thrilled to be a part of that remarkable endeavour.”

“Celmatix was founded on the idea that big data and genomics could be harnessed to provide women reproductive health information earlier in life, helping to drive better decision-making,” explained Dr Piraye Yurttas Beim, founder and CEO, Celmatix. “These insights, however, are only as powerful as the number of choices a woman has about what to do next, and so the logical next step for us was to also help expand the toolbox in the hands of physicians to help women achieve better health outcomes, more efficiently. This kind of precision health has been revolutionary for categories like oncology, and we are excited about the impact that our alliance with Evotec will have on the field of women’s reproductive health.”

Life Sciences Innovation Fund portfolio manager David Sable, MD commented: “The data platform created by Celmatix is unmatched in women’s health. It enables a much more precise understanding of diseases and the patients affected by them, provides a molecular vocabulary that can be used to identify more extensive pathways and targets for intervention, and will create a pipeline of therapeutics, diagnostics and modulators of the immune system, similar to the pace of innovation in areas like oncology.”

No financial terms of this collaboration were disclosed.

ABOUT CELMATIX, INC.
Celmatix is a data-driven, research-stage precision health company leveraging insights from its proprietary multi-omics discovery platform, Reproductive Atlas, to develop transformational therapeutics in previously under-studied areas of women’s health. With a lead program in ovarian senescence and additional programs in non-hormonal contraceptives and speciality indications such as endometriosis and polycystic ovary syndrome (PCOS), Celmatix is developing the next generation of interventions in its field, and supporting its partners in bringing innovation to a high-value market with large unmet need. For more information visit www.celmatix.com.

Media contact
Colleen McMillen, Celmatix
c.mcmillen@celmatix.com
+1.917.344.9360

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 2,900 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 and fibrosis. On this basis, Evotec has built a broad and deep pipeline of approx. 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, Celgene, 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.

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

Ad-hoc release
 

Publication of inside information pursuant to Article 17 of Regulation (EU) No 596/2014

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN OR ANY JURISDICTION IN WHICH SUCH DISTRIBUTION OR DISTRIBUTION IS UNLAWFUL.
 

MOLOGEN AG: Update on short-term financing of the Company
 

Berlin, December 2, 2019 – In order to facilitate short-term financing of MOLOGEN AG (ISIN DE000A2LQ900, WKN A2L Q90) (the Company), the Management Board is currently in discussions with two potential investor groups. The aim of these discussions is to place the convertible bond with a total nominal value of EUR 2,000,000 as announced in the Company’s ad hoc announcement of 22 November 2019 and thereby secure the Company’s existence.
 

In the course of these discussions, a group of investors in support of Prof. Dr. Burghardt Wittig propose (i) the immediate appointment of Prof. Wittig as a member of the Company’s Management Board and (ii) the short-term appointment by court order of Gerhard Greif and Kai Drabe as members of the Company’s Supervisory Board, with Mr. Greif to be elected as Chairman and Mr. Drabe as Deputy Chairman of the Supervisory Board following their respective appointments, as a prerequisite for a commitment to subscribe the entire convertible bond. The current members of the Supervisory Board, Dr. Friederike Zahm and Dr. Michael Schultz, are to resign from the Supervisory Board according to the proposal of the investor group. Oliver Krautscheid is to remain on the Supervisory Board according to the proposal of this investor group.
 

All members of the Management and the Supervisory Boards have today declared that they will continue to pursue the discussions with investors constructively in the interest of the Company. Therefore, in a joint meeting all members of the Management Board and the Supervisory Board of the Company today have declared their willingness in principle and within the limits of what is legally permissible to make their offices available at short notice under certain conditions as soon as a legally binding financing commitment in the form of subscription certificates for the convertible bond signed by this group of investors are available, in order to accommodate the demands of the group of investors and enable the Company to secure its continued existence.
 

If, on the other hand, the convertible bond cannot be placed or can only be placed in an insufficient amount, and if the other corporate financing efforts currently undertaken by the Company cannot be successfully concluded, the existence of the Company would be acutely threatened in the short term.

Important note:

This announcement constitutes neither an offer nor a solicitation to purchase or subscribe for securities in the United States of America, Australia, Canada, Japan or other jurisdictions in which an offer is unlawful. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act. There will be no public offering of the securities referred to in this announcement in the United States of America. Subject to certain exceptions under the Securities Act, the securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan or to or for the account or benefit of persons resident in Australia, Canada or Japan.

Kontakt
Mologen AG
Tel: +49 – 30 – 84 17 88 – 0
Fax: +49 – 30 – 84 17 88 – 50
investor@mologen.com

Risk note on the forward-looking statements

Certain statements in this release contain forward-looking terminology or the corresponding negative terminology, or versions or similar terminology that differ therefrom. These are referred to as forward-looking statements. In addition, all information given here relating to planned or future results of business segments, key financial figures, developments in the financial situation or other financial figures or statistical data contains such forward-looking statements. The Company advises forward-looking investors not to place undue reliance on these forward-looking statements as a guide to future events. The Company does not undertake, and shall not be liable in any manner whatsoever, to update any forward-looking statements, which speak only as of the date of their publication.

Epigenomics AG Reports on New Micro-Simulation Study Results Published in Cancer Medicine Indicating That Epi proColon Provides Clinically Meaningful Reductions in Incidence and Mortality of Colorectal Cancer

• Adherence rates and screening intervals recognized as decisive elements of successful screening strategies

Berlin (Germany), 29 November, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), today reported on micro-simulation model results indicating that Epi proColon(R), a colorectal cancer (CRC) screening test approved for patients who are unwilling or unable to be screened by the United States Preventive Services Task Force (USPSTF) recommended methods, provides clinically meaningful reductions in the incidence and mortality of CRC comparable to those of USPSTF currently recommended methods. The micro-simulation model, developed and validated at Harvard Medical School, evaluated the impact of adherence rates, testing intervals and clinical performance of different screening strategies on CRC incidence and mortality. Results show that adherence rates and screening intervals can have a profound impact on the effectiveness of screening strategies as compared to one-time sensitivity and/or specificity. The study has been published in Cancer Medicine.¹

“While colonoscopy-based screening for CRC offers the highest sensitivity of all available screening strategies, the results of this micro-simulation model demonstrate that patient adherence and prescribed screening intervals heavily influence the long-term clinical effectiveness for all CRC screening strategies,” said Daniel Sussman, MD, University of Miami Miller School of Medicine and an author on the publication. “Evaluating an environment where realistic colonoscopy adherence rates are less than 70% and the recommendation exists for ten-year intervals between colonoscopy screenings for individuals with average CRC risk, the findings of this study suggest that stool- and blood-based CRC screening strategies with higher adherence and considerably shorter intervals offer competing options to patients and clinicians in an effort to reduce CRC incidence and mortality. CRC is a disease that is largely preventable when detected and treated early.”

The study was conducted using an individual-level model to simulate the natural history of CRC and enables comparison of clinical benefits, harms, and burden of alternative strategies for CRC screening. The model was validated by comparison of predicted CRC incidence and mortality, adenoma dwell times, overall dwell times and lifetime risk of developing CRC with results from two large randomized controlled trials^2,3 and those of the National Cancer Institute’s Cancer Intervention and Surveillance Modeling Network (CISNET) models.⁴

The model used a hypothetical cohort of individuals aged 50 years or older and emulated the distribution of baseline characteristics for subjects in the landmark clinical studies. Identical cohorts were then created and assigned to different screening strategies in order to compare intervention-related differences in outcomes. The strategies and intervals summarized in the table below were analyzed under two scenarios: 1) adherence fixed at 100%; 2) adherence based on published rates. Sensitivity analyses based on varying initial and resulting overall adherence rates were also conducted.
 

Key findings from the study include:

• Assuming an adherence rate of 100%:
• FIT-DNA, FIT, HS-gFOBT, and SEPT9 averted 42-45 CRC cases and 25-26 CRC deaths
• COL averted 46 cases and 26 deaths
• CTC averted 39 cases and 23 deaths and FS averted 32 cases and 19 deaths per 1,000 individuals screened
• Estimated LYG were similar across FIT-DNA, FIT, HS-gFOBT, SEPT9, CTC, and COL strategies
• Based on reported adherence of eligible individuals to CRC screening, per 1000 individuals screened, colonoscopy produced the best outcomes unless a non-invasive method achieves a 65% – 70% or greater adherence rate
• Screening individuals with COL every ten years or SEPT9 every year (assuming reported adherence rates) resulted in more favorable outcomes compared to all other strategies (see figure below)
• The impact of analytic performance on screening outcomes is heavily influenced by adherence rates and screening interval

“The key take away from this study is that Epi proColon done annually can serve as an effective non-invasive CRC screening strategy that can provide long-term benefits similar to those of other currently recommended CRC screening methods with harms lower than those reported for colonoscopy. Most importantly, however, as stated by the authors, even for tests with the highest accuracy, such as colonoscopy, the benefit of screening could be muted by a suboptimal uptake and therefore we agree with many experts in the field in saying that the best test is the one that gets done,” said Dr. Jorge Garces, President and Chief Scientific officer at Epigenomics AG.

“We hope that this study will spur discussion within the gastroenterology community and between physicians and their patients about how to best deploy all available screening strategies to reduce CRC incidence and deaths and improve patient outcomes,” said Greg Hamilton, CEO at Epigenomics AG.

About Colorectal Cancer (CRC)

Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new colorectal cancer cases and about 76% of colorectal cancer deaths and costs. Approximately $18 billion is spent annually on this preventable disease. Over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed.

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods. It is a qualitative, in vitro diagnostic blood test for CRC that uses real-time PCR to detect methylation of a target DNA sequence within the Septin 9 gene promoter; methylation of this DNA sequence is associated with the occurrence of CRC and can be detected in cell-free DNA that circulates in the plasma.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

Epi proColon is recipient of the 2019 Excellence in Molecular Diagnostics by Corporate LiveWire’s Innovation and Excellence Awards.

For more information on Epi proColon, visit www.epiprocolon.com.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

References

¹ Dandrea A, Ahnen DJ, Sussman DA and Najafzadeh M. Quantifying the impact of adherence to screening strategies on colorectal cancer incidence and mortality. Cancer Medicine 2019.

² Atkin WS, Edwards R, Kralj-Hans I, et al. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. The Lancet 2010; 375(9726): 1624-33.

³ Schoen RE, Pinsky PF, Weissfeld JL, et al. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. New England Journal of Medicine 2012; 366(25): 2345-57.

⁴ Joseph DA, King JB, Richards TB, Thomas CC, Richardson LC. Peer Reviewed: Use of Colorectal Cancer Screening Tests by State. Preventing chronic disease 2018; 15.

Contact

Epigenomics U.S.
David Bull
Director of Marketing
Phone: 858.429.6199
David.Bull@Epigenomics.com

Contact Epigenomics AG
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BRAIN AG: New Chairman of the Management Board – Adriaan Moelker takes over from
Dr Jürgen Eck

The Supervisory Board of BRAIN AG has appointed Mr. Adriaan Moelker to the Management Board with effect from 1 February 2020 and appointed him as the future Chairman of the Board (CEO). Dr Jürgen Eck, co-founder of BRAIN, Chief Technology Officer (CTO) for around 26 years as well as CEO since 1 August 2015, will resign from the Management Board on 31 December 2019 and will leave the company by mutual agreement. Dr Eck will remain available to BRAIN as a consultant.

Adriaan Moelker has more than 20 years of professional experience in industrial biotechnology. He is currently Divisional President for Image Transfer Solutions and a member of the Flint Group Executive Management Team. Previously, the native Dutchman was CEO of AB Enzymes GmbH in Darmstadt for nine years. The Supervisory Board believes that this change in the Management Board spearheads the next development phase of BRAIN, which will focus on the consistent commercialization of the company’s product and project base.

Notifying Person:

Martina Schuster, Investor Relations

B.R.A.I.N. Biotechnology Research and Information Network AG
Darmstädter Str. 34-36, 64673 Zwingenberg, Germany
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

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