Epigenomics AG Plans to Challenge NCD Decision and Unveils Its Next Generation Liquid Biopsy Test for Colorectal Cancer Screening

• Company evaluating all options to challenge CMS’ decision to non-cover the Epi proColon test
• New blood-based test demonstrates performance characteristics that would satisfy the latest sensitivity and specificity requirements outlined in the final National Coverage Determination (NCD) issued by CMS: Decision Memo for Screening for Colorectal Cancer – Blood-Based Biomarker Tests (CAG-00454N)

Berlin (Germany) and San Diego, CA (USA), January 21, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the management disagrees and is extremely disappointed with the non-coverage decision for Epi proColon as part of the NCD issued by CMS on Tuesday. While the Company was pleased to see the elimination of guideline requirements as part of the final NCD, it was disappointed that CMS chose to retain the concept of performance criteria and a fixed testing interval. Together with several professional societies such as the American Cancer Society, which outlined its concerns as part of the public comment period for the NCD, Epigenomics believes the arbitrary performance criteria in the NCD is in conflict with the scientific evidence. The company is currently evaluating all available alternatives (appeal and/or litigation) to challenge the final decision.

“Randomly selecting sensitivity, specificity, and testing interval values from various tests and assuming it will reduce CRC mortality is not the appropriate way to make evidence-based coverage decisions”, said Greg Hamilton, CEO of Epigenomics AG. “By denying coverage for the only FDA approved blood test at this time, a portion of Medicare beneficiaries will needlessly die of colorectal cancer. This is especially true for underserved populations including minority groups and the impoverished.”

Despite the egregious decision by CMS, the Company will continue to pursue a leadership position in the colorectal cancer screening market and in liquid biopsy technology. Building on its expertise in liquid biopsy and DNA methylation biomarkers, Epigenomics AG has developed and validated a new colorectal cancer screening assay with clinical performance characteristics that meet the coverage criteria outlined in the final NCD.

The interpretive algorithm for this novel assay was trained in a study with 454 samples comprising CRC patients and clinical controls. Clinical performance was then established using a total of 2,504 plasma specimens, including 136 well-characterized colorectal cancer samples, available from two independent clinical screening trials in the average-risk population. This next generation multi-target real-time PCR blood test is based on a new proprietary core DNA methylation technology. The automated assay is highly robust, providing valid results for greater than 99% of samples analyzed, and provides a fast, easy to use and affordable option for detecting CRC in a liquid biopsy.

Greg Hamilton, CEO of Epigenomics AG: “We have been working on this new technology for the past few years and are extremely excited by the data. We look forward to pursuing multiple strategic options with this new assay either as a stand-alone entity or in partnership with other key players in our industry.”
 

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(R), 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), a blood-based test for lung cancer detection, and HCCBloodTest, a blood-based test for liver cancer detection in cirrohtic patients, have received CE mark in Europe.

For more information, visit www.epigenomics.com.
 

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: ir@epigenomics.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any expected results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics 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.

Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients

Final study data intended to support the initiation of Newron’s planned phase III pivotal trial program for evenamide
 

Milan, Italy and Morristown, NJ, USA, January 21, 2021 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the completion of enrollment for its explanatory study 008 with evenamide in patients with schizophrenia.

Results from the four-week, randomized, double-blind placebo-controlled study are expected in March 2021. Explanatory study 008 is designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed doses of evenamide (7.5 mg and 15 mg BID) in outpatients with chronic schizophrenia receiving treatment with one of the leading second-generation atypical antipsychotics. Enrollment to the study has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India.

The US Food and Drug Administration (FDA) requested that Newron complete additional short-term explanatory studies in rats and humans to address concerns from a study of evenamide in rats, and CNS events observed following high-dose administration of evenamide in dogs.

The data from study 008 will be a key component in the package of information to be submitted to the FDA to support the approval of the initiation of Newron’s planned phase III pivotal trial program for evenamide. Preclinical results confirming absence of toxicity have already been submitted to the FDA to support this package.

The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment-resistant schizophrenia.

Newron is currently evaluating potential options for partnering/co-developing the further development of evenamide.
 

About evenamide
Evenamide has the potential to be first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. The compound is an orally available New Chemical Entity that specifically targets voltage-gated sodium channels for the treatment of schizophrenia. Evenamide originates from Newron’s ion channel program and has a unique mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. It normalizes glutamate release induced by aberrant sodium channel activity. In a Phase IIa clinical study, Newron demonstrated evenamide’s evidence of efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. The study also indicated that evenamide is devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics.
 

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

For more information
Newron
Stefan Weber – CEO
+39 02 6103 46 26
pr@newron.com

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

Switzerland
Martin Meier-Pfister, IRF
+41 43 244 81 40
meier-pfister@irf-reputation.ch

Germany/Europe
Anne Hennecke/Caroline Bergmann, MC Services
+49 211 52925220
newron@mc-services.eu

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

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

Press release

The Zur Rose Group accelerates growth

– Revenue up 23.6 per cent in fourth quarter and 14.4 per cent in the full year 2020

– Growth in all markets accelerates quarter on quarter

– Number of active customers across the group rises to 10.5 million

– DocMorris to become the umbrella brand for the European healthcare ecosystem

– DocMorris+ healthcare platform and launch of the app represent strategic milestones

– Digital healthcare platform of Zur Rose Group, Allianz Care, CSS and Visana sets new standards in Swiss healthcare

– 2020 profit outlook confirmed

The Zur Rose Group exceeded its ambitious growth targets for 2020. Revenue rose sharply to CHF 1,751.9 million (including Medpex and Apotal^[1]). This is equivalent to growth of 14.4 per cent in local currency terms. The fourth quarter of 2020 saw growth accelerate to 23.6 per cent year on year in local currency terms with revenue of CHF 506.7 million, well ahead of the previous quarter (July to September). By the end of 2020 the number of active customers^[2] had risen by more than 50 per cent year on year to 10.5 million, a gain of 700,000 on the quarter.

Considerable growth in all markets
The Group saw a sharp year-on-year rise in revenue in the fourth quarter in all markets. In Germany, revenue (including Medpex and Apotal) was up 29.8 per cent in local currency terms. For the year as a whole, growth was 16.5 per cent in local currency terms. In the Swiss home market Zur Rose increased revenue by 10.0 per cent in the fourth quarter and 7.1 per cent in the full year, a growth rate well in excess of the market. The marketplace business in the Europe segment also grew strongly, with revenue rising 60.3 per cent in local currency terms in the fourth quarter. Over the year as a whole, growth was 73.5 per cent, with a peak seen during the lockdown in spring 2020.

DocMorris is the umbrella brand for the Zur Rose healthcare ecosystem
The Zur Rose Group is moving step by step from being a pure mail-order pharmacy to Europe’s digital healthcare ecosystem. The first key building blocks of the ecosystem are the telemedicine provider TeleClinic acquired in 2020 and the cooperation with Novo Nordisk announced in January 2021 to improve the health journeys of people with obesity. The Zur Rose Group is emphasising this strategic orientation with a new brand architecture: DocMorris, the best known pharmacy brand in Germany, will be the umbrella brand for the intended European healthcare ecosystem. As a first step in implementing the new brand architecture, the DocMorris pharmacy and the DocMorris+ healthcare platform in Germany have adopted a new brand identity with a green heart as icon and a symbol for health. The varying shades of green for the heart reflect the variety of current and future services, which can be made even more convenient, personal and individual thanks to digitalisation: advice, drug therapy safety, chronic patient care, electronic prescriptions and medication plans. The new brand and its visual design with all its variants will be launched and adopted in stages in all core markets except Switzerland by 2026.

DocMorris advertising film achieves over 147 million views around the world
The new brand identity of DocMorris got off to an emotional start when the Zur Rose Group launched the DocMorris Christmas story “#TakeCare” https://www.youtube.com/watch?v=2N2eSsIWtNI. The ad went live in Germany, Spain, France and Switzerland in early December 2020, and achieved more than 147 million views worldwide, including 28 million views on YouTube, 109 million on Facebook and 10 million on other channels, making it one of the most watched online Christmas videos in the world.

Launch of the DocMorris+ healthcare platform
A new business model and a new era in health care provision in Germany started in December 2020 with the launch of DocMorris+. This platform provides easy and convenient access to all healthcare services in one place – from diagnosis with an online doctor to the drug or healthcare products needed. For the first time, customers can manage their health with a single app. The launch of the DocMorris+ app is a strategic milestone on the path towards an integrated healthcare platform. In the start phase the focus is on the capabilities of the partner network and OTC orders by mail order. As the platform grows, faster delivery options will be available to customers. Once a relevant volume of e-prescriptions has been generated, the tried-and-tested e-prescription module will also be activated.

eHealth-Tec wins tender for the specialist e-prescription service as a partner to IBM
In November 2020 gematik, the software service provider of the German Federal Ministry of Health, awarded the contract for the specialist e-prescription service in Germany to IBM. Zur Rose subsidiary eHealth-Tec is involved in the implementation as a partner to IBM. This was based on the tender by gematik for the “provision of development services, computer centre infrastructure, system hardware and software as part of the launch of e-prescriptions”. eHealth-Tec contributed with its accumulated experience as a systems provider for e-prescription solutions to the IBM bid. The implementation includes supplying the necessary infrastructure and operating and supporting the hardware and software components to be able to process the entire volume of e-prescriptions generated in Germany. The successful participation in the tender reinforces the role played by the Zur Rose Group as a pioneer in systematically introducing electronic prescriptions in Germany.

Online consultations at TeleClinic rise by 500 per cent
Zur Rose subsidiary TeleClinic expanded its position as Germany’s leading telemedicine provider considerably in 2020. The number of consultations carried out over the telemedicine platform grew five-fold year on year. The increased patient demand was primarily due to the coronavirus pandemic and cost-free access for non-private patients for the first time. Thanks to its high quality standards, TeleClinic also secured its position with doctors and patients as the first port of call for digital healthcare. The offering from the Munich-based company made a major contribution towards ensuring healthcare provision across the country in 2020.

“Apps on prescription” appear in digital practices
Since October 2020 doctors in Germany have been able to prescribe not only medicines but also “apps on prescription”. TeleClinic identified the potential of certified digital healthcare applications (DiGa) at an early stage and has developed the DiGa portal as the partner to the digital healthcare system in Germany. This provides doctors with an overview of applications that have been officially approved by the Federal Institute for Drugs and Medical Devices and other information relevant to treatment, giving patients easier access to medical apps. This allows both sides to benefit from the new offering. TeleClinic includes newly approved apps as a matter of priority.

Allianz Care, CSS, Visana and Zur Rose Group launch digital healthcare platform
In November 2020 insurers Allianz Care, CSS, Visana and the Zur Rose Group established a joint venture to operate a comprehensive digital healthcare platform in Switzerland. The independent company sets a new benchmark in Swiss healthcare: it is laying the foundations for digitally supported, integrated care nationwide. The platform helps customers organise their personal healthcare at all stages of treatment. Patients have access to individually tailored, quality-assured healthcare services with a single click. The platform is open to all players in the healthcare sector: insurers, doctors, hospitals, pharmacies and other providers. When officially launched in the Swiss market in the second quarter of 2021 the platform will offer easy interactive access to healthcare for all Swiss residents. The core contribution by the Zur Rose Group will be to contribute some of the technology for the platform. Parts of the Zur Rose platform will be licensed to the joint venture for this purpose. Completion and market entry are subject to approval by the relevant competition authorities.

Zur Rose increases market presence in French-speaking Switzerland
In December 2020 joint venture partners Zur Rose and Medbase, the Migros healthcare provider, opened their first shop-in-shop pharmacy in the Migros supermarket in Crissier in the canton of Vaud. Zur Rose is also keen to use its presence to boost the activities of its online pharmacy business in French-speaking Switzerland. The expansion of the online market presence was accompanied by an extensive marketing campaign which saw unprompted brand familiarity in French-speaking Switzerland almost double to 26 per cent.

Outlook
The Zur Rose Group confirms the profit forecast for 2020: the expectation is to break even at the adjusted EBITDA level before expenditure on additional growth initiatives, especially in electronic prescriptions and European opportunities. From this year onwards the Group expects considerable growth in prescription drugs and confirms the medium-term revenue outlook of more than CHF 3 billion. The medium-term EBITDA margin target, adjusted for growth initiatives, is around 8 per cent. The introduction of mandatory electronic prescriptions from 2022 and the implementation of the healthcare ecosystem are also creating relevant potential for revenue and profit.

The Annual Report 2020 will be published on 18 March 2021.
The Zur Rose Group is planning to hold a Capital Markets Day in the second quarter of 2021. The precise date and agenda will be announced at a later date.

The elimination of revenue between markets and business models is not shown separately.

Investors and analyst contact
Christoph Herrmann, Head of Investor Relations
Email: ir@zurrose.com, phone: +41 58 810 11 49

Media contact
Lisa Lüthi, Head of Group Communications
Email: media@zurrose.com, phone: +41 52 724 08 14

Agenda
18 March 2021 2020 Full-Year Results
20 April 2021 First Quarter Trading Update
29 April 2021 Annual General Meeting
19 August 2021 Half-Year Results
21 October 2021 Q3 Trading Update

Zur Rose Group

The Swiss Zur Rose Group is Europe’s largest e-commerce pharmacy and one of the leading medical wholesalers in Switzerland. It also operates the leading marketplace in southern Europe for consumer health, beauty and personal care products commonly sold in pharmacies. The company is internationally present with strong brands, including Germany’s best-known pharmacy brand DocMorris. Zur Rose employs more than 1,800 people at sites in Switzerland, Germany, the Netherlands, Spain and France. In 2020 it generated revenue of CHF 1,752 million (including Medpex and Apotal) and currently has 10.5 million active customers in core European markets.

With its business model, the Zur Rose Group offers high-quality, safe and cost-effective pharmaceutical care. It is also characterized by the continuous further development of digital services in the field of drug management using AI-supported applications and new technology. Zur Rose is furthermore actively driving ahead its positioning as a comprehensive provider of healthcare services. By creating a digital healthcare platform – the Zur Rose ecosystem – it networks products and digital services from qualified providers. The contribution made by Zur Rose will be to take these offerings to customers and patients and to make a relevant selection. The aim is to provide people with a seamless accompaniment and empower them to manage their own health optimally using products and digital solutions.

The shares of Zur Rose Group AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker ROSE). For further information please see zurrosegroup.com.

^[1] As the separation of the mail-order business has not yet been completed, Medpex and Apotal had only a minor impact on the consolidated revenue of the Zur Rose Group.
^[2] Customers supplied by the Zur Rose Group, either directly or through its partners.

Relief Announces Implementation of New Share Subscription Facility with Main Shareholder GEM

Geneva, Switzerland, January 21, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief” or the “Company“), a biopharmaceutical company with its lead compound RLF-100^TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, today announced that it has signed a binding agreement with the Company’s main shareholder GEM Global Yield LLC SCS (“GEM“) for the implementation of a new Share Subscription Facility (“SSF“) in the amount of up to CHF 50 million. GEM is Relief’s longest standing shareholder, dating back to their initial investment in 2015, and currently owns over 1.3 billion shares of Relief common stock.

Under the terms of the SSF, Relief has the right to periodically, during a timeframe of up to three years, issue and sell shares to GEM. Under the facility, GEM undertakes to subscribe to or acquire ordinary registered RELIEF THERAPEUTICS Holding AG shares upon Relief’s exercise of a draw down notice. In accordance with the customary terms of the SSF agreement, Relief will control the timing and maximum amount of any draw down, and retains the right, not the obligation, to draw down on the full commitment amount. Future subscription prices under the SSF will correspond to 90% of the average of the closing bid prices on the SIX Swiss Exchange during the reference period, which corresponds to 15 trading days following Relief’s draw down notice.

Proceeds from the SSF drawdowns will be used to produce commercial quantities of RLF-100^TM (aviptadil) and acquire additional assets to expand and diversify Relief’s drug pipeline.

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: “Establishing a new SSF underlines GEM’s commitment to and faith in Relief. This facility gives us increased flexibility to meet anticipated demand, should RLF-100^TM show positive results in the ongoing trial in critical COVID-19 patients and gain marketing authorization. It also enables us to move quickly, should we have opportunities to build our pipeline.”

“This additional financial commitment represents our support for Relief’s plans to build the Company, as well as our dedication to the battle against COVID-19. As worldwide cases have soared to over 77 million, it is clear that new therapeutic options are urgently needed, especially for very sick patients. We believe that Relief is uniquely positioned to address COVID-19 induced lung injury as well as provide an important key to treating other respiratory illnesses,” commented Chris Brown, Founder and Director of GEM.

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ABOUT RELIEF
Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100^TM (Aviptadil), synthetic vasoactive intestinal peptide (VIP), is being developed in collaboration with NeuroRx, Inc. and is currently being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. RLF-100^TM is believed to be the first COVID-19 therapeutic to demonstrate the ability to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung. Since July 2020, severe COVID-19 patients have been treated with RLF-100^TM under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100^TM.

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.

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Data published in Molecular Diagnostics & Therapy demonstrate how Secarna’s powerful bioinformatics generate improved LNA-modified antisense oligonucleotide therapies

• Antisense oligonucleotide (ASO)-based therapeutics have evolved as a fully accepted therapeutic modality, next to small molecules and therapeutic antibodies
• During the drug candidate selection process, RNA-sequencing combined with bioinformatic screens could provide a valuable tool to assess ASO-mediated off-target effects
• Data from RNA-sequencing experiments will guide the selection process of ASO sequences to generate drug candidates with an improved target to off-target profile and therefore enable the generation of potent and safe drugs

Munich/Martinsried, Germany, January 20, 2020 – Secarna Pharmaceuticals GmbH & Co. KG (“Secarna”), a biopharmaceutical company focusing on the discovery and development of next generation antisense oligonucleotide (ASO) therapies to address challenging or previously undruggable targets via its LNAplus^TM platform, today announced the publication of data on the role of bioinformatic screening in the process of generating and selecting ASOs. The data were published in Molecular Diagnostics & Therapy and the findings support the development of more efficient and safer ASO-based therapeutics. The article, “Using RNA-seq to assess off-target effects of antisense oligonucleotides in human cell lines” is available here: https://rdcu.be/cb7d4

In this study, Secarna selected two 17-mer ASOs to be analyzed for off-target effects in distinct human cell lines by a whole-transcriptome study using RNA sequencing. Experimentally determined analysis of gene expression combined with in silico prediction tools, allows Secarna to calibrate bioinformatics criteria for ASO sequence selection and to generate LNA-gapmer ASOs with improved target to off-target profiles, thereby reducing the risk for off-target-mediated toxicities to support the development of safer ASO-based therapeutics.

“The field of antisense oligonucleotides therapeutics is rapidly growing, and oligonucleotide-based gene expression modifiers have developed as fully accepted therapeutics next to small molecules and therapeutic antibodies,” said Jonas Renz, Managing Director and Co-founder of Secarna Pharmaceuticals. “Our recently published data offer compelling insights into the benefits of bioinformatic screening in the process of selecting ASOs. Thorough in silico screens using our proprietary Oligofyer^TM platform, which is constantly improved using RNA sequencing data reduces the risk for ASO-mediated off-target RNA suppression, providing for safer ASO-based therapeutics and preventing candidates with a poor specificity profile from entering advanced testing.”

About Secarna’s proprietary drug discovery platform, LNAplus^TM

For discovering, testing and selecting antisense oligonucleotides (ASOs) for pre-clinical and clinical development, Secarna employs its proprietary, customized LNAplus^TM drug discovery platform. LNAplus^TM encompasses all aspects of drug discovery and pre-clinical development and has proven to be fast, reliable, scalable, efficient and to provide for a uniquely integrated workflow, enabling the discovery of novel antisense-based therapies for challenging or currently undruggable targets. The platform includes the powerful proprietary Oligofyer^TM bioinformatics pipeline,a streamlined, high efficiency screening process including our proprietary LNA-Vit(r)ox^TM safety test system as well as target-specific functional assays. Secarna’s platform and ASOs have been validated by numerous in-house projects as well as in several academic and industry collaborations.

About Secarna Pharmaceuticals GmbH & Co. KG

Secarna Pharmaceuticals is the next generation antisense oligonucleotide (ASO) company addressing high unmet medical needs in the areas of immuno-oncology, immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna’s mission is to maximize the performance and output of its proprietary LNAplus^TM antisense oligonucleotide discovery platform, as well as to develop highly specific, safe, and efficacious best-in-class antisense therapies for challenging or currently undruggable targets. With over 15 development programs focusing on targets in indications where antisense-based approaches have clear benefits over other therapeutic modalities, Secarna is the leading European antisense drug discovery and development company. www.secarna.com

Contact

Jonas Renz
Managing Director and Co-founder
Jonas.Renz@secarna.com

Secarna Pharmaceuticals GmbH & Co. KG
Am Klopferspitz 19
82152 Planegg/Martinsried
Tel.: +49 (0)89 215 46 375

For media enquiries:

Anne Hennecke/Vera Lang
MC Services AG
secarna@mc-services.eu
Tel.: +49 (0)211.52 92 52 22

Relief and AdVita Sign Binding Term Sheet for Relief to Acquire All Shares of AdVita to Expand Scope of Development of Inhaled Formulation of Aviptadil

Geneva, Switzerland, and Gundelfingen, Germany, January 20, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) (“Relief“), a biopharmaceutical company with its lead compound RLF-100^TM (Aviptadil) in advanced clinical development to treat severe COVID-19 patients, and AdVita Lifescience GmbH (“AdVita“), a Germany-based, privately held pharmaceutical company developing effective products and strategies to improve the treatment and diagnosis of rare lung diseases, today announced the companies have signed a binding term sheet for Relief to acquire all shares of AdVita in exchange for EUR 25 million of Relief common shares, plus possible future contingent milestone payments of up to EUR 20 million. The closing of the transaction is subject to customary closing conditions as well as legal and securities regulatory approvals and is expected to occur in Q2 2021.

Amongst the AdVita assets being acquired in this transaction, Relief will gain further pending intellectual property rights that may cover RLF-100^TM inhaled formulation specificationsand the potential application of inhaled Aviptadil in the treatment of Acute Respiratory Distress Syndrome (ARDS) and Checkpoint Inhibitor-induced Pneumonitis (CIP).

“AdVita’s intellectual property around inhaled formulations of Aviptadil and its team’s expertise with Aviptadil will be invaluable as we move forward with the development of the inhaled formulation of RLF-100(TM) for the treatment of COVID-19-related ARDS, as well as other potential lung disease indications, such as pulmonary Sarcoidosis and Chronic Beryllium Disease,” said Jack Weinstein, CFO and Treasurer of Relief. “We look forward to initiating the development of inhaled RLF-100(TM) in Europe within the coming months for COVID-19 patients using inhaled Aviptadil. Furthermore, we plan to re-start a clinical development program for RLF-100^TM in pulmonary Sarcoidosis later this year.”

Under the terms of the agreement, Relief will advance a EUR 2 million convertible secured loan to AdVita. The first tranche of EUR 1 million will be advanced concurrent with the execution of the binding term sheet and the second tranche of EUR 1 million upon the successful conclusion of Relief’s phase 2b/3 clinical trial of intravenous RLF-100^TM in the treatment of critical COVID-19 patients with respiratory failure. Top-line data from this trial are expected at the end of January or early February of this year.

Dorian Bevec, Ph.D., CSO of AdVita, commented: “We are excited to combine our specific expertise in inhaled formulations of Aviptadil with Relief’s comprehensive scientific catalog of the compound and its uses in respiratory diseases.”

###

ABOUT RELIEF

Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100^TM (Aviptadil), synthetic vasoactive intestinal peptide (VIP), is being developed in collaboration with NeuroRx, Inc. and is currently being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. RLF-100^TM is believed to be the first COVID-19 therapeutic to demonstrate the ability to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung. Since July 2020, severe COVID-19 patients have been treated with RLF-100^TM under U.S. FDA Emergency Use Investigational New Drug (IND) authorization and Expanded Access Protocol authorization for the treatment of respiratory failure in COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100^TM.

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.

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ABOUT ADVITA LIFESCIENCE GMBH

AdVita Lifescience GmbH was founded in 2019 with the purpose of developing effective products and strategies to improve the therapy and diagnosis of rare lung diseases.

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its business. 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.

U.S. Centers for Medicare & Medicaid Services publish negative NCD for Epi proColon

Berlin, January 19, 2021 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the U.S. Centers for Medicare & Medicaid Services (CMS) have issued a negative reimbursement decision in connection with the National Coverage Determination (NCD) of Epi proColon, Epigenomics’ blood test for colorectal cancer screening. The Company is currently evaluating options for an appeal, litigation and/or other alternatives to achieve Medicare coverage.
 

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, e-mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, e-mail: ir@epigenomics.com

Forward-Looking Statements

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any expected results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics 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.

Antisense oligonucleotide candidate derived from Secarna Pharmaceuticals’ LNAplus^TM platform has entered pre-clinical safety trials for the treatment of elevated blood lipids

• Secarna’s partner Lipigon has selected an LNAplus^TM ASO candidate targeting ANGPTL4, called Lipisense, which has shown unique efficacy in reducing lipid triglycerides in experimental disease models and is now entering pre-clinical safety development
• High levels of plasma lipids triglycerides are associated with a plethora of lipid-related diseases with yet unmet clinical treatment needs

Munich/Martinsried, Germany, January 19, 2021 – Secarna Pharmaceuticals GmbH & Co. KG (“Secarna”), a biopharmaceutical company focusing on the discovery and development of next generation antisense oligonucleotide (ASO) therapies to address challenging or previously undruggable targets via its LNAplus^TM platform, today announced that the company’s partner Lipigon Pharmaceuticals AB has selected a candidate drug (Lipisense) to treat elevated levels of plasma lipid triglycerides. The candidate is being developed for patients suffering from severe hypertriglyceridemia as well as the rare disease Familial Chylomicronemia Syndrome (FCS), diseases that may lead to painful and potentially life-threatening syndrome acute pancreatitis.

Lipisense, an antisense oligonucleotide (ASO) which has been developed with Secarna’s proprietary LNAplus^TM platform, is a first-in-class treatment with a novel mechanism of action central for the regulation of plasma triglycerides and other plasma lipids. The drug candidate hinders the cellular production of ANGPTL4, a protein that has a direct role in lipid metabolism by blocking the clearance of triglycerides. The protein has been associated with tumour progression and has shown a strong genetical validation and correlation with harmful plasma lipids and the associated diseases. By hindering the production of ANGPTL4 in the liver by specifically targeting its protein-coding RNA, Lipisense has great potential for the treatment of lipid-related diseases.

The LNAplus^TM ASO-based drug candidate has shown strong efficacy in experimental disease models and a good safety profile in preliminary safety studies. Lipigon will now continue preclinical development with IND enabling studies; CMC activities have commenced.

Jonas Renz, Managing Director and Co-founder of Secarna Pharmaceuticals, said: “We are excited for our partners at Lipigon to have identified an ASO-based candidate drug derived from our proprietary LNAplus^TM plattform as a first-in-class drug for the treatment of lipid-related diseases. We congratulate the team on entering into pre-clinical safety trials, as together we aim to provide a new line of treatment for patients with severe life-threatening diseases.”

Stefan K. Nilsson, CEO and Co-founder of Lipigon, said: “Choosing a candidate drug in our front runner project Lipisense is a major step for Lipigon. The unique mechanism of action opens the possibility for an attractive clinical development path where we can address both smaller indications, which do not require extensive clinical studies, and larger indications, which are more suitable for big pharma development. We are looking forward to continuing the preclinical safety development of Lipisense.”

About Secarna’s proprietary drug discovery platform, LNAplus^TM

For discovering, testing and selecting antisense oligonucleotides (ASOs) for pre-clinical and clinical development, Secarna employs its proprietary, customized LNAplus^TM drug discovery platform. LNAplus^TM encompasses all aspects of drug discovery and pre-clinical development and has proven to be fast, reliable, scalable, efficient and to provide for a uniquely integrated workflow, enabling the discovery of novel antisense-based therapies for challenging or currently undruggable targets.The platform includes the powerful proprietary Oligofyer^TM bioinformatics and LNA Vit(r)ox^TM screening system for best-in-class high volume screening, and target-specific functional assays. Secarna’s platform and ASOs have been validated by numerous in-house projects as well as in several academic and industry collaborations.

About Secarna Pharmaceuticals GmbH & Co. KG

Secarna Pharmaceuticals is the next generation antisense oligonucleotide (ASO) company addressing high unmet medical needs in the areas of immuno-oncology, immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna’s mission is to maximize the performance and output of its proprietary LNAplus^TMantisense oligonucleotide discovery platform, as well as to develop highly specific, safe, and efficacious best-in-class antisense therapies for challenging or currently undruggable targets. With 13 in-house development programs and 10 partnered programs focusing on targets in indications where antisense-based approaches have clear benefits over other therapeutic modalities, Secarna is the leading European antisense drug discovery and development company. www.secarna.com.

About Lipigon Pharmaceuticals

Lipigon are lipid biology experts focusing on developing novel therapeutics for patients with lipid- related disorders. The company is a spin-off from Umeå University, Sweden, based on five decades of lipid research. Our primary focus is orphan lipid disorders and in addition to the ANGPTL antisense program, Lipigon’s pipeline, including a project for gene therapy treatment of lipodystrophy. This program is partnered with Combigene AB (publ). www.lipigon.se.

Contact

Jonas Renz
Managing Director and Co-founder
Jonas.Renz@secarna.com

Secarna Pharmaceuticals GmbH & Co. KG
Am Klopferspitz 19
82152 Planegg/Martinsried
Tel.: +49 (0)89 215 46 375

For media enquiries:

Anne Hennecke/Vera Lang
MC Services AG
secarna@mc-services.eu
Tel.: +49 (0)211.52 92 52 22

Kleinostheim, Germany / Wake Forest, NC, USA – 19 January 2021

As of January 1, 2021, Dirk Dembski is heading curasan AG as Chief Executive Officer. The company, based in the metropolitan region of Frankfurt am Main, Germany, is a leading provider of medical solutions for regenerative bone healing, osteoarthritis therapy and hemostasis in the Dental and Orthopaedics field. The appointment of the new CEO sets the course for technology-based and sales-oriented growth.

Dirk Dembski is to put curasan AG on the road to success after the recent change of ownership. He builds on many years of experience in biotechnology and the medical device sector, including positions as Managing Director at Chinese Naton Medical Group, as Vice President Sales & Marketing at Olympus Biotech and as a member of the Supervisory Board at Bone Therapeutics SA.

“The products of curasan AG have been known and appreciated for decades by medical professionals around the globe for their quality and effectiveness. When it comes to regeneration of musculoskeletal and dental defects as well as pain management, we are among the first points of contact. Our next step will be to fill gaps in our portfolio in the short term with complementary, disruptive and innovative products. At the same time, we are working on solutions to revolutionize musculoskeletal healing. Our stated goal is to help the body to heal itself instead of making medical repairs as is common today. Meanwhile, we are also enlarging our international footprint and invest in our brand awareness with a dedicated marketing and sales approach at all touchpoints with all stakeholders.”, Dembski summarizes the curasan strategy.

Alexander Baratta, previously interim CEO and future Chairman of the Supervisory Board adds: “We are delighted to have been able to attract Dirk Dembski to our company. He brings both, the personal and professional qualifications to successfully drive curasan’s growth.”

Press contact at curasan AG:
Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
pr@curasan.com
www.curasan.com

About curasan AG:
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in Wake Forest, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide.