Archive: Company News

Company News: Curetis Acquires Patents and Rights to Genetic Antibiotic Resistance and Susceptibility (GEAR) Database and Know-How from Siemens

– Agreement gives Curetis worldwide rights to database and IP based on Next Generation Sequencing

– GEAR significantly enhances Curetis’ leading position in the area of genetic antimicrobial resistance biomarker testing

Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the signing of an asset acquisition agreement with the Siemens Technology Accelerator GmbH (STA). Under the terms of the agreement, Curetis has acquired sole commercial rights from STA to the GEAR GEnetic Antibiotic Resistance and Susceptibility platform and database with all its content, numerous GEAR-related patents and patent applications, as well as all corresponding know-how. The deal gives Curetis sole worldwide product development and commercial rights, including the right to sublicense in the fields of human and animal diagnostics as well as food safety testing. Furthermore, Curetis has secured the sole rights to leverage the GEAR assets in collaboration with pharmaceutical companies for the development of novel antimicrobial drugs for human and animal health.

As consideration for these assets, STA will receive an undisclosed upfront payment from Curetis. Furthermore, Curetis will make undisclosed milestone payments for products including GEAR biomarkers upon first CE IVD marking and first FDA approval (or similar regulatory clearance), respectively. Also, there will be royalty payments to STA in industry-typical percentage ranges on future products based on use of the GEAR platform or GEAR biomarkers. Further financial details were not disclosed.

The state-of-the-art GEAR bioinformatics platform and database was developed and compiled in collaboration with two academic partners: The Institute of Clinical Molecular Biology (IKMB) at Kiel University that carried out the next generation sequencing (NGS) of bacterial isolates and the Clinical Bioinformatics Group of Saarland University headed by Prof. Dr. Andreas Keller that developed the bioinformatics platform and performed the computational analysis of 30 Terabyte of data underlying the GEAR database. GEAR allows users to assemble and annotate bacterial genomes from NGS raw data, identify genetic variations in those genomes and correlate those with the response of the respective bacterial strain to antibiotics. Currently, the GEAR database contains the entire DNA sequences as well as sensitivity data for 21 antibiotics of more than 11,000 bacterial strains isolated from patient samples across the world over the last three decades. It will allow Curetis to rapidly identify potential novel biomarkers, biomarker combinations, and algorithms predicting antibiotic resistance, as well as potential novel targets for antimicrobial drugs.

The acquisition of the GEAR database and patent estate adds significantly to the leadership position that Curetis has established in the area of genetic antimicrobial resistance biomarker testing with its Unyvero Application Cartridges. Curetis will further expand and mine the GEAR database in collaboration with leading academic institutions as well as pharmaceutical and diagnostics companies and leverage those into commercial products on its Unyvero Molecular Diagnostics platform and beyond.

“We are thrilled to have won in the competitive bidding process for this unique and exciting asset,” said Dr. Achim Plum, Chief Commercial Officer of Curetis. “With this platform, we are planning to build a network of strong and collaborative relationships with academics, clinicians and companies in the fields of diagnostics and pharmaceuticals alike. We will develop this repository into a valuable resource of antibiotic resistance biomarkers available to the global research community, while leveraging the proprietary nature of GEAR into our own Unyvero products and platform in the future.”

Oliver Schacht, CEO of Curetis, added, “Since our IPO, we have diligently executed on our commercial and product development plans. At the same time, we have kept our eyes open for strategic opportunities such as the GEAR acquisition. GEAR allows us to significantly expand the scale and scope of the Unyvero platform and complement it with NGS-based knowledge. GEAR will become an engine for even more comprehensive and differentiated content of antibiotic resistance biomarkers in our Unyvero products and allow us to stay on top of the development of cutting-edge molecular diagnostic products for critical hospital infections.”

Prof. Keller, one of the initiators of the project, highlighted the broad and unique character of GEAR: “The more than 11,000 whole bacterial genomes collected over three decades and across many countries in combination with culture-based phenotypic resistance profiles against 21 drugs enabled us to investigate multivariate genetic resistance mechanisms in a very comprehensive manner”. Prof. Keller also underlined that Curetis is a perfect partner for commercialization of tests for antibiotic resistance derived from GEAR: “We are convinced of the success of genetic antibiotic resistance tests and committed to support Curetis in their endeavor to improve care for patients suffering from bacterial infections”

 

About the GEAR Database and Assets:

The GEAR database includes genomic data of mostly Gram negative bacteria causing pneumonia, bloodstream infections, urinary tract infections, and gastric and wound infections. Samples were carefully selected across multiple geographies (USA, EU, Asia) and have been collected over three decades to reflect resistance development and variability over time. Sample collection was done at over 200 sites on 5 continents, with over 150 US institutes contributing. In addition to many of the most troublesome Gram negative bacteria, GEAR also includes S. aureus, demonstrating feasibility also for Gram positive bacteria.

Sample collection was designed to achieve significant statistical power with over 10,000 Gram negative bacterial strains and ca. 1,000 S. aureus (both MSSA and MRSA) strains tested. Overall, 21 antibiotic drugs in 182 different concentrations with all modes of action for resistance were tested for. Most commonly used drugs have been chosen by the former Siemens Microbiology Department. Antibiotic susceptibility testing (AST) reference methods as per CLSI (Clinical and Laboratory Standards Institute) guidelines were used and results interpreted according to EUCAST (European Committee on Antimicrobial Susceptibility Testing) guidelines. Seven out of nine combinations of bacteria and antibiotics identified as being of international concern by the WHO were analyzed in detail. Individual patent filings have been made for each bacteria for all antibiotics as well as certain method and process patents.

Next generation sequencing (NGS) was performed at one of the leading German Sequencing Centers (IKMB Institute of Clinical Molecular Biology in Kiel) on HiSeq 2000 and HiSeq 2500 Sequencers with over 300 Mio bases sequenced per sample. Taken together, 4 billion reads with 0.4 trillion bases were sequenced. Advanced bioinformatics approaches developed by the group of Prof. Dr. Andreas Keller, Chair for Clinical Bioinformatics, Saarland University, were employed to combine NGS results with AST data to identify potential novel and proprietary antibiotic resistance biomarkers and biomarker combinations.

GEAR enables a wide range of valuable clinical applications such as better genetic resistance testing for specific drug classes, broader syndromic resistance biomarker panels, and, in the future, potentially fully genetic antibiograms. It therefore can provide unique content for high-, medium-, and low-plexed MDx platforms.

 

Curetis to host conference call and webcast on GEAR acquisition

Curetis will host a public conference call and webcast on September 8, 2016, at 03:00 pm CET / 09:00 am EST to present its asset acquisition agreement with Siemens Technology Accelerator GmbH (STA) announced earlier today. Under the terms of the agreement, Curetis has acquired sole commercial rights from STA to the GEAR GEnetic Antibiotic Resistance and Susceptibility platform and database with all its content, numerous GEAR-related patents and patent applications, as well as all corresponding know-how.

The conference call will be supplemented by a presentation, which can be accessed during the call at http://www.curetis.com/en/investors/background-information.html. The live webcast and a replay will be available at http://curetis080916-live.audio-webcast.com (participants’ passcode curetis0916).

To access the call, please dial the following numbers using the passcode 93120684#

Germany: +49 692 222 290 43

UK: +44 203 009 2452

US: +1 855 402 7766

For further international dial-in numbers, please open the following link: http://events.arkadin.com/ev/docs/International Access Numbers_ UKFELBRI1_SU7.pdf

Company News: Curetis to Launch Next Generation CE-IVD Unyvero Implant and Tissue Infection Application Cartridge

– Launch follows successful completion of CE Performance Evaluation Study

– ITI now covers 102 diagnostic targets, including 85 pathogens and 17 resistance markers

Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the successful completion of the CE Performance Evaluation study of the next generation of its Unyvero ITI Implant and Tissue Infection Application Cartridge (Unyvero ITI).

The new Unyvero ITI comes with an extended panel and increased sensitivity. It will be launched in the third quarter of 2016 as a CE-IVD-marked product in the European direct sales and international distribution markets. Unyvero ITI is designed for the diagnosis of many types of severe infections, including prosthetic joint infections, surgical site infections, catheter-associated infections and skin and soft tissue infections.

The next-generation cartridge now covers a total of 102 diagnostic targets: 85 of the most clinically relevant pathogenic microorganisms, including Gram positive and Gram negative bacteria, several fungi, and 17 related antibiotic resistance markers. Specifically, the next generation ITI cartridge has added a universal bacterial primer, several Candida species, various types of Streptococci, Klebsiella variicola, and other new diagnostic targets. In addition, clinical sensitivity has been significantly improved for many key pathogens. Unyvero ITI is the most comprehensive commercially available panel for this indication area in a cartridge-based sample-to-answer format. The first generation ITI Application Cartridge launched in 2014 covered a total of 80 diagnostic targets.

Sold as a consumable running on the Curetis Unyvero System, the product analyzes many challenging and heterogeneous sample types such as fluids, tissues, swabs and others. It is the second Application Cartridge for the Unyvero System launched in 2016, following the recent launch of the BCU Blood Culture Application Cartridge.

In the performance evaluation study, a total of 1,100 samples were tested with the next generation ITI Cartridge. These included 700 samples positive for microbial growth in the routine work-up of patients.

Final validation results from patient samples demonstrated

  • an overall sensitivity for all pathogens of 86.9% and
  • an overall specificity for all pathogens of 99.2%.

Several customer sites at renowned hospitals in Europe have already agreed to further evaluate the second generation Unyvero ITI product in their clinical routine.

“We are excited to start marketing the new ITI Application Cartridge for our Unyvero Platform,” said Dr. Achim Plum, Chief Commercial Officer of Curetis. “Our development team has done a tremendous job and provided us with an improved, next generation product with higher clinical sensitivity overall, as well as an even broader panel. With more than 100 diagnostic targets covered by the new Unyvero ITI cartridge, we believe we have a solution with the broadest available panel for suspected implant and tissue infections and an unmatched versatility allowing the use of a wide range of routine clinical patient sample types.”

Curetis´ CEO Oliver Schacht, PhD, added, “A key priority for us since the IPO has been the expansion and acceleration of our product pipeline. With the successful validation and launch of the BCU product in Q2 and now the second generation ITI cartridge in Q3, we continue to deliver on key milestones of our equity story outlined at the time of our IPO.”

Company News: Agena Bioscience Names Genelex as Certified Service Provider for Targeted Genetic Analysis

Agena Bioscience today announced the successful certification of Genelex as a Certified Service Provider of the MassARRAY® technology.

The MassARRAY System is used to identify and validate SNPs, INDELs, CNV’s, translocations, somatic mutations, including rare variants, and methylation profiles across a variety of sample types. The flexibility and scalability of the platform facilitate easy development of custom panels and validation across large numbers of samples.

As a Certified Service Provider, Genelex will provide dedicated customer support, customizable assay design, test development and validation across multiple platforms. The laboratory has integrated robotics and secure Laboratory Information Systems to ensure high accuracy, low error, and rapid turnaround on results.

“Certified Service Providers like Genelex enable our customers to perform translational research in a CAP/CLIA environment and receive high quality support and data,” said Marisa Pearce, Sr. Director of Marketing at Agena Bioscience.

Genelex is accredited by the College of American Pathologists; certified under the Clinical Laboratory Improvement Amendments Act; is Washington State Medical Test Site; licensed by the New York Department of Health; compliant with Code of Federal Regulations (CFR) 21 and Health Insurance Portability and Accountability Act (HIPAA) and is licensed to perform high complexity clinical testing in all US states.

Genelex CSO and Lab Director, Tia Aulinskas commented, “From standard testing to customized assays, Genelex provides actionable data with >99% reportable tests. Our team has the knowledge and experience on the MassARRAY System, and the dedication to ensure the accurate and timely delivery of your data.”

Company News: Curetis Reports Financial Results for the First Six Months of 2016

– Key business and commercial milestones and goals met

– Global presence further strengthened with subsidiaries in the U.S., UK, France and the Netherlands

Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today reported its financial results for the first six months ended June 30, 2016, and provided an update on its financial and business guidance for the second half 2016 and beyond.

 

Operational and Business Highlights 2016 to Date

  • In April 2016, Curetis successfully completed the CE performance evaluation study and subsequently launched its Unyvero BCU Blood Culture Application Cartridge during ECCMID 2016 in Amsterdam. The CE-marked BCU Application is designed for diagnosing infections spreading through the blood stream in positively flagged blood cultures. The comprehensive panel covers 87 of the most relevant pathogens, including Gram negative and Gram positive bacteria, and 16 related resistance markers. Interim data from a prospective multicenter evaluation showed 98% concordance with conventional microbiology and Unyvero results were on average available 24 hours earlier than results obtained by routine diagnostic methods.
  • The U.S. FDA trial for the Unyvero LRT Application in lower respiratory tract infections is almost completed. Prospective and retrospective sample enrolment has been successfully concluded on schedule in the first half of 2016. In less than a year, a total number of more than 2,250 samples including approximately 1,700 prospective and over 550 retrospective patient samples, have been enrolled at nine clinical trial sites across the U.S., including, amongst others, Mayo Clinic, Northwestern University, Johns Hopkins Hospital, UCLA and Columbia University Medical Center.
  • Curetis has continued its commercial expansion in both the United States and Europe. In the U.S., the Company has appointed Christopher M. Bernard as President and Chief Executive Officer of the newly-formed North American subsidiary Curetis USA, Inc.. Christopher Bernard is a seasoned executive with significant expertise in sales, marketing and commercialization of in-vitro diagnostic platforms. Prior to Curetis, he has worked in several executive management roles at Epic Sciences, Metabolon, Inc., Abaxis, Inc. and Cytyc Corporation (Hologic, Inc.). At Curetis, he will be responsible for the development of the new subsidiary and will lead the marketing and sales initiatives of Curetis in the U.S..

In Europe, the Company has hired Willem Haagmans as Head of Sales EMEA. He brings a strong track record and extensive leadership experience with both large and small-to-medium sized molecular diagnostics companies. Prior to joining Curetis, he worked as General Manager Benelux at Beckman Coulter. Previously, he held international management positions at Roche, Nimblegen, and Vela Diagnostics.

In addition, the Company has hired key commercial staff in the UK, France and Benelux that is currently on boarded. This new staff will significantly strengthen Curetis´ direct commercial footprint and position the Company to accelerate new Unyvero installations in these key markets.

Curetis has also established wholly owned sales subsidiaries in the UK in May and in the Netherlands for the Benelux area in June and is in the process of setting up an additional subsidiary in France.

  • In June 2016, the Company signed an exclusive, three-year distribution agreement with Axon Lab AG for Curetis’ Unyvero products in Central and Eastern European countries, including Austria, the Czech Republic, Slovakia, Slovenia and Croatia.
  • The Company is in the final stage of completing the development of a second-generation Unyvero ITI Application Cartridge and is progressing the development of its IAI Intra-Abdominal Infection Cartridge. In addition, the partnered Sepsis Host Response program is progressing according to plan.
  • Curetis has continued to expand the installed base of Unyvero Analyzers to 113 as of June 30, 2016 (vs. 70 instruments as of June 30, 2015).
  • During the Annual Shareholder Meeting held on June 16, 2016, Dr. Prabhavathi Fernandes, CEO of Cempra Pharmaceuticals Inc., Chapel Hill, NC, USA, has been elected as a member of the Curetis N.V. Supervisory Board. Dr. Prabhavathi Fernandes has profound knowledge in infectious diseases and antibiotics as well as experience in successfully founding, building and leading several biotech companies and taking one public on Nasdaq, raising more than half a billion U.S. dollars. Moreover, Dr. Holger Reithinger and Dr. Rudy Dekeyser were re-elected for another one-year term, respectively. In addition, the proposed resignation of Dr. Frank Muehlenbeck, the creation of a new Stock Option Program for the Company and associated changes to the Supervisory Board remuneration policy as well as changes to the Management Board’s Remuneration Policy and Stock Option grants were also approved by the shareholders.
  • Additionally, Curetis has established a Medical Advisory Board with experts from the US (Robin Patel, MD, Mayo Clinic), Belgium (Jean-Louis Vincent, MD, Erasme University Hospital), Switzerland (Reno Frei, MD, University Hospital Basel, as well as Laurent Poirel, MD, University of Fribourg), and Germany (Mathias Pletz, MD, Jena University Hospital). The advisors bring strong expertise in intensive care, clinical microbiology, sepsis, prosthetic joint infections, and antibiotic resistance.

Financial Highlights, First Half-Year 2016

  • Revenues: EUR 655 thousand (vs. EUR 742 thousand in the first half-year of 2015).
  • Gross loss: EUR 9 thousand (vs. a gross profit of EUR 77 thousand in the first half-year of 2015).
  • Net cash burn in the first half-year 2016 was EUR 6.4 million.
  • Expenses: EUR 7.5 million (vs. EUR 6.4 million in the first half-year of 2015).
  • Net loss: EUR 6.7 million (vs. EUR 12.4 million in the first half-year ended June, 30 2015).
  • Cash and cash equivalents: EUR 39.7 million as of June 30, 2016 (vs. EUR 46.1 million as of December 31, 2015).

 

Anticipated Milestones

  • For the U.S. FDA trial with the Unyvero LRT Application in lower respiratory tract infections, Curetis targets completion of the contrived specimen study, molecular composite comparator testing for all samples and ancillary preclinical work packages in the second half of 2016, with top line data expected to be available after un-blinding.
  • The submission of Curetis´ (de novo) 510(k) data package to the U.S. FDA is anticipated by year-end 2016 with the goal of achieving FDA clearance for Unyvero and starting commercialization in the first half of 2017.
  • The Company has begun preparing to enter U.S. FDA trials for its next U.S. product. To that end, Curetis has already submitted a so-called pre-submission package to the U.S. FDA in which the Company has outlined the intended use claims and a proposed study design for a U.S. version of its Unyvero ITI Cartridge. Depending on the FDA’s feedback later this year, the Company will determine appropriate next steps and timelines for a U.S. FDA trial for its second U.S. product. Further details will be announced later this year.
  • The Company and its partner BCB are progressing the regulatory trials for product clearance in China with important data and preclinical parts of the trial expected to be run in H2-2016 under the auspices of the Beijing Institute of Medical Device Testing of the Beijing Center for Medical Device Quality Supervision and Testing of the Chinese State Food and Drug Administration (CFDA). BCB has expressed its goal to obtain CFDA clearance in 2017 and to begin commercialization in mainland China thereafter. Commercial efforts in Hong Kong and Taiwan, which are not subject to first obtaining CFDA approval, have already begun with a first commercial installation at a major hospital in Hong Kong successfully completed in July.
  • Curetis’ partner Acumen has recently submitted a filing to the regulatory authorities in Singapore with the goal of achieving regulatory clearance for the Unyvero HPN (Hospitalized Pneumonia) Application which is equivalent to the current EU P55 Pneumonia cartridge. Acumen has also started preparing respective filing documents for the Unyvero BCU Blood Culture Application and plans to apply for the ITI Application once the second-generation has been CE-IVD marked in Europe. Regulatory approval for the Unyvero Platform and Products is expected not before 2017.
  • The Japanese Patent Office has decided to grant a key patent for the Unyvero Platform combining PCR amplification and array-based detection in the Unyvero Cartridges. The patent will become effective with the issuance of an official note by the Japanese patent office.
  • The European launch of the second-generation Unyvero ITI Application Cartridge is expected in Q3-2016. Completion of development of the IAI Intra-Abdominal Infection Cartridge is planned by year-end 2016. Moreover, the partnered Sepsis Host Response program is anticipated to be completed not before the end of 2017.
  • Together with its Medical Advisory Board, the Company is in the process of defining and prioritizing multiple additional new infectious disease indication areas of high unmet medical need for further Unyvero Cartridge developments and will update its product pipeline shortly.
  • With the commercial teams in all European direct selling markets now in place and getting up to speed, the Company believes that there are several dozen well-qualified Unyvero placement opportunities for H2-2016. Therefore, the Company reiterates its guidance of an expected global installed base of 150 to 200 Unyvero Analyzers by year-end 2016.
  • Following the formation of Curetis USA, Inc. in San Diego, CA, and the start of recruitment of a core team of senior U.S. marketing and sales leadership, the Company is planning direct commercialization of all Unyvero products in the U.S. hospital market.
  • Further Curetis subsidiaries are to be incorporated in France and Switzerland in Q3-2016.

“We are very satisfied that we could meet our key corporate milestones in the first six months of 2016,” said Oliver Schacht, Chief Executive Officer of Curetis. “As our product and commercial development is progressing well, we are convinced that we can continue to deliver on the anticipated milestones communicated during our IPO. The market launch of our BCU Cartridge and the expected roll-out of our second-generation ITI and the new IAI Application Cartridges provide opportunities for further commercial upside. With our EMEA team fully built out by mid-year, we are now looking forward to accelerating our commercial momentum in the second half of 2016.”

 

Financial Development and Guidance

For the six months ended June 30, 2016, revenues were EUR 655 thousand, as compared to revenues of EUR 742 thousand in the same period 2015. While revenues in the first half of 2015 included EUR 297 thousand Unyvero Systems sales to a pharma partner, revenues in the same period in 2016 did not include any such system sales to pharma. In general, revenues are expected to remain volatile from quarter-to-quarter, as early-stage instrument sales to distribution partners are unevenly spread throughout the year.

Expenses in the first six months of 2016 amounted to EUR 7.5 million (vs. EUR 6.4 million in the first half-year 2015). The increase is in line with the operational and organizational growth and driven by higher R&D expenses, increased marketing, sales and distribution costs as well as G&A costs.

Gross loss for the first six months of 2016 totaled EUR 9 thousand, compared with a gross profit of EUR 77 thousand for the same period in 2015. The relatively low gross margin is mainly due to IFRS accounting requiring idle capacity of manufacturing line and facility to be allocated to cartridge output.

Net loss for the first six months of 2016 was EUR 6.7 million compared with a net loss of EUR 12.4 million in the same period in 2015.

As of June 30, 2016, the Company had a strong cash position of EUR 39.7 million cash on hand and a net cash burn of EUR 6.4 million for all operating, investment and financing activities combined. The company expects a cash position of 31 to 32 million at the end of 2016.

 

Earnings Conference Call and Webcast

Curetis will host a public earnings conference call and webcast today, August 19, 2016, at 03:00pm CET / 09:00am EST to discuss the financial results of the first six months 2016, highlight the most important events and provide an outlook for the second half 2016 and beyond.

The conference call will be supplemented by a presentation which can be accessed during the call at http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html (participants’ passcode curetis0816).The live webcast and a replay will be available at http://curetis120416-live.audio-webcast.com

To access the call, please dial the following numbers using the passcode 93120684#

D: +49 69 222229043

NL: +31 1071 372 73

UK: +44 20 30092452

US: +1 855 4027766

For further international dial-in numbers, please open the following link: http://events.arkadin.com/ev/docs/International%20Access%20Numbers_%20UKFELBRI1_SU7.pdf

The first half-year financial report 2016 will be available as of today, August 19, 2016, at http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html

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