- U.S. FDA trial completed with excellent top-line data
- Leading position in genetic antimicrobial resistance biomarker
testing strengthened by GEAR acquisition
Amsterdam, the Netherlands, and Holzgerlingen, Germany, November 18, 2016 -
Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of
next-level molecular diagnostic solutions, today published a business and financial update
for the first nine months ended September 30, 2016 and provided an outlook to coming
months.
Recent Operational and Business Highlights
Unyvero US FDA Trial
• Curetis successfully completed the U.S. FDA trial for the Unyvero Platform and its
LRT Application in lower respiratory tract infections and reported positive top-line
data in October 2016. The prospective and retrospective study met its primary
endpoint by demonstrating an overall weighted average sensitivity of 90.2% and an
overall average weighted specificity of 99.3%. These data are fully consistent and in
line with the performance evaluation previously conducted by Curetis for CE IVD
marking in Europe, as well as published data from various European KOLs and
customer sites.
• The submission of Curetis´ (de novo) 510(k) data package to the U.S. FDA is
expected in due course. FDA feedback and the potential clearance for Unyvero and
start of commercialization are expected in the first half of 2017.
• Curetis is preparing to enter U.S. FDA trials for its next U.S. product. To that end,
the Company has submitted a so-called pre-submission package to the FDA for a
U.S. version of its Unyvero ITI Cartridge. Based on the FDA’s feedback and
additional market research data that are expected in Q4-2016, Curetis will determine
appropriate next steps and timelines for a U.S. FDA trial for this second product.
Further details will be announced in 2017.
Acquisition of NGS Database GEAR and IP from Siemens
• Curetis has acquired sole commercial rights from Siemens Technology Accelerator 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 assets in
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.
• The state-of-the-art bioinformatics database comprises more than 11,300 bacterial
strains that have been collected at more than 200 sites on 5 continents over 30
years. The next gene sequencing (NGS) data with 0.4 trillion reads is a wealth of
comprehensive and internationally relevant information amounting to 30 terabytes
in total.
• GEAR allows 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 leading position that Curetis has established
in the area of genetic antimicrobial resistance biomarker testing with its Unyvero
Cartridges. Curetis intends to 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.
Commercial Expansion
• United States
Following the appointment of Christopher M. Bernard as President and Chief
Executive Officer of Curetis USA, Inc. in La Jolla, San Diego, CA, the Company
has been building its senior leadership and U.S. commercial core team for the North
American market during the second half of 2016. The U.S. subsidiary has been
founded to drive the future commercial development and sales of the Company’s
Unyvero Platform in North America. Curetis is planning direct commercialization of all
Unyvero Products in the U.S. hospital market.
• Europe
The Company has made excellent progress in expanding its commercial footprint in
its direct sales territories. To this end, Curetis has established four new wholly owned
commercial subsidiaries in Europe covering the UK, the Netherlands for the Benelux
area, France and Switzerland and has hired senior market development managers
and key account managers from industry leaders such as Roche, Cepheid, Abbott
and others.
Product Development
• After launching the BCU Blood Culture Application Cartridge in Q2-2016, Curetis has
launched its second Unyvero Test this year with its next generation Unyvero ITI
Cartridge for Implant and Tissue Infections in September 2016. The CE performance
evaluation study was successfully completed and demonstrated an overall average
sensitivity for all pathogens of 86.9% and an overall average specificity for all
pathogens of 99.2% in a total of 1,100 samples. The next-generation cartridge now
covers a total of 102 (up from 80 in first generation) 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.
• The Company has furthermore progressed the development of the IAI IntraAbdominal
Infection Cartridge, its fourth Unyvero Application, towards
completion by the end of this year. In addition, the partnered Sepsis Host Response
program (anticipated completion not before the end of 2017) is progressing
according to plan.

Installed Base
• Curetis has continued to expand the installed base of Unyvero Analyzers to 121 as of September 30, 2016 (vs. 79 instruments as of September 30, 2015, i.e. an increase by 53% year over year).

Financial Highlights for the First Nine Months 2016
• Revenues: EUR 1.1 million (vs. EUR 0.9 million in the nine months ended
September 30, 2015). Overall revenues were up by 21.7% year over year. While
revenues in the first half of 2015 had included EUR 297 thousand generated by
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: EUR 12.0 million (vs. EUR 9.6 million in the nine months ended
September 30, 2015). The increase is in line with the operational and organizational growth strategy and driven by higher R&D expenses, distribution costs as well as
G&A costs.
• Gross loss: EUR 0.1 million (vs. a gross loss of EUR 0.5 million in the nine months ended September 30, 2015). The relatively low gross margin is significantly impacted by the mix of systems sales to cartridge sales and by IFRS accounting requiring excess capacity of the cartridge manufacturing line and facility to be allocated to actual period cartridge output.
• Net loss: EUR 10.7 million (vs. a profit of EUR 13.5 million in the nine months ended September 30, 2015). The profit in the nine months ended September 30, 2015 was
due to 23.6 million financial income resulting from a one-time accounting-effect due to the revaluation of preferred and common shares under IFRS.
• Cash and cash equivalents: A strong cash position of EUR 35.4 million as of
September 30, 2016 (vs. EUR 46.1 million as of December 31, 2015) and a net cash
burn of 10.6 EUR million during the nine months of 2016 for all operating, investment and financing activities combined.

Key non-audited financials as of September 30, 2016
Curetis N.V.
consolidated numbers in ´000 Euros
For the nine months ended September 30, 2016
For the nine months ended September 30, 2015
Revenues 1,077 885
Operating loss (10,760) (8,676)
Total comprehensive income (10,731) 13,493
September 30, 2016 December 31 2015
Cash and cash equivalents 35,415 46,060
Comparative figures for the nine months ended September 30, 2015, are those of Curetis GmbH (former AG).
„We are very happy with the operational development,” said Dr. Oliver Schacht, CEO of Curetis. “We completed the U.S. FDA study on time and as planned. We are now using the outcome, a very strong and comprehensive data set, for compiling the final submission documents and look forward to receiving feedback from the FDA. In addition, we launched the next-generation Unyvero ITI Cartridge for Implant and Tissue Infections and submitted
the pre-submission package to the FDA for a U.S. version of the Unyvero ITI Cartridge.”
“Furthermore, the GEAR acquisition allows us to significantly expand the scale and scope of the Unyvero Platform and complement it with NGS-based knowledge,” he added. “GEAR will
allow us to stay on top of the development of cutting-edge molecular diagnostic products for critical hospital infections as it will serve as an engine for even more comprehensive and differentiated content of antibiotic resistance biomarkers in our Unyvero Products. Last but
not least, the commercial expansion is also progressing in both Europe and the U.S., where we have built a senior leadership and U.S. commercial core team for the North American market.”

For further information, please visit www.curetis.com

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