Archive: Company News
Company News: Curetis Publishes First Quarter 2016 Business and Financial Update
– Worldwide commercial expansion and US FDA trial on track
– Installed base of Unyvero Analyzers increased to 107 devices
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today published its business update for the quarter ended March 31, 2016, and confirmed its outlook for the full year 2016.
First Quarter 2016 Operational and Business Highlights
Unyvero US FDA trial
- The US FDA trial for the Unyvero LRT Application in lower respiratory tract infections is nearing completion, with expected enrolment targets to be reached by mid-year. At the end of March 2016, more than 1,600 patient samples had been enrolled, with over 2,000 prospective and retrospective patient samples enrolled to-date;
- Curetis anticipates completing 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 upon unblinding, not before fall 2016;
- The submission of 510(k) data package to the US FDA is expected before year-end 2016.
- The Company also continues to prepare for the second Unyvero Application Cartridge to enter US FDA trials in the second half of 2016. Further details will be announced later this year.
Commercial Expansion
- 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, Haagmans 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, significantly strengthening its direct commercial footprint and positioning the Company to accelerate new Unyvero installations in these key markets.
- Curetis has established a wholly owned sales subsidiary in the UK (Curetis UK Ltd, London, UK) at the beginning of May 2016 and anticipates to incorporate further subsidiaries in France (Curetis France SARL) and the Netherlands (Curetis Benelux BV) in the coming months.
Product Development
- Curetis has successfully completed the CE performance evaluation study and subsequently launched its Unyvero BCU Blood Culture Application Cartridge during ECCMID 2016 in Amsterdam in April. 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.
- The Company has advanced the development of a second-generation Unyvero ITI Application Cartridge (expected European launch in mid-2016) and IAI Intra-Abdominal Infection Cartridge (expected development completion by year-end 2016). In addition, the partnered Sepsis Host Response program (anticipated completion in late 2017) is progressing according to plan.
- 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), and Germany (Mathias Pletz, MD, Jena University Hospital). The advisors bring strong expertise in intensive care, clinical microbiology, sepsis and prosthetic joint infections. Recently, Curetis added Dr. Laurent Poirel (University of Fribourg, Switzerland), an expert in antibiotic resistance markers, to its MAB. Dr. Poirel has a long-standing scientific career at the French National Institute of Health and Medical Research (INSERM) in Paris / France with a focus on the genetics, biochemistry and epidemiology of antibiotic resistance determinants. In addition, he and his team have jointly developed a variety of rapid diagnostic tests for the detection of extended-spectrum ß-lactamases and carbapenemases.
Installed Base
- Curetis has expanded the installed base of Unyvero Analyzers to 107 at the end of the first quarter 2016 (vs. 58 at the end of the first quarter 2015).
- The Company reiterates its guidance of an expected global installed base of 150 to 200 Unyvero Analyzers by year-end 2016.
Supervisory Board
- Curetis announced the nomination of Dr. Prabhavati Fernandes, CEO of Cempra Pharmaceuticals Inc., Chapel Hill, NC, USA, as a candidate for Curetis N.V.´s Supervisory Board. The election is to be held during the upcoming Annual General Meeting on June 16, 2016. Further important resolutions in the agenda are the resignation of Dr. Frank Mühlenbeck, and the re-election of Dr. Holger Reithinger and Dr. Rudy Dekeyser for another one-year term.
First Quarter 2016 Financial Highlights
- Revenues: EUR 132.8 k (vs. EUR 228.4 k in the first quarter 2015). 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 3.3 million (vs. EUR 2.7 million in the first quarter 2015). The increase is in line with the operational and organizational growth, and driven by higher R&D expenses, distribution costs as well as G&A costs only partly compensated by less cost of sales.
- Gross loss: EUR 30.1 k (vs. EUR 54.2 k in the first quarter 2015). This is mainly due to IFRS accounting requiring idle capacity of manufacturing line and facility to be allocated to cartridge output.
- Net loss: EUR 3.2 million (vs. EUR 2.6 million in the first quarter 2015).
- Cash and cash equivalents: EUR 43.2 million (vs. EUR 46.1 million as of 31 Dec 2015). Net cash burn in the first quarter 2016 was EUR 2.9 million.
Key non-audited financials as of March 31, 2016
| Curetis N.V. | ||
| consolidated numbers in ´000 Euros | ||
| For the three months ended March 31, 2016 | For the three months ended March 31, 2015 | |
| Revenues | 133 | 228 |
| Operating loss | (3,125) | (2,461) |
| Total comprehensive income | (3,169) | (2,588) |
| March 31, 2016 | December 31, 2015 | |
| Cash and cash equivalents | 43,190 | 46,060 |
„We are very pleased with the operational progress in the first quarter of 2016. Year-to-date, we have successfully tested more than 2,000 patient samples in our FDA trial, with enrolment for prospective and retrospective sample testing nearing completion. This progress keeps us on-track to report top-line data from the trial during the latter part of 2016 and submit our 510(k) package to the FDA by year-end,” said Oliver Schacht, CEO of Curetis. “In addition to advancing our U.S. trial, we have strengthened our commercial infrastructure through key sales hires in the UK, France and Benelux, and additions to our application specialist and marketing teams in Germany.”
“The expansion of our direct sales organization in Western Europe is fully on track, and we continue to pursue strategic distribution partnerships aimed at providing Unyvero access to additional markets and potentially bolstering our presence in existing markets,” he added. “The successful launch of our Unyvero BCU Blood Culture Application Cartridge adds a third comprehensive syndromic panel to the Unyvero Platform in Europe, further strengthening our product portfolio. With several other cartridges in development and expected to launch in the coming years, we believe that Curetis is optimally positioned to succeed in the global MDx market.”
Company News: Curetis shall hold its Annual General Shareholders’ Meeting on June 16, 2016
– Nominating Dr. Prabhavathi Fernandes for election to its Supervisory Board
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced the invitation to its annual general shareholders’ meeting (“AGM”).
Curetis will hold its AGM on June 16, 2016, at Steigenberger Hotel, Stationsplein Zuid-West 951, 1117 CE Schiphol-Oost/Amsterdam, the Netherlands. The meeting is scheduled to commence at 13.30 hours CEST; registration starts at 12.30 hours CEST. Also Curetis will be offering electronic pre-voting starting on May 20, 2016 at 08:00 hours CEST.
A copy of the convening notice for the AGM, including a description of the formalities to participate in the AGM, is available at http://www.curetis.com/en/investors/share-information/annual-general-meeting.html
The most important resolutions in the agenda of the AGM relate to changes in the Supervisory Board, i.e. the proposed election of new Supervisory Board member Dr. Prabhavathi Fernandes (CEO of Cempra Pharmaceuticals, Inc., Chapel Hill, NC, USA) for a three-year term until 2019, the resignation of Dr. Frank Mühlenbeck and the re-election of Dr. Holger Reithinger and Dr. Rudy Dekeyser for another one-year term, respectively.
Also on the agenda is the creation of a new Stock Option Program for the Company and associated changes to the Supervisory Board remuneration, making Supervisory Board members also eligible to such new plan, as well as changes to the Management Board’s Remuneration Policy and Stock Option grants.
Company News: ISA Pharmaceuticals obtains broad patent protection in the US for proprietary AMPLIVANT® platform and compounds
– Granted US patent provides market exclusivity until 2032
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced it has been granted a US patent on its AMPLIVANT® technology and compounds (patent no. 9,314,521). The patent ensures market protection in the United States until 2032 and covers the compounds, either as a stand-alone substance or in combination with antigenic peptides, nucleic acids or antibodies. The patent also covers the process for preparing the compounds.
ISA’s AMPLIVANT® technology provides an adjuvant that has been demonstrated to improve the immunostimulatory potency of SLP® immunotherapeutics 100- to 1000-fold. It comprises a synthetic small molecule toll-like receptor 1/2 (TLR1/2) ligand with enhanced immunostimulatory activity that can be used as a stand-alone additive or chemically coupled to immunotherapeutic compounds like synthetic peptides during the SLP® manufacturing process. SLP®-AMPLIVANT® conjugate compounds allow for lower doses at higher efficacy through better dendritic cell antigen processing and presentation as well as enhanced T cell priming. At present, clinical researchers at Leiden University Medical Center are evaluating the safety and immunogenicity of two SLP®-AMPLIVANT® conjugates in patients affected by HPV16+ disease (HESPECTA trial).
“This patent is the first of a family of patents and highly significant for the future development and protection of our next-generation SLP products,” said Ronald Loggers, ISA Pharmaceutical’s Chief Executive Officer. “With market protection in the US until 2032, we have added another level of protection to our products and, potentially, other applications.”
Company News: ISA Pharmaceuticals’ Lead Product ISA101 Efficiently Engages the Immune System Against Virus-Induced Pre-malignant and Malignant Lesions
– ISA101 clinically effective against HPV-induced vulvar / vaginal lesions and cervical cancer
– Optimum immunotherapy window in cancer identified
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, has announced the publication of two peer-reviewed research manuscripts demonstrating the clinical efficacy of its lead product ISA101 in treating high-grade vulvar intraepithelial neoplasia (VIN), and synergy with chemotherapy in cervical cancer. In cervical cancer, the optimum window for treatment with ISA101 starts two weeks after the second chemotherapy cycle has been completed. The multi-center research was conducted in close collaboration with Leiden University Medical Center (LUMC). Publications appeared in Clinical Cancer Research[1] and Science Translational Medicine[2], respectively.
Infections with HPV are known to cause genital and, head & neck lesions which lead to cancer in a certain percentage of patients. While today selected high-risk HPV infections can be prevented by vaccination, this does not hold true for lesions and cancer formation once an HPV infection has occurred. To treat both pre-malignant (e.g. VIN) and malignant tissue damage (e.g. cervical cancer) in HPV-infected patients, ISA Pharmaceuticals has developed ISA101, a synthetic long peptide (SLP®) immunotherapeutic, to engage the immune system against these lesions.
In a combined analysis of animal and clinical studies in cervical cancer published in Science Translational Medicine, researchers discovered that a timed combination of ISA101 with standard carboplatin and paclitaxel chemotherapy can significantly improve immunity in advanced cervical cancer patients. Researchers also found that the most pronounced effect was seen if ISA101 was administered starting two weeks after the second cycle of chemotherapy.
“We looked into the mechanism of action,” said Kees Melief, CSO of ISA. “In both mice and patients, the presence of a growing tumor was associated with abnormally high frequencies of circulating myeloid-derived suppressor cells. Administration of chemotherapy normalized the abnormal levels of these circulating myeloid cells and this was associated with increased T-cell reactivity to recall antigens. The effect was most pronounced starting two weeks after the second cycle of chemotherapy , providing an optimal immunological treatment window. We also observed that ISA101 treatment at this point resulted in unusually strong HPV16-specific T-cell responses, which were sustained after completing all cycles of chemotherapy. So one should consider chemotherapy as a treatment for the immune system rather than a mere treatment for the tumor.”
The second paper in Clinical Cancer Research features a Phase I/II clinical study of ISA101 in 43 VIN patients demonstrating that advanced stages of VIN can be safely and effectively treated with the compound. All patients displayed drug-induced T-cell responses, which were significantly stronger in patients with complete clinical responses. Importantly, viral clearance occurred in all but one of the patients with complete histological clearance.
“The outcome of the VIN trial demonstrates once again the safety and efficacy of ISA101 in a premalignant setting,” said Melief, who co-authored the study. “This study confirms the correlation between immune response and clinical outcome. It shows complete histopathological regressions and viral clearance, and the data demonstrate that the clinical efficacy of the immunotherapeutic is related to the strength of a drug-induced immune response. Rather than using post-hoc analyses for efficacy, we performed immunological assays and statistical analyses that were predefined.”
“The results of these papers clearly emphasize the importance of our strategy in the cancer immunotherapy field, and prove that we have identified an effective, clinically relevant approach to engage the immune system against virus-induced cell damage,” said Ronald Loggers, CEO of ISA. “They also demonstrate that our lead candidate ISA101 is a very effective treatment for both non-malignant and malignant diseases caused by HPV infections.”
ISA101 is currently explored in two Phase I/II trials in anal intraepithelial neoplasia and HPV-positive cervical cancer, and in a Phase II Nivolumab combination trial in HPV-positive solid cancers. Further details can be found at http://www.isa-pharma.com/clinical-studies.
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[1] Van Poelgeest MIE et al. 2016. “Vaccination against oncoproteins of HPV16 for non-invasive vulvar/vaginal lesions: lesion clearance is related to the strength of the T-cell response.” Clin Cancer Res Published Online First on January 26, 2016; DOI: 10.1158/1078-0432.CCR-15-2594.
[1] Welters MJ et al. 2016. “Vaccination during myeloid cell depletion by cancer chemotherapy fosters robust T-cell responses.” Sci Transl Med 13 April 2016; DOI: 10.1126/scitranslmed.aad8307.