Summary of Interim Report January – September, 2016

“We continue to build a new global leader in the field of patient monitoring”

Financial information third quarter, 2016

  •  Net sales amounts to KSEK 900 (33)
  •  Income after financial items amounts to KSEK -1,964 (-1,968).
  •  Earnings per share before dilution amounts to SEK -0.06 (-0.12) and after dilution to SEK -0.06 (-0.12).
  •  Cash and cash equivalents per September 30, 2016 equal SEK 15.8 million (17.3).
  •  Number of shares per September 30, 2016 amounts to 36,172,643 (32,153,460).

Financial information January – September, 2016

  •  Net sales amounts to KSEK 1,443 (111).
  •  Income after financial items amounts to  KSEK -5,840 (-5,769).
  •  Earnings per share before dilution amounts to SEK -0.24 (-0.40) and after dilution to SEK -0.24       (-0.40).

Definitions. Earnings per share: Net income for the period divided by the average numbers of shares during the period. In parentheses describes comparative period last year. Unless otherwise stated, all information refers to the Group.

Significant events during the third quarter

  •  July 2016. New share issue with preferential rights for existing shareholders that was performed during May – June is now registered with the Company´s Registration Office. The proceeds in the issue totals SEK 15.3 million before transaction costs.
  •  August 2016. Örebro University has been awarded SEK 11 million and will together with Senzime, Sandvik, Techtum and Nanoxis explore why the immune system reacts differently in different people after an operation, during an infection or because of polluted air.

Significant events after the end of the period

  •  October 2016. New Swedish registry study – a national collaboration between Senzime, Swedish Medtech, Skåne University Hospital in Lund and University of Gothenburg and the national quality registry for esophageal and gastric cancer.  A clinical trial investigating the OnZurf Probe for continuous, organ specific monitoring of lactate trends in postoperative esophageal cancer patients is ongoing in Lund. The clinical trial is being expanded in order to examine how the new OnZurf Probe solution may mitigate the healthcare costs associated with this disease.
  •  November 2016. Senzime is initiating a series of clinical studies to be performed at Mayo Clinic, USA. The studies are intended to evaluate Senzime’s patient neuromonitoring system called TetraGraph, used during anesthesia. Data about the monitor’s ease of clinical use, form factor, design, and ease of set-up will be collected. The clinical validation studies at Mayo Clinic are intended to compare its usability to that of the now-discontinued former market leading monitoring system. Results are scheduled for presentation as early as December 2016.
  •  November 2016. Senzime launches a clinical study at NorthShore University HealthSystem, Chicago, USA, a Teaching Affiliate of the University of Chicago Pritzker School of Medicine. Professor Glenn Murphy will head this clinical investigation of the leading neuromuscular monitoring system, the TetraGraph. This study is designed to investigate the clinical utility of the TetraGraph System in a total of 150 patients, and will compare its ease of use, reliability and precision to the former leading product that has been discontinued from the market.
  •  November 2016. Senzime launches a clinical study at the University of Debrecen, Hungary. This study will evaluate Senzime’s patient neuromonitoring system TetraGraph. This study is designed to investigate the clinical utility of the system in a total of 40 patients, and will compare its ease of use, reliability and precision to the former leading product, the TOF-Watch, that has been discontinued from the market. Results are scheduled for presentation as early as the first quarter of 2017.

Statement of the CEO

“We continue to build a new global leader in the field of patient monitoring”

Senzime develops unique medical devices that make it possible to monitor patients' biochemical and physiological processes before, during and after an operation. The solutions are designed to ensure maximum patient benefit, reduce complications associated with surgery and reduce health care costs.

During the second quarter of 2016, Senzime AB acquired Acacia BV, a medical device company that has developed a novel and reliable method of monitoring the depth of neuromuscular block and determine the adequacy of neuromuscular recovery during general anesthesia. The method of monitoring is designed to reduce perioperative complications in surgical patients. The merger between Senzime and Acacia creates a company with a broader market offering of patient monitoring systems of biological and physiological processes in perioperative surgical patients. The new company significantly increases Senzime’s market potential and opportunities, and benefits from Acacia’s existing international clinical network.

We are building a global leader in patient monitoring, an area which continues to gain ground in pace with increased demands for patient safety and lower health care costs. As part of this strategy, in the third quarter we continued our product development, clinical verification, sharpen our patent portfolio and strengthen the organization to build the new Senzime. We have a unique and competitive portfolio of products in patient monitoring that faces the market launch 2017.

During the quarter we, Sandvik, Techtum and Nanoxis also began a collaboration with Örebro University that aims to improve patient safety and reduce healthcare costs. Senzime will supply the resources, instruments, consumables and microdialysis probes needed to investigate the immune system receptors called inflammasomes and the role they play in a host of inflammatory disorders. Understanding these protein complexes may provide early detection of changes in the maintenance of homeostatic biological functions in patients at risk, and facilitate the clearance of pathogens and damaged cells.

We also launched a Swedish registry study in collaboration with Swedish Medtech, Skåne University Hospital in Lund, Gothenburg University and the National Registry of esophageal and gastric cancer. In Lund, a clinical study using OnZurf Probe is already ongoing. The OnZurf Probe is our product for continuous, organ-specific postoperative measurement of lactate in patients with cancer of the esophagus, a disorder that affects approximately 500,000 patients worldwide annually. This study has now been expanded further in cooperation with additional partners to also evaluate health economic issues. Results from this study are expected to be reported in the second quarter of 2017.

After the reporting period, we began study partnerships with two of the world's foremost hospitals: The Mayo Clinic and North Shore University Hospital, both in the United States. The studies planned are intended to evaluate the TetraGraph. The study results are expected in December 2016, and they will provide the needed data as a first step towards future market introduction in the US. Additionally, a validation study has been initiated in cooperation with Debrecen University in Hungary, one of Europe's leading universities in the area of neuromuscular monitoring; these results are expected early in 2017.

Finally, and as I said earlier, we remain confident that we have highly attractive products and that we are targeting the right market at the right time. Discussions with potential license partners continues, we are approaching market launch of our products; we look forward to an eventful end to 2016 and an exciting and promising start of 2017.

Uppsala in November 2016

Lena Söderström, CEO of Senzime AB (publ)

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