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Interim Report for Saniona AB (publ)

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Saniona well positioned to start Phase 2 clinical studies

Financial highlights

Jan-Sep 2015 (Jan-Sep 2014)

  • Net revenues were KSEK 11,803 (17,998)
  • EBIT was KSEK -22,748 (2,016)
  • Earnings per share were SEK -1.05 (-0.11)
  • Diluted earnings per share were SEK -1.04 (-0.11)

    Q3 2015 (Q3 2014)
  • Net revenues were KSEK 1,955 (5,247)
  • EBIT was KSEK -10,857 (-2,322)
  • Earnings per share were SEK -0.46 (-0.13)
  • Diluted earnings per share were SEK -0.46 (-0.13)



Business highlights in Q3 2015           

  • Saniona expects to initiate a confirmatory Phase 2a study with Tesomet in the first half of 2016.

  • FDA accepts the University of Pennsylvania Treatment Research Center’s IND for conducting a Phase 2 clinical trial for NS2359 for cocaine addiction. Saniona retains all commercial rights.

  • The Board decides to perform a rights issue of SEK 60.7 million with a subscription price of SEK 14.00 per share. The rights issue is secured up to approximately 80 per cent equivalent to SEK 48.8 million.

  • Saniona and Pfizer terminate the research collaboration within neurological diseases. Saniona maintains the rights to continue the program.

  • Preliminary preclinical toxicology data published for AN363 and announces that it will perform additional studies on a finding seen at higher doses in rats. Subject to a positive outcome of these investigations, Saniona can initiate the clinical Phase 1 trial at the Centre for Human Drug Research in Holland, CHDR.

  • New clinical data published which strongly supports the concept for the use of Tesomet for treatment of type 2 diabetes.

  • Professor Carl Johan Sundberg is appointed as new member of the Board of Directors at the extraordinary general meeting on September 4, 2015.

  • IFRS implemented from the Q2 interim report 2015 in preparation for the planned listing on Nasdaq Stockholm Small Cap in 2016.

  • Saniona and Ataxion extend their on-going drug discovery and development collaboration on a three month rolling basis with the aim of identifying a development candidate.

  • Rights issue is subscribed to 80.4% and the company raises about SEK 48.8 Million before issue expenses, amounting to around SEK 5.3 million.

  • New pre-clinical efficacy data for AN363 published at the Society for Neurosciences 2015 Conference in Chicago along with new scientific data in relation to the AN346 program.

Significant events after the reporting period

Comments from the CEO

”With the recent completion of the rights issue we are ready for a new era. Within a short period we have gone

from being an early stage company to a clinical stage company with the lead compound entering Phase 2 in first half of 2016. I am thrilled by the development in the company,” says Jørgen Drejer, CEO of Saniona.

For more information please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@saniona.com

Letter from the CEO

”With the completion of the recent rights issue in November, Saniona is now positioned to enter into a completely new era. We are leaving the early stage with only preclinical programs behind us. We are entering a stage where several programs can enter the clinical phase, two programs in Phase 2 and potentially one program in Phase 1. Still we have retained our broad portfolio comprising a number of exciting programs and opportunities.

We are primarily focusing on the three programs, which can enter clinical phase:

  • Tesomet is planned to initiate Phase 2a studies in the first half of 2016 for type 2 diabetes. Tesomet is a combination of a weight-loss drug candidate, tesofensine, and a beta blocker, metoprolol.

  • NS2359 obtained an IND by the FDA in August to start Phase 2 clinical trials in the US for cocaine addiction. These studies can bet started without significant investments by Saniona. Researchers at the University of Pennsylvania are currently applying for public funds to support this study. Saniona retains all rights.

  • Regarding AN363, provided that the results of the additional toxicological studies in rats are positive, we can initiate Phase 1 clinical studies in 2016 for neuropathic pain.

With respect to Tesomet, we are looking very much forward to initiate our Phase 2a clinical study in the first half of 2016. It represents to a large extent a confirmatory study of the results we have seen in pre-diabetes patients. A retrospective analysis of existing data from a previous clinical Phase 2 trial in humans shows that tesofensine reduces the glycemic parameters in individuals with pre-diabetes. In addition, a retrospective analysis of a Phase 1 study with tesofensine and metoprolol shows that metoprolol prevents the increase in heart rate caused by tesofensine in human volunteers.

A part of our strategy is to develop selected programs internally through the early phases of drug development in order to build further value into these programs before out-licensing to third parties. The largest value increase is often generated during or upon completion of Phase 2a clinical studies. We believe that we can create significant value in the above-mentioned programs. They have a very large market potential with sales of existing products in the single or double digit billion dollar range, they are addressing indications with significant unmet medical need and importantly, Saniona will subject to sufficient funding be able to complete Phase 2a clinical trials.

Despite the focus on the above three programs, we shall not forget Saniona’s platform and broad portfolio of other programs. Especially our collaboration with Ataxion, which was extended recently. Furthermore, although that Pfizer and Saniona recently have terminated their collaboration due to strategic decisions at Pfizer, we do see significant opportunities for developing this program with another partner. We are continuing working on business development activities in respect to various programs and we see good opportunities to enter into new agreements on our platform where we have several programs in early stages.

Therefore, we are convinced that Saniona has an exciting future.

I want to take this opportunity to thank all the shareholders and not least the guarantors and presubscribes who supported us in the last rights issue. Thank you."

Jørgen Drejer

CEO, Saniona AB


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