FIT Biotech Oy
Company release 01.03.2018 at 11:00 am EET  


This company release is a summary of FIT Biotech's Financial Statement Bulletin January-December 2017, which is available in full in the pdf file attached to this company release.

Shift to gene therapies, new collaboration and financing

Company highlights July-December 2017

  • U.S. patent for treating HIV with FIT Biotech's HIV-vaccine was granted
  • Gene therapy research collaboration initiated with Avacta Group Plc
  • EHVA financing of 645 thousand euros received as a part of a contractual agreement to produce FIT-06 clinical trial material
  • 10 million euros financing agreement signed with Alpha Blue Ocean and first tranche draw down of 500 thousand euros
  • Publication of FIT-06 Phase 1 clinical trial demonstrates safety and tolerability and produces the desired immune response

Company highlights January-December 2017

  • A major research milestone was met in utilizing gene therapy vector gtGTU
  • Preparations for manufacturing HIV vaccine FIT-06 for the EU Horizon 2020 EHVA project were completed and manufacturing of GMP grade clinical trial materials was initiated
  • Possibilities to apply for a secondary listing on the First North Sweden marketplace has been explored
  • Cash flow from operations was -2,505 (-2,487) thousand euros
  • Equity including additions according to the Companies Act was 239 (-630) thousand euros at the end of the review period
  • The Board of Directors proposes to the AGM that no dividend will be paid
  • Earnings per share were -0,05 (-0,06) euros

Post period end highlights

  • The Board of Directors appointed Erkki Pekkarinen as the new CEO in January
  • Extraordinary General meeting approved the Alpha Blue Ocean financing agreement
  • Bracknor financing was discontinued as part of the new financing arrangement
  • Own equity negative at the end of January, corrected by draw down of second 500 thousand euros tranche Alpha Blue Ocean financing on February 14, 2018

Outlook for 2018

FIT Biotech actively seeks partners and licensees for further development and commercialization of its GTU and gtGTU technologies. The Company also continues to work on developing novel therapeutic applications using its proprietary technology and expects to initiate new projects. The Company's HIV vaccine, FIT-06, will be tested as a functional HIV-cure by the EU Horizon 2020 EHVA Consortium. This phase 2 clinical trial is expected to be started during 2018.

The Board of Directors and the Management of the Company believe that the financing of the Company is secured for the next twelve months.

Key financial figures

1000 EUR 1-12/2017 1-12/2016 7-12/2017 7-12/2016
Net sales   10    
Grants 599 191 248 191
Personnel expenses 1,204 992 511 485
Depreciations, amortisations and impairments 292 159 211 52
Other operating expenses 1,514 1,704 855 1,004
Operating profit/loss -2,838 -3,030 -1,517 -1,572
Profit/loss for the period -3,301 -3,651 -1,921 -2,193
Cash flow from operations -2,505 -2,487 -1,105 -1,187
Cash in hand and in bank 429 486 429 486
Equity -13,321 -12,404 -13,321 -12,404
Equity including additions according to Companies Act 239  

239 -630
Balance sheet total 1,071 1,428 1,071 1,428
Equity ratio, % 22,3 negat. 22,3 negat.
Return on investment (ROI), % negat. negat. negat. negat.
Earnings per share -0,05   -0,06 -0,03 -0,04
Number of shares in the end of the period (pcs) 224,956,112 43,022,718 224,956,112 43,022,718
Number of treasury shares (pcs) 131,045,831 10,000,000 131,045,831 10,000,000
Number of voting rights (pcs) 93,910,281 33,022,718 93,910,281 33,022,718
Average number of shares during the period (pcs) *) 61,416,522 28,107,614 78,774,808 28,540,193

*) Excluding the shares owned by the company. The average number of shares used in calculating the earnings per share was the average number as of  31 December 2017.

CEO Erkki Pekkarinen comments: 
"FIT Biotech is a biotechnology company focusing on research and commercialization aiming to revolutionize health care by developing safer as well as more cost-efficient and functional cures.

Innovative gene delivery technologies and DNA vaccines can be applied, inter alia, towards cancer immunotherapy, enzyme replacement in certain orphan diseases as well as the prevention and treatment of different infectious diseases such as HIV. All of our R&D targeted products would represent medical breakthroughs if they succeed.

FIT Biotech's technology offers the technological advantage of scalability as it serves as a platform for developing gene-based therapies at a faster rate. Our product development is focusing on DNA based technology free of virus unlike most operators in this sector. In addition to medical benefits, DNA based drugs also offer significant cost savings.

In November, we were granted a patent that gives us exclusive intellectual property rights in the United States to commercialize our GTU®-based DNA vaccines, including FIT-06, for the treatment of HIV patients. This is of great economic consequence since it gives us possibility to exclusive rights to commercialize our vaccine candidate at a premium price. The patent is a prerequisite for licensing the marketing rights to a major pharmaceutical company. The next step will be launching Phase 2 clinical trial with European HIV and Vaccine Alliance (EHVA). The objective of the clinical trial is to provide a safer and cost-effective functional cure for HIV patients.

FIT Biotech offers investors an unique opportunity to participate in the commercialization of drug candidates based on own patents. While drug development is a long-term process and high-risk venture, there should be multiple milestones met along the way although early stage licensing agreements are increasingly common.

Our business model is based on licensing our drug candidates to corporate partners who develop them further and introduce drugs on the market. We have multiple drug development projects as well as collaborative projects with international biotech companies, pharmaceutical companies and academic research institutions.

I started as the CEO of FIT Biotech in January 2018 after serving 16 years as a member of the Board. I am particularly proud of our dedicated top-team with long experience and expertise in the international pharmaceutical business. With this team and our unique, proprietary technology platform we pursue a role as a leading and recognized European biopharmaceutical company in the field of biotechnology."


Board of Directors

Further information:
CEO Erkki Pekkarinen
Tel: +358 44 027 0080

Certified Advisor: Aalto Capital Partners Oy, mobile +358 40 587 7000

FIT Biotech in brief

FIT Biotech Oy is a biotechnology company established in 1995 that develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines.

FIT Biotech applies its GTU® technology in its development projects, which at the time include gene-based treatments, genetic vaccines and research collaboration. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines.

FIT Biotech K-shares are listed on the First North Finland market maintained by Nasdaq Helsinki Ltd.

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