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Press Release

FIT Biotech Oy: FIT BIOTECH OY HALF-YEARLY FINANCIAL REPORT JANUARY 1 - JUNE 30, 2018


Posted on: 06 Sep 18

FIT Biotech Oy
Company release 6.9.2018 at 8:30 EET           

FIT BIOTECH OY HALF-YEARLY FINANCIAL REPORT JANUARY 1 - JUNE 30, 2018
Unaudited

This company release is a summary of FIT Biotech's Half-yearly Financial Report January-June 2018, which is available in full in the pdf file attached to this company release.

PROJECTS PROCEEDING AS PLANNED, NEW OPENINGS, NEW PEOPLE

Figures in brackets, unless otherwise stated, refer to the same period of the previous year.

Company highlights January-June 2018

  • FIT Biotech and Avacta Group plc (Avacta) plan to expand their collaboration in developing next-generation biological drugs
  • Targeted commercializing of gene-based therapies moving forward: two new patent applications filed
  • EHVA (European HIV Vaccine Alliance) clinical trial authorization granted for testing FIT-06 in Switzerland and UK
  • Funding programme between FIT Biotech Oy and Alpha Blue Ocean ("ABO") approved by the Extraordinary General Meeting and Bracknor financing discontinued thereafter
  • The Company drew down from ABO Programme the tranches 2-5 of each of 500 thousand euros and totalling to 2,000 thousand euros
  • The Board of Directors appointed Erkki Pekkarinen as the new CEO in January
  • Tommi Holopainen, MSc Economics, eMBA, appointed as CFO, started July 1st 2018
  • Cash flow from operations was -1,849 (-1,400) thousand euros
  • Equity including additions according to the Companies Act was 407 (260) thousand euro

Post period-end highlights

  • Due to medical reasons of Rabbe Slätis resigned as Chairman and Dr. Chitra Bharucha was elected August 16 2018, as the Chairman of the Board. Rabbe Slätis continues as a Member of the Board.
  • After conducting additional research the Company has concluded that a secondary listing to First North Sweden -market is not relevant at this time.
  • The Company decided to draw down the sixth tranche in August of 500 thousand euros of ABO Programme.
  • First patch of FIT-06 HIV vaccines have been delivered in August to EHVA consortium (European HIV Vaccine Alliance) for clinical trials.

Outlook for 2018

FIT Biotech actively seeks partners and licensees for further development and commercialization of its GTU® technology. 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 I/II clinical trial is expected to be started Q4 2018.

The Board of Directors and the Management of the Company has secured the financing of the Company for the next twelve months.

Key financial figures for January-June 2018

Key financial figures     
1000 EUR Jan 1 - June 30, 2018 Jan 1 - June 30, 2017 Jan 1 - Dec 31,
2017
     
Net sales      
Grants 97 351 599
Personnel expenses 652 693 1,204
Depreciations, amortizations and impairments 102 81 292
Other operating expenses 916 659 1,514
Operating profit/loss -1,773 -1,321 -2,838
Profit/loss for the period -1,832 -1,379 -3,301
       
Cash flow from operations -1,849 -1,400 -2,505
Cash in hand and in bank 34 18 429
Equity -13,117 -12,614 -13,321
Equity including additions according to Companies Act 407 260 239
Balance sheet total 1,141 1,237 1,071
       
Equity ratio, % 35.6 21.0 22.3
Return on investment (ROI), %  negat. negat. negat.
Earnings per share -0.002 -0.032 -0.054
Number of shares in the end of the period (pcs) 3,109,302,152 64,460,629 224,956,112
Number of treasury shares (pcs) 1,001,924,221 10,000,000 131,045,831
Number of voting rights (pcs) 2,107,377,931 54,460,629 93,910,281
Average number of shares during the period (pcs) 981,412,670 47,381,179 61,416,522

CEO Erkki Pekkarinen comments 

"FIT Biotech is a globally focused Finnish biotechnology company. We aim to become a leader in the development of gene-based treatments. Our gene transfer technology offers a technological advantage in the form of scalability, providing a platform for developing gene-based therapies faster and at lower production costs, with the potential for better and safer therapies.

We develop our technologies further in order to bring better, safer and more cost-efficient drugs to the market. Our aim is to bring added value to the pharmaceutical distributors and health care professionals; however, our main target is to provide better treatment for patients and improve their quality of life.

We create disruptive therapeutic solutions for the benefit of patients and healthcare providers. Our technology platforms facilitate development of safe and affordable therapies. Our most advanced product is a DNA vaccine FIT-06 that we develop for treating HIV. Clinical trials have proven it to be safe, fast to produce and cost-efficient.

During the first half of the year, we started new research projects. We also reached an important milestone as the medicine agencies in Switzerland and Great Britain granted European HIV Vaccine Alliance (EHVA) a permission to launch a phase I/II clinical trial as planned. The FIT-06 vaccine candidate of FIT Biotech is a part of treatment which is being tested in terms of its efficiency and safety on HIV positive persons.p.o.

During the reporting period, we filed two international patent applications which are of strategic importance as we continue commercialization of our technology and drug candidates. The patent applications relate to our vector technology platforms that have been developed further and the usage of our technology in cancer treatment. These patent applications are very important for us in commercializing the gene-based treatments.

In addition, we are preparing new drug candidates for product development.

We have continued international networking and made a major effort to achieve on commercial contract negotiations. We have achieved best progress with a British company Avacta, and we are currently clarifying the next steps of our co-operation.

At the end of 2017, we concluded a funding agreement with Alpha Blue Ocean. Thanks to this agreement, we had an opportunity to start new development projects which I believe will be advantageous to our shareholders in the long term. Diversifying our product development portfolio helps us to diversify business risks significantly.

During the first half of the year we have also improved our corporate processes and implemented improved routines. Thanks to the organisational efforts, we are now better equipped to develop our business and to receive international funding.

One of our objectives is also to increase our shareholder value. We put a lot of effort on improving our investor relations and on transparency through more efficient communication. We aim to pass on comprehensive facts and ideas of our business to the markets and deliver information of our full potential."

Briefing

A briefing for analysts, portfolio managers, and media representatives will be held on September 6, 2018, starting at 9:30 a.m. at Pörssitalo (Fabianinkatu 14, 00100 Helsinki). The presentation materials will be available on the company's website at www.fitbiotech.com after the event.

FIT BIOTECH OY

Board of Directors

Further information:
CEO Erkki Pekkarinen
Tel: +358 44 027 0080
E-mail: erkki.pekkarinen@fitbiotech.com

Certified Advisor: Aalto Capital Partners Oy, mobile +358 40 5877000

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.

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

DISTRIBUTION:
Nasdaq Helsinki
Principal media
www.fitbiotech.com

Attachment

GlobeNewswire
globenewswire.com

Last updated on: 06/09/2018

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