FIT BIOTECH OY FINANCIAL STATEMENT BULLETIN

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FIT Biotech Oy: BULLETIN OF THE FINANCIAL STATEMENTS OF FIT BIOTECH OY JANUARY 1 – DECEMBER 31, 2017

FIT Biotech Oy
Company press release 03/01/2018 at 11:00 a.m. EET

FIT BIOTECH OY FINANCIAL STATEMENT BULLETIN JANUARY 1 – DECEMBER 31, 2017
(unaudited)

This company press release is a summary of the bulletin of the financial statements of FIT Biotech from January to December 2017, which is available in its entirety in the pdf file attached to this company press release.

Switching to gene therapies, new collaborations and funding

Company highlights July-December 2017

  • US patent for treatment of HIV with HIV vaccine from FIT Biotech granted

  • Gene therapy research collaboration initiated with Avacta Group Plc

  • EHVA funding of 645 thousand euros received as part of a contractual agreement to produce FIT-06 clinical trial material

  • Signature of a financing agreement of 10 million euros with Alpha Blue Ocean and drawdown of the first tranche of 500 thousand euros

  • Publication of FIT-06 Phase 1 Clinical Trial Demonstrates Safety and Tolerability and Produces Desired Immune Response

Company highlights January-December 2017

  • A major research milestone has been taken using the gtGTU gene therapy vector

  • Preparations for the manufacture of the HIV vaccine FIT-06 for the EU’s Horizon 2020 EHVA project have been completed and the manufacture of GMP grade clinical trial materials has been started

  • The possibilities of applying for a secondary listing on the First North Sweden market have been explored.

  • Operating cash flow amounted to -2,505 (-2,487) thousand euros

  • Equity including additions in accordance with company law amounted to 239 (-630) thousand euros at the end of the review period

  • The Board of Directors proposes to the General Meeting that no dividend be paid

  • Earnings per share amounted to -0.05 (-0.06) euros

Highlights after the end of the period

  • Board of Directors appointed Erkki Pekkarinen as new CEO in January

  • The Extraordinary General Meeting approved the Alpha Blue Ocean financing agreement

  • Bracknor’s funding halted under new funding agreement

  • Negative equity at the end of January corrected for the drawdown of the second tranche of 500 thousand euros of the Alpha Blue Ocean financing on February 14, 2018

Outlook for 2018

FIT Biotech is actively seeking partners and licensees to further develop and commercialize its GTU and gtGTU technologies. The Company also continues to work on the development of new therapeutic applications using its proprietary technology and plans to launch new projects. The company’s HIV vaccine, FIT-06, will be tested as a functional remedy for HIV by the European Horizon 2020 EHVA consortium. This phase 2 clinical trial should start in 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 euros 1-12 / 2017 1-12 / 2016 7-12 / 2017 7-12 / 2016
Net sales ten
Subsidies 599 191 248 191
Personal expenses 1,204 992 511 485
Depreciation, amortization and depreciation 292 159 211 52
Other operating expenses 1,514 1,704 855 1004
Operating result -2 838 -3,030 -1 517 -1 572
Profit / loss for the period -3 301 -3 651 -1 921 -2 193
Operating cash flow -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 in accordance with company law 239

-630

239 -630
Total balance 1,071 1,428 1,071 1,428
Equity ratio,% 22.3 negative. 22.3 negative.
Return on investment (ROI),% negative. negative. negative. negative.
Earnings per share -0.05 -0.06 -0.03 -0.04
Number of actions at 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 shares held by the company. The average number of shares used to calculate earnings per share is the average number at December 31, 2017.

CEO Erkki Pekkarinen comments:
“FIT Biotech is a research and commercialization-driven biotechnology company aimed at revolutionizing healthcare by developing safer, more cost-effective and more functional treatments.

Innovative gene delivery technologies and DNA vaccines can be applied, among others, to cancer immunotherapy, enzyme replacement of certain orphan diseases as well as prevention and treatment of various infectious diseases such as HIV . All of our products targeted in R&D would represent medical breakthroughs if they were successful.

FIT Biotech’s technology offers the technological advantage of scalability as it serves as a platform to develop gene therapies at a faster rate. Our product development focuses on virus-free DNA technology unlike most operators in this industry. In addition to the medical benefits, DNA drugs also offer significant savings.

In November, we obtained a patent which grants us exclusive intellectual property rights in the United States to commercialize our GTU®-based DNA vaccines, including FIT-06, for the treatment of patients with HIV infection. This is of great economic consequence as it gives us the possibility of exclusive rights to market our vaccine candidate at a higher price. The patent is a prerequisite for the licensing of marketing rights to a large pharmaceutical company. The next step will be the launch of a phase 2 clinical trial with the European Alliance for HIV and Vaccines (EHVA). The aim of the clinical trial is to provide a safer and more cost-effective functional cure for patients with HIV.

FIT Biotech offers investors a unique opportunity to participate in the commercialization of drug candidates based on their own patents. Although drug development is a long-term process and a high-risk enterprise, there are several steps that should be taken along the way, although early-stage licensing agreements are increasingly common.

Our business model is based on licensing our drug candidates to partner companies who further develop them and bring drugs to market. We have several drug development projects as well as collaborative projects with international biotechnology companies, pharmaceutical companies and academic research institutes.

I started as CEO of FIT Biotech in January 2018 after serving on the board for 16 years. I am particularly proud of our dedicated high-level team with many years of experience and expertise in the international pharmaceutical industry. With this team and our exclusive and unique technological platform, we are pursuing a role as a leading and recognized European biopharmaceutical company in the field of biotechnology. “

FIT BIOTECH OY

Board of directors

More information :
CEO Erkki Pekkarinen
Phone. : +358 44 027 0080
Email: [email protected]

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

FIT Biotech in brief

FIT Biotech Oy is a biotechnology company founded in 1995 which develops and licenses its patented vector technology GTU® (Gene Transport Unit) for next generation medical treatments. GTU® is a gene transport technology that addresses 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 included gene-based treatments, genetic vaccines and research collaborations. Areas of application include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines.

FIT Biotech’s K shares are listed on the First Market of Northern Finland managed by Nasdaq Helsinki Ltd.

DISTRIBUTION:
Nasdaq Helsinki
Main media
www.fitbiotech.com


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