BIOPHYTIS (EPA:ALBPS) - BIOPHYTIS : 2017 Full Year Results

Transparency directive : regulatory news

28/03/2018 08:00

Press release

                      BIOPHYTIS : 2017 Full Year Results

* Launch and progress in the SARA-OBS observational clinical study in the
  United States, Belgium, France, and Italy;
* Agencies' authorizations of SARA-INT phase 2b interventional clinical study
  in the United States and Belgium;
* Completion of Macuneos non-clinical regulatory studies prior to the launch of
  the MACA-PK Phase 1/2a clinical trial;
* Sarconeos proof of concept communication in Duchenne Muscular Dystrophy and
  design of the clinical plan in this indication;
* Implementation of a EUR15million bond financing line ("ORNANEBSA") and issue
  of two tranches of bonds for EUR6 million;
* Completion of 3 private placements (april 3rd, October 10th, October 31st)
  for a total amount of EUR21,3M;
* Cash at year-end 20,0 MEUR

Paris (France), March 28th, 2018, 8:00 am - BIOPHYTIS (Euronext Growth Paris:
ALBPS), a biotechnology company specializing in the development of drug
candidates for the treatment of degenerative age-related or genetic linked
diseases, released its financial results today, and reviewed its activities.

"In 2017, significant progress has been realized in our two key clinical
programs, as described in the development plan presented in 2016 : SARA in
sarcopenia, and MACA in AMD ; we also have communicated preclinical results
which allow us to consider a second clinical program for Sarconeos. The MYODA
program will be developed in Duchenne Muscular Dystrophy, a degenerative
disease of genetic origin. The company simultaneously raised the necessary
capital to fund its clinical programs" stated Stanislas Veillet, Chairman and
CEO of BIOPHYTIS, adding: "2018 will be a year of value creation, as the
efficacy of our drug candidates will be tested for the first time in patients
with age-related, disabling diseases for which no treatment exists. Sarconeos
will be tested in sarcopenic patients in Europe and the United States, as part
of the SARA-INT Phase 2b study. Macuneos will be tested in patients with
Age-Related Macular Degeneration (dry AMD) in Europe as part of the MACA-PK
Phase 1/2a study. In addition, we will prepare the clinical development plans
of our drug candidates in orphan secondary indications, Sarconeos in Duchenne
myopathy and Macuneos in Stargardt's disease."

2017 KEY HIGHLIGHTS

The different steps of the SARA clinical program followed the program described
in 2016, in particular:

* Clinical data production of SARA-PK study. Their analysis allow to confirm
the good pharmacokinetic profile in elderly healthy subjects, to confirm the
therapeutic window of the Sarconeos drug candidate, and to specify the doses
that will be used for the Phase 2b SARA-INT clinical trial.

* Authorization by the regulatory authorities to launch the SARA-OBS clinical
trial in Sarcopenia and to open 9 clinical centers in the United States,
Belgium, France and Italy. SARA-OBS is a 6-months observational clinical study
involving more than 300 patients with sarcopenia. Patients' mobility and
muscular quality will be assessed, based on the following criteria: 6-minute
walk test, mobility (SPPB test), muscle strength (grip test), body composition
and plasmatic parameters. Data from SARA-OBS will provide a better
characterization of the target population for the Sarconeos treatment. Patients
in the SARA-OBS study will be included in the phase 2b study of SARA-INT at the
end of 6 months, once consent is given.

* Approval of the Food and Drug Agency (FDA) and from the FAMHP (Belgian
Regulatory Agency) to launch Phase 2b SARA-INT interventional study in
Sarcopenia. SARA-INT's objectives are to assess the safety and efficacy of two
doses of BIO101 (175 mg bid and 350 mg bid) orally administered for 26 weeks,
against placebo in a population of men and women aged over 65 with a risk of
motor disability; and to evaluate the treatment impact, namely the improved
physical function and the reduced risk of motor disability, after a six months
treatment against placebo in the targeted population. The study should include
334 subjects reporting a loss of physical function in the last 6-12 months and
considered at risk of motor disability.

A new therapeutic opportunity has been identified for Sarconeos:

* The abstract entitled : "Sarconeos demonstrates a significant improvement in
muscle functions and anti- fibrotic properties in the animal model of Duchenne
muscular dystrophy", was presented at the World Muscle Society's International
Congress in October in Saint Malo, France. These results demonstrate the
efficacy of Sarconeos in improving dystrophic muscle function and preventing
the onset of fibrosis. This paves the way for a new therapeutic solution for
patients with DMD.

* As a result, Professor Thomas Voit, a specialist in pediatric diseases,
joined the Biophytis Scientific Advisory Board to participate in the design of
the MYODA clinical program in DMD. Dr. Voit is the Director of the Center for
Biomedical Research (BRC) at the Great Ormond Street Children's Hospital NHS
Foundation Trust and the Institute of Child Health, University College London.
Professor Voit was previously Medical and Scientific Director of the Institute
of Myology (La Pitié Salpêtrière Hospital).

The company's financial situation has been considerably strengthened:

* On April 3rd: a capital increase subscribed by several private investors and
management, amounting to EUR3.7M, was realized by the issue of 1,310,431 new
shares at a unit price of EUR2.85,

* Simultaneously: set up of a financing line that can go up to EUR15 million,
with Bracknor Fund, in the form of 5 tranches of EUR3M of Redeemable Bonds in
cash or in New or Existing Shares with BSA (ORNANEBSA) ,

* In May: drawdown of the first tranche of bond warrants redeemable in cash
and/or in new and/ or existing shares with a par value of EUR3M; the totality
of the bonds has been converted,

* In July: drawdown of a second tranche of bond warrants redeemable in cash
and/or in new and/or existing shares with a par value of EUR3M; the totality of
the bonds has been converted,

* October 10: completion of a EUR10.4M capital increase through a private
placement and the issuance of 1,989,000 new ordinary shares at a unit price of
EUR5.25 subscribed by qualified investors,

* October 31: completion of a EUR7.5M capital increase through a private
placement and the issuance of 1,513,000 new ordinary shares at a unit price of
EUR5.00 subscribed by qualified investors.

2018 PERSPECTIVES

In the continuity of its development plan, Biophtis has set three major
objectives for the current year :

* Pursuit of the SARA clinical plan in sarcopenia with the conduct of the
SARA-INT Phase 2b interventional study: regulatory approvals have been granted
in Belgium and the United States, and the granting process is continuing in
other countries. Based on patients already selected for the SARA-OBS study, the
company plans to include the first patient in the second quarter of 2018. More
than 150 patients will have spent 6 months under observation and approximately
another 150 will be recruited specifically in SARA-INT. Accordingly, the
administration period could end in the first half of 2019, followed by the
publication of preliminary results in the summer of 2019.

* Pursuit of the MACA clinical plan in AMD with the launch of the MACA-PK Phase
1/2a study in Europe: the regulatory approval process is underway and the
Single Ascending Dose (SAD) phase of the study could begin this summer. The
results of the SAD phase are expected before the end of the year.

* Preparatory work for the MYODA clinical program (in Duchenne Muscular
Dystrophy): the clinical plan of Sarconeos in DMD is being developed with the
clinicians and the CRO. It is planned to start with a first safety and
pharmacokinetics validation, MYODA-PK, of the drug candidate in young patients
with DMD (aged 2 to 18 years). MYODA-PK could be launched in the second half of
2018. An application for Orphan Drug designation has also been filed with the
European Medicines Agency.

FINANCIAL HIGHLIGHTS

The Group's Income Statement, Consolidated Balance Sheet and Statement of Cash
Flows have been drawn up in accordance with IFRS. The consolidated financial
statements have been audited. The financial statements for the year ended
December 31, 2017 were approved by the Board of Directors on March 26, 2018.
The certification report has been issued on March 27, 2018.

Net loss of EUR11.4 million, up by EUR3.4 million mostly due to investments in
the clinical program and the financial charge linked to the convertible bonds
issuance.

The table below summarizes the key figures of the income statement:

In EUR thousands                         2017     2016
Net Research and Development Costs     (7,043)  (5,121)
Research and Development Costs         (9,593)  (6,788)
Grants                                  2,550    1,667
General and administrative expenses    (2,865)  (2,820)
Operating income                       (9,908)  (7,942)
Financial income                       (1,501)     (13)
Net Income                            (11,409)  (7,954)

The increase in development costs (launch and development of SARA-OBS,
non-clinical regulatory studies for MACA) was the main reason for the
significant increase in R&D expenses.

However, general and administrative expenses remain stable on the period.

Financial expenses are mainly due to the effect of the recognition at fair
value of the Redeemable in Cash or New or Existing Shares with Subscription
Warrants ("ORNANEBSA"), issued by the company in May 2017 and July 2017. This
charge has no impact on the Company's cash position.

The Company increased its cash position to EUR20.0 million at December 31,
2017, following various capital increases during the year.

The table below summarizes the key figures for Company cash:

in EUR thousands                   2017      2016
Non-current financial assets
(liquidity contract)                190        98
Cash and cash equivalents        19,858     3,036
Short-Term deposits               9,857     2,001
Bank accounts                    10,001     1,065
Available Cash                   20,048     3,134

The company completed several private placements by issuing new shares
generating a capital increase of EUR21.7 million, as follows:

In April 2017 :

- a EUR3.2 million private placement by issuing 1,117,449 new shares at a unit
  price of EUR2.85.
- a EUR550,000 capital increase subscribed by the Company's management through
  the issuance of 192,982 new shares at a unit price of EUR2.85.

In October 2017 :

- a EUR10.4 million private placement by issuing 1,989,000 new shares at a unit
  price of EUR5.25.
- a EUR7.6m private placement by issuing 1,513,000 new shares at a unit price
  of EUR5.

In May and July 2017, the company issued two convertible bonds tranches
("ORNANEBSA") for EUR3 million each. The Company has the option to issue 900
additional bond warrants, which allows the company to draw a maximum additional
amount of EUR9 million.

About SARCONEOS
Sarconeos is a first-in-class drug candidate based on the activation of the MAS
receptor (major player of the renin-angiotensin system) restoring muscular
anabolism, inhibiting myostatin, and that had demonstrated meaningful activity
in animal models of muscular dystrophies. Sarconeos is developed in the
treatment of sarcopenia, an age-related degeneration of skeletal muscle,
leading to loss of mobility in elderly people. This condition, for which no
medical treatment currently exists, was first described in 1993 and has entered
the International Classification of Diseases (M62.84) in 2016. It affects more
than 50 million people worldwide.

About MACUNEOS:
Macuneos is the first representative of a new class of drug candidates,
agonists of nuclear receptor PPAR. Macuneos protects retinal pigment
epithelium: Biophytis has shown in animal models a protection of retinal cells
against phototoxic effects of A2E in the presence of blue light (oxidative
stress), a reduction in accumulation of A2E, and eventually a slowdown of the
degenerative process of the retina. Macuneos is a drug candidate against the
dry form of AMD: AMD affects the central part of the retina, called the macula,
causing severe visual impairment and irreversible loss of central vision beyond
60 years old. Macuneos is in tablet form (once per day), containing 100 mg or
350 mg of active Pharmaceutical Ingredient (API).

About BIOPHYTIS
Biophytis SA (www.biophytis.com), founded in 2006, develops drug candidates
targeting diseases of aging. Using its technology and know-how, Biophytis has
begun clinical development of innovative therapeutics to restore the muscular
and visual functions in diseases with significant unmet medical needs.
Specifically, the company is advancing two lead products into mid-stage
clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and
Macuneos (BIO201) to treat dry age-related macular degeneration (AMD).

The business model of BIOPHYTIS is to ensure the conduct of the project until
clinical activity in the patient is proven, then to license the technologies in
order to continue the development in partnership with a pharmaceutical
laboratory.

The company was founded in partnership with researchers at the UPMC (Pierre and
Marie Curie University) and also collaborates with scientists at the Institute
of Myology, and the Vision Institute.

BIOPHYTIS is listed on the Euronext Growth market of Euronext Paris
(ALBPS; ISIN: FR0012816825).

For more information: http://www.biophytis.com

Follow us on Twitter @biophytis

BIOPHYTIS is eligible for the SMEs scheme

Disclaimer
This press release contains certain forward-looking statements. Although the
Company believes its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those anticipated.
For a discussion of risks and uncertainties which could cause the Company's
actual results, financial condition, performance or achievements to differ from
those contained in the forward looking statements, please refer to the Risk
Factors ("Facteurs de Risque") section of the Listing Prospectus upon the
admission of Company's shares for trading on the regulated market Euronext
Growth of Euronext Paris filed with the AMF, which is available on the AMF
website (www.amf- france.org) or on BIOPHYTIS' website (www.biophytis.com).

This press release and the information contained herein do not constitute an
offer to sell or a solicitation of an offer to buy or subscribe to shares in
BIOPHYTIS in any country. Items in this press release may contain
forward-looking statements involving risks and uncertainties. The Company's
actual results could differ substantially from those anticipated in these
statements owing to various risk factors which are described in the Company's
prospectus. This press release has been prepared in both French and English. In
the event of any differences between the two texts, the French language version
shall prevail.

BIOPHYTIS
Stanislas VEILLET
CEO
contact@biophytis.com
Tel: +33 (0) 1 44 27 23 00

Citigate Dewe Rogerson
International media & Investors
Laurence BAULT/Antoine DENRY
Laurence.bault@citigatedewerogerson.com
antoine.denry@citigatedewerogreson.com
Tel: +33 (0)1 53 32 84 78
Mob: +33(0)6 64 12 53 61

LifeSci Advisors
Chris MAGGOS
Managing Director, Europe
chris@lifesciadvisors.com
Tel: +41 79 367 6254

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BIOPHYTIS (EPA:ALBPS) - BIOPHYTIS : 2017 Full Year Results

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