BIOPHYTIS (EPA:ALBPS) - Biophytis Reports H1 2020 Financial Results and Provides Business Update

Transparency directive : regulatory news

18/09/2020 18:00

Press Release

  Biophytis Reports H1 2020 Financial Results and Provides Business Update

* COVA: Initiation of the Phase 2/3 study for the treatment of COVID-19 related
  respiratory failure in five countries: France, Belgium, UK, USA and Brazil.
  First patient dosed in Belgium, and active opening of new investigation
  centers.

* SARA-INT: Treatment period extended by 3 months based on favorable risk
  profile of Sarconeos (BIO1010) in sarcopenia Phase 2b study. Last patient out
  expected by end 2020.

* Cash on hand increased to EUR12.2 million as of June 30th 2020, and to EUR18
  million as of July 3 2020 following the last capital increase.

* Call for the next Extraordinary General Assembly on May 10, 2021.

Paris (France), Cambridge (Massachusetts, U.S.), September 18, 2020, 08:00 CET
- Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage biotechnology
company specialized in the development of drug candidates for treatment of
age-related diseases, including neuromuscular diseases, today publishes its
interim financial report for the 1st half of 2020 and provides a business
update. The half year financial report is available on the Company's website.

Stanislas Veillet, Chief Executive Officer, stated: "Biophytis, like many other
companies, has experienced some disruptions due to the COVID-19 pandemic. I
would like to thank all Biophytis teams and our service providers for their
remarkable work in helping us adapt to this health crisis. The pandemic and
subsequent lockdowns have resulted in a delay on the Sarconeos (BIO101)
clinical trial in sarcopenia. However, we were able to adapt the protocol to
ensure safety of our patients and the continuity of the SARA-INT trial and we
remain confident that our last patient will exit the study by the end of this
year, allowing us to report the first results by mid-2021.

We have responded rapidly to the COVID-19 situation over the past few months to
leverage our scientific know-how and join the global effort to fight the
SARS-CoV-2 virus and its effects.

In April we launched COVA, an international Phase 2/3 clinical study with
Sarconeos (BIO101) as a potential treatment for acute respiratory failure
associated with COVID-19. We are committed to providing an improved and
differentiated treatment option that can help patients with COVID-19, and
especially those in vulnerable categories who are most at risk of suffering
from severe respiratory complications. The first patient has already been
recruited in Belgium and we expect centers in France, the United States and
Brazil to start enrolling patients in the coming weeks.

Investors have recognized and supported our strategy and development programs,
through three successful private placement transactions for a total of EUR13.4
million, allowing the Company to significantly strengthen its cash and equity
positions."

Income Statement Summary (*)
                                    For the Half Years Ended June 30,
(amounts in thousands of euros,
except share data)                       2019             2020
Research and development, net .........(4,828)          (5,192)
General and administrative expenses ...(4,789)          (2,269)
Operating Loss ........................(9,617)          (7,461)
Net financial expense ...................(581)          (1,999)
Loss before taxes ....................(10,198)          (9,460)
Income taxes benefit .....................-                -
Net loss .............................(10,198)          (9,460)
Basic and diluted weighted average
number of shares outstanding ......13,366,218       37,211,432
Basic and diluted loss per share
(EUR/share) ........................... (0.76)           (0.25)

(*) the interim 2020 consolidated financial statements were subject to limited
review by the Statutory Auditors.

Operational Update

* SARA clinical program in sarcopenia. On February 11, 2020, the Belgian and
  American health authorities agreed to amend the SARA-INT study protocol
  reducing the number of patients needed in the clinical trial from 334 to 231.

On March 24, 2020, the company announced that it had completed patient
recruitment for its Phase 2b study in sarcopenia.

Due to COVID-19 and subsequent lockdowns in Belgium and several American states
(California and New York in particular) the progress of SARA-INT has been
impacted. In order to preserve the health of patients and given governments and
health authorities measures to restrict movement , Biophytis had to adapt the
SARA-INT protocol in order to ensure the continuity of the trial, in particular
by:
* closing all on-site activities and
* organizing patient follow-up to take place at home.

As a result of these protocol changes, and depending on the evolution of the
pandemic, the last patient out from the SARA-INT study is now expected at the
end of 2020. The initial results are expected by mid-2021.

* New Phase 2/3 COVA study for acute respiratory failure associated with
  COVID-19. On April 7, 2020, Biophytis announced the launch of COVA, a new
  study against Acute Respiratory Distress Syndrome (ARDS) linked to the
  SARS-CoV-2 virus, with its most advanced drug candidate: Sarconeos (BIO101).

COVID-19 can cause ARDS by disrupting the renin-angiotensin system (RAS), which
has a key role in regulating respiratory function. It is believed that
SARS-CoV-2 enters cells in various tissues using the Angiotensin 2 Converting
Enzyme (ACE-2), a key enzyme in the RAS, thus inhibiting the system's
protective arm.

Sarconeos (BIO101) could activate the MAS receptor, a key component of the
protective arm of the RAS, and has been shown to restore respiratory function
in several preclinical models.

The COVA clinical program is an international Phase 2/3, randomized,
double-blind, placebo-controlled, adaptive and group sequential study assessing
Sarconeos (BIO101) in patients infected with SARS-CoV-2. At the time of writing
the half-yearly report, the study has been authorized in 5 countries: France,
the USA, Brazil, Belgium and the UK. The clinical trial started in Belgium with
the inclusion of the first patient on September 1, 2020.

The company has also announced the reopening of its subsidiary in Brazil in
order to conduct the clinical trial there.

* MYODA clinical program in Duchenne muscular dystrophy (DMD). On March 30,
  2020, Biophytis received approval from the Belgian regulatory agency, Federal
  Agency for Medicines and Health Products (FAMHP), to start the clinical study
  of its product Sarconeos (BIO101) in non-ambulatory patients with DMD.

The planned MYODA clinical program is based on a 3-part, randomized, double
blind, adaptive seamless Phase 1 to 3 clinical study, to evaluate the safety
and efficacy of a pediatric formulation of Sarconeos (BIO101) in non-ambulatory
patients with DMD and evidence of respiratory deterioration. FAMHP also cleared
a protocol adjustment that changed respiratory function to the primary
endpoint.

This protocol also obtained IND clearance with the USA Food and Drug
Administration (FDA) in December 2019.

Depending on the evolution of the pandemic, this trial might start by the end
of 2020.

Governance Update and convening of the next EGM

* The combined General Meeting was held on May 11, 2020. In the absence of a
  sufficient quorum, ordinary and extraordinary resolutions could not be put to
  a vote. A second combined General Meeting was convened on May 28, 2020 during
  which all of the resolutions relating to the combined General Assembly were
  approved by a large majority, and in particular those ratifying the
  delegationsof powers to the board of directors at the effect of deciding on
  the issue of shares and / or securities and the authorizations to be granted
  to the board of directors for the purpose of deciding the exercise of
  various financial instruments.

* As the company's net equity is now less than 50% of Biophytis' share capital
  and in accordance with French regulations, shareholders are invited to a new
  Extraordinary General Meeting which will be held on May 10, 2021. The
  modalities of the EGM will be announced in the coming weeks depending on the
  evolution of the pandemic.

Interim 2020 Financial Results

* Cash and Cash Equivalents. Cash and cash equivalents as of June 30, 2020 were
  EUR12.2 million, an increase of EUR5.8 million as compared to EUR6.3 million
  as of December 31, 2019. During the 1st half of 2020, cash used in operating
  activities and investing activities were close to 0, while cash provided by
  financing activities amounted to EUR5.8 million.

* Research and Development Expenses. Net research and development expenses were
  EUR5.2 million for the 1st half of 2020, an increase of EUR0.4 million as
  compared to EUR4.8 million for the 1st half of 2019. This increase in net
  research and development expenses was primarily related to the advancement of
  our lead drug candidate, Sarconeos (BIO101), in the SARA-INT program, and
  preliminary expenses for the launch of the COVA program.

* General and Administrative Expenses. General and administrative expenses were
  EUR2.3 million for the 1st half of 2020, a decrease of EUR2.5 million as
  compared to EUR4.8 million for the 1st half of 2019. This decrease in general
  and administrative expenses was primarily related to the absence of the
  one-time costs associated with the postponed Nasdaq listing in the USA during
  the same period in 2019, as well as staff downsizing.

* Net Loss. Net loss was EUR9.5 million for the 1st half of 2020, as compared
  to EUR10.2 million for the 1st half of 2019. Net loss per share (based on
  weighted-average number of shares outstanding over the period) was EUR0.25
  for the 1st half of 2020 and EUR0.76 for the 1st half of 2019.

Despite the loss realized in the first half of 2020 amounting to EUR 9.5
million, the Board of Directors approved the accounts assuming continuity of
operation.

The cash and cash equivalents available as of June 30, 2020 amounted to EUR12.2
million, and to EUR18 million following the completion of a capital increase by
private placement of EUR6.1 million on July 3, 2020 (see Note 21). The Company
believes that this amount, supplemented by existing lines of credit, is
sufficient to cover the Company's cash requirements for the next 12 months.

Upon termination of the Negma ORNANEBSA contract, that led to a litigation
procedure currently on going, the Company has signed a new ORNANE contract with
Atlas Capital for a total of EUR24 million.

Following the drawing of the 3rd tranche from Atlas, the possible use of this
convertible line (see Note 12.2) may provide an additional financing of EUR15
million for the Company.

The share capital of Biophytis is comprised of 67 227 789 ordinary shares
outstanding as of September 18, 2020.

About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specialized in the
development of drug candidates to slow down degenerative processes and improve
functional abilities in patients with age-related diseases, including
neuromuscular diseases.

Sarconeos (BIO101), our leading drug candidate, is a small molecule,
administered orally, currently in clinical Phase 2b in sarcopenia (SARA-INT) in
the United States and Europe. A pediatric formulation of Sarconeos (BIO101) is
being developed for the treatment of Duchenne Muscular Dystrophy (DMD). The
company plans to start the clinical development (MYODA) in H2 2020.

Sarconeos (BIO101) is also being developed as a treatment for patients with
COVID-19 related respiratory failure in a Phase 2/3 clinical study (COVA) in
the United States, Europe and Latin America.

The company is based in Paris, France, and Cambridge, Massachusetts. The
company's common shares are listed on the Euronext Growth Paris market (Ticker:
ALBPS -ISIN: FR0012816825). For more information visit www.biophytis.com

Disclaimer

This press release contains forward-looking statements. While the Company
considers its projections to be based on reasonable assumptions, these
forward-looking statements may be called into question by a number of hazards
and uncertainties, so that actual results may differ materially from those
anticipated in such forward-looking statements. For a description of the risks
and uncertainties likely to affect the results, BIOPHYTIS' financial position,
performance or achievements and thus cause a change from the forward-looking
statements, please refer to the "Risk Factors" section of the Company's 2020
Annual Report available on BIOPHYTIS website (www.biophytis.com).

This press release, and the information contained in it, does not constitute an
offer to sell or subscribe, nor the solicitation of a purchase or subscription
order, of BIOPHYTIS shares in any country. The elements contained in this
communication may contain forward-looking information involving risks and
uncertainties. The Company's actual achievements may differ materially from
those anticipated in this information due to different risk and uncertainty
factors. This press release was written in French and English; If there is a
difference between the texts, the French version will prevail.

Biophytis Contact for Investor Relations
Evelyne Nguyen, CFO
evelyne.nguyen@biophytis.com

Media contact
Citigate Dewe Rogerson
Sylvie Berrebi/ Nathaniel Dahan/ David Dible / Quentin Dussart
mailto:biophytis@citigatedewerogerson.com
Tel: +44 (0) 20 7638 9571 / +33 (0)1 55 30 70 91

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BIOPHYTIS (EPA:ALBPS) - Biophytis Reports H1 2020 Financial Results and Provides Business Update

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