Biophytis Reports 2019 Full Year Results and Provides Operational Update
* Successful completion of our SARA-OBS observational study in sarcopenia
supporting the SARA-INT Phase 2b study
* Protocol amendment for SARA-INT study approved by FDA resulting in a
reduction of the cohort size from 334 to 231 patients; topline results
expected by end 2020
* Acceleration of recruitment in SARA-INT study with 227 patients now recruited
in 22 clinical centers in the US and Europe
* IND granted by FDA to start the clinical development of Sarconeos (BIO101) in
Duchenne Muscular Dystrophy (DMD)
* Consolidation of financial resources through successful completion of a
private equity placement of EUR3.3 million and a contracted convertible bond
financing of up to EUR24 million with Negma
Paris, France, Cambridge (Massachusetts, United States), March 17, 2019, 8:00
am CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company with a primary focus on the development of its lead drug
candidate, Sarconeos (BIO101), for the treatment of neuromuscular diseases,
today announces its audited financial results for the year ended December 31,
2019, and provides updates on key operational developments.
Stanislas Veillet, President and CEO of Biophytis, said: "Biophytis has made
significant progress in the last several months. The FDA approval of our
protocol amendment for the SARA-INT study with Sarconeos (BIO101), along with
the acceleration in patient inclusion means we expect to complete recruitment
of this important trial in the coming weeks. The recent equity financing will
allow us to start the clinical development of BIO101 in Duchenne Muscular
Dystrophy (DMD) and to complete the SARA- INT study, for which topline results
are expected by the end of 2020. I am looking forward to the next 12 months
with confidence. "
The Company's annual 2019 consolidated financial statements prepared in
accordance with IFRS were approved by the Company's Board of Directors on March
13, 2020. Audit procedures were completed, the issuance of the audit report is
pending, and will be included in the Company's upcoming 2019 annual financial
Annual 2019 Financial Results
- Cash and Cash Equivalents. Cash and cash equivalents as of December 31, 2019
were EUR6.3 million, a decrease of EUR8.1 million compared to EUR14.4 million
as of December 31, 2018. During 2019, cash used in operating activities and
investing activities was EUR15.3 million and EUR0.3 million respectively. This
was partially offset by EUR7.5 million of cash provided by financing
- Research and Development Expenses. Net research and development expenses were
EUR9.0 million for 2019, a decrease of EUR0.5 million compared to EUR9.5
million for 2018. This slight decrease reflects the company's prioritization of
its financial resources to advance the SARA-INT Phase 2b clinical trial in
sarcopenia, and the MYODA IND filing for DMD with the US & French regulatory
authorities. This focus allowed to significantly accelerate patient enrollment
into the SARA-INT clinical trial, as well as gain FDA authorization in December
2019 to start the MYODA trial.
Net research and development expenses included research tax credits (French
'Crédit Impôt Recherche', or CIR) and other subsidies totaling EUR2.8 million
in 2019 compared to EUR3.1 million in 2018.
- General and Administrative Expenses. General and administrative expenses were
EUR6.6 million for 2019, an increase of EUR2.3 million compared to EUR4.3
million for 2018. This increase in general and administrative expenses was
primarily related to the fees and expenses linked to the proposed listing of
the Company's shares on Nasdaq and the expansion of our operations in the US.
- Net Loss. Net loss was EUR17.8 million for 2019, as compared to EUR14.0
million for 2018. Net loss per share (based on weighted-average number of
shares outstanding over the period except the treasury shares) was EUR1.05 in
both 2019 and 2018.
The table below summarizes operating results.
(amounts in thousands of euros, except share data) 2019 2018
Net Research and development expenses (9,089) (9,513)
General and administrative expenses (6,593) (4,348)
Operating Loss (15,682) (13,861)
Net financial expenses (2,134) (198)
Loss before taxes (17,816) (14,059)
Income taxes benefit 28 72
Net loss (17,788) (13,987)
Non diluted weighted average number of shares
outstanding, except treasury shares 16 882 661 13,374,426
Basic and diluted loss per share (EUR/share) (1,05) (1,05)
SARA clinical program in sarcopenia :
* In April 2019, the Company completed the observational SARA-OBS study with
218 sarcopenia patients in the US and Europe (France, Italy and Belgium). The
SARA-OBS study was designed to better understand disease progression in the
target population of the phase 2b SARA-INT clinical trial in sarcopenia, and
to provide further data on the design of the clinical trial and the number of
patients that were needed to be recruited in to the study.
* In October 2019, following the preliminary analysis of the SARA-OBS study,
including a 6 month assessment of the 400 meters walking test (400MWT), the
Company was able to confirm that the target population for the SARA-INT study
is optimal, and that indeed these are patients that are at high risk for
Based on this analysis, the Company filed a protocol amendment for the phase 2b
SARA-INT clinical trial with the FDA and AFMPS. The amendment proposed a
reduction in the number of patients that needed to be recruited into the study
from 334 to 231. The amendment also included an interim analysis on patients'
mobility after 6 months to estimate the probability of success of the SARA-INT
study based on the lower number of patients to be included in the trial.
* In October 2019, the company reached its objective of opening 22 clinical
sites in the SARA-INT clinical trial, including globally recognized
hospitals and geriatric centres in the US and Belgium.
* In December 2019, the company presented the preliminary analysis of the
SARA-OBS study at the 12th Annual Congress of The Society on Sarcopenia,
Cachexia and Wasting Disorders (SCWD) in Berlin, Germany. The company also
presented the preliminary results in March 2020 at the 10th International
Conference on Frailty and Sarcopenia Research (ICFSR 2020) in Toulouse,
* In February 2020, the Company announced the protocol amendment approval filed
in October 2019, as well as an increase in the rate of recruitment of
patients into the SARA-INT study. At that time 80% of the revised patient
recruitment target had been reached. Completion of patient recruitment is
expected in Q2 2020, and an interim analysis by the study's data safety and
monitoring board (DSMB) is also expected to take place in Q2 2020.
MYODA clinical program in DMD:
Regulatory agencies have been consulted about the design of the planned MYODA
clinical program for BIO101 in Duchenne Muscular Dystrophy (DMD) :
* In 2019, the Company continued its preclinical and regulatory efforts in
support of the planned MYODA clinical program. This program intends to use a
'seamless' clinical trial design that will encompass all three phases of
clinical development (Phase 1 to Phase 3), using several criteria, including
respiratory function and muscular strength. This clinical trial will evaluate
safety and efficacy of a pediatric formulation of BIO101 for ambulatory and
non-ambulatory DMD patients.
* In June 2019, the Company announced a EUR400.000 financing from AFM
Téléthon as part of a collaboration to develop BIO101 in DMD.
* In October 2019, the Company presented three posters on BIO101 in relation to
its development for DMD at the 24th annual congress of the World Muscle
Society (WMS) in Copenhagen, Denmark. Biophytis provided details about the
clinical trial protocol, as well as the respiratory data obtained in DMD
* In November 2019, the Company filed an IND with the FDA, which was granted in
MACA clinical program in Age-related Macular Degeneration :
Non-clinical regulatory formulation work has been undertaken to prepare for the
MACA clinical program in AMD.
Following the company withdrawal of its public offering on Nasdaq at the end of
July 2019, the Company secured a line of funding that could reach EUR24
million, set up with Negma (in August 2019).
The instrument is in the form of 2,400 note warrants for Bonds Redeemable in
Cash or New or Existing Shares (ORNANE), at a par value of EUR10,000 each,
combined with Share Subscription Warrants (BSAs), together referred to as
ORNANEBSA. The EUR24m financing can be exercised for 4 years, without
obligation to do so, through 8 successive tranches of EUR3 million each.
In addition, on February 12 2020, the company successfully completed a private
placement for a total amount of approximately EUR3,3 million. Securities were
subscribed by European and American institutional investors, most of whom have
supported the company since its IPO.
The placement price was set at EUR0.27 per share following an accelerated order
book construction procedure. This price corresponds to a 29.5% discount to the
weighted average Biophytis stock price over the last 10 trading sessions prior
to the private placement.
Corporate governance and appointments:
In April 2019, the Board of Directors noted the resignation of Mr Jean-Gérard
Galvez as a member of the Board.
In October 2019, the Board of Directors named Mr Jean Mariani as a new Director
of the Board, (pending the confirmation of his appointment at the next
shareholder meeting). Mr Mariani replaced Mr Eric Rowinsky following his
In January 2020, Biophytis announced the appointment of Evelyne Nguyen as Chief
Financial Officer (CFO). The Board also appointed Pierre J. Dilda, PhD, as
Chief Scientific Officer (CSO) replacing Professor René Lafont, who became
Scientific Advisor; and Waly Dioh, PhD, as Chief Operating Officer (COO).
2020 outlook :
Predictable changes for 2020 in two main areas:
1/ Completion of the phase 2b clinical study of Sarconeos (BIO101) in
sarcopenia to obtain clinical proof of concept, particularly in terms of
efficacy, safety, and tolerance in patients with severe symptoms.
It is important to note that Sarconeos (BIO101) is the only drug candidate
currently in an advanced stage of development in humans for sarcopenia, a
pathology that can affect between 6 and 22% of people aged 65 and more.
2/ Start of the clinical trial of Sarconeos (BIO101) in DMD following the IND
approval from the FDA. The aim is to open at least two clinical centers in the
US and recruit the first patient in 2020.
In view of the current and rapidly changing COVID-19 situation, Biophytis is
taking the necessary steps to protect its employees, partners and operations.
Biophytis' employees, both in France and the US, have been asked to work from
home and hold meetings and events virtually wherever possible. There is no
travel to restricted areas for work-related reasons.
To date, we have seen limited impact on our daily operations, including our
interactions with clinical investigators, regulators, the scientific community
and other stakeholders.
As a result, we remain on track in all key areas, particularly with regard to
our Phase 2b SARA-INT trial, where we expect to complete patient recruitment in
the coming weeks.
However the situation might evolve. While follow up of participants in the
SARA-INT study is currently running smoothly, we are monitoring the situation
closely and assessing various options to continue with participants' follow up
in a timely manner in order to complete the study as planned.
Biophytis SA is a clinically staged biotechnology company specializing in the
development of drug candidates to slow down degenerative processes and improve
functional abilities in patients with age-related diseases, particularly
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 BIO101 is being
developed for the treatment of Duchenne myopathy (DMD) for which the company
received IND status by the U.S. Food and Drug Administration (FDA) in December
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 www.biophytis.com.
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 2018
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