Biophytis Reports H1 2019 Financial Results and Provides Business Update
- Achieved target number of 22 clinical sites opened and recruiting patients in
the U.S. and Belgium. Filed protocol amendment with the regulatory agencies
in both countries to optimize the SARA-INT Phase 2b clinical trial
- SARA-INT patient recruitment expected to be completed in mid-2020 with
topline results by end of 2020
- IND to be filed with FDA for MYODA program in DMD in Q4 2019
Paris (France), Cambridge (Massachusetts, U.S.), October 31, 2019, 08:00 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 provides
a business update and publishes its interim financial report for the 1st half
of 2019, which are available on the Company's website.
Stanislas Veillet, Chief Executive Officer, stated: "Biophytis has made strong
operational progress in 2019, delivering multiple milestones as we execute our
strategy, which is focused on the development of Sarconeos (BIO101) in
sarcopenia and Duchenne muscular dystrophy (DMD). We have completed the
SARA-OBS observation study, which preliminary analysis has led us to file an
amendment with the U.S. Food and Drug Administration (FDA) to optimize the
SARA-INT Phase 2b clinical trial. This protocol amendment aims to reduce the
number of participants that is needed in the trial and to potentially
accelerate the timeline.
Throughout 2019, we have been focused on driving patient recruitment in the
SARA-INT trial, including opening new clinical centers so that we can complete
enrollment in mid-2020 and report top line results by end of 2020. We believe
generating SARA-INT results will be a major milestone as sarcopenia remains an
important unmet medical need due to the disability, and mortality it causes,
and the fact that there are currently no approved medications to prevent or
slowdown disease progression. Additionally, we are excited about the progress
we have made with our MYODA clinical program in DMD and plan to file an
investigational new drug (IND) application with the FDA before the year end."
Income Statement Summary (*)
For the Half Years Ended June 30,
Income Statement Summary (*)
For the Half Years Ended June 30,
(amounts in thousands of euros, except
share data) 2018 2019
Research and development, net .................(4,136) (4,828)
General and administrative expenses ...........(1,542) (4,789)
Operating Loss ................................(5,678) (9,617)
Net financial expense .......................... (12) (581)
Loss before taxes .............................(5,690) (10,198)
Income taxes benefit .............................- -
Net loss ......................................(5,690) (10,198)
Basic and diluted weighted average
number of shares outstanding ..............13,410,659 13,366,218
Basic and diluted loss per share (EUR/share)....(0.42) (0.76)
(*) the interim 2019 consolidated financial statements were subject to limited
review by the Statutory Auditors.
- SARA clinical program in sarcopenia. During the 2nd quarter of 2019, we
completed the SARA-OBS study of 218 participants with sarcopenia in the U.S.
and Europe (France, Italy and Belgium). The SARA-OBS study was designed to
better understand disease progression in the target population of the SARA-INT
Phase 2b clinical trial and to inform on the design and sample size.
In October 2019, based on preliminary analysis of the SARA-OBS data, Biophytis
filed an amendment to the SARA-INT clinical trial protocol with the U.S. FDA
and Belgian AFMPS, which proposes a reduction in patient population and
includes a plan for an unblinded interim analysis. The goal of the interim
analysis is to reconfirm patient deterioration of mobility over 6 months and to
assess the likelihood of trial success of the SARA-INT study based on the
revised patient population size. (see press release from October 31st, 2019)
In October 2019, we also reached our target of 22 clinical centers open in the
U.S. and Belgium, including leading hospitals and geriatric centers for the
ongoing SARA-INT clinical trial.
Based on these achievements, we currently expect to complete patient
recruitment in mid-2020 and report topline results by end of 2020 for the
SARA-INT Phase 2b trial.
- MYODA clinical program in Duchenne muscular dystrophy (DMD). In 2019, we
continued our preclinical and regulatory efforts for the MYODA clinical
program, which intends to use a seamless trial design from Phase 1 to 3 and a
composite score to assess the safety and efficacy of a pediatric formulation of
Sarconeos (BIO101) for both ambulatory and non-ambulatory patients with DMD.
In October 2019, we presented three posters on Sarconeos (BIO101) in DMD at the
24th Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark,
which provided details on the proposed seamless trial design and composite
score, as well as preclinical respiratory data in animal models of DMD.
We are on schedule to submit an IND application to the FDA and clinical trial
applications to the applicable regulatory agencies in Europe before the end of
- Board of Directors. Effective as of October 29, 2019, Mr. Eric Rowinsky has
resigned from the Board for personal reasons and to focus his activities in the
field of oncology. Professor Jean Mariani, MD, PhD, current Chairman of
Biophytis' Scientific Advisory Board (SAB) has been added to the Company's
Board of Directors, effective as of October 29, 2019. He is a professor at
Sorbonne University (formerly the Pierre and Marie Curie University) in Paris,
one of the largest European universities specializing in science and medicine,
where he teaches neuroscience and the biology of aging. Professor Mariani is
the Director of the University Hospital Department FAST (Fight Ageing and
Stress), a multi-unit network of excellence conducting research into
age-related diseases, and also the Director of the Charles Foix Institute of
Longevity. Professor Mariani will remain Chairman of our SAB.
Interim 2019 Financial Results
- Cash and Cash Equivalents. Cash and cash equivalents as of June 30, 2019 were
EUR5.2 million, a decrease of EUR9.2 million as compared to EUR14.4 million as
of December 31, 2018. During the 1st half of 2019, cash used in operating
activities and investing activities were EUR10.4 million and EUR0.3 million,
respectively, which were partially offset by cash provided by financing
activities of EUR1.5 million.
- Research and Development Expenses. Net research and development expenses were
EUR4.8 million for the 1st half of 2019, an increase of EUR0.7 million as
compared to EUR4.1 million for the 1st half of 2018. This increase in net
research and development expenses was primarily related to the advancement of
our lead drug candidate, Sarconeos (BIO101), including conducting the SARA-INT
Phase 2b clinical trial in sarcopenia, as well as preclinical and regulatory
development of our MYODA program in DMD.
- General and Administrative Expenses. General and administrative expenses were
EUR4.8 million for the 1st half of 2019, an increase of EUR3.3 million as
compared to EUR1.5 million for the 1st half of 2018. This increase in general
and administrative expenses was primarily related to the one-time costs
associated with the postponed Nasdaq listing in the U.S.
- Net Loss. Net loss was EUR10.2 million for the 1st half of 2019, as compared
to EUR5.7 million for the 1st half of 2018. Net loss per share (based on
weighted-average number of shares outstanding over the period) was EUR0.76 for
the 1st half of 2019 and EUR0.42 for the 1st half of 2018.
In order to cover the Company's future financing requirements for the next 12
months, Biophytis assumes access to the following instruments:
- The line of funding set up with Negma allowing up to EUR24 million of
financing to be raised through the issuance of convertible bonds and warrants
(ORNANEBSAs), of which the first tranche of EUR3 million has been drawn to
- The expected reimbursement of the 2018 Research Tax Credit (CIR) for EUR3.1
The share capital of Biophytis is comprised of 16,563,254 ordinary shares
outstanding as of October 29, 2019.
Biophytis is a clinical-stage biotechnology company focused on developing
therapeutics that slow the degenerative processes associated with aging and
improve functional outcomes for patients suffering from age-related diseases,
with a primary focus on neuromuscular diseases.
Biophytis' lead drug candidate, Sarconeos (BIO101), is an orally administered
small molecule, which is currently in a Phase 2b clinical trial for sarcopenia
(SARA-INT) in the U.S. and Europe. A pediatric formulation of Sarconeos
(BIO101) is being developed for the treatment of Duchenne muscular dystrophy
(DMD). Biophytis expects Sarconeos (BIO101) to be ready to enter the clinic for
DMD in 2020, subject to regulatory approval. Biophytis' preclinical drug
candidate, Macuneos (BIO201), is an orally administered small molecule in
development for the treatment of retinopathies, including dry age- related
macular degeneration (AMD) and Stargardt disease.
Biophytis is headquartered in Paris, France, and has offices in Cambridge,
Massachusetts. The Company's ordinary shares are listed on Euronext Growth
Paris (Ticker: ALBPS - ISIN: FR0012816825).
For more information please visit www.biophytis.com.
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 securities
of Biophytis in any country. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements and estimates,
which speak only as of the date hereof. Other than as required by applicable
law, Biophytis undertakes no obligation to update or revise the information
contained in this press release. 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.