Biophytis Reports Annual 2018 Financial Results and Provides Operational Update
March 11 2019 - 10:00PM
Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company focused on the development of novel
treatments for age-related diseases, today announced annual 2018
financial results and provided an operational update. The Company’s
annual 2018 consolidated financial statements prepared in
accordance with IFRS were approved by the Company’s Board of
Directors on March 8, 2019. Audit procedures were completed by the
auditors and the issuance of the audit report is pending and will
be included in the Company’s upcoming 2018 annual registration
document.
Annual 2018 Financial
Results
- Cash and Cash Equivalents. Cash and cash
equivalents as of December 31, 2018 were €14.4 million, a decrease
of €5.5 million as compared to €19.9 million as of December 31,
2017. During 2018, cash used in operating activities and investing
activities were €12.3 million and €0.1 million, respectively, which
were partially offset by cash provided by financing activities of
€7.1 million.
- Research and Development Expenses. Net
research and development expenses were €9.5 million for 2018, an
increase of €2.5 million as compared to €7.0 million for 2017. This
increase in net research and development expenses was primarily
related to the advancement of our lead drug candidate, Sarconeos
(BIO101), including the SARA-OBS observational study and the
SARA-INT Phase 2b clinical trial in sarcopenia, as well as
preclinical and regulatory development of our MYODA program in
Duchenne Muscular Dystrophy. Net research and development expenses
included research tax credits (French Crédit Impôt Recherche, or
CIR) and other subsidies totaling €3.2 million in 2018 and €2.6
million in 2017.
- General and Administrative Expenses. General
and administrative expenses were €4.4 million for 2018, an increase
of €1.5 million as compared to €2.9 million for 2017. This increase
in general and administrative expenses was primarily related to the
expansion of operations in the U.S. through our U.S. subsidiary and
an increase in headcount.
- Net Loss. Net loss was €14.0 million for 2018,
as compared to €11.4 million for 2017. Net loss per share (based on
weighted-average number of shares outstanding over the period) was
€1.04 in 2018 and €1.24 in 2017.
The table below summarizes operating results.
|
|
For the Years Ended December 31, |
(amounts in thousands of euros, except share
data) |
|
2017 |
|
2018 |
Net Research and
development expenses |
|
(7,043) |
|
(9,513) |
General and administrative expenses |
|
(2,865) |
|
(4,348) |
Operating Loss |
|
(9,908) |
|
(13,861) |
Net
financial expenses |
|
(1,500) |
|
(198) |
Loss before taxes |
|
(11,408) |
|
(14,059) |
Income taxes benefit |
|
- |
|
72 |
Net loss |
|
(11,408) |
|
(13,987) |
Non
diluted weighted average number of shares outstanding |
|
9,188,179 |
|
13,463,413 |
Basic and diluted loss per share (€/share) |
|
(1.24) |
|
(1.04) |
“We are very pleased with the operational
progress we made in 2018, including executing on our clinical
objectives for our SARA program. We are currently enrolling
patients in the SARA-INT Phase 2b clinical trial, which we believe
is now the most advanced ongoing clinical trial in sarcopenia, a
large disease indication affecting millions of elderly people
worldwide, with no approved medication. We look forward to 2019 and
beyond as we aim to advance Sarconeos (BIO101) into the clinical
for Duchene muscular dystrophy and begin to deliver clinical
proof-of-concept starting in 2020,” stated Dr Stanislas
Veillet, Chief Executive Officer of Biophytis.
Operational Update
- SARA clinical program in sarcopenia. In 2018,
we completed the enrollment of 218 patients in the SARA-OBS
observational study at sites in Europe (Belgium, Italy and France)
and the U.S., which commenced in 2017. Additionally, we commenced
testing of the safety and efficacy of Sarconeos (BIO101) in an
ongoing global, randomized, multicenter, double‑blind,
placebo‑controlled SARA-INT Phase 2b clinical trial of 334
patients. We currently have 11 sites open in Belgium and the U.S.,
and are primarily focusing our efforts on opening additional sites
to deliver clinical proof-of-concept.
- MYODA clinical program in DMD. In 2018, we
focused on regulatory advancement of our clinical program for
Sarconeos (BIO101) in DMD. We received orphan drug designation from
the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA), and held regulatory and scientific meetings
with the FDA and EMA regarding our clinical plans. Our goal is to
prepare and submit an investigational new drug, or IND, application
to the FDA and clinical trial applications to the applicable
regulatory agencies in Europe in the second half of 2019 to
commence a clinical proof-of-concept trial.
- Increased presence in the U.S. Through our
U.S.-based subsidiary, Biophytis, Inc., we opened offices in
Cambridge, MA. We hired Dr Sam Agus, our Chief Medical Officer, and
Daniel Schneiderman, our Chief Financial Officer to lead our
growing financial, clinical and regulatory operations. We plan to
continue to expand our efforts in the U.S. to support increased
clinical and regulatory activity.
- MACA program for retinal diseases. In 2018, we
focused on preclinical and regulatory development of Macuneos
(BIO201) for dry age-related macular degeneration (AMD). We aim to
advance our regulatory strategy and hold scientific advice meetings
with the applicable regulatory agencies in Europe in the second
half of 2019 regarding clinical development.
About BiophytisBiophytis is a
clinical-stage biotechnology company focused on the development of
novel therapeutics that slow the degenerative processes and improve
functional outcomes for patients suffering from age-related
diseases. Our therapeutic approach targets key biological
resilience pathways that can protect against and counteract the
effects of the multiple biological stresses that lead to
age-related diseases. Our lead drug candidate, Sarconeos
(BIO101), is for the treatment of neuromuscular diseases,
including sarcopenia and Duchenne muscular dystrophy. Our second
drug candidate, Macuneos (BIO201), is for the treatment of retinal
diseases, 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.
DisclaimerThis press release
contains certain forward-looking statements. Although the Company
believes its expectations are based on reasonable assumptions,
these forward-looking statements are not promises or guarantees and
are subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated. For a
discussion of the risks and uncertainties that could cause the
Company's actual results, financial condition, performance or
achievements to differ from those contained in the forward looking
statements, please consult the Risk Factors section of the
Company's registration document and other regulatory filings filed
with the French Autorité des Marchés Financiers (AMF), which are
available on the AMF website (www.amf-france.org) and at
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.
Biophytis Investor Relations
ContactDaniel Schneiderman,
CFO dan.schneiderman@biophytis.com Tel: +1 (857)
220-9720
U.S. Media Contact LifeSci
Public Relations Cherilyn Cecchini,
M.D. ccecchini@lifescipublicrelations.com Tel: +1 (646)
876-5196
Europe Media
Contact Citigate Dewe Rogerson Antoine Denry
antoine.denry@citigatedewerogerson.com Tel: +33 (0) 1 53 32 84
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