BIOPHYTIS (EPA:ALBPS) - Biophytis Reports 2020 Full Year Results

Transparency directive : regulatory news

26/02/2021 08:00

Press release

                 Biophytis Reports 2020 Full Year Results

Paris, France, Cambridge (Massachusetts, United States), February 26, 2021 -
8am CET - Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS),
("Biophytis" or the "Company"), a clinical- stage biotechnology company focused
on the development of therapeutics that are aimed at slowing the degenerative
processes associated with aging and improving functional outcomes for patients
suffering from age-related diseases, including severe respiratory failure in
patients suffering from COVID-19, today announces its non-audited financial
results for the year ended December 31, 2020, and provides updates on key
operational developments and financing transactions.

* Major milestones achieved during 2020

* Launch of the phase 2-3 COVA trial assessing Sarconeos (BIO101) as a
  potential treatment for acute respiratory failure linked to COVID-19
o global, multicenter, double-blind, placebo-controlled, group-sequential and
  adaptive design two-part Phase 2-3 study approved in 5 countries: the US,
  Brazil, France, Belgium and the UK
o Patient enrollment for Part 1 completed with 50 patients, and trial moving to
  Part 2 following approvals from certain Regulatory Authorities
o Interim Analysis of Part 1 expected in Q1 2021 and results from the full
  study (Part 1 and Part 2) expected in Q2 2021, subject to any delays in
  patient recruitment or retention, interruptions in sourcing or supply chain,
  regulatory authorizations and procedures, COVID-19-related delays, and the
  impact of the current pandemic
* Treatment completed for the last patient in the Phase 2 SARA-INT trial for
  the treatment of sarcopenia. Top-line results expected in Q2 2021
* Successful completion of four private placements, strengthening significantly
  company financial resources, with total cash and cash equivalents and other
  current financial assets amounting to EUR18.8 million as of December 31, 2020

* Successful IPO on Nasdaq Capital Market closed on February 12, 2021 for total
  gross proceeds of $20.1 million

Stanislas Veillet, President and CEO of Biophytis, said: "2020 marked a turning
point for Biophytis. Four successful private placements have allowed us to
strengthen our financial situation in order to enter a new and exciting phase
in the development of the company. At the same time, we have been making strong
progress in clinical operations. We are proud to participate in the world fight
against SARS-CoV-2 through the launch of COVA, our phase 2-3 study assessing
Sarconeos (BIO101) as a potential treatment for patients with severe
respiratory manifestation of COVID-19. The study is now entering Phase 3 in
Brazil, the United States, France and Belgium, and full results are expected in
Q2 2021. Our last patient completing last visit in the SARA-INT Phase 2 trial
in sarcopenia is also an important milestone, and we look forward to top-line
results which are also expected in Q2 2021."

The Company's annual 2020 non-audited consolidated financial statements
prepared in accordance with IFRS were reviewed by the Company's Board of
Directors on February 23, 2021. Audit procedures are being completed, the
issuance of the audit report is pending, and will be included in the Company's
upcoming 2020 annual financial report and SEC Form 20-F.

Annual 2020 Financial Results

* Cash and cash equivalents and other current financial assets. Cash and cash
equivalents and other current financial assets as of December 31, 2020 were
EUR18.8 million, an increase of EUR12 million compared to EUR6.8 million as of
December 31, 2019.

During 2020, cash used in operating activities was EUR9.9 million. Cash used in
investment activities was EUR12.7 million, of which EUR12.5 million are linked
to fixed term deposit contracts. These uses were offset by EUR22.1 million of
cash provided by financing activities.

* Research and Development Expenses. Net research and development expenses were
EUR9.9 million for 2020, an increase of EUR0.8 million, or 9%, compared to
EUR9.1 million for 2019. This increase is mainly linked to the launch of the
COVA program. In parallel, SARA-INT, our Phase 2 trial in Sarcopenia is
progressing. Patients recruitment was completed in March 2020, and the last
dosing of our last patient was achieved in December 2020.

Net research and development expenses included research tax credits (French
'Crédit Impôt Recherche', or CIR) and other subsidies totaling EUR3.3 million
in 2020 compared to EUR2.8 million in 2019.

* General and Administrative Expenses. General and administrative expenses were
EUR4 million for 2020 compared to EUR6.6 million for 2019, a decrease of EUR2.6
million, or 39%. This significant decrease was primarily linked to the fees and
expenses incurred in 2019 in connection with our attempted listing on Nasdaq,
and to cost reduction efforts related to personnel and structure expenses in
2020 compared to 2019.

* Net Loss. Net loss was EUR17.1 million for 2020, as compared to EUR17.8
million for 2019. Net loss per share (based on weighted-average number of
shares outstanding over the period except the treasury shares) was EUR0.28 in
2020 compared to EUR1.05 in 2019.

The table below summarizes the non-audited operating results.

(amounts in thousands euros, except for share data)     2019           2020
Net
Research and Development expenses                     (9 089)        (9 921)
General and administrative expenses                   (6 593)        (4 021)
Operating loss                                       (15 682)       (13 942)
Net financial loss                                    (2 134)        (3 112)
Loss before tax                                      (17 816)       (17 054)
Income tax                                                28             -
Net loss                                             (17 788)       (17 054)
Non diluted weighted average number of
shares outstanding, except treasury shares        16 882 661     59 974 486
Basic and non diluted loss per share (EUR/action)      (1,05)         (0,28)

Summary of operational events (more details are provided in the corresponding
press releases available on Biophytis's website: www.biophytis.com)

Launch of the Phase 2-3 COVA study in patients with severe respiratory
manifestation of COVID-19

* In May 2020, Biophytis received approval from the Belgian Federal Agency for
  Medicines and Health Products (FAMHP), to proceed with its clinical
  development program COVA, a two-part study assessing Sarconeos (BIO101) in
  patients aged 45 and older, hospitalized with severe respiratory
  manifestations followingCOVID-19 infection;
* Biophytis received approvals for COVA from the UK Medicines Healthcare
  Products Regulatory Agency (MHRA) in June 2020, from the United States Food
  and Drug Administration (FDA) and the French Health Authority (ANSM) in July
  2020 and the Brazilian Health Regulatory Agency (ANVISA) in August 2020;
* In August 2020, the first participant for Part 1 of the study was enrolled in
  Belgium;
* In October 2020, the first US and Brazilian patients were enrolled in COVA,
  with clinical centers opened and ready to recruit in Belgium, France, Brazil
  and the US. In December 2020, the first patient was enrolled in France;
* In February 2021, authorization for patient recruitment for Part 2 of COVA
  was obtained from regulatory authorities in Brazil, the United States, France
  and Belgium. Part 2 of COVA is a Phase 3 pivotal randomized study
  investigating the safety and efficacy of Sarconeos (BIO101) on the
  respiratory function from 310 COVID-19 patients (including the 50 patients
  from Part 1 of the study).
* The Company expects to report full results (For Part 1 and Part 2) in Q2
  2021, subject to any delays in patient recruitment or retention,
  interruptions in sourcing or supply chain, regulatory authorizations and
  procedures, COVID-19-related delays, and the impact of the current pandemic.

SARA clinical program in sarcopenia :

* In March 2020, due to COVID-19, Biophytis adapted the protocol of SARA-INT to
  allow patient follow up to take place at home, based on guidelines from
  regulators, including the U.S. FDA;
* In March 2020, Biophytis completed enrolment of the 233 patients into
  SARA-INT;
* In December 2020, the last patient in SARA-INT completed his final
  on-treatment visit;
* Biophytis expects to report top-line data from SARA-INT in Q2 2021, subject
  to any delays in patient recruitment or retention, interruptions in sourcing
  or supply chain, regulatory authorizations and procedures, COVID-19-related
  delays, and the impact of the current pandemic.

MYODA clinical program in Duchenne Muscular Dystrophy (DMD):

* After an IND ''may proceed'' letter from the FDA (USA)in December 2019, in
  March 2020 Biophytis received approval from the Belgian FAMHP to proceed with
  its clinical investigation of Sarconeos (BIO101) in non-ambulatory patients
  with DMD.
* Depending on the evolution of the pandemic and its impact on our operational
  capabilities, the MYODA study is expected to start in H1 2021.

Financing

1/ Debt financing: Replacement of the convertible ORNANEBSA from Negma by the
convertible ORNANE from Atlas:

In April 2020, the Company secured a new line of financing of EUR24 million
from Atlas Special Opportunities LLC, a specialized investment fund based in
New York (United States) providing for the issuance of 960 3- year note
warrants. The 960 3-year note warrants require their holder to exercise them,
at our request, in tranches of 120 warrants each. Each warrant grants its
holder the right to one ORNANE. The ORNANE have a par value of EUR25,000.

In April 2020, the Company formerly notified NEGMA Group LTD of its decision to
terminate the contract signed in August 2019. The Negma agreement provided for
up to EUR24 million in financing through the issuance of multiple tranches of
convertible notes with attached warrants. This termination has led to
litigation between Negma and Biophytis, and legal proceedings are ongoing.

2/ Equity raising:

In 2020, the Company successfully raised capital through several
transactions:

- Public offering of share subscription warrants:
In April 2020, the Company closed a public offering of warrants to purchase
ordinary shares, allowing shareholders registered as of April 8, 2020 to
benefit from a non-negotiable and non-transferable subscription priority period
and then new shareholders, to subscribe for warrants to purchase ordinary
shares. Demands exceeded three times the number of available warrants. A total
of 7,475,708 warrants were subscribed for total proceeds of EUR448 thousand.

- Private placement transactions :
The Company successfully closed four private placement transactions which
strengthened significantly its equity position.
In February, June, July and October 2020, the Company issued shares to
institutional investors totaling EUR3.3 million, EUR4 millions, EUR6.1 million
and EUR10 million, respectively, and for a total of EUR23.4 million.

Appointments:
In January 2020, Biophytis appointed Evelyne Nguyen as Chief Financial Officer
in replacement of Daniel Schneiderman.

2021 Outlook:

Programs:
The COVA study: The full results (Part 1 and Part 2) are expected in Q2 2021.
Subject to any COVID-19 related delays, the Company anticipates applying for
Emergency Use Authorization from FDA, and Conditional Market Approval from EMA
in Q2 2021.

The SARA -INT study: Following the last visit completion of the last patient in
December 2020, the Company is preparing to release top-line results of this
Phase 2 trial during Q2 2021.

The MYODA study: Depending on the evolution of the COVID-19 pandemic, the
Company is intending to start in H1 2021 the Phase 1-3 MYODA trial.

These plans remain subject to any delays in patient recruitment or retention,
interruptions in sourcing or supply chain, regulatory authorizations and
procedures, COVID-19-related delays, and the impact of the current pandemic.

Nasdaq IPO:
On February 12, 2021, the Company closed its previously announced initial
public offering on the Nasdaq Capital Market by way of a capital increase of
12,000,000 ordinary shares represented by 1,200,000 American Depositary Shares
("ADSs"), with each ADS representing 10 ordinary shares, at a price of $16.75
per ADS. Total gross proceeds were approximately $20.1 million. The Company
received net proceeds of approximately $16.35 million or EUR13.5 million, after
deducting underwriting discounts and commissions, management fee and estimated
offering expenses payable by the Company. Since February 10, 2021, Biophytis
ADSs are listed on Nasdaq Capital Market (US trading ticker: BPTS)

Coronavirus Statement
We are closely monitoring how the spread of COVID-19 is affecting our
employees, business, preclinical and clinical studies. As part of our COVID-19
pandemic response, most of our employees have transitioned to working remotely
and travel has been restricted. During the pandemic, we instructed our
employees to work remotely as much as possible except for essential and
required activities that needed to be performed in laboratories. Such access
and work must comply with social distancing and other local government and
facility requirements and policies were implemented during initial and
subsequent waives of COVID-19. While we have substantially completed enrollment
dosing of Sarconeos (BIO101) in our SARA-INT study, limitations on in-office
visits due to study site closures during the initial COVID-19 wave required
adaptation of the study protocol including closing on-site activities,
organizing patient follow-ups to take place at home, and expanding treatment
from six to nine months for some patients. All such changes to the protocol
were submitted to, reviewed and approved by reviewing IRBs. Despite these
impediments, the last patient completed his final on treatment visit in
December 2020.
However, the impact of continued and prolonged disruptions caused by the
COVID-19 pandemic may result in further difficulties or delays in initiating,
enrolling, conducting or completing our ongoing and planned clinical trials,
which could result in additional unforeseen costs. The impact of COVID-19 on
our future clinical research and development progress will largely depend on
future developments of the pandemic. These future COVID-19 developments are
highly uncertain and cannot be predicted with confidence, and include issues
such as: the rate and ultimate geographic spread of the disease; the duration
of the pandemic; travel restrictions and social distancing requirements in the
U.S., Brazil, the UK, France and other countries; business disruptions and
closures; impact on financial markets and the global economy; and the
effectiveness of actions taken to contain, treat and prevent the disease.

                                     * * * *

About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specialized in the
development of therapeutics that are aimed at slowing the degenerative
processes associated with aging and improving functional outcomes for patients
suffering from age-related diseases, including severe respiratory failure in
patients suffering from COVID-19. Sarconeos (BIO101), our leading drug
candidate, is a small molecule, administered orally, being developed as a
treatment for sarcopenia in a Phase 2 clinical trial in the United States and
Europe (SARA-INT). It is also being studied in a clinical two-part Phase 2-3
study (COVA) for the treatment of severe respiratory manifestations of COVID-19
in Europe, Latin America, and the US. A pediatric formulation of Sarconeos
(BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy
(DMD). 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), and ADSs are listed on Nasdaq Capital Market
(Ticker BPTS - ISIN: US09076G1040). For more information visit
www.biophytis.com

Disclaimer
This press release contains forward-looking statements. Forward-looking
statements include all statements that are not historical facts. In some cases,
you can identify these forward-looking statements by the use of words such as
"outlook," "believes," "expects," "potential," "continues," "may," "will,"
"should," "could," "seeks," "predicts," "intends," "trends," "plans,"
"estimates," "anticipates" or the negative version of these words or other
comparable words. These forward-looking statements include statements regarding
Biophytis' anticipated timing for its Interim Analysis of Part 1 and release of
full study results. Such forward- looking statements are based on assumptions
that Biophytis considers to be reasonable. However, there can be no assurance
that the statements contained in such forward-looking statements will be
verified, which are subject to various risks and uncertainties including,
without limitation, delays in patient recruitment or retention, interruptions
in sourcing or supply chain, its ability to obtain the necessary regulatory
authorizations, COVID-19-related delays, the impact of the current pandemic on
the Company's clinical trials and other risks described in our filings with the
U.S. Securities and Exchange Commission. The forward-looking statements
contained in this press release are also subject to risks not yet known to
Biophytis or not currently considered material by Biophytis. Accordingly, there
are or will be important factors that could cause actual outcomes or results to
differ materially from those indicated in these statements. In France, please
also refer to the "Risk Factors" section of the Company's Annual 2019 Report
and the Company's Half Year 2020 Report available on BIOPHYTIS website
(www.biophytis.com). We undertake no obligation to publicly update or review
any forward-looking statement, whether as a result of new information, future
developments or otherwise, except as required by law.

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

Media contact
LifeSci Advisors
Sophie Baumont/Chris Maggos/John Hodgson
E: sophie@lifesciadvisors.com
T: +33 6 27 74 74 49

Investor Relations
LifeSci Advisors, LLC
Sandya von der Weid
E: svonderweid@lifesciadvisors.com
T: +41 78 680 05 38

BIOPHYTIS's latest news

14/05/2024 07:00

BIOPHYTIS (EPA:ALBPS) - Biophytis Reports 2020 Full Year Results

Transparency directive : regulatory news

BIOPHYTIS's latest news

Other stories