BIOPHYTIS (EPA:ALBPS) - Biophytis reports H1 2021 financial results and provides business update

Transparency directive : regulatory news

17/09/2021 08:00

Press release

   Biophytis reports H1 2021 financial results and provides business update

- SARA-INT: Positive top line results of Phase 2 study demonstrate efficacy of
  Sarconeos (BIO101) in sarcopenia and support progress into Phase 3
- COVA: DMC second interim analysis shows efficacy results in the promising
  zone allowing continuation of the phase 2/3 study with Sarconeos (BIO101) in
  COVID-19. Top line results of the full study are expected in Q1 2022
- Manufacturing scale up signed with a major global CDMO to increase potential
  supply of Sarconeos (BIO10) in anticipation of COVA positive results
- Biophytis leadership team reinforced with new senior appointments
- Cash on hand increased to EUR23 million as of June 30th 2021, compared to
  EUR18.8 million as of December 31 2020, following successful IPO on Nasdaq in
  February 2021. In addition, new convertible bond financing of EUR32 million
  signed with Atlas

Paris (France), Cambridge (Massachusetts, U.S.), September 17, 2021, 8:00 am.
CET - Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a
clinical-stage biotechnology company focused on the development of therapeutics
that slow the degenerative processes associated with aging and improve
functional outcomes for patients suffering from age-related diseases, including
severe respiratory failure in patients suffering from COVID-19, today publishes
its interim financial report for the first half of 2021 and provides updates on
key operational developments and financing transactions.

Stanislas Veillet, CEO of Biophytis, said: "During the first half of 2021
Biophytis reached a major milestone with positive results from the SARA-INT
Phase 2 trial, which demonstrated the efficacy of Sarconeos (BIO101) in
sarcopenia. Indeed Sarconeos (BIO101) at the highest dose (350 mg bid) showed a
clinically meaningful improvement in the 400-meter walk test (400MWT), the
primary endpoint of the study. We are now committed to progressing Sarconeos
(BIO101) into phase 3 for this indication either alone or through partnerships
with pharmaceutical companies. Moreover, recommendations from DMC a few days
ago for our COVA study to continue without any modification, based upon
efficacy results in the promising zone following the second interim analysis,
are very encouraging. We hope that Sarconeos (BIO101) will become one of the
first drug candidates able to restore breathing capabilities for hospitalized
patients in severe conditions, and therefore avoiding their admission to ICUs.
The whole Company is now focused on the next milestones, ie complete the trial
as soon as possible, as well as industrial scaling up and regulatory approvals
in Europe, USA and Brazil. We want to be ready for commercialization of our
Sarconeos (BIO101) in COVID-19 first half of 2022.
From a financial perspective, our cash position was strengthened following our
successful IPO in the US market. We also closed a new ORNANE contract with
Atlas up to 32MEUR securing the outlook of the Company's financing."

Income Statement Summary (*)

(amounts in thousands of euros,        For the Half Years Ended June 30,
except share data)                            2020           2021

Research and development, net of
research tax credit                         (5,192)        (7,594)
General and administrative expenses         (2,269)        (2,919)
Operating Loss                              (7,461)       (10,513)
Net financial expense                       (1,999)        (5,352)
Loss before taxes                           (9,460)       (15,865)
Net loss                                    (9,460)       (15,865)
Basic and diluted weighted average
number of shares outstanding            37,211,432    110,680,727
Basic and diluted loss per share
(EUR/share)                                  (0.25)         (0.14)

(*) the interim 2021 consolidated financial statements were subject to limited
review by the Statutory Auditors.

Operational Update

- SARA clinical program in sarcopenia. On August 2, 2021, Biophytis announced
top line results of the SARA-INT phase 2 clinical study with Sarconeos (BIO101)
in Sarcopenia.

Sarconeos (BIO101) at the highest dose (350 mg bid) showed a clinically
meaningful improvement in the 400-meter walk test (400MWT), the primary
endpoint of the study. Sarconeos (BIO101) also showed a very good safety
profile at the doses of 175 mg bid and of 350 mg bid with no Serious Adverse
Events (AE) related to the product.

The results of Sarconeos (BIO101) on the 400MWT as the primary endpoint are
promising since no other alternative treatment exists as of today. This paves
the way towards an upcoming confirmatory phase 3 study in sarcopenia and allows
further development of Sarconeos (BIO101) in this indication.

This is a key milestone for Biophytis after 15 years of research and
development with Sorbonne University.

- Phase 2/3 COVA study for acute respiratory failure associated with COVID-19.
On September 10 2021, the Data Monitoring Committee (DMC) recommended to
continue the Phase 2-3 COVA study without any modification of the protocol
after the Interim Analysis 2 found efficacy results in the promising zone,
based on 155 COVID-19 patients hospitalized with respiratory failure. This
recommendation completes previous safety evaluation performed by DMC last
August that confirmed the good safety profile of Sarconeos (BIO101).

As of September 15, 35 clinical centers are opened to recruit COVID-19 patiens
in the USA, Brazil, France and Belgium. 200 patients are randomized in COVA
trial to this date.
15 additional sites will be opened to accelerate recruitment in USA, Brazil,
France, UK and Belgium, where the COVA study is already approved.
With this new network of 50 sites, top line results of the study are expected
in Q1 2022, depending on the evolution of the pandemic.

On June 30, 2021, Biophytis announced it had secured contracts with a major
global Custom Development and Manufacturing Organization (CDMO) for the
manufacturing of registration batches of Sarconeos (BIO101). These contracts
were signed in preparation of the potential filing of the product in COVID-19
for Emergency Use Authorization with the FDA, and/or Conditional Marketing
Authorization with the EMA.

- MYODA clinical program in Duchenne muscular dystrophy (DMD). Following
Biophytis' receipt of the Investigational New Drug Application obtained from
the FDA and authorization from the Belgian authorities in early 2020, the study
was delayed due to the COVID-19 pandemic.

Biophytis now intends to resume preparations for launching the MYODA phase 1/2
clinical trial of Sarconeos (BIO101) in Duchenne muscular dystrophy, which will
now be initiated in 2022, depending on the evolution of the pandemic.

- New senior appointments reinforce Biophytis' leadership teams. On July 8,
2021, Biophytis announced the appointment of Claude Allary as Board member.
Claude Allary has 40 years of experience with pharmaceuticals industries and
was co-founder of Bionest Partners.
The Company also hired new experienced healthcare executives:
   - Benoit Canolle, was appointed Chief Business Officer. Benoît brings
     extensive background in R&D and business development, mostly from Sanofi
     and Pierre Fabre,
   - Rob van Maanen MD, MBA, FFPM, was named new Chief Medical Officer. Rob was
     previously CMO of Khondrion, a Dutch clinical-stage company, and has held
     several senior positions, leading Medical Affairs in numerous global
     pharma companies: Astellas, Eisai, Novartis and Organon.

The appointment of these highly experienced healthcare executives strengthens
Biophytis' leadership teams at an important time in the development of the
Company.

Financial update

- Nasdaq IPO successfully closed in February 2021. On February 12, 2021,
Biophytis closed its announced initial public offering (IPO) 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 fees and estimated offering expenses
payable by the Company. Since February 10, 2021, Biophytis ADSs are listed on
the Nasdaq Capital Market (US trading ticker: BPTS).

- New convertible bond financing signed with Atlas. On June 18, 2021, Biophytis
announced a new ORNANE contract with Atlas Capital for EUR32 million (the "2021
Atlas Contract"). This line of financing can be drawn by Biophytis over the
next three years, without obligation, through 8 successive tranches of EUR4
million each. This facility will allow to secure the Company treasury in order
to continue the development of its clinical activities, in particular the
further development of Sarconeos (BIO101).

Interim 2021 Financial Results

- Cash and Cash Equivalents. Cash and cash equivalents as of June 30, 2021 were
EUR23 million, an increase of EUR4.7 million as compared to EUR18.3 million as
of December 31, 2020, and an increase of EUR10.8 million vs EUR12.2 million as
of June 2020.
During the 1st half of 2021, cash used in operating activities and investing
activities amounted to EUR-0.9 million, compared to 0 last year. Cash provided
by financing activities amounted to EUR18.1 million for the first half of 2021,
compared to EUR5.8 million last year.

- Research and Development Expenses. Net research and development expenses were
EUR7.6 million for the 1st half of 2021, an increase of EUR2.4 million as
compared to EUR5.2 million for the 1st half of 2020. This increase was
primarily related to the advancement of our lead drug candidate, Sarconeos
(BIO101), in the COVA phase 2-3 program, and activities related to the final
completion of our SARA- INT phase 2 program.

- General and Administrative Expenses. General and administrative expenses were
EUR2.9 million for the 1st half of 2021, an increase of EUR0.6 million as
compared to EUR2.3 million for the 1st half of 2020 linked to our Nasdaq
listing.

- Financial loss. Our financial loss increased from EUR2.0 million last year to
EUR5.4 this year. reflecting the accrual of financial costs incurred by
Biophytis following the execution of the judgment rendered on July 16, 2021, by
the Paris Judicial Court in the proceedings between Biophytis and Negma Group
Ltd.

- Net Loss. Net loss was EUR15.9 million for the 1st half of 2021, as compared
to EUR9.5 million for the 1st half of 2020. In addition to clinical costs
ramping up linked to our COVA development, net loss was highly impacted by
financial loss (re above). Net loss per share (based on weighted-average number
of shares outstanding over the period) was EUR0.14 for the 1st half of 2021 and
EUR0.25 for the 1st half of 2020.

The cash and cash equivalents available as of June 30, 2021, amounted to EUR23
million. 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.

The share capital of Biophytis is comprised of 125 762 242 ordinary shares
outstanding as of September 16, 2021.

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 ordinary shares are listed on Euronext Growth (Ticker: ALBPS - ISIN:
FR0012816825) and ADSs (American Depositary Shares) 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. 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. 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. Please also refer to the "Risk and uncertainties the Company is to
face" section from the Company's 2020 Annual Report available on BIOPHYTIS
website (www.biophytis.com) and as exposed in the "Risk Factors" section of
form 20-F as well as other forms filed with the SEC (Securities and Exchange
Commission, USA). 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
Investors@biophytis.com

Media contact
Life Sci Advisors
Sophie Baumont
E: sophie@lifesciadvisors.com
T: +33 6 27 74 74 49

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BIOPHYTIS (EPA:ALBPS) - Biophytis reports H1 2021 financial results and provides business update

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