DJ Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities
Biophytis / Key word(s): Half Year Results
Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities
30-Sep-2024 / 23:00 CET/CEST
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Biophytis Publishes First-Half Financial Results
and Provides an Update on its Business Activities
Paris (France) and Cambridge (Massachusetts, USA), September 30, 2024 - 11:00pm CET - Biophytis SA (Euronext Growth
Paris: ALBPS) ("Biophytis" or the "Company"), a clinical-stage biotechnology company focused on developing treatments
for age-related diseases, publishes today its financial results for the first half of 2024 and provides an update on
the company's key achievements.
Stanislas Veillet, CEO of Biophytis, commented:
"We are particularly pleased with the progress made in the first half of 2024. The launch of our clinical program OBA
for obesity, addressing a major public health issue, and our partnership with Blanver to develop BIO101 in Latin
America, are key milestones that demonstrate Biophytis' ability to innovate and capitalize on market opportunities.
We are now entering a critical phase where the results of our clinical trials, especially in the obesity field, along
with our continued strategy of regional pharmaceutical partnerships, particularly in Asia, could significantly
transform the company's future.
Despite the ongoing challenges in financial markets, the Company has been able to extend its bond financing line, and
is actively working on recapitalization solutions to support its future growth."
Key Highlights for the First Half of 2024:
Launch of a new obesity program with BIO101 (20-hydroxyecdysone): In April 2024, Biophytis announced the launch of its
OBA program targeting obesity with BIO101 (20-hydroxyecdysone). The global market for obesity treatments, valued at USD6
billion in 2023, is projected to reach USD100 billion by 2030, with an average annual growth rate of 42%. Biophytis is
positioned to capitalize on this trend with BIO101, the first oral MAS receptor activator, already recognized for its
beneficial effects on muscle mass and fat mass regulation in preclinical models. A phase 2 clinical trial for the OBA
program, involving 164 patients with obesity, is set to begin in the second half of 2024. Results from this pivotal
study are expected by the end of 2025 and could pave the way for new therapeutic options for millions of patients
struggling with obesity.
Exclusive Licensing Agreement with Blanver for Latin America: In June 2024, Biophytis entered into an exclusive
licensing agreement with Blanver, a leading pharmaceutical player in Latin America, for the registration and
commercialization of BIO101 across all its current indications: sarcopenia, obesity, COVID-19, and Duchenne muscular
dystrophy. This strategic partnership could generate up to EUR108 million in revenue for Biophytis through milestone
payments and sales-based royalties. The first phase of the agreement involves regulatory submissions in several key
Latin American countries at the beginning of 2025.
Expansion of Financing Capabilities: During the first half of 2024, Biophytis leveraged its bond financing line with
Atlas through a new issuance of EUR4 million. The contract, set to expire in June 2024, was renewed for two years with a
total value of EUR16 million, allowing the Company to draw EUR2 million every 40 trading days. This amendment provides the
Company with a bond financing facility, complementing equity financing or non-dilutive funding options.
Financial highlights:
06/30/2023 06/30/2024
6 months 6 months
(amounts in thousands of euros, except share data)
Research and development costs, net (3,763) (2,105)
General and administrative expenses (2,761) (2,285)
Operating income (6,524) (4,390)
Financial expenses (795) (1,545)
Financial income 143 121
Change in fair value of convertible bonds (589) (3)
Net financial income (1,240) (1,427)
Profit before tax (7,764) (5,817)
Income tax - -
Net income (loss) (7,764) (5,817)
Biophytis' operating result shows a loss of EUR4.4 million as of June 30, 2024, compared to EUR6.5 million a year earlier. External expenses have significantly decreased, particularly in R&D activities. This change is explained by the completion of clinical trials for the COVA and SARA programs in the first half of 2023, along with substantial internalization of regulatory and clinical work associated with the launch of the OBA obesity program initiated in April 2024, as well as a global reduction in overhead expenses.
The financial result decreased from -EUR1.2 million as of June 30, 2023, to -EUR1.4 million as of June 30, 2024, mainly driven by expenses related to convertible and non-convertible bond borrowings with Atlas Capital and Blackrock (formerly Kreos Capital).
The net loss amounts to EUR5.7 million as of June 30, 2024, compared to EUR7.8 million for the same period in 2023.
The company's available cash stood at EUR2.2 million as of June 30, 2024, compared to EUR5.6 million as of December 31, 2023. These resources, which include non-dilutive financing obtained during the summer totaling EUR0.8 million (including Bpifrance subsidies and partial pre-financing of the 2024 CIR), are expected to fund operations until the end of October 2024. Drawing a new EUR2 million tranche from the bond facility with Atlas Capital could extend the cash horizon until the end of 2024. This drawdown is conditional upon the outstanding debt with Atlas, which must not exceed EUR2 million at the time of the drawdown. It is noted that the current outstanding debt is EUR2.3 million.
Outlook and Next Steps
The Company will continue in 2024 and 2025 with its value creation strategy focused on the development of its therapeutic innovations.
Based on its financing capabilities, the Company plans to advance its drug candidate BIO101 (20-hydroxyecdysone) through proof of concept in humans, demonstrating tolerance and efficacy in a phase 2 study across two indications: obesity and Duchenne muscular dystrophy. For its sarcopenia and severe COVID-19 programs with BIO101, the Company will actively seek co-development partnerships based on the positive results already achieved in terms of efficacy and safety.
-- OBA Program - Development of BIO101 for Obesity
The Company plans to initiate the Phase 2 OBA study in the second half of 2024, in the United States, with potential additional centers in Europe. Preliminary results on the efficacy of BIO101 are expected by the end of 2025.
-- MYODA - Development of BIO101 for Duchenne Muscular Dystrophy (DMD)
The Company plans to start a phase 1/2 OBA study in non-ambulant DMD patients in 2025.
-- SARA (development of BIO101 in sarcopenia) and COVA (development of BIO101 in severe forms of COVID-19)programs
Over the past few years, the Company has achieved significant results in terms of efficacy, particularly in patients with sarcopenia and severe forms of COVID-19, while demonstrating good tolerance in these fragile patients. The next development steps for the SARA and COVA programs will require long and costly Phase 3 studies, for which the support of a pharmaceutical partner will be necessary through co-development and licensing agreements.
Following the agreement with Blanver in June 2024 for Latin America, Biophytis is now focusing its search for potential partners in the Asia region. Sarcopenia is a widespread condition in this region, particularly in China and Japan. In these two countries, nearly 38 million people over the age of 65 suffer from sarcopenia[1], and this population is expected to grow by over 5% per year through 2030[2], making it an especially attractive target market.
Upcoming events:
-- October 2, 2024: European Midcap Event - Paris
-- December 6-8, 2024: International Conference on Sarcopenia, Cachexia, and Wasting Disorders (SCWDInternational Conference) - Washington DC, USA
About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start, and Duchenne muscular dystrophy, Phase 1-2 to be started), respiratory diseases (COVID-19, Phase 2-3 completed), and metabolic disorders (obesity, Phase 2 to be started). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company's ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). For more information, visit www.biophytis.com.
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