Ruvembri

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 30, 2024 / 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 $6 billion in 2023, is projected to reach $100 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 €108 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 €4 million. The contract, set to expire in June 2024, was renewed for two years with a total value of €16 million, allowing the Company to draw €2 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 (amounts in thousands of euros, except share data) 6 months 6 months 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 €4.4 million as of June 30, 2024, compared to €6.5 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 -€1.2 million as of June 30, 2023, to -€1.4 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 €5.7 million as of June 30, 2024, compared to €7.8 million for the same period in 2023. The company’s available cash stood at €2.2 million as of June 30, 2024, compared to €5.6 million as of December 31, 2023. These resources, which include non-dilutive financing obtained during the summer totaling €0.8 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 €2 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 €2 million at the time of the drawdown. It is noted that the current outstanding debt is €2.3 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 (SCWD International 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 . 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 comparable words. These forward-looking statements are based on assumptions that Biophytis considers reasonable. However, there is no guarantee that the forward-looking statements contained in these statements will be accurate, as they 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 significant by Biophytis. Therefore, there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. Please also refer to the “Risks and Uncertainties” section of the Company’s 2023 annual financial report available on the BIOPHYTIS website ( ), and as outlined in the “Risk Factors” section of Form 20-F and other forms filed with the SEC (Securities and Exchange Commission, USA). We do not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future developments, or otherwise, unless required by law. Biophytis Contacts Investor Relations Nicolas Fellmann, Chief Financial Officer Investors@biophytis.com Media Contacts Antoine Denry: antoine.denry@taddeo.fr - +33 6 18 07 83 27 Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50 Consolidated financial statement 12/31/2023 06/30/2024 (amounts in thousands of euros) ASSETS Patents and software 2,637 2,535 Property, plant and equipment 315 275 Property, plant and equipment - right of use 186 160 Other non-current financial assets 158 161 Total non-current assets 3,110 2,970 Other receivables 2,916 3,442 Other current financial assets 368 113 Cash and cash equivalents 5,567 2189 Total current assets 8,850 5,744 TOTAL ASSETS 11,960 8,714 LIABILITIES Capital 2,081 4,203 Additional paid-in capital 13,483 14,062 Own shares (12 ) (9 ) Conversion differences (25 ) (58 ) Reserves - Group share (2,357 ) (18,771 ) Net income - Group share (17,026 ) (5,812 ) Shareholder equity - Group share (3,857 ) (6,385 ) Non-controlling interests (32 ) (33 ) Total shareholder equity (3,889 ) (6,418 ) Staff commitments 237 224 Non-current borrowing 3,247 818 Total non-current liabilities 3,484 1,041 Current borrowings 5,023 8,838 Short-term lease liabilities 54 Provision 223 179 Trade accounts payable 5,392 3,758 Tax and social security liabilities 1,348 940 Current derivative liabilities 1 Other creditors and accrued liabilities 378 322 Total current liabilities 12,365 14,091 TOTAL LIABILITIES 11,960 8,714 Consolidated income statement 06/30/2023 06/30/2024 (amounts in thousands of euros, except share data) 6 months 6 months Revenues - - Cost of sales - - Gross margin - - 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 ) Of which Group share (7,764) (5,812) Of which non-controlling interests - (5 ) Weighted average number of shares outstanding (excluding treasury shares) 818,873 3,499,971 Basic earnings per share (€/share) (9.48 ) (1.66 ) Diluted earnings per share (€/share) (9.48 ) (1.66 ) Note: for comparison purposes, the number of shares used to calculate earnings per share as of 06/30/2023 retrospectively takes into account the reverse stock-split of May 3, 2024 on the basis of one new share for 400 old shares Statement of consolidated comprehensive income 06/30/2023 06/30/2023 6 months 6 months (amounts in thousands of euros) Net income (loss) (7,764 ) (5,817 ) Items not recyclable in the income statement Actuarial gains and losses on post-employment benefits 23 10 Items recyclable in the income statement Conversion difference variation 18 10 Other comprehensive income items 41 20 Comprehensive income (loss) (7,724 ) (5,797 ) Of which Group share (7,724) (5,796) Of which non-controlling interests - (1) Statement of consolidated cash flows 06/30/2023 06/30/2024 (amounts in thousands of euros) 6 months 6 months Cash flow from operating activities Net income (loss) (7,764 ) (5,817 ) Elimination of depreciation on fixed assets 256 148 Provisions, net of reversals (200 ) (64 ) Share-based payment costs 322 515 Gross interest paid 549 547 Change in fair value of convertible bonds 589 236 Discounting / undiscounting advances 12 Amortized cost of convertible and non-convertible bonds 149 Other items without cash impact 760 Cash flow from operating activities before changes in working capital (6,086 ) (3,674 ) (+) Change in working capital (net of impairment of trade receivables and inventories) (2,075 ) (2,278 ) (Increase) decrease in other non-current financial assets 9 (Increase) decrease in other receivables 2,018 122 (3,230 ) (1,574 ) Increase (decrease) in tax and social security liabilities (876 ) (735 ) 4 (91 ) Cash flow from operating activities (8,204 ) (5,951 ) Cash flow related to investment operations Acquisition of intangible assets and property, plant and equipment (90 ) (9 ) Subscription of term deposits classified as other current financial assets (695 ) Decrease (increase) in term deposits classified as other non-current financial assets 8 Cash flow related to investment operations (177 ) (9 ) Cash flow related to financing operations Capital increase 2,303 - Expenses relating to capital increase (339 ) - Exercise of ‘BSA’ warrants and ‘BSPCE’ warrants - 9 Receipt of grants - - Payment of CIR (Research tax credit) pre-financing net of deposit 1,059 164 Payment of repayable advances - Repayment of repayable advances (165 ) (110 ) Gross interest paid (246 ) (547 ) Issue of convertible and non-convertible bonds 1,890 4,000 Repayments of convertible and non-convertible bonds (615 ) (680 ) Repayment of lease liabilities (144 ) (26 ) Bond issue costs (55 ) (220 ) Other cash flows related to financing operations (8 ) Cash flow related to financing operations 3,691 2,582 Impact of exchange rate fluctuations (24 ) Increase (decrease) in cash flow (5,272 ) (3,378 ) Opening cash and cash equivalents 11,053 5,567 End of year cash and cash equivalents 5,782 2,189 1 Yuan 2023, Epidemiology of Sarcopenia, Metabolism; Shafiee 2017, Prevalence of Sarcopenia in the world, Journal of diabetes & metabolic disorders; 2 Marché du traitement de la sarcopénie - Analyse des tendances et de la croissance | Année de prévision 2030 - - SOURCE: Biophytis

PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 11, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, today announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-André Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study. Professor Marc-André Cornier commented: "I am very happy that the IND for the phase 2 OBA clinical study with BIO101 (20-hydroxyecdysone) has been approved by the FDA. It is critical for us to study the safety and efficacy of new therapies designed to reduce the risk of muscle mass loss and resulting muscle weakness with functional consequences that may be associated with incretin-based therapies. Additionally we might observe further weight loss over and above that obtainable with a GLP-1 RA." The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20-hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study. Stanislas Veillet, CEO de Biophytis, stated: "Obesity represents a major medical challenge and a significant growth opportunity for Biophytis. The obesity treatment market, estimated at $6 billion in 2023, is expected to reach $100 billion by 2030, with an average annual growth rate of 42%. Obtaining an IND from the FDA is a crucial step that will enable us to make rapid progress in this indication and attract new pharmaceutical partners. We are convinced that BIO101 could become a reference treatment for preserving muscle mass, strength and function in obese patients treated with GLP-1 RAs. This development has convinced our partner Blanver in Latin America, and we are convinced that it will attract new ones in other regions of the world where obesity is a major health issue." **** About BIOPHYTIS Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular (sarcopenia, phase 3 ready and Duchenne muscular dystrophy, phase 1-2 study to be started, respiratory (Covid-19, phase 2 completed) and metabolic diseases (obesity, phase 2 to be started). The company is based in Paris, France, and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825). For more information, visit Forward-looking statements 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 2023 Financial Report available on BIOPHYTIS website ( ) 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 contacts Investor relations Nicolas Fellmann, CFO Investors@biophytis.com Media Antoine Denry:antoine.denry@taddeo.fr - +33 6 18 07 83 27 Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50 SOURCE: Biophytis View the original press release on accesswire.com