Latest news with #clinicaldevelopment
National Post
5 days ago
- Business
- National Post
Agenus and Zydus Lifesciences Enter $141M Strategic Collaboration to Advance BOT/BAL, Expand Zydus' Biologics Manufacturing in the US
Article content LEXINGTON, Mass. — Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced it has signed definitive partnership agreements with Zydus Lifesciences Ltd. (NSE: ZYDUSLIFE), including its subsidiaries/affiliates, hereafter referred to as 'Zydus,' designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL). Article content The strategic collaboration includes an exchange of Agenus' state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75M; Agenus to receive up to an additional $50M in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies globally. Agenus will become Zydus' first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen's BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization. Article content Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus' established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries. Article content In a demonstration of mutual commitment, Zydus will also make a strategic equity investment in Agenus by purchasing approximately 2.1 million shares of common stock at $7.50 per share, totaling approximately $16 million in gross proceeds. Agenus intends to apply the net proceeds from the sale of the purchased shares for working capital and general corporate purposes, and will accelerate ongoing clinical development, registration and potential commercialization of BOT/BAL. Article content By uniting Agenus' pioneering research and development capabilities with Zydus' worldwide manufacturing, commercialization and operational strength, this partnership sets the stage for a new era in cancer immunotherapy in India and beyond. Article content 'With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations,' said Dr. Garo Armen, CEO of Agenus. 'There is also a growing recognition by both countries of the need for the United States to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States. The administration has created an environment that has brought these two trading partners together. The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now.' Article content 'We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally. We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer,' said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd. Article content The transaction is subject to customary closing conditions and satisfactory due diligence. The parties aim to complete closing agreements within 60 days. Article content Conference Call and Webcast Article content As part of this effort, Agenus was advised by Biotech Value Advisors (BVA), a strategic advisory firm, which provided guidance on transaction structure, partner selection and negotiations. Article content About Agenus Article content Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Article content About Zydus Lifesciences Article content Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit Article content Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to 'cold' tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Article content Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus' investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit Article content About Balstilimab (BAL) Article content Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Article content Forward-Looking Statements Article content This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words 'may,' 'believes,' 'expects,' 'anticipates,' 'hopes,' 'intends,' 'plans,' 'forecasts,' 'estimates,' 'will,' 'establish,' 'potential,' 'superiority,' 'best in class,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Article content Article content Article content Article content Article content Contacts Article content Article content Article content
Associated Press
21-05-2025
- Business
- Associated Press
Protagonist Therapeutics to Participate in the Jefferies Global Healthcare Conference 2025
NEWARK, CA / ACCESS Newswire / May 21, 2025 / Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will present a company overview at the Jefferies Global Healthcare Conference taking place June 3-5, 2025, in New York, NY. The Company will also participate in one-on-one meetings. Jefferies Global Healthcare Conference - June 3-5, 2025 Format: Company Presentation Day/Time: Wednesday, June 4 at 1:25 P.M. ET Webcast: If you are interested in meeting with the Protagonist team during the conference, please reach out to your Jefferies representative. A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage for one year following the event. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ('IL-23R') which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 [email protected] Media Contact Virginia Amann, Founder/CEO +1 833 500 0061 ext 1 ENTENTE Network of Companies [email protected] SOURCE: Protagonist Therapeutics press release
Associated Press
12-05-2025
- Business
- Associated Press
Pharmaceutical Regulatory Affairs in China - 2 Day Online Training Course (June 25-26, 2025)
DUBLIN--(BUSINESS WIRE)--May 12, 2025-- The 'Pharmaceutical Regulatory Affairs in China Training Course (ONLINE EVENT: June 25-26, 2025)' has been added to offering. Explore the comprehensive landscape of pharmaceutical marketing authorization in China, including Hong Kong, Macau, and Taiwan, through this specialized two-day seminar. This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course will cover: Benefits of attending: Who Should Attend: This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance in this region. You will find this seminar useful both as an introductory or refresher course. Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities. Certifications: Course Agenda: Day 1 General introduction to the PRC and the pharmaceutical market P.R. China - Drug Regulatory Systems P.R. China - Clinical Product Development Hong Kong SAR Macau SAR Day 2 P.R. China - Regulatory Strategies P.R. China - Health Authority Interactions P.R. China - Maintenance Taiwan (Republic of China) P.R China - Recent Developments For more information about this training course visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: ASIA PACIFIC CHINA HONG KONG MACAU TAIWAN INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 05/12/2025 09:46 AM/DISC: 05/12/2025 09:46 AM
Yahoo
12-05-2025
- Business
- Yahoo
AB Science reports its revenues for the year 2024 and provides an update on its activities
PRESS RELEASE AB SCIENCE PRESENTS ITS FINANCIAL INFORMATION AS OF DECEMBER 31, 2024 AND THE KEY EVENTS OF THE PERIOD Financial and corporate situation Operating deficit of 6,1 million euros as of December 31, 2024, down 55% compared to December 31, 2023 Cash position of 8,0 million euros as of December 31, 2024 Clinical development Masitinib platform: Update on the development of masitinib in progressive forms of multiple sclerosis following the ECTRIMS 2024 conference Positive results from the phase 2 study of masitinib in Covid-19 Update on the EMA's decision concerning the application for conditional marketing authorization for masitinib in the treatment of amyotrophic lateral sclerosis Health Canada re-examination procedure Update on the confirmatory programme for neurodegenerative diseases Strengthening the intellectual property of masitinib in mastocytosis Strengthening the intellectual property of masitinib in sickle cell disease Microtubule platform: Update on the AB8939 microtubule program and in in particular on the ability of AB8939 to generate a response on MECOM rearrangement Paris, May 12, 2025, 8am CET AB Science SA (Euronext - FR0010557264 - AB) today reports its revenues for the year 2024 and provides an update on its activities. CLINICAL DEVELOPMENT KEY EVENTS DURING THE YEAR 2024 AND SINCE DECEMBER 31, 2024 Update on the AB8939 microtubule program and in particular on the ability of AB8939 to generate a response on MECOM rearrangement AB Science provided an update on the microtubule program AB8939. AB8939 is a next-generation synthetic microtubule destabiliser and ALDH1/2 inhibitor targeting stem cells with key differentiating factors for the treatment of relapsed/refractory acute myeloid leukaemia (AML). Animal experiments have demonstrated the relevant properties of AB8939 to the treatment of AML The objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) for three different cycles of AB8939. The first stage of Phase 1 was completed with 28 patients enrolled, assessing the maximum tolerated dose after 3 consecutive days of treatment with AB8939. The second stage of phase 1 was nearing completion by 31 December 2024, assessing the maximum tolerated dose after 14 consecutive days of treatment with AB8939. The next step is to assess the maximum tolerated dose after 14 consecutive days of treatment with AB8939 in combination with either venetoclax or azacitidine and in combination with venetoclax plus azacitidine, both of which are widely used in AML and for which AB8939 has shown an additive effect. The MECOM gene is associated with a poor prognosis, with almost all patients dying within 12 months of relapse. AB8939 is an ALDH-targeted stem cell therapy with potential use in AML with MECOM. AB8939 has shown activity against the MECOM gene rearrangement, based on non-clinical and early clinical data, with an observed response rate of 50%. The next steps in clinical development will be discussed with the FDA and the EMA. The first objective is to develop AB8939 in patients suffering from AML with the MECOM gene. The second objective is to position AB8939 in broader forms of AML. The intellectual property rights of AB8939 in AML are guaranteed until 2036 through a 'composition of matter' patent and potentially until 2044 in AML with chromosomal abnormalities, including the MECOM gene, through a 'second medical use' patent. AB Science is the sole owner of AB8939 and its family of compounds. Update on the development of masitinib in progressive forms of multiple sclerosis following the ECTRIMS 2024 conference AB Science provided an update on the development of masitinib in progressive forms of multiple sclerosis (MS), following the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 conference. The development of masitinib in progressive forms of multiple sclerosis is based on the MAXIMS study (AB20009), a randomized, double-blind, phase 3 study of masitinib 4.5 mg/kg/day in patients with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (nSPMS). The recent results of tolebrutinib in non-active secondary progressive MS presented at the ECTRIMS 2024 conference, reinforce the scientific hypothesis that targeting microglia in nSPMS is a valid approach. Tolebrutinib belongs to a class of drugs that target microglia through an enzymatic target called BTK (Bruton Tyrosine Kinase). Masitinib also targets microglia but through a different enzymatic target called M-CSFR1 (Macrophage Colony Stimulating Factor Receptor-1) and generated positive results in phase 2B (AB07002), which are consistent with BTK data. EDSS progression confirmed at 3 months was reduced by 37% with masitinib in study AB07002 and by 23% with tolebrutinib in the Hercules study (although the reduction in study AB07002 did not reach the conventional 5% p-value since the study was not powered to detect a significant effect in this secondary endpoint, having 300 patients in the masitinib 4.5 or placebo arms as compared with 1100 patients in the Hercules trial). EDSS progression confirmed at 6 months was reduced by 32% with masitinib and by 31% with tolebrutinib. Importantly, Masitinib significantly improved manual dexterity measured by 9-hole Peg test, in study AB07002 (-4,28 ; p=0,0388). Masitinib has shown the ability to decrease serum neurofilament light chain (NfL) concentration in an animal model of MS, and by extension therefore, possibly neuronal damage. Masitinib not only targets microglia but also mast cells, which play a crucial role in progressive MS and in the experimental autoimmune encephalomyelitis (EAE) model of MS, as shown by numerous publications. Masitinib benefits from a large safety database with long-term exposure across various indications. In non-oncology indications, around 2,200 patients have received at least one dose of masitinib, more than 1,300 patients have received masitinib for more than six months and close to 1,000 patients have received masitinib for more than one year. As a conclusion, masitinib represents a potential credible alternative to BTK inhibitors in the development of new drugs both in primary and non-active secondary progressive MS. Positive results from the phase 2 study of masitinib in Covid-19 AB Science announced the results of a Phase 2 study evaluating masitinib in COVID-19. This Phase 2 study (AB20001) was designed to evaluate the safety and efficacy of masitinib plus isoquercetin in hospitalized patients with moderate COVID-19 (WHO 7-point ordinal scale level 4) or severe COVID-19 (level 5). The study initially planned to recruit 200 patients (over 18 years of age with no upper age limit). The primary objective was to improve the clinical status of patients after 15 days of treatment, as measured by the WHO 7-point ordinal scale. Following a DSMB recommendation, decision was taken to continue the study only in level 4 patients (i.e. hospitalized patients with oxygen supply <6 L/min with SpO2 maintained ≥92%). The study could not recruit the planned 200 patients. The decision was therefore taken to stop inclusion after 95 patients were randomized. The objective was to detect a trending treatment effect with 95 patients that would translate into a significant effect when simulating the same effect with the planned enrolment of 200 patients. If this objective was reached, then the conclusion would be that it is worth continuing to evaluate masitinib as an agent in the treatment of covid in patients hospitalized with moderate need of oxygen. The study showed an odds ratio of 2.4 in favor of the treatment arm after 15 days of treatment, superior to the odds ratio of 2.2 initially hypothesized, with p=0.038 simulated with 200 patients and p=0.072 detected with 95 patients recruited. Sensitivity analyses at day 12, 13 and 14 with 95 patients recruited displayed a p-value of respectively p=0.016, 0.019, 0.018 and odds ratio 3.2, 3.2 and 3.4. This was due to improvement of certain placebo patients at day 15 but not before. The safety was in line with the known safety profile of masitinib. Update on the EMA's decision concerning the application for conditional marketing authorization for masitinib in the treatment of amyotrophic lateral sclerosis Health Canada re-examination procedure AB Science announced that the European Medicines Agency (EMA) confirmed a negative opinion for the conditional marketing authorization of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), following a vote adopted during the Committee for Medicinal Products for Human Use (CHMP) meeting on 14-17 October 2024. The Conditional Marketing Authorization of masitinib had been under review by the CHMP in response to the company's request for a re-examination of the negative opinion issued in June 2024. Separately, Health Canada recently informed AB Science that key analyses presented for the reconsideration submitted in May 2024 [1], have been considered as new data, rather than re-analyses of existing data. Considering that Health Canada guideline prevent the use of new data as part of the re-examination procedure, AB Science has decided to notify Health Canada it will not pursue the reconsideration. Health Canada has offered the possibility to submit a new application to resolve this issue. Update on the confirmatory programme for neurodegenerative diseases AB Science provided an update on the masitinib platform by indication. Amyotrophic lateral sclerosis: A new confirmatory study AB23005, which simplifies patient recruitment and targets the best responders to masitinib, will be launched in accordance with FDA and EMA recommendations. The study design has been approved by the FDA and the EMA. The confirmatory study has been approved by the FDA. The first AB10015 study generated a strong hypothesis in patients with normal progression and before any loss of function, with a significant survival of +12 months. Long-term follow-up showed that 53% of patients survived beyond 5 years, with a benefit of +36 months compared with the ENCALS prediction. Some patients have survived between 10 and 15 years and continue to receive treatment. Progressive forms of multiple sclerosis. The mechanism of action targeting microglia reinforced after the success of a BTK inhibitor which also targets microglia. Targeting mast cells adds to the efficacy since mast cells activate microglia and directly acts on myelin degradation. Masitinib Hazard Ratio of EDSS progression compared with BTK inhibitor Hazard Ratio published shows that masitinib is competitive, even if the populations are not comparable and the comparison is indirect. Alzheimer's disease. Targeting the innate immune reaction stands out in addition to main strategy with biologics aimed at reducing beta amyloid or Tau protein plaques. Masitinib is the only drug that generated positive results in moderate Alzheimer's Disease. Masitinib could be combined with biologics in early and mild Alzheimer's Disease. More generally, the failure of multiple programs for decades reinforces the value of masitinib approach to target the innate immune reaction through modulation of microglia and mast cells. The unmet medical need in those three indications is immense. The markets are huge with potential sales exceeding billions in each indication. Masitinib IP rights are secured through use patent until 2037 in ALS and up to 2041 in MS and AD, and by orphan drug status in ALS and data protection of 10 years in Europe and 8 years in the USA. Strengthening the intellectual property of masitinib in mastocytosis AB Science announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e. a medical use patent) with masitinib. This new European patent provides intellectual property protection for masitinib in this indication until October 2036. The same medical use patent strategy has been successfully applied in amyotrophic lateral sclerosis, with a worldwide patent granted until 2037, and is being applied in other indications such as multiple sclerosis, Alzheimer's disease for protection until 2041, and in prostate cancer for protection until 2042. Strengthening the intellectual property of masitinib in sickle cell disease AB Science announced that the United States Patent Office has issued a Notice of Allowance for a method patent (i.e. a medical use patent) for the treatment of sickle cell disease with its lead compound, masitinib, based on preclinical results. This new US patent protects masitinib's intellectual property in this indication until November 2040, and further strengthens masitinib's intellectual property, following a Notice of Allowance received from the European Patent Office in October 2024 for the same patent. CONSOLIDATED FINANCIAL INFORMATION FOR THE YEAR 2024 The operating result as of December 31, 2024 was a loss of 6,083 thousand euros, compared to a loss of 13,429 thousand euros as of December 31, 2023, representing a reduction in the operating deficit of 7,346 thousand euros (55%). Operating income consists exclusively of revenue related to the exploitation of a veterinary medicine. Revenue was 10% higher than at 31 December 2023, at 1,072 thousand euros at 31 December 2024 compared with 970 thousand euros a year earlier. Operating expenses decreased by 50%, or 7,244 thousand euros, between the years ended 31 December 2024 and 2023. This change in the 2024 financial year is attributable to the following factors: Cost of sales of 176 thousand euros, mainly due to the effect of changes in inventories relating to the reconstitution of AB8939 product inventories for phase 1 in progress. A 39.5% decrease in marketing expenses (206 thousand euros), reflecting ongoing efforts to control costs. A 62% (6,541 thousand euros) reduction in research and development costs, reflecting ongoing efforts to control costs and seeking of partnerships. Net financial income amounted to a loss of 1,749 thousand euros for the year ended 31 December 2024, compared with income of 1,444 thousand euros for the year ended 31 December 2023. Other financial income amounted to 469 thousand euros, mainly relating to : The change in the fair value of the warrants attached to the EIB loan: a gain of 143 thousand euros The change in the fair value of the ADPEs: a gain of 57 thousand euros Income of 269 thousand euros from the extinguishment of a lease liability (IFRS 16) in connection with the early termination of a contract. Other financial expenses amounted to 994 thousand euros in 2023 compared with 107 thousand euros in 2024, the decrease being mainly due to the reversal of the fair value of the 'share conversion option' component of the bond issue, which generated an expense of 969 thousand euros. As a reminder, at 31 December 2023 other financial income of 1,670 thousand euros related mainly to : The difference between the derecognition of the ADPC debt following their cancellation for 3,692 thousand euros and the recognition of the new E shares, created to replace the ADPCs and with a value of 2,908 thousand euros. This transaction generated net income of 784 thousand euros The change in fair value of the warrants attached to the EIB loan: a gain of 285 thousand euros The change in the fair value of the ADPEs: a gain of 421 thousand euros. These effects have no impact on cash flow. The consolidated net loss as of 31 December 2023 is 7,831 thousand euros compared to a loss of 11,985 thousand euros as of 31 December 2023, a decrease of 35%. The following table summarizes the consolidated financial statements for the year 2024 prepared in accordance with IFRS, and comparative information with the year 2023: In thousands of euros, except for share data 31/12/2024 31/12/2023 Net turnover 1,072 970 Cost of sales and marketing expenses 176 (383) Marketing expenses (316) (522) Administrative expenses (3,079) (3,017) Research and development expenses (3,936) (10,477) Operating income (6,083) (13,429) Financial income 678 4,993 Financial expenses (2,427) (3,549) Financial income (1,749) 1,444 Net income (7,831) (11,985) Other comprehensive income for the period net of tax (7,809) (11,729) Total comprehensive income for the period (0.15) (0.24) Basic earnings per share - in euros (0.15) (0.24) Diluted earnings per share - in euros 1,072 970 In thousands of euros 31/12/2024 31/12/2023 Cash and cash equivalents 7,987 6,066 Total assets 23,175 25,499 Equity (23,754) (21,010) Non-current liabilities 26,496 27,825 Trade payables 10,028 11,075 Current liabilities 20,433 18,683 OTHER CORPORATE INFORMATION FOR YEAR 2024 AND SINCE DECEMBER 31, 2024 Capital increase by private placement for an amount of 5 million euros AB Science has announced a capital increase of 5.0 million euros through the issue of 5,368,725 new ordinary shares, each of which is attached to share subscription warrants. This capital increase was subscribed by qualified European investors. The Capital Increase consisted of a private placement pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code and has been carried out with a waiver of preferential subscription rights, pursuant to the delegation of authority granted to the Board of Directors under the 19th resolution of the Combined General Shareholders' Meeting of June 26, 2024. The Capital Increase has taken the form of the issuance of 5,368,725 new ordinary shares (the 'New Shares') to each of which are attached a share subscription warrant (the 'Warrants'). Two tranches of New Shares have been issued: for the first tranche of 4,294,980 New Shares, two Warrants give right to the subscription of one ordinary share; for the second tranche of 1,073,745 New Shares, three Warrants give right to the subscription of one ordinary share. The Capital Increase is made through a cash contribution of 5.0 million euros. All of the 5,368,725 New Shares and all of the 2,505,405 new shares that would be issued upon exercise of the warrants, i.e. a total of 7,874,130 shares in the Company, represent 13.3% of the Company's current share capital. The issue price of the New Shares has been set at 0.93132 euro (0.01 euro par value and 0,92132 euro of issue premium) and the exercise price of the Warrants at 1.16415 euro, representing a total fundraising of 5.0 million euros (taking into account the exercise of the warrants, the maximum amount of the Capital Increase could be increased to a total amount of 7.9 million euros). The issue price of the New Shares has been calculated based on the volume-weighed average price of AB Science shares over the last three trading days (on Euronext Paris) preceding the price calculation, with a 10% discount. The Warrants may be exercised from November 26, 2026 to December 31, 2028, will be immediately detached from the New Shares upon their issuance and will not be listed. AB Science completed the settlement and delivery of this capital increase. The proceeds of the Capital Increase will provide AB Science with the additional resources necessary to finance its activities over the next twelve months. Subscription by Alpha Blue Ocean of a tranche of one million shares within the framework of the Term Capital Increase Program (PACTTM) The PACT TM program entered into with Alpha Blue Ocean (ABO) was renewed on April 28, 2023 for a period of 24 months. The Board of Directors of AB Science decided to draw down one million shares under this program, on the basis of the 17th resolution of the combined general meeting of shareholders of June 30, 2023 (reserved cash capital increase with waiver of preferential subscription rights). They were subscribed by Alpha Blue Ocean at the end of March 2024 at a price of 2.5701 euros (i.e. the volume-weighted average price of AB Science's shares on Euronext Paris during the three trading sessions preceding the drawdown request). AB Science received the entire proceeds from the issue of the shares subscribed by Alpha Blue Ocean, and 80% of these proceeds were placed in an escrow account. Alpha Blue Ocean is now responsible for selling, in an orderly manner, the subscribed AB Science shares. During the first half of 2024, 377,393 shares were placed. 95% of the sale proceeds (reduced by a structuring fee equal to 3% of the issue price) is paid monthly to AB Science, directly by Alpha Blue Ocean or by drawing on the escrow account referred to above, after deduction of the 20% deposit of the issue proceeds retained by AB Science. In total, over the first half of 2024, these disposals resulted in payments by ABO, net of commission, of 682,181 euros (including the 20% of the issue proceeds initially retained by AB Science). The IFRS accounting treatment of the PACT TM program is detailed in note 13 of the appendix to the half-yearly accounts (impact on equity and debts, cash receipts, amount of the escrow account as of June 30). Coverage initiation by DNA Finance and In Extenso Finance AB Science announced that two financial analysis firms, DNA Finance and In Extenso Finance, have initiated the coverage of the Company. DNA Finance estimates that AB Science stands out as a compelling investment opportunity in the biotech sector. In Extenso has initiated a strong buy opinion on the share. These new coverages aim to strengthen the AB Science visibility among French and international institutional investors and to broaden its investor base. They are in addition to the coverage by Chardan, an investment bank based in the United States and specialized in biotechnologies and health technologies. Partial payments of 2020, 2021 and 2022 research tax credit by the tax administration in 2024, for a total amount of 7,913 thousand euros Confirmation by the Paris Court of Appeal of the acquittal of the CEO of AB Science, Alain Moussy, and reduction of the amount of the financial penalty imposed on AB Science AB Science and the Chairman of the French market regulator (Autorité des Marchés Financiers - AMF) had filed an appeal to the Paris Court of Appeal against the decision of the AMF Sanctions commission, dated March 24, 2022, which acquitted Alain Moussy, CEO of AB Science, for an alleged insider trading and sanctioned AB Science for a failure to comply with some of its communication obligations (as part of the assessment of conditions for a deferral of privileged information publication), as indicated in the AB Science press release of March 29, 2022. The Paris Court of Appeal confirmed the fully acquittal of Alain Moussy and reduced by 200,000 euros the amount of the financial penalty pronounced against AB Science. This amount of 200,000 euros will have to be reimbursed by the French Treasury, as AB Science has paid the full financial penalty initially pronounced by the AMF Sanctions commission on March 24, 2022. Transactions involving securities The balance of 262,704 category C preference shares (the 'ADPC') was repurchased for a symbolic euro by AB Science with a view to their cancellation, in application of the financial restructuring agreement signed on April 21, 2023. During 2024, the following securities were subscribed: 7,722,8993 share warrants, including 5,368,725 warrants as part of the capital increase in September 2024, which may give rise to the creation of 2,505,405 54,000 new shares, including 1,558,953 warrants exercisable at a price of 9.00 euros and subject to the Company entering into a licensing agreement or obtaining marketing authorization for at least two indications and with at least one of its molecules, including 760,894 BSAs subscribed by Meeteam, 19,327 warrants in remuneration of a contributor and 15,000 warrants to directors, 125,000 stock options to Company employees. Finally, in September 2024, 12,539 free shares (AGAP B'), issued one year earlier, were definitively allocated. At its meeting on 3 January 2025, the Board of Directors noted that the stock options and warrants listed below had lapsed, as the exercisability of these securities was conditional on the Company obtaining marketing authorisation for masitinib before 31 December 2024. Securities Name Date granted by the Board of Directors Beneficiary Number of securities BSA BSA 2021-A 28/09/2021 AMY SAS 1.000.000 BSA BSA QN2 28/09/2021 Quercegen 800.000 BSA BSA QN3 28/09/2021 Quercegen 20.000 SO SO2019-A 20/05/2019 Guy, Laurent 274.000 SO SO2019-B 10/07/2019 Guy, Laurent 59.000 On 3 January 2025, the Board of Directors also noted, after reviewing the terms and conditions of the B preference shares (and in particular the operational criteria and the financial performance criteria that must be met for the B shares to be converted into ordinary shares), that out of a total of 45,134 B shares: 37,427 B shares may not be converted into ordinary shares and will therefore be bought back by the Company at their nominal value with a view to their cancellation; and 7,707 B shares may be converted into 419,982 ordinary shares with effect from 1st January 2025. On 17 January 2025, the President of the Paris Business Court opened conciliation proceedings in favour of AB Science for a period of four months, and appointed SELARL AJ UP, represented by Maître Paul-Henri Audras, as conciliator. The task of the conciliator is to negotiate with AB Science's banking partners and to facilitate the release of the CIR2023. The bank debts currently being repaid are PGEs and an innovation loan totalling €3.8 million (at 31 December 2024). AB Science's objective is to concentrate resources on its R&D programme. Finally, the CIR 2023 (also the subject of the conciliation procedure) is for an amount of €3.45 million. In April 2025, 15,000 free shares (AGAP B') were issued. These free shares will be definitively allocated in April 2026. On 28 April 2025, the PACTTM programme was extended identically for a period of 12 months. About AB ScienceFounded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB). Further information is available on AB Science's website: Forward-looking Statements - AB ScienceThis press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB ScienceFinancial Communication & Media Relations investors@ Attachment AB SCIENCE Resultats 2024 VEng VF
Yahoo
12-05-2025
- Business
- Yahoo
AB Science reports its revenues for the year 2024 and provides an update on its activities
PRESS RELEASE AB SCIENCE PRESENTS ITS FINANCIAL INFORMATION AS OF DECEMBER 31, 2024 AND THE KEY EVENTS OF THE PERIOD Financial and corporate situation Operating deficit of 6,1 million euros as of December 31, 2024, down 55% compared to December 31, 2023 Cash position of 8,0 million euros as of December 31, 2024 Clinical development Masitinib platform: Update on the development of masitinib in progressive forms of multiple sclerosis following the ECTRIMS 2024 conference Positive results from the phase 2 study of masitinib in Covid-19 Update on the EMA's decision concerning the application for conditional marketing authorization for masitinib in the treatment of amyotrophic lateral sclerosis Health Canada re-examination procedure Update on the confirmatory programme for neurodegenerative diseases Strengthening the intellectual property of masitinib in mastocytosis Strengthening the intellectual property of masitinib in sickle cell disease Microtubule platform: Update on the AB8939 microtubule program and in in particular on the ability of AB8939 to generate a response on MECOM rearrangement Paris, May 12, 2025, 8am CET AB Science SA (Euronext - FR0010557264 - AB) today reports its revenues for the year 2024 and provides an update on its activities. CLINICAL DEVELOPMENT KEY EVENTS DURING THE YEAR 2024 AND SINCE DECEMBER 31, 2024 Update on the AB8939 microtubule program and in particular on the ability of AB8939 to generate a response on MECOM rearrangement AB Science provided an update on the microtubule program AB8939. AB8939 is a next-generation synthetic microtubule destabiliser and ALDH1/2 inhibitor targeting stem cells with key differentiating factors for the treatment of relapsed/refractory acute myeloid leukaemia (AML). Animal experiments have demonstrated the relevant properties of AB8939 to the treatment of AML The objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) for three different cycles of AB8939. The first stage of Phase 1 was completed with 28 patients enrolled, assessing the maximum tolerated dose after 3 consecutive days of treatment with AB8939. The second stage of phase 1 was nearing completion by 31 December 2024, assessing the maximum tolerated dose after 14 consecutive days of treatment with AB8939. The next step is to assess the maximum tolerated dose after 14 consecutive days of treatment with AB8939 in combination with either venetoclax or azacitidine and in combination with venetoclax plus azacitidine, both of which are widely used in AML and for which AB8939 has shown an additive effect. The MECOM gene is associated with a poor prognosis, with almost all patients dying within 12 months of relapse. AB8939 is an ALDH-targeted stem cell therapy with potential use in AML with MECOM. AB8939 has shown activity against the MECOM gene rearrangement, based on non-clinical and early clinical data, with an observed response rate of 50%. The next steps in clinical development will be discussed with the FDA and the EMA. The first objective is to develop AB8939 in patients suffering from AML with the MECOM gene. The second objective is to position AB8939 in broader forms of AML. The intellectual property rights of AB8939 in AML are guaranteed until 2036 through a 'composition of matter' patent and potentially until 2044 in AML with chromosomal abnormalities, including the MECOM gene, through a 'second medical use' patent. AB Science is the sole owner of AB8939 and its family of compounds. Update on the development of masitinib in progressive forms of multiple sclerosis following the ECTRIMS 2024 conference AB Science provided an update on the development of masitinib in progressive forms of multiple sclerosis (MS), following the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 conference. The development of masitinib in progressive forms of multiple sclerosis is based on the MAXIMS study (AB20009), a randomized, double-blind, phase 3 study of masitinib 4.5 mg/kg/day in patients with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (nSPMS). The recent results of tolebrutinib in non-active secondary progressive MS presented at the ECTRIMS 2024 conference, reinforce the scientific hypothesis that targeting microglia in nSPMS is a valid approach. Tolebrutinib belongs to a class of drugs that target microglia through an enzymatic target called BTK (Bruton Tyrosine Kinase). Masitinib also targets microglia but through a different enzymatic target called M-CSFR1 (Macrophage Colony Stimulating Factor Receptor-1) and generated positive results in phase 2B (AB07002), which are consistent with BTK data. EDSS progression confirmed at 3 months was reduced by 37% with masitinib in study AB07002 and by 23% with tolebrutinib in the Hercules study (although the reduction in study AB07002 did not reach the conventional 5% p-value since the study was not powered to detect a significant effect in this secondary endpoint, having 300 patients in the masitinib 4.5 or placebo arms as compared with 1100 patients in the Hercules trial). EDSS progression confirmed at 6 months was reduced by 32% with masitinib and by 31% with tolebrutinib. Importantly, Masitinib significantly improved manual dexterity measured by 9-hole Peg test, in study AB07002 (-4,28 ; p=0,0388). Masitinib has shown the ability to decrease serum neurofilament light chain (NfL) concentration in an animal model of MS, and by extension therefore, possibly neuronal damage. Masitinib not only targets microglia but also mast cells, which play a crucial role in progressive MS and in the experimental autoimmune encephalomyelitis (EAE) model of MS, as shown by numerous publications. Masitinib benefits from a large safety database with long-term exposure across various indications. In non-oncology indications, around 2,200 patients have received at least one dose of masitinib, more than 1,300 patients have received masitinib for more than six months and close to 1,000 patients have received masitinib for more than one year. As a conclusion, masitinib represents a potential credible alternative to BTK inhibitors in the development of new drugs both in primary and non-active secondary progressive MS. Positive results from the phase 2 study of masitinib in Covid-19 AB Science announced the results of a Phase 2 study evaluating masitinib in COVID-19. This Phase 2 study (AB20001) was designed to evaluate the safety and efficacy of masitinib plus isoquercetin in hospitalized patients with moderate COVID-19 (WHO 7-point ordinal scale level 4) or severe COVID-19 (level 5). The study initially planned to recruit 200 patients (over 18 years of age with no upper age limit). The primary objective was to improve the clinical status of patients after 15 days of treatment, as measured by the WHO 7-point ordinal scale. Following a DSMB recommendation, decision was taken to continue the study only in level 4 patients (i.e. hospitalized patients with oxygen supply <6 L/min with SpO2 maintained ≥92%). The study could not recruit the planned 200 patients. The decision was therefore taken to stop inclusion after 95 patients were randomized. The objective was to detect a trending treatment effect with 95 patients that would translate into a significant effect when simulating the same effect with the planned enrolment of 200 patients. If this objective was reached, then the conclusion would be that it is worth continuing to evaluate masitinib as an agent in the treatment of covid in patients hospitalized with moderate need of oxygen. The study showed an odds ratio of 2.4 in favor of the treatment arm after 15 days of treatment, superior to the odds ratio of 2.2 initially hypothesized, with p=0.038 simulated with 200 patients and p=0.072 detected with 95 patients recruited. Sensitivity analyses at day 12, 13 and 14 with 95 patients recruited displayed a p-value of respectively p=0.016, 0.019, 0.018 and odds ratio 3.2, 3.2 and 3.4. This was due to improvement of certain placebo patients at day 15 but not before. The safety was in line with the known safety profile of masitinib. Update on the EMA's decision concerning the application for conditional marketing authorization for masitinib in the treatment of amyotrophic lateral sclerosis Health Canada re-examination procedure AB Science announced that the European Medicines Agency (EMA) confirmed a negative opinion for the conditional marketing authorization of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), following a vote adopted during the Committee for Medicinal Products for Human Use (CHMP) meeting on 14-17 October 2024. The Conditional Marketing Authorization of masitinib had been under review by the CHMP in response to the company's request for a re-examination of the negative opinion issued in June 2024. Separately, Health Canada recently informed AB Science that key analyses presented for the reconsideration submitted in May 2024 [1], have been considered as new data, rather than re-analyses of existing data. Considering that Health Canada guideline prevent the use of new data as part of the re-examination procedure, AB Science has decided to notify Health Canada it will not pursue the reconsideration. Health Canada has offered the possibility to submit a new application to resolve this issue. Update on the confirmatory programme for neurodegenerative diseases AB Science provided an update on the masitinib platform by indication. Amyotrophic lateral sclerosis: A new confirmatory study AB23005, which simplifies patient recruitment and targets the best responders to masitinib, will be launched in accordance with FDA and EMA recommendations. The study design has been approved by the FDA and the EMA. The confirmatory study has been approved by the FDA. The first AB10015 study generated a strong hypothesis in patients with normal progression and before any loss of function, with a significant survival of +12 months. Long-term follow-up showed that 53% of patients survived beyond 5 years, with a benefit of +36 months compared with the ENCALS prediction. Some patients have survived between 10 and 15 years and continue to receive treatment. Progressive forms of multiple sclerosis. The mechanism of action targeting microglia reinforced after the success of a BTK inhibitor which also targets microglia. Targeting mast cells adds to the efficacy since mast cells activate microglia and directly acts on myelin degradation. Masitinib Hazard Ratio of EDSS progression compared with BTK inhibitor Hazard Ratio published shows that masitinib is competitive, even if the populations are not comparable and the comparison is indirect. Alzheimer's disease. Targeting the innate immune reaction stands out in addition to main strategy with biologics aimed at reducing beta amyloid or Tau protein plaques. Masitinib is the only drug that generated positive results in moderate Alzheimer's Disease. Masitinib could be combined with biologics in early and mild Alzheimer's Disease. More generally, the failure of multiple programs for decades reinforces the value of masitinib approach to target the innate immune reaction through modulation of microglia and mast cells. The unmet medical need in those three indications is immense. The markets are huge with potential sales exceeding billions in each indication. Masitinib IP rights are secured through use patent until 2037 in ALS and up to 2041 in MS and AD, and by orphan drug status in ALS and data protection of 10 years in Europe and 8 years in the USA. Strengthening the intellectual property of masitinib in mastocytosis AB Science announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e. a medical use patent) with masitinib. This new European patent provides intellectual property protection for masitinib in this indication until October 2036. The same medical use patent strategy has been successfully applied in amyotrophic lateral sclerosis, with a worldwide patent granted until 2037, and is being applied in other indications such as multiple sclerosis, Alzheimer's disease for protection until 2041, and in prostate cancer for protection until 2042. Strengthening the intellectual property of masitinib in sickle cell disease AB Science announced that the United States Patent Office has issued a Notice of Allowance for a method patent (i.e. a medical use patent) for the treatment of sickle cell disease with its lead compound, masitinib, based on preclinical results. This new US patent protects masitinib's intellectual property in this indication until November 2040, and further strengthens masitinib's intellectual property, following a Notice of Allowance received from the European Patent Office in October 2024 for the same patent. CONSOLIDATED FINANCIAL INFORMATION FOR THE YEAR 2024 The operating result as of December 31, 2024 was a loss of 6,083 thousand euros, compared to a loss of 13,429 thousand euros as of December 31, 2023, representing a reduction in the operating deficit of 7,346 thousand euros (55%). Operating income consists exclusively of revenue related to the exploitation of a veterinary medicine. Revenue was 10% higher than at 31 December 2023, at 1,072 thousand euros at 31 December 2024 compared with 970 thousand euros a year earlier. Operating expenses decreased by 50%, or 7,244 thousand euros, between the years ended 31 December 2024 and 2023. This change in the 2024 financial year is attributable to the following factors: Cost of sales of 176 thousand euros, mainly due to the effect of changes in inventories relating to the reconstitution of AB8939 product inventories for phase 1 in progress. A 39.5% decrease in marketing expenses (206 thousand euros), reflecting ongoing efforts to control costs. A 62% (6,541 thousand euros) reduction in research and development costs, reflecting ongoing efforts to control costs and seeking of partnerships. Net financial income amounted to a loss of 1,749 thousand euros for the year ended 31 December 2024, compared with income of 1,444 thousand euros for the year ended 31 December 2023. Other financial income amounted to 469 thousand euros, mainly relating to : The change in the fair value of the warrants attached to the EIB loan: a gain of 143 thousand euros The change in the fair value of the ADPEs: a gain of 57 thousand euros Income of 269 thousand euros from the extinguishment of a lease liability (IFRS 16) in connection with the early termination of a contract. Other financial expenses amounted to 994 thousand euros in 2023 compared with 107 thousand euros in 2024, the decrease being mainly due to the reversal of the fair value of the 'share conversion option' component of the bond issue, which generated an expense of 969 thousand euros. As a reminder, at 31 December 2023 other financial income of 1,670 thousand euros related mainly to : The difference between the derecognition of the ADPC debt following their cancellation for 3,692 thousand euros and the recognition of the new E shares, created to replace the ADPCs and with a value of 2,908 thousand euros. This transaction generated net income of 784 thousand euros The change in fair value of the warrants attached to the EIB loan: a gain of 285 thousand euros The change in the fair value of the ADPEs: a gain of 421 thousand euros. These effects have no impact on cash flow. The consolidated net loss as of 31 December 2023 is 7,831 thousand euros compared to a loss of 11,985 thousand euros as of 31 December 2023, a decrease of 35%. The following table summarizes the consolidated financial statements for the year 2024 prepared in accordance with IFRS, and comparative information with the year 2023: In thousands of euros, except for share data 31/12/2024 31/12/2023 Net turnover 1,072 970 Cost of sales and marketing expenses 176 (383) Marketing expenses (316) (522) Administrative expenses (3,079) (3,017) Research and development expenses (3,936) (10,477) Operating income (6,083) (13,429) Financial income 678 4,993 Financial expenses (2,427) (3,549) Financial income (1,749) 1,444 Net income (7,831) (11,985) Other comprehensive income for the period net of tax (7,809) (11,729) Total comprehensive income for the period (0.15) (0.24) Basic earnings per share - in euros (0.15) (0.24) Diluted earnings per share - in euros 1,072 970 In thousands of euros 31/12/2024 31/12/2023 Cash and cash equivalents 7,987 6,066 Total assets 23,175 25,499 Equity (23,754) (21,010) Non-current liabilities 26,496 27,825 Trade payables 10,028 11,075 Current liabilities 20,433 18,683 OTHER CORPORATE INFORMATION FOR YEAR 2024 AND SINCE DECEMBER 31, 2024 Capital increase by private placement for an amount of 5 million euros AB Science has announced a capital increase of 5.0 million euros through the issue of 5,368,725 new ordinary shares, each of which is attached to share subscription warrants. This capital increase was subscribed by qualified European investors. The Capital Increase consisted of a private placement pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code and has been carried out with a waiver of preferential subscription rights, pursuant to the delegation of authority granted to the Board of Directors under the 19th resolution of the Combined General Shareholders' Meeting of June 26, 2024. The Capital Increase has taken the form of the issuance of 5,368,725 new ordinary shares (the 'New Shares') to each of which are attached a share subscription warrant (the 'Warrants'). Two tranches of New Shares have been issued: for the first tranche of 4,294,980 New Shares, two Warrants give right to the subscription of one ordinary share; for the second tranche of 1,073,745 New Shares, three Warrants give right to the subscription of one ordinary share. The Capital Increase is made through a cash contribution of 5.0 million euros. All of the 5,368,725 New Shares and all of the 2,505,405 new shares that would be issued upon exercise of the warrants, i.e. a total of 7,874,130 shares in the Company, represent 13.3% of the Company's current share capital. The issue price of the New Shares has been set at 0.93132 euro (0.01 euro par value and 0,92132 euro of issue premium) and the exercise price of the Warrants at 1.16415 euro, representing a total fundraising of 5.0 million euros (taking into account the exercise of the warrants, the maximum amount of the Capital Increase could be increased to a total amount of 7.9 million euros). The issue price of the New Shares has been calculated based on the volume-weighed average price of AB Science shares over the last three trading days (on Euronext Paris) preceding the price calculation, with a 10% discount. The Warrants may be exercised from November 26, 2026 to December 31, 2028, will be immediately detached from the New Shares upon their issuance and will not be listed. AB Science completed the settlement and delivery of this capital increase. The proceeds of the Capital Increase will provide AB Science with the additional resources necessary to finance its activities over the next twelve months. Subscription by Alpha Blue Ocean of a tranche of one million shares within the framework of the Term Capital Increase Program (PACTTM) The PACT TM program entered into with Alpha Blue Ocean (ABO) was renewed on April 28, 2023 for a period of 24 months. The Board of Directors of AB Science decided to draw down one million shares under this program, on the basis of the 17th resolution of the combined general meeting of shareholders of June 30, 2023 (reserved cash capital increase with waiver of preferential subscription rights). They were subscribed by Alpha Blue Ocean at the end of March 2024 at a price of 2.5701 euros (i.e. the volume-weighted average price of AB Science's shares on Euronext Paris during the three trading sessions preceding the drawdown request). AB Science received the entire proceeds from the issue of the shares subscribed by Alpha Blue Ocean, and 80% of these proceeds were placed in an escrow account. Alpha Blue Ocean is now responsible for selling, in an orderly manner, the subscribed AB Science shares. During the first half of 2024, 377,393 shares were placed. 95% of the sale proceeds (reduced by a structuring fee equal to 3% of the issue price) is paid monthly to AB Science, directly by Alpha Blue Ocean or by drawing on the escrow account referred to above, after deduction of the 20% deposit of the issue proceeds retained by AB Science. In total, over the first half of 2024, these disposals resulted in payments by ABO, net of commission, of 682,181 euros (including the 20% of the issue proceeds initially retained by AB Science). The IFRS accounting treatment of the PACT TM program is detailed in note 13 of the appendix to the half-yearly accounts (impact on equity and debts, cash receipts, amount of the escrow account as of June 30). Coverage initiation by DNA Finance and In Extenso Finance AB Science announced that two financial analysis firms, DNA Finance and In Extenso Finance, have initiated the coverage of the Company. DNA Finance estimates that AB Science stands out as a compelling investment opportunity in the biotech sector. In Extenso has initiated a strong buy opinion on the share. These new coverages aim to strengthen the AB Science visibility among French and international institutional investors and to broaden its investor base. They are in addition to the coverage by Chardan, an investment bank based in the United States and specialized in biotechnologies and health technologies. Partial payments of 2020, 2021 and 2022 research tax credit by the tax administration in 2024, for a total amount of 7,913 thousand euros Confirmation by the Paris Court of Appeal of the acquittal of the CEO of AB Science, Alain Moussy, and reduction of the amount of the financial penalty imposed on AB Science AB Science and the Chairman of the French market regulator (Autorité des Marchés Financiers - AMF) had filed an appeal to the Paris Court of Appeal against the decision of the AMF Sanctions commission, dated March 24, 2022, which acquitted Alain Moussy, CEO of AB Science, for an alleged insider trading and sanctioned AB Science for a failure to comply with some of its communication obligations (as part of the assessment of conditions for a deferral of privileged information publication), as indicated in the AB Science press release of March 29, 2022. The Paris Court of Appeal confirmed the fully acquittal of Alain Moussy and reduced by 200,000 euros the amount of the financial penalty pronounced against AB Science. This amount of 200,000 euros will have to be reimbursed by the French Treasury, as AB Science has paid the full financial penalty initially pronounced by the AMF Sanctions commission on March 24, 2022. Transactions involving securities The balance of 262,704 category C preference shares (the 'ADPC') was repurchased for a symbolic euro by AB Science with a view to their cancellation, in application of the financial restructuring agreement signed on April 21, 2023. During 2024, the following securities were subscribed: 7,722,8993 share warrants, including 5,368,725 warrants as part of the capital increase in September 2024, which may give rise to the creation of 2,505,405 54,000 new shares, including 1,558,953 warrants exercisable at a price of 9.00 euros and subject to the Company entering into a licensing agreement or obtaining marketing authorization for at least two indications and with at least one of its molecules, including 760,894 BSAs subscribed by Meeteam, 19,327 warrants in remuneration of a contributor and 15,000 warrants to directors, 125,000 stock options to Company employees. Finally, in September 2024, 12,539 free shares (AGAP B'), issued one year earlier, were definitively allocated. At its meeting on 3 January 2025, the Board of Directors noted that the stock options and warrants listed below had lapsed, as the exercisability of these securities was conditional on the Company obtaining marketing authorisation for masitinib before 31 December 2024. Securities Name Date granted by the Board of Directors Beneficiary Number of securities BSA BSA 2021-A 28/09/2021 AMY SAS 1.000.000 BSA BSA QN2 28/09/2021 Quercegen 800.000 BSA BSA QN3 28/09/2021 Quercegen 20.000 SO SO2019-A 20/05/2019 Guy, Laurent 274.000 SO SO2019-B 10/07/2019 Guy, Laurent 59.000 On 3 January 2025, the Board of Directors also noted, after reviewing the terms and conditions of the B preference shares (and in particular the operational criteria and the financial performance criteria that must be met for the B shares to be converted into ordinary shares), that out of a total of 45,134 B shares: 37,427 B shares may not be converted into ordinary shares and will therefore be bought back by the Company at their nominal value with a view to their cancellation; and 7,707 B shares may be converted into 419,982 ordinary shares with effect from 1st January 2025. On 17 January 2025, the President of the Paris Business Court opened conciliation proceedings in favour of AB Science for a period of four months, and appointed SELARL AJ UP, represented by Maître Paul-Henri Audras, as conciliator. The task of the conciliator is to negotiate with AB Science's banking partners and to facilitate the release of the CIR2023. The bank debts currently being repaid are PGEs and an innovation loan totalling €3.8 million (at 31 December 2024). AB Science's objective is to concentrate resources on its R&D programme. Finally, the CIR 2023 (also the subject of the conciliation procedure) is for an amount of €3.45 million. In April 2025, 15,000 free shares (AGAP B') were issued. These free shares will be definitively allocated in April 2026. On 28 April 2025, the PACTTM programme was extended identically for a period of 12 months. About AB ScienceFounded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB). Further information is available on AB Science's website: Forward-looking Statements - AB ScienceThis press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB ScienceFinancial Communication & Media Relations investors@ Attachment AB SCIENCE Resultats 2024 VEng VFError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
