Abivax Announces Trading Resumption of its Ordinary Shares on Euronext Paris
- PARIS, FRANCE / ACCESSWIRE / October 20, 2023 / Abivax SA (Euronext Paris:FR0012333284 - ABVX) ("Abivax" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, announced the trading resumption of its ordinary shares on Euronext in Paris ("Euronext Paris") as from 4:20 p.m. CEST.
- 10/20/2023
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Abivax Announces the Pricing of its Initial Public Offering on the Nasdaq Global Market
- PARIS, FRANCE / ACCESSWIRE / October 20, 2023 / Abivax SA (Euronext Paris:FR0012333284:ABVX) (" Abivax " or the " Company "), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, announced today the pricing of its initial public offering on the Nasdaq Global Market by way of a capital increase of 20,325,500 new ordinary shares (the " New Shares "), consisting of a public offering of 18,699,460 ordinary shares in the form of American Depositary Shares (" ADSs "), each representing the right to receive one ordinary share, in the United States (the " U.S. Offering ") and a concurrent offering of 1,626,040 ordinary shares in certain jurisdictions outside of the United States to certain investors (the " European Private Placement " and together with the U.S. Offering, the " Global Offering "). The offering price was set at $11.60 per ADS in the U.S. Offering and a corresponding offering price of €10.9864 per ordinary share based on an exchange rate of €1.00 = $1.0559 as published by the European Central Bank on October 19, 2023.
- 10/20/2023
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Abivax increases size of Nasdaq uplisting deal
- Abivax S.A. ABVX, -2.53% has increased the size of its global offering to 20.33 million shares from 18.68 million shares as part of its uplisting to the Nasdaq under the ticker symbol “ABVX” from Euronext Paris, according to a filing late Wednesday.
- 10/19/2023
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Abivax Announces the Filing of an Amended Registration Statement, Including an Estimated Initial Public Offering Price Range
- PARIS, FRANCE / ACCESSWIRE / October 18, 2023 / Abivax SA (Euronext Paris: FR0012333284 - ABVX) ("Abivax" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today announced the formal commencement of book-building and the filing of an amended registration statement on Form F-1, including an estimated initial public offering price range, in connection with its intention to issue, subject to market and other conditions, approximately 20,325,500 ordinary shares (including ordinary shares in the form of American Depositary Shares ("ADSs")) of the Company in an initial public offering of ADSs, each representing one ordinary share, in the United States (the "U.S. Offering") and a concurrent offering of ordinary shares in certain jurisdictions outside of the United States (the "European Private Placement", and together, the "Global Offering"). Abivax intends to grant the underwriters (the "Underwriters") a 30-day option to purchase additional ADSs and/or ordinary shares in an aggregate amount of up to 15% of the total number of ADSs and ordinary shares proposed to be sold in the Global Offering.
- 10/18/2023
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Abivax Readies $250 Million U.S. IPO For Drug Pipeline
- Abivax has filed proposed terms to raise $250 million in an IPO to fund the development of its treatment candidates for chronic inflammatory diseases. The company's lead candidate, Obefazimod, is entering Phase 3 clinical trials for Ulcerative Colitis and Phase 2 trials for Crohn's Disease. The global market for treatments for ulcerative colitis is expected to reach $10.25 billion by the end of 2027, providing a significant opportunity for Abivax.
- 10/18/2023
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Abivax Announces the Start of the Roadshow for its Proposed Global Offering and Proposed Nasdaq Listing
- PARIS, FRANCE / ACCESSWIRE / October 16, 2023 / Abivax SA (Euronext Paris: FR0012333284 - ABVX) ("Abivax" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today announced the start of its roadshow in connection with its intention to issue, subject to market and other conditions, 18,675,500 ordinary shares of the Company in an initial public offering of American Depositary Shares ("ADSs"), each representing one ordinary share, in the United States (the "U.S. Offering") and a concurrent offering of ordinary shares in certain jurisdictions outside of the United States (the "European Private Placement", and together, the "Global Offering"). Abivax intends to grant the underwriters a 30-day option to purchase additional ADSs and/or ordinary shares in an aggregate amount of up to 15% of the total number of ADSs and ordinary shares proposed to be sold in the Global Offering.
- 10/16/2023
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U.S. IPO Weekly Recap: Birkenstock Missteps In Public Debut
- U.S. IPO Weekly Recap: Birkenstock Missteps In Public Debut
- 10/14/2023
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Abivax SA Starts U.S. IPO Process
- Abivax SA has filed for a $100 million IPO in the U.S. to raise funds for its pipeline development plans. The company's lead candidate, Obefazimod, is entering Phase 3 clinical trials for Ulcerative Colitis and Phase 2 trials for Crohn's Disease. The global market for treatments for ulcerative colitis is expected to exceed $10 billion by 2027, driving the growth of Abivax's products.
- 10/03/2023
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Abivax reports impressive results in clinical phase 2a trial of
ABX464 as an oral treatment for ulcerative colitis patients
- PARIS--(BUSINESS WIRE)--Regulatory News: Abivax (Euronext Paris: FR0012333284 – ABVX), a biotechnology company harnessing the immune system to develop a functional cure for HIV, as well as treatments for inflammatory/autoimmune diseases and cancer, today announced topline results from its Phase 2a clinical trial, ABX464-101. This clinical trial was conducted in 32 patients for induction treatment of moderate-to-severe ulcerative colitis (UC), refractory to anti-TNF monoclonal antibodies or corticosteroids. In summary, the topline data indicate that ABX464 was safe, well-tolerated, and demonstrated statistically significant efficacy based on both clinical and endoscopic endpoints in this study. The mechanism of action of ABX464 is triggered by an increased expression of miR124, which is a potent anti-inflammatory microRNA. The final 8-week top-line data from this study are as follows: The difference between ABX464 and placebo in colorectal mucosal healing was statistically significant (p2.7 million globally. Pharmaceutical sales for this disease in the major global markets3 are estimated to be around $5.5 billion in 2017. For IBD (inflammatory bowel disease), which includes both ulcerative colitis and Crohn’s disease, the sales in the major global markets are estimated to be around $ 15 Billion for the same period. The financial potential of treatments in the anti-inflammatory space are exemplified by anti-TNF monoclonal antibodies (Humira, Remicade, Simponi) with estimated global annual sales of > $30 billion, including at least $2.5 billion for ulcerative colitis4. “These impressive clinical trial data are indicative of the potential for ABX464’s unique mechanism of action to safely and effectively bring substantial clinical benefit to patients who are not adequately helped by currently available therapeutics and are struggling from the devastating consequences of this inflammatory disease,” said Prof. Dr. Hartmut Ehrlich, M.D., Chief Executive Officer at Abivax. “Based on these exciting results, Abivax will initiate, without delay, a phase 2b dose-ranging study in Europe, with potential input from US KOLs and FDA on study design. Furthermore, these data strongly encourage us to pursue phase 2 clinical trials in other inflammatory indications including Crohn’s disease.” A detailed presentation of these top line results will be run by the Management of ABIVAX during a conference call from 4 to 5 p.m. CEST/10 to 11 am ET on Tuesday, September 4th, 2018 (phone number table appended). About ABX464 Inflammation is a cornerstone of inflammatory bowel disease (IBD), more specifically in ulcerative colitis and Crohn’s disease. When evaluated in a mouse model of IBD, ABX464 demonstrated a long-lasting effect in preventing the typical symptoms of inflammatory colitis, including histological improvements5. A ten-fold increase of miR124, a micro-RNA with potent anti-inflammatory properties in peripheral blood mononuclear cells (PBMCs) was observed. ABX464 was shown to target the cap binding complex (CBC), which is a novel mechanism of action for anti-inflammatory drugs. By ABX464 binding to the CBC, it reinforces the biological functions of this complex in cellular RNA biogenesis including splicing. Therefore, the molecule acts inside injured immune cells to preserve the integrity of newly synthesized RNA. ABX464 enhanced the expression and splicing of a single long non coding RNA to generate the anti-inflammatory miR-124. This work was conducted by the cooperative laboratory between Abivax and the CNRS (Centre National de Recherche Scientifique) in Montpellier, France, headed by Prof. Jamal Tazi. WEBCAST PRESENTATION Abivax senior management will host a webcast and teleconference today at 4:00 pm CET (Paris time) / 10am ET (NYC time), to discuss these clinical results and address questions. Attendees can participate using the following coordinates: Confirmation code : 1766735 To access the presentation: https://edge.media-server.com/m6/p/w9fv6njz The UK local number +44 330 336 9411 should be used as International Dial in number About ABIVAX (www.abivax.com) ABIVAX is mobilizing the body’s natural immune machinery to treat patients with viral infections, autoimmune diseases and cancer. A clinical-stage company, ABIVAX leverages its antiviral and immune enhancing platforms to optimize candidates to cure HIV and treat inflammatory bowel diseases, as well as liver cancer. ABIVAX is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). More information on the company is available at www.abivax.com/en. Follow us on Twitter @ABIVAX_ 1 Company estimate based on GlobalData 2 The partial Mayo Score is composed of stool frequency, rectal bleedings and the physician’s global assessment.of disease severity. 3 The total Mayo score is composed of the 3 parameters listed above, plus mucosal appearance at endoscopy 4 US, Germany, France, Uk, Spain, Italy, Japan 5 Source: Global Data (2017) 6 K Chebli et al., The Anti-HIV Candidate ABX464 Dampens Intestinal Inflammation by Triggering Il-22 Production in Activated Macrophages. Nature Scientific Reports 2017, DOI:10.1038/s41598-017-04071-3 DISCLAIMER This press release contains forward-looking statements, forecasts and estimates with respect to certain of the Company's programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its registration document (Document de Référence). Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. ABIVAX disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction, in particular in France. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgement. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.
- 09/04/2018
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Analysis of Ongoing ABX203 Phase IIb/III Trial in Chronic Hepatitis B
Virus Infection Shows Good Safety, but Primary Endpoint of Study is
Unlikely to Be Reached
- PARIS--(BUSINESS WIRE)--Regulatory News: ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), an innovative company developing anti-viral therapies and immunotherapeutics for infectious diseases like HIV/AIDS, chronic hepatitis B (CHB), chikungunya, ebola as well as an adjuvant to enhance the immune response, today announced that a futility analysis on the primary end-point of its ABX203-002 trial, a Phase IIb/III trial of ABX203 in CHB patients, determined that the trial is unlikely to reach its primary endpoint. The ABX203-002 study is an open-label, randomized, comparative study designed to assess the efficacy of ABX203 to maintain control of the hepatitis B virus after cessation of nucleotide analogs (NUCs), in particular in controlling viral load for a much longer period of time when compared to current treatment options. This study is ongoing in seven Asian/Pacific countries (Taiwan, Hong-Kong, Thailand, Singapore, South Korea, Australia and New-Zealand). In this large scale controlled and randomized study, where 276 subjects were enrolled as of September 2015, one group of patients received ABX203 for 24 weeks, in addition to the current standard of care (nucleoside analogues, NUCs). All therapy was stopped after 24 weeks, and these patients are evaluated against a control group receiving NUCs only. The study’s primary efficacy endpoint is the percentage of subjects with viral load <40 IU/mL at week 48, i.e 24 weeks after the treatment with ABX203 has been completed. An unscheduled futility analysis was initiated because of a recent increase in the patients’ drop out rate related to viral escape. A futility analysis is conducted during an ongoing clinical trial to describe the probability of a study to reach its primary endpoint. The result of this analysis shows that a positive outcome of the study regarding its primary endpoint is unlikely. The Data Safety and Monitoring Board (DSMB) of study ABX203-002 was convened. The DSMB has recognized the good safety profile of ABX203 and recommended that the study should continue as per protocol, to monitor patients 24 weeks post-treatment in order to continue to assess their viral load and to have a comprehensive view of the secondary endpoints. Investigators, health authorities and patients are being informed of the conclusions of the DSMB. In a previous Phase II study, with a different design and carried out in Asia, treatment-naïve patients with chronic hepatitis B were administered ABX203 as monotherapy. That study established a significantly longer period to viral rebound as compared to patients receiving Peg-Interferon Alpha. The future development of ABX203 is under review, including the usefulness of an adjuvant boosting the response to this immunotherapy, as well as new administration schedules and therapeutic combinations that may be evaluated via other preclinical and, potentially, clinical testing. The ABIVAX portfolio includes other product candidates that are progressing to plan. ABX464, which is in development for the treatment of HIV, recently started a second Phase IIa trial after demonstrating its safety and anti-viral properties in the first Phase IIa study earlier this year. The ongoing placebo controlled Phase IIa study ABX464-004 is designed to demonstrate the long-lasting effect of ABX464, which has been observed in preclinical studies. The study is enrolling 28 patients whose HIV infection is already fully controlled by boosted Darunavir; 21 of the patients will be administered ABX464, and seven will receive placebo in addition to their current antiretroviral therapy. After 28 days, all treatment will be discontinued and the primary endpoint will compare the time elapsed until the HIV viral load rebounds in the ABX464-treated patients and the placebo control group. The primary efficacy endpoint measures time to rebound of the viral load. Such rebound is believed to originate from the HIV reservoirs, which are not affected by current combination antiretroviral treatments. Preliminary results of this study are expected in Q4 2016. ABIVAX is leveraging three distinct drug discovery platforms, outlined below: 1) A unique and proprietary anti-viral discovery platform, which ABIVAX used to identify ABX464. ABIVAX also is currently optimizing two small molecule therapeutic candidates, discovered using the platform, which have potential for treatment of chikungunya. Additionally, the anti-viral discovery platform is currently being used to generate additional new chemical entities to treat dengue, RSV and other infectious diseases. 2) An adjuvant discovery platform, used to identify lead adjuvant ABX196, an immune enhancer for infectious diseases and oncology. 3) A hyperimmune platform, currently focused on discovering a novel approach to treating Ebola. Further details regarding these discovery platforms and the exciting molecules that they have produced will be communicated in an R&D day during the second half of this year. ABIVAX senior management will host a conference call to discuss these developments today at 7PM CET/1PM EDT. Following are the dial-in details. From France: +33 (0)1 76 77 22 31From Germany: +49 (0)69 2222 10626From the United Kingdom: +44 (0)203 427 1916From the United States: +1 212 444 0895 Pass code: 8743808 A replay of the conference call will be available for seven days by dialing the following numbers: France: +33 (0)1 74 20 28 00Germany: +49 (0)89 2030 3201United Kingdom: +44 (0)20 3427 0598United States: +1 347 366 9565 Replay Passcode: 8743808 ABIVAX is an innovative biotechnology company in the discovery and development of anti-viral therapeutics and immunotherapeutics to treat some of the world’s most life-threatening infectious diseases, including HIV/AIDS and chronic Hepatitis B. ABIVAX has 2 compounds in clinical stage research: ABX464 a novel first-in-class resistance-proof oral small molecule HIV/AIDS therapy; and, ABX203, an immunotherapy recently approved in Cuba and in late-stage clinical development in other countries that could cure chronic Hepatitis B. ABIVAX also is advancing additional anti-viral compounds and immunotherapeutics that may enter the clinical stage in the coming 18 months. A recently updated corporate presentation, which includes a timeline for the company’s anticipated news flow, is available at www.abivax.com. Follow us on Twitter @ABIVAX
- 06/17/2016
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