Cerenis Therapeutics, Inc.

Shares in Abionyx Pharma rose around 15% in early trading in Paris. Abionyx Pharma has hailed the success of a phase 2a clinical trial designed to resurrect a cholesterol drug that first flamed out almost a decade ago. But with the French biotech yet to share numbers from the study, it is unclear whether the mimic of HDL cholesterol has a future in the treatment of septic patients. Cerenis Therapeutics originally developed the drug candidate, CER-001, as a treatment for cardiovascular diseases. The wheels came off between 2014 and 2018 when the prospect failed to move the needle in phase 2 and 3 trials of patients with acute coronary disease, post-acute coronary syndrome and genetic HDL deficiency. Cerenis rebranded as Abionyx in 2019 and shifted its focus to other indications.  A phase 2a clinical trial in septic patients at high risk of developing acute kidney injury is an early test of the pivot. Abionyx said CER-001 cleared the test—but the data-devoid statement published by the biotech makes it impossible for outsiders to fully gauge how the candidate performed in the trial. According to Abionyx, the study met its primary objective. The EU clinical trial registry lists the co-primary endpoints of the trial as determination of the optimal dose and the onset and severity of acute kidney injury. The study’s lead investigator noted the “trend observed in reducing renal damage” in a statement to disclose the results.  Abionyx also noted “positive results” on secondary endpoints. The biotech reported a “significant effect” on endotoxin removal and “consequent reduction in the inflammatory cascade,” plus a “significant protective effect … on endothelial functionality” and trends toward fewer ICU days, lower requirement for organ support and improved 30-day survival.  Safety was reportedly in line with the results of a COVID-19 trial that read out last year. Abionyx is yet to say when it will present the full data set but did outline plans to discuss the results with regulators, first in Europe and later in the U.S., “to design an appropriate clinical and regulatory development strategy for this disease state.” Abionyx will need to secure funding for further development. The biotech ended September with just 3.8 million euros ($4.1 million) to its name. Shares in Abionyx rose around 15% in early trading in Paris, climbing to 2.22 euros per share.

TOULOUSE, France & ANN ARBOR, MI--(BUSINESS WIRE)-- Cerenis Therapeutics (Cerenis), a biopharmaceutical company specializing in the research and development of novel therapies based on HDL (“good” cholesterol) to treat cardiovascular and other metabolic diseases, announced today it has raised a further €10 million in a second close of its Series C financing. This takes the total funds raised in the Series C to €50 million and the total equity investment raised to date by the Company to €117 million. The latest €10 million came from the group IRDI-IXO (€2.5 million each) and undisclosed international private investors. These investors join an impressive shareholder base alongside first close new investor, Strategic Investment Fund (FSI), which invested €20 million, and all historic investors: Sofinnova Partners, HealthCap, Alta Partners, TVM Capital, EDF Ventures, OrbiMed and DAIWA Corporate Investment who invested the remaining €20 million. The first close was announced in July this year. Jean-Louis Dasseux, co-founder and CEO of Cerenis said: "We are delighted to close this additional Series C financing. Cerenis is now well positioned to continue its growth and HDL program development. ” This financing will fund Phase II development of the lead Cerenis program, CER-001, an HDL-mimetic for the treatment of cardiovascular disease; it will also support the development of other new HDL therapies. Overall, the investment supports Cerenis’ objective to bring major innovative breakthroughs to one of the main areas of need in human health. CER-001, Cerenis’ lead product, is being developed to rapidly regress atherosclerotic plaque, and is currently targeted for patients with Acute Coronary Syndrome. CER-001 has the potential to be the first and best in class recombinant HDL mimetic and a novel approach to treating cardiovascular disease and atherosclerosis, which remains the leading cause of death and morbidity worldwide. About Cerenis Cerenis Therapeutics is a pharmaceutical company focused on the discovery, development and commercialization of breakthrough HDL therapies for the treatment of cardiovascular and metabolic diseases. Based on pioneering research conducted by Cerenis' team of world leaders in HDL therapy, the company is pursuing a range of HDL product candidates that are positioned to represent major advances in patient care and significant commercial opportunities in the treatment of cardiovascular and metabolic diseases. Cerenis has raised over €117 million in venture financing and has operations in Toulouse, France and Ann Arbor, Michigan. For more information please visit: About IXO Private Equity and IRDI IXO Private Equity is a private equity firm managing FCPR and FIP and advises IRDI. IXO invests in Venture Capital, LBO and Capital Development. Founded 30 years ago and located in Toulouse, IXO is the most important French regional independent actor in private equity managing 300 m€. It invests from 0,5 m€ to 10 m€ by target company in the West and South of France.