Pathalys secures $105M Series B for FDA approval of Japan-approved kidney drug

Pathalys Pharma, based in Research Triangle Park, North Carolina, has successfully raised $105 million through a series B funding round. This kidney-disease-focused biotechnology company intends to utilize the funds to advance its leading candidate, upacicalcet, through the concluding stages of clinical development. The primary aim is to enhance the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing hemodialysis.

Upacicalcet is a calcimimetic, meaning it mimics the action of calcium on tissues to treat conditions related to calcium homeostasis and skeletal integrity. Amgen's Sensipar, a drug approved for SHPT, operates on a similar mechanism. In May, Pathalys initiated two phase 3 clinical trials for upacicalcet, enrolling 375 patients each. The trials target SHPT, a common but significant complication affecting patients with chronic kidney disease, especially those receiving hemodialysis.

Japan has already approved upacicalcet for SHPT, and according to Pathalys, the drug has shown outstanding performance in late-stage studies conducted there. The newly acquired funds will be channeled into finalizing these clinical trials and preparing for an FDA approval submission. Additionally, the company plans to accelerate preapproval commercialization activities.

The recent funding round was oversubscribed and led by TCGX, with contributions from prominent investors such as J.P. Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, and JPS Growth Investment Limited Partnership. Pathalys' co-founders, Catalys Pacific and DaVita Venture Group, also participated in the round.

The influx of funds will also result in new additions to Pathalys' board, including Joe Siletto, the managing partner at J.P. Morgan Life Sciences Private Capital. Pathalys CEO Neal Fowler expressed optimism about the company's progress, stating that since its inception, Pathalys has made significant advancements towards offering a top-tier treatment for end-stage kidney disease (ESKD). Fowler emphasized the importance of the continued support from prominent life science investors, affirming that this backing indicates Pathalys is on the right path.

Earlier in January 2023, Pathalys had secured $150 million through a blend of product financing and equity. This substantial prior funding, combined with the recent $105 million, underscores the robust financial backing and investor confidence in the company's potential to innovate in the treatment of kidney disease.