Pathalys Pharma has brought in $105 million via a series B fundraise that the kidney-disease-focused biotech will use to take its lead candidate through the final stages of clinical development.
The company’s primary focus is upacicalcet, a calcimimetic with the potential to improve the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients. Calcimimetics, such as Amgen’s approved SHPT drug Sensipar, mimic calcium's action on tissues in order to treat disorders related to calcium homeostasis or skeletal integrity.
In May, Pathalys launched upacicalcet into two identical 375-person phase 3 trials for SHPT. The common, but serious, complication of chronic kidney disease is often seen in patients on hemodialysis.
Upacicalcet is already approved for SHPT in Japan, where the drug “performed exceptionally well” in late-stage studies, Pathalys said earlier this year.
The new funds will be used to finalize those studies as well as begin the process of preparing an approval submission to the FDA and the “acceleration of preapproval commercialization preparations,” the biotech explained in an Aug. 20 release.
The oversubscribed round was led by TCGX with participation from the likes of 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 were also both involved.
The financing will see three additions to Pathalys’ board, including Joe Siletto, managing partner of J.P. Morgan Life Sciences Private Capital.
“Since our inception, Pathalys has made significant strides toward our goal of delivering a best-in-class treatment for those with end-stage kidney disease (ESKD), including the near completion of two phase 3 clinical trials for upacicalcet,” Pathalys CEO Neal Fowler said in the Aug. 20 release.
“We believe the continued expansion of our syndicate of prominent life science investors, with representative board members, is indicative of the fact that we are on the right path at Pathalys,” Fowler added.
The Research Triangle Park, North Carolina-based biotech previously brought in $150 million in January 2023 via a combination of secured product financing and equity.