On January 18, 2022, Zosano Pharma Corporation resubmitted its M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”) to the U.S. Food and Drug Administration (FDA) following the Complete Response Letter received on October 20, 2020. In line with the Company's previously disclosed resubmission strategy, the NDA has been resubmitted under Section 505(b)(2) of the Food, Drug, and Cosmetic Act and relies on the FDA's findings of safety and efficacy of ZOMIG® nasal spray (NDA 21-450) (“Listed Drug”). The resubmitted NDA relies primarily on data from the recently completed Phase 1 pharmacokinetic (“PK”) study (CP 2021-001), along with previous PK studies evaluating M207 (CP-2018-002 and CP-2019-002), to establish a PK bridge to the Listed Drug, with the goal of establishing comparative bioavailability to the Listed Drug.

Prior to the resubmission, the FDA provided Zosano with written feedback which, among other things, noted concerns regarding the Company's approach for establishing a PK bridge to the Listed Drug through comparisons across multiple PK studies of M207, particularly Study CP-2019-002, which included PK outliers. Zosano believes that the data provided in its resubmitted NDA demonstrates an adequate bridge to the Listed Drug. With this resubmission that includes additional PK data from CP 2021-001 study, the FDA can evaluate and determine the adequacy of the data package to potentially support M207 approval.