PPD is a major depressive disorder that is under diagnosed in the U.S., impacts approximately 1 in 7 women after giving birth. PPD can lead to devastating consequences for a woman, her newborn and her family. Currently, there is no oral therapy approved for the treatmant of PPD. The active moiety in LPCN 1154 is an endogenous positive allosteric modulator of y-aminobutyric acid ("GABAa") receptor. LPCN 1154 is expected to be an "at home" treatment with easier treatment access than the current standard of care invasive option that requires hospitalization with significant limitations. Moreover, LPCN 1154 is expected to provide the required level of privacy for a mother, avoiding bonding/breast feeding interruptions due to the required hospitalizations for the current option.

On June 14, 2021, we announced that the FDA has cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapuetic potential of LPCN 1154 for the treatment of PPD in adults. We recently initiated a pharmacokinetic ("PK") study to aseess dose proportionality with LPCN 1154 with top-line results expected in the third quarter of 2021. Following the PK study, we plan to conduct a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD. We expect the first subject dosed will occur in the fourth quarter of 2021.