A Study of NT-814 in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

This is a multi-centre, multi-country, double-blind, randomised, placebo-controlled Phase 2b
study. The study will have a single-blind run-in period and will be adaptive with respect to
the number of subjects recruited into each dose group.

Four doses of NT-814 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a
day) will be investigated and compared to placebo, in five parallel groups.

Subjects will participate in the study for a total of approximately 19 weeks, comprising a
screening period of 1 week, a 14 week treatment period, and then a final follow up visit 4
weeks after the end of the treatment period. There will be a total of 8 visits whilst
participating in the study.

Subjects will record their hot flashes in an electronic diary during the screening period to
establish eligibility and throughout the study after randomisation.

Key Inclusion Criteria:

- Postmenopausal

- Body mass index between 18 and 38 kg/m2, inclusive

- Subject has experienced an average of at least 7 moderate or severe hot flashes per
day (including night-time) for the last 7 days recorded using an electronic diary

Key Exclusion Criteria:

- Inability to comply with the use of prohibited and allowed medications as described in
the protocol.

- Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12
months of Screening.

- Any clinically significant prior or ongoing history of arrhythmias, either determined
through clinical history or on ECG evaluation.

- Any clinically significant abnormal laboratory test result(s) measured at Screening.

- Any active ongoing condition that could have caused difficulty in interpreting
vasomotor symptoms such as: infection that could have caused pyrexia,
pheochromocytoma, hyperthyroidism, carcinoid syndrome, alcohol abuse.

- Uncontrolled hypertension.

- A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at
Screening. Treated hypothyroidism with normal thyroid function test results at
Screening is acceptable.