A Study of MF101 in Postmenopausal Women

Menopausal women often experience debilitating menopausal vasomotor symptoms and associated
insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are
very effective; however, randomized clinical trials have shown that postmenopausal
combination hormone therapy increases the risks for stroke, cardiovascular events, and
breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms
are therefore needed.

MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a
randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety
and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal
women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe
hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5
g/day and 10 g/day) compared to placebo after 12 weeks of treatment.

Inclusion Criteria (limited):

- Confirmed postmenopausal women aged 40-65

- Provide written informed consent

Exclusion Criteria (limited):

- History of malignancy, with the exception of certain types of skin cancer or cervical
cancer

- Known carrier of BRCA1 or BRCA2

- Abnormal mammogram or breast examination suggestive of cancer within 9 months of
screening

- Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of
fibroids)

- Clinical evidence of active ischemic heart disease, history of cardiovascular
disease, uncontrolled hypertension, or a history of transient ischemic attacks or
cerebrovascular accidents

- History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic
constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or
unexplained weight loss

- Active liver disease or gall bladder disease

- History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV
infection

- Use of prescription medications or herbal/dietary supplements for the treatment of
hot flushes or those with known estrogenic/progestogenic activity within required
wash-out timeframes

- Use of selective receptor modulators (SERMs), aromatase inhibitors,
gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors
(SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or
clonidine within required wash-out timeframes

- Chronic use of morphine or other opiates