Business Description

Overview We are a late clinical-stage therapeutics company focused on developing and potentially commercializing new medicines for patients with social anxiety disorder, depression, menopausal hot flashes, psychomotor impairment due to mental fatigue, and cancer cachexia. Each of the five clinical-stage intranasal pherine product candidates in our neuroscience pipeline has a novel neurocircuitry-focused proposed mechanism of action (MOA) and at least one positive clinical study in its targeted patient population. Leveraging our deep understanding of nose-to-brain neurocircuitry, we have designed our intranasal pherine product candidates are designed to rapidly, specifically and selectively bind to peripheral receptors in human nasal chemosensory neurons and rapidly activate neurocircuits believed to regulate brain areas, without requiring systemic absorption or uptake into the brain to achieve desired therapeutic benefits. Our most advanced intranasal pherine product candidate, fasedienol, is being investigated in a U.S. Phase 3 development program for the acute treatment of social anxiety disorder. Itruvone is being developed for treatment of major depressive disorder, refisolone for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause, PH15 for improvement of psychomotor impairment due to mental fatigue and PH284 for the treatment of cancer cachexia. We are passionate about developing transformative treatment options with potential to meet clear and growing unmet patient needs and delivering long-term value to our stockholders. Our Intranasal Pherine Product Candidates (1) U.S. IND enabling activities are necessary to facilitate further Phase 2 development in the U.S. 1 Table of Contents Fasedienol Overview of Social Anxiety Disorder Social anxiety disorder (SAD) is a highly prevalent, serious, and sometimes life-threatening psychiatric mental health disorder affecting over 30 million adults in the U.S. With onset typically early in life, usually during adolescence, SAD persists for many years thereafter, with a reported mean duration of about 20 years. Individuals with SAD experience extreme anxiety, distress, fear, and impairment due to their fear of being watched, embarrassed, judged, humiliated, negatively evaluated, and scrutinized. The profound acute anxiety associated with SAD often results in avoidance of everyday interactions and opportunities in academic, social and vocational settings, which can lead to impaired personal relationships, unsatisfactory work performance, and substance abuse, significantly impacting various aspects of daily life. Individuals with SAD face an increased risk of serious and life-threatening co-morbid depression, substance abuse, suicidal ideation and suicide. Fasedienol for the Acute Treatment of Social Anxiety Disorder Fasedienol our most advanced neurocircuitry-focused pherine product candidate is in U.S. Phase 3 clinical development for the acute treatment of anxiety in adults with SAD. Fasedienol's proposed MOA is fundamentally differentiated from all FDA-approved anti-anxiety medications. When administered intranasally in microgram-level doses, neurocircuitry-focused fasedienol is proposed to modulate the nasal-limbic amygdala fear and anxiety neurocircuits involved in the pathophysiology of SAD. Fasedienol is pharmacologically active without requiring apparent systemic absorption or uptake into the brain to achieve its rapid-onset anxiolytic effects. Fasedienol also has no observed binding on certain cellular receptors isolated from the brain that are associated with known drug abuse liability potential (for example, dopamine and opiate receptors) which are activated by certain other pharmaceutical compounds used for neuropsychiatric and neurological disorders. Unlike benzodiazepines, data showed that fasedienol has no observed potentiation of GABA-A receptors.…