VistaGen Therapeutics (NASDAQ: VTGN) Featured Research Report

16 A EGIS C APITAL C ORP. Market and competition Existing SAD treatment options include non-medication methods such as psychotherapy and support groups, as well as medication including anti-anxiety medications, antidepressants, and beta-blockers. 5 VistaGen has stated that the commercial opportunity for PH94B in the US SAD market is $2.17bn-$3.1bn, citing a commercial assessment from i3 Strategy (Winter 2019). The revenues produced by prescription drugs that serve the SAD, or relate end-markets, are significant. For example, Zoloft, a selective serotonin reuptake inhibitor (SSRI), with a broad label covering MDD, SAD, PTSD, and other conditions saw sales of $3.3bn in 2005. Additionally, Lexapro, an SSRI with a label including MDD, and GAD, saw $3bn of sales in 2011. There are many generics in the broader psychiatry space, including many antidepressants. The existing medication options have pros and cons. For example, the anti-anxiety medications may work quickly, but patients could develop tolerance. The antidepressants may take a long time to work (several weeks or longer), and could have side effects including headaches and nausea. Beta blockers (beta-adrenergic blocking agents) are known to reduce heart rate, open up veins and arteries, and improve bloodflow. 5 These agents block the effects of the hormone epinephrine (adrenaline); brand name example including Sectral, Tenormin, Bystolic, and others. With use in several indications, including outside psychiatry, the relevant indication/use-case here, is in anxiety. According to Anxiety and Depression Association of America’s (ADAA) clinical practice review for Social Anxiety Disorder, first line treatment includes psychotherapy, such as cognitive behavioral therapy (CBT). On average, CBT consists of 15-20 sessions. Aspects of CBT includes psychoeducation about the condition, as well as exposure to feared situations. There are both individual and group CBT settings. 6 Additionally, front-line treatments include pharmacotherapy. Therapies utilized as front-line treatments for SAD include SSRIs and SNRIs. Drugs in this class, approved by the FDA for SAD and other conditions include sertraline (Zoloft), fluvoxamine controlled release, and venlafaxine extended release. Other medications in these classes with evidence of efficacy from randomized controlled trials include citalopram (Celexa), escitalopram (Lexapro), and vilazodone (Viibryd). Fluoxetine (Prozac) has had mixed results in randomized controlled trials. 6 Second-line treatments include variations of CBT. Options may include group therapy, or therapy delivered over the internet. Additionally, mindfulness and acceptance-based therapies may be employed. Further options delineated as psychotherapy delineated as second-line include applied relaxation training, social skills training, interpersonal psychotherapy, psychodynamic psychotherapy. In terms of second-line pharmacotherapy options, another SSRI or SNRI could be employed (e.g. if the patient did not respond to the first-line option). 6 Second-line pharmacotherapy options may also include other antidepressants such as Mirtazapine (e.g. Remeron), Moclobemide (e.g. Amira), Phenelzine (e.g. Nardil). Another option are the Benzodiazepines, such as Clonazepam (Klonopin), alprazolam (Xanax), and bromazepam, although risks of abuse and lack of efficacy for comorbid depression are cited. 6 VistaGen Therapeutics, Inc. October 8, 2020