Auris recently announced the development of the AM-301 nasal spray for protection against SARS-COV-2 (COVID-19) infection (though it is also intended to protect against other airborne pathogens and allergens as well). AM-301 is a gel that would form a protective layer in the nasal mucosa, preventing contact between the pathogen and cells. In vitro data so far suggest contact between AM-301 and COVID-19 reduced the viral load by up to 99%. The company is targeting regulatory submission as an over the counter (OTC) product in 2021.
Part A of the TRAVERS trial of AM-125 in patients with acute vertigo showed a dose dependent improvement in balance in patients (three dose levels were tested, 1mg, 10mg and 20mg three times daily). At the highest dose (20mg), patients receiving AM-125 were able to balance themselves for 6.0 seconds vs 3.1 seconds on placebo 14 days post-surgery. In a separate test where patients were asked to stand on foam, AM-125 patients stood for 10.5 seconds versus 4.3 seconds for those who received placebo. The changes were statistically significant vs baseline.
Following the interim results from part A, the company has selected the two highest doses from part A (10mg and 20mg three times daily) for Part B, which will be testing those doses versus placebo in 72 patients. Improvement in the standing on foam test (2 weeks after surgery) will be the sole primary endpoint while the Tandem Romberg test (6 weeks after surgery) will be the key secondary endpoint.
At the 30mg dose of AM-201 for anti-psychotic induced weight gain, subjects receiving 30mg three times daily in the Phase Ib study showed a 24% reduction in weight gain following treatment with olanzapine at the 28 day time point (2.8kg gained for those taking AM-201 in addition to olanzapine vs 3.7kg weight gain for those only on olanzapine, p<0.02). The company is preparing for a Phase II trial.
We are adjusting our valuation to $127.1m or $17.93 per basic share, from $121.1m or $27.47 per basic share. The total value increased as we rolled forward our NPV though this was partially offset by lower net cash. The per-share value fell due to a higher number of shares outstanding as the company raised capital.