Second Nasdaq compliance notice adds to Auris’ woes

Nasdaq
Nasdaq previously wrote to Auris about its failure to meet the minimum bid price.

Nasdaq has hit Auris Medical with another noncompliance notice. The stock exchange has given Auris until Oct. 2 to meet the stockholders’ equity requirement, a few days more than it has to regain compliance with the minimum bid price rule.

Zug, Switzerland-based Auris received the latest note after Nasdaq noticed its stockholders’ equity had sunk to $5.6 million (€4.7 million) as of the end of June. That puts Auris well below the $10 million it needs to comply with the requirements of the Nasdaq Global Market. Auris has about 5 weeks to meet the requirement, otherwise its listing may move to the Nasdaq Capital Market.

By then, another compliance issue may already have forced Auris off the main Nasdaq exchange. Nasdaq wrote to Auris in March after the minimum bid price of the ear disease specialist fell below $1 for 30 consecutive days. Auris has until Sept. 26 to put together a run of 10 days in which its closing bid price tops $1. The stock closed at $0.65 yesterday.

Auris’ share price has fallen a long way from the $6 a piece it commanded at the time of its 2014 IPO, let alone the $10 to $12 it initially hoped to raise in the Nasdaq listing. The biotech’s decline was gradual for its first two years on public markets, over which time it slipped about $2. But the situation deteriorated quickly this time last year when Auris disclosed a phase 3 failure.

The study found that AM-101, also known as Keyzilen, failed to beat placebo in terms of improving tinnitus loudness and burden. 

Bruised by the setback, Auris amended the protocol for another trial of the drug to make change in tinnitus functional index an alternative primary efficacy endpoint. The change gives Auris a way to put a positive spin on the phase 3 trial even if, like the earlier study, it fails to meet its original primary endpoint. But it also pushed back the forecast completion date from late 2016 to early 2018.  

Those data will arrive too late to deliver the stock boost Auris needs to regain compliance with the Nasdaq requirements. But together with data from two phase 3 trials of AM-111 in acute inner ear hearing, they form part of a window running from the fourth quarter of this year through the first half of 2018 that will dictate whether Auris has a future.