Auris Medical Holding AG (NASDAQ: EARS) focuses on the development of novel products for the treatment of inner ear disorders. Its product candidates include AM-101, which is in phase III clinical development for the treatment of acute inner ear tinnitus; and AM-111 that is in phase III clinical development for the treatment of acute inner ear hearing loss.
EARS shares were up 50% in intra-day trading on October 8th as an analyst initiated coverage with a “buy” rating and a price target far above the current price. Trading volume exceeded 15X the average daily volume.
August 30, 2018. Auris Medical Holding AG (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental disorders supportive care, announced feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) related to the development plan and regulatory pathway for AM-111, its investigational treatment for sudden sensorineural hearing loss. The Type C meeting had been requested by the Company following the results of the HEALOS phase 3 trial. https://ir.aurismedical.com/news-releases/news-release-details/auris-medical-receives-fda-guidance-type-c-meeting-am-111
Auris is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the treatment of antipsychotic-induced weight gain and somnolence (AM-201). This program is currently in Phase 1.
In addition, Auris Medical has two Phase 3 programs under development: AM-111 for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. AM-111 has been granted orphan drug status by the FDA and the EMA.
Auris Medical Holding AG, a clinical-stage biopharmaceutical company, focuses on the development of novel products for the treatment of inner ear disorders. Its product candidates include AM-101, which is in phase III clinical development for the treatment of acute inner ear tinnitus; and AM-111 that is in phase III clinical development for the treatment of acute inner ear hearing loss. The company is also developing AM-125 for the treatment of vestibular disorders; and other pre-clinical stage products comprising AM-102 and AM-123. It has a collaboration and license agreement with Xigen S.A. to develop, manufacture, and commercialize pharmaceutical products, as well as drug delivery devices and formulations for local administration of therapeutic substances to the inner ear for the treatment of ear disorders. The company was formerly known as Auris Medical AG and changed its name to Auris Medical Holding AG in April 2014. Auris Medical Holding AG was founded in 1998 and is headquartered in Zug, Switzerland.
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1 Wall Street analysts have issued ratings and price targets for Auris Medical in the last 12 months. Their average twelve-month price target is $2.50, suggesting that the stock has a possible upside of 278.79%. The high price target for EARS is $2.50 and the low price target for EARS is $2.50. There are currently 1 buy rating for the stock, resulting in a consensus rating of “Buy.”
Date Brokerage Action Rating Price Target
10/8/2018 Eurobank EFG Initiated Coverage Buy ➝ Buy $2.50
Second Quarter 2018 Financial Results
EARS is a clinical stage company and has not yet generated revenue.
Cash and cash equivalents at June 30, 2018 totaled CHF 4.4 million.
Total operating expenses for the second quarter of 2018 were CHF 3.1 million compared to CHF 6.0 million for the second quarter of 2017.
Research and development expenses for the second quarter of 2018 were CHF 2.0 million compared to CHF 4.7 million for the second quarter of 2017.
General and administrative expenses for the second quarter of 2018 were CHF 1.1 million compared to CHF 1.2 million for the second quarter of 2017.
Net loss for the second quarter of 2018 was CHF 3.1 million, or CHF 0.50 per share, compared to CHF 5.4 million, or CHF 1.22 per share, for the second quarter of 2017.
The Company continues to expect that its operating expenses in 2018 will be in the range of CHF 10 to 12 million.
Stock influences and risk factors
Continuing positive data from the company’s clinical trials may act as a catalyst for their shares.
They are a development-stage company and have a limited operating history and a history of operating losses.
They may need substantial additional funding. If they are unable to raise capital when needed, they could be forced to delay, reduce or eliminate product development programs or commercialization efforts.
Clinical drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes.
On Monday, October 8, 2018, EARS shares were at $.70 per share on traded volume of 28.9 million shares. The current RSI (14) is 80.51
At $.70, EARS shares are trading above their 50 DMA of $.31 and below their 200 DMA of $1.72
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