Auris Medical Holding AG (NASDAQ: EARS) is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology.
The company is focused on the Phase 3 development of treatments for acute inner ear hearing loss (AM-111) and for acute inner ear tinnitus (Keyzilen®; AM-101) by way of intratympanic administration with biocompatible gel formulations.
EARS recently announced the execution of two share purchase agreements for up to $15.0 million with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor. The share purchase agreements provide great flexibility and the potential to extend the financial runway for the company.
On the operational front, the company continues to make great progress with its clinical-stage pipeline, including the completed enrollment of AM-111 HEALOS trial in acute inner ear hearing loss and the ramp-up of the AM-125 program with intranasal betahistine for Meniere’s disease and other vestibular disorders.
More recently, EARS also completed the recruitment of patients for TACTT3, its pivotal trial with Keyzilen® in Europe. Keyzilen® has the potential to become the first specific pharmacological treatment for patients with inner ear tinnitus and the management look forward to announcing top-line results from TACTT3 early next year.
TACTT3 is a randomized, double-blind, placebo-controlled Phase 3 trial in inner ear tinnitus following traumatic cochlear injury or otitis media. The primary efficacy endpoints for the trial include either the improvement of tinnitus loudness or improvement in Tinnitus Functional Index score. Also, the amended protocol includes certain patient subgroups in confirmatory statistical testing, and the trial size was increased.
Furthermore, EARS is also moving toward initiating a second Phase 1 trial for AM-125, and announcing top-line Phase 3 results from the HEALOS trial. With positive HEALOS results, AM-111 has the potential to become the first-in-class treatment for acute inner ear hearing loss.
Auris Medical has a few major catalysts lined up including phase 3 data releases expected. We expect that action would continue to drive EARS higher during the upcoming periods as the trial initiates and as markets factors in a successful outcome. Several equities research analysts recently issued favorable reports on EARS shares. On average, the consensus target is $4.25 over the medium term.
About the company: Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AGtrade on the NASDAQ Global Market under the symbol “EARS.”
EARS currently have two late-stage development programs: Keyzilen® for the treatment of acute inner ear tinnitus and AM-111 for the treatment of acute inner ear hearing loss. Keyzilen®’s therapeutic time window beyond the acute stage is currently being evaluated as part of the TACTT3 clinical trial in Europe.
Early-stage development programs focus on vestibular disorders (AM-125), a second-generation tinnitus treatment (AM-102) and a treatment for a major rhinology indication (AM-123).
Key Upcoming Milestones:
2nd Quarter 2017 Financial Results:
- Cash and cash equivalents at June 30, 2017, totaled CHF 26.2 million.
- Total operating expenses for the second quarter of 2017 were CHF 6.0 million compared to CHF 9.0 million for the second quarter of 2016.
- Research and development expenses for the second quarter of 2017 were CHF 4.7 million compared to CHF 7.3 million for the second quarter of 2016.
- Net loss for the second quarter of 2017 was CHF 5.4 million, or CHF 0.12 per share, compared to CHF 8.4 million, or CHF 0.25 per share, for the second quarter of 2016.
- The Company continues to expect that its operating expenses in 2017 will be in the range of CHF 28 to 32 million and that existing cash and cash equivalents will enable the funding of operations into the first quarter of 2018.
Upcoming Results: EARS will release their next quarterly earnings announcement on Tuesday, November 28th, 2017.
Key risk factors and potential stock drivers:
- There is the potential upside catalyst for the company and, if news hits press favorably, the stock of the company will be on a growth trajectory. Even if it misses, the subsequent dip in share price will serve as an option to make a position for the eventual upside run.
- Notwithstanding promising data and partnerships, EARS does not have a product yet approved. There is a risk that their potential product candidates might fail during the clinical trials.
- Given the current burn rate, the company might need incremental working capital. Therefore, we might see a near-term raise and subsequent dilution.
- The company may experience financial, regulatory, or operational difficulties, which may impair its ability to commercialize their drug products.
On Monday, November 6th, 2017, EARS closed at $0.728/share, with an above average volume of 455,130.00 shares exchanging hands. Market capitalization is $32.22 million. The current RSI is 35.39
In the past 52 weeks, shares of EARS have traded as low as $0.60 and as high as $1.50
At $0.728, shares of EARS are trading below its 50-day moving average (MA) at $0.770 and below its 200-day MA at $0.799 as well.
The present support and resistance levels for the stock are at $0.66 & $0.80 respectively.
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