On Tuesday, Auris Medical Holding AG (NASDAQ:EARS) gained 2.38% with the overall traded volume of 2.17M shares above its average volume of 646,294.00 shares. The company has the market value of $31.79M and its EPS ratio for the past year was $-0.89. The company finished business at $0.865.
Auris Medical Holding AG (EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, recently offered a business update and declared financial results for the full year ended December 31, 2016.
Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer commented that the company is proud to be leading the charge in the development of new, much-needed therapies for inner ear disorders. “We are moving toward the awaiting Phase 3 results from the AM-111 HEALOS trial for acute inner hearing loss while also moving ahead with Keyzilen®, our late-stage tinnitus program. Furthermore, we are finalizing our plans for AM-125 in Meniere’s disease and vestibular vertigo and look forward to initiating a second Phase 1 trial later this year. With the addition of AM-125, we have built a broad, diverse pipeline of drug candidates that present multiple opportunities for Auris Medical to assist patients.”
Development Program Updates:
AM-111 for Acute Inner Ear Hearing Loss
- Received fast track designation from the FDA for AM-111 in acute sensorineural (inner ear) hearing loss, emphasizing the seriousness of the condition in addition to the unmet medical need.
- Advanced with enrollment in the Phase 3 HEALOS trial, which is being conducted in several European and Asian countries. The trial intends to enroll about 255 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical anticipates completing enrollment in the second quarter of 2017 and declaring top-line results from this trial in the third quarter of 2017.
- Continued ramp-up of the Phase 3 ASSENT trial, which is being conducted in the US, Canada and South Korea. The trial intends to enroll about 300 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical anticipates declaring top-line results from this trial in the second half of 2018.
Keyzilen® (AM-101) for Acute Inner Ear Tinnitus
- Resumed enrollment in the Phase 3 TACTT3 trial, which is being conducted in Europe. The trial previously enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and about 330 patients during the post-acute tinnitus stage (Stratum B). An additional 60 patients are now being enrolled in each stratum. Auris Medical anticipates declaring top-line results from the expanded trial in early 2018.
- Accomplished the AMPACT open-label studies, which assesed the long-term safety of Keyzilen®. Auris Medical anticipates declaring results from these studies in the second quarter of 2017.
AM-125 for Meniere’s Disease and Vestibular Vertigo
- Reached a contract with Otifex Therapeutics Pty. Ltd. to purchase various assets related to intranasal betahistine, counting preclinical and clinical data in addition to certain intellectual property rights. In a Phase 1 trial conducted by Otifex, intranasal betahistine showed good tolerance and a significantly higher bioavailability than stated for oral betahistine administration.
- Under the product code AM-125, Auris Medical is developing betahistine in a spray formulation for the intranasal treatment of Meniere’s disease and vestibular vertigo. Oral betahistine is approved for the treatment of Meniere’s disease and vestibular vertigo and marketed in more than 80 countries worldwide. Auris Medical plans to start a second Phase 1 trial in 2017.
- Extended the AM-102 King’s College London collaboration, which is focused on the discovery of small molecule compounds for a second-generation tinnitus treatment. Auris Medical anticipates choosing a lead compound by year-end 2017.
- Accomplished a public offering of 10,000,000 common shares and 10,000,000 warrants with net proceeds of $9.1 million. The common shares and warrants were sold in units comprised of one common share and one warrant at the price of $1.00 per unit. Each warrant entitles its holder to purchase 0.70 of a common share at the price of $1.20 per share.
- Anne Sabine Zoller, who has served as Auris Medical’s General Counsel since 2015, has decided to leave the Company in the coming months to pursue another opportunity.
Full Year 2016 Financial Results:
- Cash and cash equivalents totaled CHF 32.40M at December 31, 2016, which does not include the $9.10M of net proceeds received from the February 2017 public offering.
- Total operating expenses for 2016 were CHF 30.20M contrasts to CHF 30.90M for 2015.
- Research and development expenses for 2016 were CHF 24.80M contrasts to CHF 26.50M for 2015.
- General and administrative expenses for 2016 were CHF 5.40M contrast to CHF 4.30M for 2015.
- Net loss for 2016 was CHF 30.70M, or CHF 0.89 per share, contrast to CHF 29.70M, or CHF 0.92 per share, for 2015.
Auris Medical anticipates that its operating expenses in 2017 will be in the range of CHF 28.0 to 32.0 million. With the proceeds from the February 2017 offering, the Company’s cash runway has been extended into the first quarter of 2018.
Annual General Meeting:
Auris Medical’s Annual General Meeting will take place in Zug, Switzerland, on April 13, 2017, at 10:00 am CET. At the meeting, the Company will propose the re-election of its current members of the Board of Directors with the exception of Professor Wolfgang Arnold and James I. Healy. The Board of Directors proposes the election of Mats Blom as a new Board member.
Mats Blom is Senior Vice President and Chief Financial Officer (CFO) of Zealand Pharma A/S. Before joining Zealand, he served as CFO of Swedish Orphan International, an orphan drug company attained by BioVitrum in 2009. In addition, Mr. Blom has extensive managerial experience and has held CFO positions at Active Biotech AB and Anoto Group AB. Formerly, he served as a administration consultant at Gemini Consulting and Ernst & Young. Mats Blom holds a BA in Business Administration and Economics from the University of Lund and an MBA from IESE University of Navarra, Barcelona.
“We would like to thank Wolfgang Arnold and James Healy for their great contribution to our Board of Directors,” Thomas Meyer said. “At the same time, we are delighted to propose the election of Mats Blom to our Board of Directors. Mats has built a great track record in key roles with several innovative European biotech and pharmaceutical companies and will provide great support as we advance our clinical-stage programs and move toward commercialization.”
The company has 34.33M shares outstanding and 52.90% shares of the company were owned by institutional investors. The company has 0.00 value in price to sale ratio while price to book ratio was recorded as 1.50. The company earned $-30.30M in prior twelve months on revenue of $0.00. It beta stands at 0.00.
Analyst recommendation for this stock stands at 1.50.