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Net cash inflow of $13.4 million from recent registered direct offering and warrant exercises
AM-301 program progressing towards clinical and regulatory milestones
Strategy review ongoing
Hamilton, Bermuda, December 15, 2020 – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today provided a business update related to the Company’s funding position, its AM-301 program for the protection against airborne pathogens and allergens and the ongoing strategy review process.
Significant change in funding position
On December 2, 2020, the Company entered into securities purchase agreements with several institutional investors for the purchase and sale of 2,000,000 common shares at an offering price of $4.00 per share, pursuant to a registered direct offering. The net proceeds of the offering, which closed on December 4, 2020, were approximately $7.3 million. In addition, certain investors in the May 2019 financing of common shares and warrants exercised warrants for 1,263,845 common shares at the exercise price of CHF 4.34 (approximately $4.82) per share, for net proceeds of CHF 5.5 million. Taken together, these two transactions provided net proceeds of approximately $13.4 million to the Company.
Further progress with AM-301 program
The Company’s AM-301 program for the development of a drug-free nasal spray for protection against airborne pathogens and allergens, is progressing towards important milestones. The Company’s affiliate Altamira Medica Ltd. is planning to conduct a clinical investigation of AM-301 with human volunteers in an allergen challenge chamber in Europe. Subject to approval by the relevant Ethics Committee, the study is expected to start in the first quarter 2021 and to conclude within approximately 3 months. The Company expects to meet the requirements for CE marking, a prerequisite for commercializing AM-301 in Europe, in the second quarter of 2021. Further, Altamira Medica has requested guidance from the FDA on the proposed product development plan, the applicable regulatory pathway, as well as the potential eligibility for Emergency Use Authorization of AM-301 for use against SARS-CoV-2.
Strategy review ongoing
On September 17, 2020, the Company announced that its Board of Directors had initiated a review of strategic options with the objective of unlocking the potential of its assets and maximize shareholder value. Following the review of various scenarios and opportunities, the Board has entered into discussions with a number of parties about certain potential transactions. At this point, there can be no assurance the Company’s strategy review will result in the completion of any particular course of action, and there is no defined timeline for completion of the review process.
“We are very pleased about the recent capital raises which have significantly strengthened our cash and equity position“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We estimate that our cash runway now extends to the end of 2021 or into early 2022, thus covering a period during which we expect to reach important milestones. These include the read-out from the Phase 2 clinical trial with AM-125 in acute vertigo and readiness for commercialization of our AM-301 nasal spray for the protection against airborne pathogens and allergens.”
AM-301 is a drug-free nasal spray for personal protection against airborne pathogens and allergens. Upon application into the nose, AM-301 forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or other pathogens and allergens with cells; in addition, the composition serves to “trap” such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory infections and promote alleviation of allergic symptoms. In an in vitro model of reconstituted human nasal epithelia infected with SARS-CoV-2, daily treatment with AM-301, beginning right before inoculation, showed effective protection against viral infection. 48 hours post-infection, average virus titers were 90.0% lower than those observed in controls (p<0.01). 72 hours and 96 hours post-infection, average virus titers were 99.2 and 99.4% lower, respectively (p<0.001).
About Auris Medical
Auris Medical is a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders. The Company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125, in Phase 2) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201, post Phase 1b). Through its affiliate Altamira Medica, the Company is developing a nasal spray for protection against airborne pathogens and allergens (AM-301). In addition, Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol “EARS.”
This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may”, “might”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “projects”, “potential”, “outlook” or “continue”, or the negative of these terms or other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, Auris Medical’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the ability to pursue strategic partnering and non-dilutive funding for its Phase 3 programs, the results of Auris Medical’s review of strategic options and the outcome of any action taken as a result of such review, the timing and conduct of clinical trials of Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F for the year ended December 31, 2019, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.