Edison Investment Research - Auris Medical Holding AG (EARS) Auris Medical Holding - Full-year results and near-term trial initiations

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Edison Investment Research

Maxim Jacobs

Auris Medical Holding - Full-year results and near-term trial initiations

Auris recently announced its full-year 2018 financial results and provided an update on its active intranasal betahistine programs. R&D expenditure for the year was down roughly 65% compared to FY17, which reflects the shift to focus on earlier-stage program development. Auris plans to initiate the AM-125 Phase II trial of intranasal betahistine for treating acute vertigo in Q119 following the finalisation of clinical site selection, which it states is nearly complete. Additionally, Auris plans to initiate its AM-201 Phase I trial for olanzapine-induced weight gain in Q119.

21/03/2019 7 EN

Underlying

Auris Medical Holding AG

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CH0408330303 Switzerland

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Maxim Jacobs

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Auris Medical Holding - Termination of coverage

Edison Investment Research is terminating coverage on Auris Medical Holding (EARS). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

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Auris Medical Holding - A nasal spray to help protect against COVID-19

Auris recently announced the development of the AM-301 nasal spray for protection against SARS-COV-2 (COVID-19) infection (though it is also intended to protect against other airborne pathogens and allergens as well). AM-301 is a gel that would form a protective layer in the nasal mucosa, preventing contact between the pathogen and cells. In vitro data so far suggest contact between AM-301 and COVID-19 reduced the viral load by up to 99%. The company is targeting regulatory submission as an over the counter (OTC) product in 2021.

September 18, 2020 September 18, 2020 5 EN

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Auris Medical Holding - AM-201 data expected in early May

Auris has announced that final data from its 80-subject AM-201 Phase Ib trial for olanzapine-induced weight gain and somnolence should be available in early May. The key component of this release will be the data from the final dose level of 30mg in 30 healthy volunteers (we had previously only seen data in patients dosed up to 20mg). Due to the coronavirus, enrolment has been paused in the Phase II TRAVERS trial of 118 patients with surgically induced acute vertigo. Interim data from Part A of that trial now will likely not be available until Q320 at the earliest.

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Record’s Q424 trading update demonstrated continued growth in assets under management equivalent (AUME), which will support management fee growth into FY25. In FY24, AUME grew 17% to US$102.2bn, setting a new milestone in business scale. Net inflows for FY24 were US$6.8bn (FY23: US$9.1bn) or 8% of opening AUME. Performance fees of US$5.8m matched the record FY23 figure, and we expect this to offset the negative product mix in FY24. We have reduced our FY24e EPS by 1%, which is affected by £2.4bn in IT restructuring and impairment charges announced in March 2024. New CEO Dr Jan Witte is putting...

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Actinogen Medical - Funding in place through key catalysts

Actinogen announced a capital increase of up to A$8.9m on 3 May, consisting of a A$5.0m (gross) placement along with a shareholder rights offering (‘entitlement offer’) designed to raise up to A$3.9m (gross) from existing shareholders. The closing date of the rights offer is 29 May and, given that Actinogen shares are currently trading at c A$0.028, we assume full exercise of the rights offering in Q424 (Q2 CY24). The company expects that the proceeds (assuming full exercise of the rights offering) will extend its operating runway beyond the interim results release of the first 100 patients of...

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Auris Medical Holding - Full-year results and near-term trial initiations

Auris Medical Holding - Termination of coverage

Auris Medical Holding - A nasal spray to help protect against COVID-19

Auris Medical Holding - AM-201 data expected in early May

Record - AUME momentum and a sharper focus

Actinogen Medical - Funding in place through key catalysts

Henderson Opportunities Trust - A differentiated exposure to smaller companies

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