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Auris Medical Provides Business Update and Reports First Half 2020 Financial Results
- Advancing Phase 2 trial with AM-125 in acute vertigo based on positive interim data
- Positive outcome from AM-201 trial in prevention of antipsychotic-induced weight gain
- Addition of new intranasal program with development of drug-free spray for protection against airborne pathogens and allergens
- Review of strategic options initiated
“Over the past few months we reached major milestones with our intranasal betahistine program, reporting positive safety and tolerability data as well as significant efficacy signals in two clinical trials,” stated
Development Program Updates
AM-125 for Treating Acute Vertigo
- Reported positive results from interim analysis in Phase 2 trial with AM-125 in acute vertigo. On
September 3, 2020the Company announced top-line data from Part A of the TRAVERS trial, which enrolled 33 patients suffering from vertigo following neurosurgery. The patients were treated with AM-125 (intranasal betahistine) at 1, 10 or 20 mg or placebo (3 x daily) for four weeks. At the highest dose of 20 mg, AM-125-treated patients improved their performance of the “Tandem Romberg” and the “Standing on Foam” balance tests from baseline to 14 days post-surgery (primary endpoint) on average 1.9 to 2.4 times more than placebo-treated patients (6.0 vs. 3.1 and 10.5 vs. 4.3 seconds, respectively). In contrast to placebo, the improvement from baseline was statistically significant for AM-125 20 mg and for all active dose groups, respectively (p<0.02 and p<0.01 to p<0.05, respectively).
- Selected doses and key endpoints for Part B of TRAVERS trial. Based on the results from the interim analysis, the two highest doses, 10 and 20 mg, were selected by the Company to be tested against placebo in 72 patients in Part B of the trial. The improvement in the “Standing on Foam” test two weeks post-surgery will be the sole primary efficacy endpoint, whereas the improvement in the “Tandem Romberg” test six weeks post-surgery will be the key secondary efficacy endpoint. Part B of the trial is expected to start shortly, as open label testing of oral betahistine for reference purposes will be completed (n=16).
AM-201 for Preventing Antipsychotic-Induced Weight Gain
- Reported positive results from Phase 1b trial with AM-201 in antipsychotic-induced weight gain. On
May 26, 2020, the Company reported top-line results from its Phase 1b trial in 80 healthy volunteers who were treated with oral olanzapine 10 mg and AM-201 (intranasal betahistine) at up to 30 mg or placebo 3x daily for four weeks. At the highest dose of 30 mg, the mean weight gain from baseline in AM-201-treated participants was 2.8 kg compared against 3.7 kg in control subjects; the primary efficacy endpoint of mean reduction in weight gain was 0.9 kg and statistically significant (p<0.02; n=81 with pre-specified Bayesian augmented controls). In a next step, following additional pre-clinical testing, the Company intends to file for an IND in 2021.
AM-301 for Protecting Against Airborne Pathogens and Allergens
- Initiated development of a nasal spray for protection against airborne pathogens and allergens. On
September 8, 2020the Company announced that it had initiated under product code AM-301 the development of a drug-free nasal spray for personal protection against airborne pathogens and allergens. AM-301 is a gel which works by forming a protective layer on the nasal mucosa, acting as a physical barrier against airborne pathogens and allergens. In addition, the composition serves to “trap” such particles and help with their discharge. Together, this is designed to reduce the risk of infection and promote alleviation of allergic symptoms.
- Demonstrated significant binding of SARS-CoV-2 in vitro. Testing the key component of AM-301 at various concentrations in a SARS-CoV-2 assay demonstrated a reduction in the viral infectious load of up to 99%. The Company intends to perform additional testing involving various pathogens and allergens.
- Set up new subsidiary dedicated to AM-301. The new subsidiary,
Altamira Medica Ltd.(“Altamira”), is based in Zug, Switzerland, and has a share capital of CHF 0.5 mn. Currently owned 100% by Auris Medical Holding Ltd., ownership in Altamira is expected to decrease as other investors will be invited to join as shareholders once additional financing is required.
CHF 1.5 millionthrough a convertible loan. Under the agreement, Altamira obtained CHF 1.5 mnfrom FiveT Capital Holding Ltd., a Swiss investment management firm, to fund the development of AM-301. The loan has a term of 18 months, carries an interest rate of 8% p.a. and is convertible including accrued interest into common shares of either Altamira or Auris Medical Holding Ltd.
- Initiated a review of strategic options. The Company’s Board of Directors has started a process to explore, review and evaluate a broad range of potential strategic alternatives. These alternatives include but are not limited to the partnering of its various clinical and preclinical programs, or a sale or merger of the Company, in an effort to unlock the potential of those assets and maximize shareholder value.
- Regained compliance with Nasdaq minimum bid price requirement. On
August 20, 2020, the Company received a letter from Nasdaq stating that because the Company’s shares had a closing bid price at or above $1.00per share for a minimum of ten (10) consecutive business days, the Company’s stock had regained compliance with the Minimum Bid Price Requirement for continued listing on Nasdaq, and that the matter was closed.
- Effected reduction in par value per share. As approved by the Company’s annual general meeting, the par value of each common share was reduced from
CHF 0.40to CHF 0.01, effective June 30, 2020. The transaction was cash neutral with the reduction in issued share capital being credited to the contributed surplus account.
First Half 2020 Financial Results
- Total operating expenses for the first half of 2020 were
CHF 2.4 millioncompared to CHF 4.1 millionfor the first half of 2019.
- Research and development expenses for the first half of 2020 were
CHF 0.9 millioncompared to CHF 1.3 millionfor the first half of 2019.1
- General and administrative expenses for the first half of 2020 were
CHF 1.5 millioncompared to CHF 2.8 millionfor the first half of 2019.
- Net loss for the first half of 2020 was
CHF 2.7 million, or CHF 0.58per share, compared to CHF 3.7 million, or CHF 1.66per share, for the first half of 2019.
The Company expects its total cash needs in 2020, including project AM-301, to be in the range of
Conference Call & Webcast Information
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, whether the
Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Loss
For the Six Months Ended
|Research and development||(884,747)||(1,304,291)|
|General and administrative||(1,535,960)||(2,803,267)|
|Foreign currency exchange gain/(loss), net||(30,022)||(264,121)|
|Revaluation gain / (loss) from derivative financial instruments||4,353||531,245|
|Loss before tax||(2,669,143)||(3,865,695)|
|Income tax gain/(loss)||10,642||261,394|
|Net loss attributable to owners of the Company||(2,658,501)||(3,604,301)|
|Other comprehensive income/(loss):|
|Items that will never be reclassified to
profit or loss
|Remeasurement of defined benefit liability||(78,010)||(115,366)|
|Items that are or may be reclassified to
profit or loss
|Foreign currency translation differences||16,396||6,666|
|Other comprehensive income/(loss)||(61,614)||(108,700)|
|Total comprehensive loss attributable
to owners of the Company
|Basic and diluted loss per share||(0.58)||(1.66)|
|Average weighted number of shares outstanding, adjusted for effect of reverse stock split||4,585,054||2,173,307|
Condensed Consolidated Statement of Financial Position
|Property and equipment||54,434||66,672|
|Other non-current financial receivables||20,001||20,001|
|Total non-current assets||7,573,926||6,852,286|
|Derivative financial instruments||-||219,615|
|Cash and cash equivalents||39,939||1,384,720|
|Total current assets||389,801||2,373,865|
|EQUITY AND LIABILITIES|
|Foreign currency translation reserve||(11,169)||(27,565)|
|Total shareholders (deficit)/equity attributable to owners of the Company||4,478,591||6,036,133|
|Derivative financial instruments||-||4,353|
|Deferred tax liabilities||136,507||147,149|
|Total non-current liabilities||1,063,283||911,949|
|Trade and other payables||1,256,352||938,247|
|Total current liabilities||2,421,853||2,278,069|
|Total equity and liabilities||7,963,727||9,226,151|
1 Does not include capitalized costs related to expenses for the AM-125 program in accordance with IAS38.
Source: Auris Medical AG