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Auris Medical Reports Second Quarter 2018 Financial Results and Provides Business Update
- Dosing in second Phase 1 clinical trial with intranasal betahistine nearing completion
- Approaching important interactions with regulatory agencies
- Progressing with strategic repositioning of Company
"In the past weeks and months we took important steps to reposition our Company", stated
Development Program Updates
AM-125 for Vertigo
- Approaching completion of second Phase 1 clinical trial in healthy volunteers. The third and final part of the randomized placebo-controlled trial with dose escalation of repeated doses of AM-125 (three times daily for three days) is nearing completion. In the first two parts of the trial escalating doses of oral betahistine up to 384 mg and of intranasal betahistine up to 60 mg were administered. The trial will provide important additional data on the pharmacokinetics, safety and tolerability of AM-125. An earlier single dose Phase 1 clinical trial with intranasal betahistine up to 40 mg had shown a relative bioavailability which was 20-40 times higher compared with plasma levels in an independent Phase 1 clinical trial with oral betahistine at 3 x 48 mg/day. Top-line data from the second Phase 1 trial are expected to become available in early
- Further evidence for dose-dependent effects of betahistine and relationship to bioavailability in animal model of acute vertigo. A peer-reviewed article by Tighilet and colleagues in Frontiers in Neurology showed that a higher dose of betahistine administered to cats following acute loss of unilateral vestibular function resulted in faster improvement of acute symptoms than with a lower dose, accelerated significantly the recovery process. Further, it was associated with a significant increase of histaminergic activity in the hypothalamus and substantially higher bioavailability in blood plasma.
- Initiated scientific advice procedure with the
European Medicines Agency(EMA). The Company initiated a scientific advice procedure with the EMA to discuss the development plan for AM-125 and in particular the planned Phase 2 clinical trial in acute vertigo. The Agency's feedback is expected in fall of 2018.
AM-201 for Olanzapine-Induced Weight Gain
- Initiated AM-201 development program with intranasal betahistine for prevention of olanzapine-induced weight gain. In
May 2018the Company announced the expansion of its intranasal betahistine development program beyond the treatment of vertigo into mental health supportive care. Under project code AM-201 the Company will develop intranasal betahistine for the prevention of weight gain associated with the treatment of olanzapine in schizophrenia and bipolar disorder. Preclinical and clinical studies conducted by other parties have demonstrated a key role for the histamine 1 receptor in olanzapine-induced weight gain and betahistine's capacity to counteract olanzapine's effect at this receptor through competitive inhibition. Established Scientific Advisory Boardfor project AM-201. In order to support the AM-201 development program, the Company assembled a Scientific Advisory Boardcomprising Dr Nir Barak(founder and former Chief Scientific Officer of Obecure, Israel), Dr Christoph Correll(Professor of Child and Adolescent Psychiatry, Charité Medical School, Berlin, Germany), Dr John Kane(Professor and Chairman of Psychiatry at The Donald and Barbara Zucker School of Medicineat Hofstra/Northwell, Hempstead NY), and Dr John Newcomer(Professor of Integrated Medical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton FL).
- Initiated preparations for Phase 1 pharmacokinetic/pharmacodynamic clinical trial. The Company has started preparations for a randomized placebo-controlled Phase 1 trial in healthy volunteers to evaluate the safety, pharmacokinetics and pharmacodynamic effects of AM-201 in co-administration with olanzapine. The trial is expected to start in early 2019.
AM-111 for Acute Inner Ear Hearing Loss
FDAguidance on AM-111 development program. The Company was granted a type C meeting with the FDAto discuss the development and regulatory path forward with AM-111. The Agency's feedback is expected during the third quarter of 2018. The Company had previously obtained scientific advice (protocol assistance) from the EMA, which included endorsement of the proposed design for a single pivotal trial with AM-111 0.4 mg/mL in patients suffering from acute profound hearing loss.
Corporate and Other Developments
- Raised further equity in a
$7mpublic offering. On July 17, 2018we completed an underwritten public offering of 17,948,717 common shares with 6,282,050 Series A warrants and 4,487,179 Series B warrants. The issue price was $0.39per share and attached warrants, resulting in net proceeds to the Company of approximately $6.2m.
- Departure of
Andrea Braun, Head of Regulatory and Quality Affairs. Andrea Braun, PhD, who joined Auris Medicalin 2016, will leave the Company to pursue a new career opportunity.
Second Quarter 2018 Financial Results
- Cash and cash equivalents at
June 30, 2018totaled CHF 4.4 million.
- Total operating expenses for the second quarter of 2018 were
CHF 3.1 millioncompared to CHF 6.0 millionfor the second quarter of 2017.
- Research and development expenses for the second quarter of 2018 were
CHF 2.0 millioncompared to CHF 4.7 millionfor the second quarter of 2017.
- General and administrative expenses for the second quarter of 2018 were
CHF 1.1 millioncompared to CHF 1.2 millionfor the second quarter of 2017.
- Net loss for the second quarter of 2018 was
CHF 3.1 million, or CHF 0.50per share, compared to CHF 5.4 million, or CHF 1.22per share, for the second quarter of 2017.
The Company continues to expect that its operating expenses in 2018 will 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
Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Loss
For the Three Months Ended
| THREE MONTHS
ENDED JUNE 30
|Research and development||(2'014'400)||(4'722'899)|
|General and administrative||(1'098'707)||(1'235'665)|
|Foreign currency exchange loss, net||22'376||(592'876)|
|Revaluation gain from derivative financial instruments||607'262||1'527'508|
|Loss before tax||(3'088'255)||(5'419'463)|
|Income tax gain||8'727||8'191|
|Net loss attributable to owners of the Company||(3'079'528)||(5'411'272)|
|Other comprehensive loss:|
|Items that will never be reclassified to
profit or loss
|Remeasurement of defined benefit liability, net of taxes of CHF 0.00||804'301||55'810|
|Items that are or may be reclassified to
profit or loss
|Foreign currency translation differences, net of taxes of CHF 0.00||(34'164)||39'985|
|Other comprehensive income,
net of taxes of CHF 0
|Total comprehensive loss attributable
to owners of the Company
|Basic and diluted loss per share||(0.50)||(1.22)|
|Average weighted number of shares outstanding, adjusted for effect of reverse stock split||
Condensed Consolidated Statement of Financial Position
|Property and equipment||206'591||252,899|
|Derivative financial instruments||252'351||-|
|Other non-current financial receivables||76'710||76,710|
|Total non-current assets||2'199'415||1,958,709|
|Cash and cash equivalents||4'421'771||14,973,369|
|Total current assets||5'268'283||15,867,563|
|EQUITY AND LIABILITIES|
|Foreign currency translation reserve||(52'076)||(33,047)|
|Total shareholders (deficit)/equity attributable to owners of the Company||(3'548'451)||(2,162,209)|
|Derivative financial instruments||412'552||1,836,763|
|Deferred tax liabilities||161'357||178,809|
|Total non-current liabilities||1'565'097||9,562,839|
|Trade and other payables||2'274'746||1,200,820|
|Total current liabilities||9'451'052||10,425,642|
|Total equity and liabilities||7'467'698||17,826,272|
 The overall design of that trial is described in Barak et al. (2016), Journal of Psychopharmacology 30(3): 237-241.
 Tighilet B, Léonard J, Watabe I, Bernard-Demanze L, Lacour M (2018). Betahistine treatment in a cat model of vestibular pathology: pharmacokinetic and pharmacodynamic approaches. Front Neurol. 11(9):431.
 Loss per share for second quarter 2017 adjusted for subsequent reverse stock split.
Source: Auris Medical AG