UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934


For the month of September, 2014
 

 
Commission File Number: 001-36582

Auris Medical Holding AG
(Exact name of registrant as specified in its charter)

Bahnhofstrasse 21
6300 Zug, Switzerland
(Address of principal executive office)


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F
X
 
Form 40-F
 


Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Yes
   
No
X


Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Yes
   
No
X

 


 
 
 
 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
Auris Medical Holding AG
 
     
     
 
By:
/s/ Thomas Meyer
 
   
Name:
Thomas Meyer
 
   
Title:
Chief Executive Officer
 

Date: September 15, 2014
 
 
 

 
 
EXHIBIT INDEX
 
Exhibit Number
Description
99.1
Unaudited Condensed Consolidated Interim Financial Information
99.2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
99.3
Press Release dated September 15, 2014
99.4
Second Quarter 2014 Earnings and Business Update Presentation dated September 15, 2014
 
 
 

 

Exhibit 99.1
 
Unaudited Condensed Consolidated Interim Financial Information as of June 30, 2014 and For the Six Months Ended June 30, 2014 and 2013
 
Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income
Condensed Consolidated Interim Statement of Financial Position
Condensed Consolidated Interim Statement of Cash Flows
Selected Additional Information to the Consolidated Financial Information
 
 

 
 
 

 

AURIS MEDICAL HOLDING AG
 
Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income (unaudited)
For the Six Months Ended June 30, 2014 and 2013 (in CHF)


 
 
Note
 
SIX MONTHS ENDED JUNE 30 2014
   
SIX MONTHS ENDED JUNE 30 2013
 
Research and development
      -8,350,008       -6,384,347  
General and administrative
      -2,554,288       -732,210  
                   
Operating loss
      -10,904,296       -7,116,557  
                   
Finance expense
      -68,031       -11,366  
Finance income
      121,144       51,119  
                   
Loss before tax
      -10,851,183       -7,076,804  
                   
Net loss for the period attributable to owners of the Company
      -10,851,183       -7,076,804  
                   
Other comprehensive income:
                 
Items that will never be reclassified to profit or loss
                 
Remeasurements of defined benefit liability
      -423,811       91,981  
Items that are or may be reclassified to profit or loss
                 
Foreign currency translation differences
      2,817       -25,915  
                   
Other comprehensive income for the period, net of tax
      -420,994       66,066  
                   
Total comprehensive loss for the period attributable to owners of the Company
      -11,272,177       -7,010,738  
                   
Basic and diluted loss per share
6
    -0.59       -0.52  


 
 
2

 

AURIS MEDICAL HOLDING AG
 
Condensed Consolidated Interim Statement of Financial Position
As of June 30, 2014 (unaudited), and December 31, 2013
(in CHF)
 

 
         
June 30,
   
December 31,
 
   
Note
   
2014
   
2013
 
ASSETS
                 
Non-current assets
                 
Property and equipment
          251,095       195,915  
Intangible assets
          1,482,520       1,482,520  
                       
Total non-current assets
          1,733,615       1,678,435  
                       
Current assets
                     
Other receivables
          694,396       524,786  
Prepayments
          713,889       183,137  
Cash and cash equivalents
          12,130,954       23,865,842  
                       
Total current assets
          13,539,239       24,573,765  
                       
Total assets
          15,272,854       26,252,200  
                       
EQUITY AND LIABILITIES
                     
Equity
                     
Share capital
            7,536,510       6,487,130  
Share premium
            48,232,566       35,608,210  
Foreign currency translation reserve
            56,812       53,995  
Accumulated deficit
            -44,295,487       -33,115,689  
Total shareholders’ equity attributable to owners of the Company
            11,530,401       9,033,646  
                         
Non-current liabilities
                       
Employee benefits
    5       745,440       328,342  
Deferred tax liabilities
            327,637       327,637  
                         
Total non-current liabilities
            1,073,077       655,979  
                         
Current liabilities
                       
Convertible loans
    4       -       13,711,200  
Trade and other payables
            1,105,180       954,257  
Accrued expenses
            1,564,196       1,897,118  
                         
Total current liabilities
            2,669,376       16,562,575  
                         
Total liabilities
            3,742,453       17,218,554  
                         
Total equity and liabilities
            15,272,854       26,252,200  
 

 
 
3

 
 
AURIS MEDICAL HOLDING AG
 
Condensed Consolidated Interim Statement of Cash Flows (unaudited)
For the Six Months Ended June 30, 2014 and 2013 (in CHF)
 

 
   
Note
   
SIX MONTHS ENDED JUNE 30 2014
   
SIX MONTHS ENDED JUNE 30 2013
 
Cash flows from operating activities
                 
Net loss
          -10,851,183       -7,076,804  
Adjustments for:
                     
Depreciation
          34,006       13,562  
Unrealized exchange differences
          2,835       -25,686  
Net interest income
          19,750       -2,181  
Share based payments
    5       95,197       51,325  
Employee benefits
            -6,713       17,995  
                         
Changes in:
                       
Other receivables
            -169,492       -17,091  
Prepayments
            -530,752       72,325  
Trade and other payables
            150,901       139,438  
Accrued expenses
            -332,923       1,110,023  
                         
Cash used in operating activities
            -11,588,374       -5,717,094  
                         
Cash flows from investing activities
                       
Purchase of property and equipment
            -89,185       -30,233  
Sale of financial assets
            -       -  
Interest received
            29,885       12,096  
                         
Net cash used in investing activities
            -59,300       -18,137  
                         
Cash flows from financing activities
                       
Proceeds from share capital increase
            49,600       24,480,060  
Share issuance costs
            -136,699       -242,115  
Interest paid
            -       -9,915  
                         
Net cash from financing activities
            -87,099       24,228,030  
                         
Net increase/(decrease) in cash and cash equivalents
            -11,734,773       18,492,799  
Cash and cash equivalents at beginning of the period
            23,865,842       63,967  
Net effect of currency translation on cash
            -115       614  
                         
Cash and cash equivalents at end of the period
            12,130,954       18,557,380  
 


 
4

 
AURIS MEDICAL HOLDING AG
Additional information to the consolidated financial information
as of June 30, 2014 and for the six months ended June 30, 2014 and  2013 (in CHF)
 
 
 
1.  
Reporting entity
 
Auris Medical Holding AG (the “Company”) is domiciled in Switzerland. The Company’s registered address is at Bahnhofstrasse 21, 6300 Zug. These consolidated interim financial information comprise the Company and its subsidiaries (together referred to as the “Group” and individually as “Group entities”). The Company is the ultimate parent of the following Group entities:
 
 
§
Auris Medical AG, Basel, Switzerland (100%)
 
 
§
Otolanum AG, Zug, Switzerland (100%)
 
 
§
Auris Medical Inc., Chicago, United States (100%)
 
 
§
Auris Medical Ltd., Dublin, Ireland (100%)
 
On April 22, 2014, we changed our name from Auris Medical AG to Auris Medical Holding AG and transferred our operational business to our newly incorporated subsidiary Auris Medical AG, which is now our main operating subsidiary. The Group is primarily involved in the development of pharmaceutical products for the treatment of inner ear disorders, in particular tinnitus and hearing loss. Its most advanced projects are in the late stage of clinical development.
 
 
2.
Basis of preparation
 
This interim financial information has been prepared using the same accounting policies and methods of computation as compared with the most recent annual financial statements. The financial information included here-in is not intended to fully comply with IFRS, and in particular with IAS 34. New accounting standards, which have been applied in 2014 for the first time, did not have an impact on the company’s financial position, results or cash flows.

The financial information included in this quarterly press release and shareholder information has not been reviewed or audited by our auditors. Quarter results are not necessarily indicative of results to be expected for the full year.
 
The Group has not early adopted any standard, interpretation or amendment that was issued but is not yet effective.
 
 
 
5

 
 
AURIS MEDICAL HOLDING AG
Additional information to the consolidated financial information
as of June 30, 2014 and for the six months ended June 30, 2014 and 2013 (in CHF)
 
 
 
3.
Capital and reserves
 
Share capital
 
The issued share capital of Auris Medical Holding AG consisted of:
 
    AS OF JUNE 30, 2014     AS OF DECEMBER 31, 2013
    NUMBER     CHF     NUMBER     CHF
Common shares with a nominal value of CHF 0.40 each
    88,100       35,240       72,600       29,040
Preferred shares Series A with a nominal value of CHF 0.40 each
    5,999,750       2,399,900       5,999,750       2,399,900
Preferred shares Series B with a nominal value of CHF 0.40 each
    5,509,100       2,203,640       5,509,100       2,203,640
Preferred shares Series C with a nominal value of CHF 0.40 each
    7,244,325       2,897,730       4,636,375       1,854,550
      18,841,275       7,536,510       16,217,825       6,487,130
 
All shares are fully paid in. All disclosed numbers and nominal value of shares in these interim financial statements are adjusted for the 25:1 stock split effected in December 2013 unless otherwise indicated.
 
  Common shares   Preferred shares
  2014 2013   2014 2013
           
As of January 1
72,600
72,600
 
16,145,225
11,508,850
Common shares with a nominal value of CHF 0.40 each
15,500
-
 
2,607,950
-
As at June 30, 2014, and June 30, 2013
88,100
72,600
 
18,753,175
11,508,850
 
Issue of common shares upon exercise of options
 
On January 21, 2014, three beneficiaries of Option Plan A exercised their right to acquire common shares of the Company at CHF 3.20 per share. This resulted in an increase in the number of outstanding common shares of 15,500 and an increase in the share capital of CHF 6,200. Total proceeds from the exercise to the company were CHF 49,600.

 
 
6

 
 
 
AURIS MEDICAL HOLDING AG
Additional information to the consolidated financial information
as of June 30, 2014 and for the six months ended June 30, 2014 and 2013 (in CHF)
 
 
4.
Convertible loans
 
On December 9, 2013, the Company issued non-interest bearing convertible loans to two shareholders with a nominal value of CHF 13,769,976 and a maximum term of 12 months. On January 27, 2014, the loans were converted into new registered Series C shares with nominal value of CHF 0.40 each for CHF 5.28 per share. The company issued 2,607,950 Series C shares with a nominal value of CHF 0.40 each.
 
On the conversion date of the loan, the liability was derecognized and CHF 1,043,180 was recognized as share capital and CHF 12,717,655 as share premium.
 
 
JUNE 30,
2014
Convertible loans as at December 31
13,711,200
Loss on derecognition
9,141
Imputed interest expense for the period
49,635
Derecognition of liability at conversion into equity 13,769,976
Convertible loans at June 30, 2014
-
 
 
 
5.
Employee benefits

 
SIX MONTHS
ENDED JUNE 30,
2014
SIX MONTHS
ENDED JUNE 30,
2013
Salaries
980,518 356,110
Pension costs 59,547  39,387
Other social benefits  82,149  30,425
Share option cost 95,197 51,325
Other employee cost 97,871 44,774
Total employee benefits
1,315,280 522,021

 
6.
Loss per share
 
 
SIX MONTHS
ENDED JUNE 30,
2014
SIX MONTHS
ENDED JUNE 30,
2013
Loss attributable to owners of the Company -10,851,183 -7,076,804
Weighted average number of shares outstanding 18,448,274 13,616,303
Basic and diluted loss per share -0.59 -0.52
 
For the periods ended June 30, 2014 and 2013 basic and diluted loss per share is based on the weighted average number of shares issued and outstanding and excludes shares to be issued under the stock option plans (Note 7) and, for the 2013 period only, conversion rights related to the convertible loans (Note 8) as they would be anti-dilutive. In case the Group shows a profit in the future, the options may have a dilutive effect on earnings per share and will need to be included in the above calculation.

 
7

 
 
AURIS MEDICAL HOLDING AG
Additional information to the consolidated financial information
as of June 30, 2014 and for the six months ended June 30, 2014 and 2013 (in CHF)
 
 
 
7.
Related party transactions
 
In January 2014 the convertible loan lenders exercised their conversion option, and the total loan amount of CHF 13,769,976 was converted into 2,607,950 Series C shares of the Company (See Note 8).
 
The service agreement with Altamira Pharma GmbH, a company fully owned by the CEO, was terminated as of January 31, 2014 with a final payment of CHF 14,500. From 2011, the CEO had been compensated under this agreement. The Company entered into an employment contract with the CEO effective January 1, 2014.  
 
 
8.
Events after the balance sheet date

On August 6, 2014, the underwriters for the Company’s IPO subscribed to 9,400,000 shares at USD 6.00 per share yielding gross proceeds (before underwriting fees and IPO costs) of USD 56.4 million. The shares started trading under the ticker symbol EARS on the NASDAQ Global Market on August 7, 2014.
 
On August 13, 2014, the underwriters exercised their overallotment option for 713,235 shares of the Company, resulting in gross proceeds of USD 4.3m
 
The combined net proceeds after underwriting fees are USD 56.4 million. Following the IPO and the issue of shares under the underwriter overallotment option, there are 28,954,510 common shares of the Company outstanding.
 
 
 
8

 
 
Exhibit 99.2

 
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial information as of June 30, 2014 and for the six months ended June 30, 2014 and 2013 included as Exhibit 1 to this Report on Form 6-K. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements and unaudited condensed consolidated interim financial statements, and the notes thereto, which appear in our prospectus (our “Final Prospectus”) relating to our Registration Statement on Form F-1, as amended (Registration No. 333-197105), filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to Rule 424(b) under the U.S. Securities Act of 1933, as amended.
 
Unless otherwise indicated or the context otherwise requires, all references to “Auris Medical” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to Auris Medical AG and its subsidiaries prior to the completion of our corporate reorganization in connection with our initial public offering, and Auris Medical Holding AG and its subsidiaries as of the completion of our corporate reorganization and thereafter. See “Prospectus Summary—Corporate Information” in the Final Prospectus
 
We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in Swiss Francs. We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussions and analysis are in Swiss Francs.
 
This discussion and analysis is dated as of September 15, 2014.
 
Overview
 
We are a clinical-stage biopharmaceutical company focused on the development of novel products for the treatment of inner ear disorders. Our most advanced product candidate, AM-101, is in Phase 3 clinical development for acute inner ear tinnitus under a special protocol assessment, or SPA, from the FDA. In two recently completed Phase 2 clinical trials, AM-101 demonstrated a favorable safety profile and statistically significant improvement in tinnitus loudness and other patient reported outcomes. We expect to have top-line Phase 3 clinical data for AM-101 in early 2016. We are also developing AM-111 for acute inner ear hearing loss (acute sensorineural hearing loss, or ASNHL). Following feedback from a pre-IND meeting with the FDA in September 2014, we plan to finalize the design of the late-stage AM-111 clinical program.  Implementation of the late-stage AM-111 clinical program may require additional funding. Both acute inner ear tinnitus and hearing loss are conditions for which there is high unmet medical need, and we believe that we have the potential to be the first to market in these indications.
 
To date, we have financed our operations through our initial public offering of our common shares, private placements of equity securities and short term loans. We have no products approved for commercialization and have never generated any revenues from royalties or product sales.  Based on our current plans, we do not expect to generate royalty or product revenues unless and until we obtain marketing approval for, and commercialize, AM-101, AM-111 or any of our other product candidates.
 
Since inception, we have incurred significant operating losses. We incurred net losses (defined as net losses attributable to the owners of the company) of CHF 15.0 million and CHF 4.6 million for the years ended December 31, 2013 and 2012, respectively and for the six months ended June 30, 2014 and 2013, we incurred net losses of CHF 10.9  million and CHF 7.1 million, respectively. As of June 30, 2014,
 
 
 

 
 
we had an accumulated deficit of CHF 44.30 million.  We expect to continue incurring losses as we continue our clinical and preclinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval of our product candidates, build a sales and marketing force in preparation for the potential commercialization of our product candidates.
 
Recent Developments
 
On August 11, 2014, we completed our initial public offering of common shares pursuant to a Registration Statement on Form F-1, as amended (Registration No. 333-197105) that was declared effective on August 5, 2014. Under the registration statement, we sold an aggregate of 10,113,235 common shares, which included 713,235 common shares sold on August 19, 2014 pursuant to an over-allotment option granted to the underwriters.  All of these common shares were sold at a price to the public of $6.00 per share.  The offering expenses, not including the underwriting discounts and commissions, are estimated at $2.4 million and are payable by us. The offering expenses include SEC registration fees, FINRA filing fees, Nasdaq listing fees and expenses, legal fees and expenses, printing expenses, transfer agent fees and expenses, accounting fees and expenses as well as other miscellaneous fees and expenses. Our common shares are listed on the NASDAQ Global Market under the symbol “EARS.”
 
Collaboration and License Agreements
 
There have been no material changes to our collaboration and license agreements from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Collaboration and License Agreements” in the Final Prospectus.
 
Research and Development Expense
 
Our research and development expense is highly dependent on the development phases of our research projects and therefore may fluctuate substantially from period to period.  Our research and development expense mainly relates to the following key programs:
 
 
·
AM-101. We have commenced a Phase 3 program of AM-101 comprising two Phase 3 clinical trials (TACTT2 and TACTT3) as well as two open label extension studies (AMPACT1 and AMPACT2). We expect top-line data from the TACTT trials in early 2016. We anticipate that our research and development expenses will increase substantially in connection with these clinical trials.
 
 
·
AM-111. Following feedback from a pre-IND meeting with the FDA in September 2014, we plan to finalize the design of our late-stage AM-111 clinical program for ASNHL. Implementation of the late-stage AM-111 clinical program may require additional funding .  We anticipate that our research and development expenses will increase substantially with the continuation of AM-111’s clinical development program.
 
 
·
Other development programs. Other research and development expenses mainly relate to our preclinical studies of AM-102 and AM-123. The expenses mainly consist of costs for production of the preclinical compounds and costs paid to academic research institutions in conjunction with preclinical testing.
 
For a discussion of our other key financial statement line items, please see “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Financial Operations Overview” in the Final Prospectus.
 
Results of Operations
 
The discussion below should be read along with our unaudited condensed consolidated interim financial information as of June 30, 2014 and for the six months ended June 30, 2013 and 2014, and is qualified in its entirely by reference to them.
 
 
2

 

 
Comparison of the three months ended June 30, 2014 and 2013
 
   
Three months ended June 30,
 
   
2014
   
2013
   
Change
 
   
(in thousands of CHF)
   
%
 
Research and development
    (4,201 )     (4,411 )     (5) %
General and administrative
    (845 )     (462 )     83 %
Operating loss
    (5,046 )     (4,873 )     4 %
Finance expense
    (17 )     (1 )        
Finance income
    71       27       164 %
Loss before tax
    (4,991 )     (4,847 )     3 %
Net loss attributable to owners of the company
    (4,991 )     (4,847 )     3 %
Other comprehensive income:
                       
Items that will never be reclassified to profit or loss
                       
Remeasurements of defined benefits liability
    (407 )     49          
Items that are or may be reclassified to profit or loss
                       
Foreign currency translation differences
    (3 )     4          
Other comprehensive income
    (410 )     53          
Total comprehensive loss attributable to owners of the company
    (5,401 )     (4,794 )     13 %
 
Research and development expense
 
   
Three months ended June 30,
 
Research and development expense
 
2014
   
2013
   
Change
 
   
(in thousands of CHF)
   
%
 
Clinical Projects
    (2,757 )     (3,235 )     (15) %
Pre-clinical projects
    (587 )     (301 )     95 %
Drug manufacture and substance
    (159 )     (665 )     (76) %
Employee benefits
    (428 )     (125 )     242 %
Other research and development expenses
    (269 )     (85 )     217 %
Total
    (4,201 )     (4,411 )     (5) %

 
Research and development expense decreased 5% from CHF 4.4 million in the three months ended June 30, 2013 to CHF 4.2 million in the three months ended June 30, 2014. The variances in expense between the three months ended June 30, 2013 and the corresponding period in 2014 are mainly due to the following projects:
 
 
·
Clinical Projects.  In the three months ended June 30, 2014 we incurred lower clinical expenses than in the three months ended June 30, 2013 primarily due to fluctuations in upfront and milestone costs charged by contracted service providers.
 
 
·
Pre-clinical projects. In the three months ended June 30, 2014, pre-clinical expenses were higher than in the three months ended June 30, 2013 as additional studies for AM-111 were ongoing.
 
 
·
Drug manufacture and substance.  In the three months ended June 30, 2014 we incurred lower costs related to the manufacture, and storage of supplies for clinical material compared to the three months ended June 30, 2013, primarily due to fluctuations in the timing of raw material purchases and the manufacture of clinical trial supplies.
 
 
·
Employee Benefits.  Employee expenses were significantly higher in the three months ended June 30,2014 than in the three months ended June 30, 2013 due to a higher headcount.
 
 
3

 
 
General and administrative expense
 
General and administrative expense increased 83% from CHF 0.5 million in the three months ended June 30, 2013 to CHF 0.9 million in the three months ended June 30, 2014. The increase was primarily related to higher legal and auditing expenses in connection with preparation for the IPO.
 
We expect that general and administrative expense will increase in the future as our business expands and we incur additional costs associated with operating as a public company.
 
Finance income
 
Finance income increased 164% to CHF 0.1 million in the three months ended June 30, 2014. Finance income in these periods consisted primarily of interest income recognized on short-term deposits.
 
Finance income increased in the three months ended June 30, 2014 as compared to the three months ended June 30, 2013 as a result of higher unrealized exchange gains.
 
Finance expense
 
Finance expense was insignificant in the three months ended June 30, 2014 and 2013.
 
Remeasurements of defined benefits liability
 
Remeasurements of the net defined benefit liability, which comprise actuarial gains and losses, the return on plan assets (excluding interest) and the effect of the asset ceiling (if any, excluding interest), decreased from CHF 0.1 million in the three months ended June 30, 2013 to CHF (0.4) million in the three  months ended June 30, 2014.
 
Foreign currency translation differences
 
Foreign currency translation differences were insignificant in the three months ended June 30, 2014 and 2013.
 
Comparison of the six months ended June 30, 2014 and 2013
 
   
Six months ended June 30,
 
   
2014
   
2013
   
Change
 
   
(in thousands of CHF)
   
%
 
Research and development
    (8,350 )     (6,384 )     31 %
General and administrative
    (2,554 )     (732 )     248 %
Operating loss
    (10,904 )     (7,117 )     53 %
Finance expense
    (68 )     (11 )     499 %
Finance income
    121       51       137 %
Loss before tax
    (10,851 )     (7,077 )     53 %
Net loss attributable to owners of the company
    (10,851 )     (7,077 )     53 %
Other comprehensive income:
                       
Items that will never be reclassified to profit or loss
                       
Remeasurements of defined benefits liability
    (424 )     92          
Items that are or may be reclassified to profit or loss
                       
Foreign currency translation differences
    3       (26 )        
Other comprehensive income
    (421 )     66          
Total comprehensive loss attributable to owners of the company
    (11,272 )     (7,011 )     61 %
 
 
4

 
 
Research and development expense
 
   
Six months ended June 30,
 
Research and development expense
 
2014
   
2013
   
Change
 
   
(in thousands of CHF)
   
%
 
Clinical Projects
    (5,161 )     (4,298 )     20 %
Pre-clinical projects
    (1,152 )     (701 )     64 %
Drug manufacture and substance
    (784 )     (894 )     (12) %
Employee benefits
    (797 )     (349 )     129 %
Other research and development expenses
    (455 )     (143 )     218 %
Total
    (8,350 )     (6,384 )     31 %
 
Research and development expense increased 31% from CHF 6.4 million in the six months ended June 30, 2013 to CHF 8.4 million in the six months ended June 30, 2014. The variances in expense between the six months ended June 30, 2013 and the corresponding period in 2014 are mainly due to the following projects:
 
 
·
Clinical Projects.  In the six months ended June 30, 2014 we incurred higher clinical expenses due to the progression of our AM-101 Phase III clinical development program. In addition, we conducted preparatory activities related to our late stage AM-111 clinical program, whereas in the six months ended June 30, 2013 the Phase II had been completed with a concomitant decline in spending.
 
 
·
Pre-clinical projects. In the six months ended June 30, 2014, pre-clinical expenses were higher than in the six months ended June 30, 2013 as more pre-clinical projects were ongoing related to the AM-101 and AM-111 projects.
 
 
·
Drug manufacture and substance.  In the six months ended June 30, 2014 we continued to incur substantial costs related to the manufacture, packaging and distribution of clinical trial supplies. However, expense levels decreased compared to the six months ended June 30, 2013 primarily due to fluctuations in the timing of purchases of raw material and the manufacture of clinical trial supplies.
 
 
·
Employee Benefits.  Employee expenses were significantly higher in the six months ended June 30, 2014 than in the six months ended June 30, 2013 due to a higher headcount.
 
General and administrative expense
 
General and administrative expense increased more than threefold from CHF 0.7 million in the six months ended June 30, 2013 to CHF 2.6 million in the six months ended June 30, 2014. The increase was primarily related to higher legal and auditing expenses in relation to the IPO preparations.
 
We expect that general and administrative expense will increase in the future as our business expands and we incur additional costs associated with operating as a public company.
 
Finance income
 
Finance income increased 137% to CHF 0.1 million in the six months ended June 30, 2014. Finance income in these periods consisted primarily of unrealized exchange gains and interest income recognized on short-term deposits.
 
Finance income increased in the six months ended June 30, 2014 as compared to the six months ended June 30, 2013 as a result of an increase in average cash and cash equivalents following our private placement of preferred equity securities to new and existing investors and the issuance of a convertible
 
 
5

 
 
bond to existing investors with total net proceeds of CHF 24.1 million and CHF 13.8 million, in April and December 2013, respectively.
 
Finance expense
 
Finance expense increased fivefold to CHF 0.1 million in the six months ended June 30, 2014. Higher finance expenses were mainly due to an increase in interest expenses due to the issuance to existing shareholders of the convertible bond in a principal amount of CHF 13.8 million in December 2013.
 
Remeasurements of defined benefits liability
 
Remeasurements of the net defined benefit liability, which comprise actuarial gains and losses, the return on plan assets (excluding interest) and the effect of the asset ceiling (if any, excluding interest), decreased from CHF 0.1 million in the six months ended June 30, 2013 to (CHF 0.4) million in the six  months ended June 30, 2014.
 
Foreign currency translation differences
 
Foreign currency translation differences were insignificant in the six months ended June 30, 2014 and 2013.
 
Liquidity and Capital Resources
 
Since inception, we have incurred significant operating losses.  To date, we have not generated any product sale revenue.  We have financed our operations primarily through our initial public offering of our common shares, private placements of equity securities and loans from existing shareholders.
 
Cash flows
 
Comparison of the three months ended June 30, 2014 and 2013
 
The table below summarizes our consolidated statement of cash flows for the three months ended June 30, 2014 and 2013:
 
   
Three months ended
June 30,
 
   
2014
   
2013
 
   
(in thousands of CHF)
 
Cash used in operating activities
    (6,402 )     (4,208 )
Net cash used in investing activities
    (3 )     (7 )
Net cash from financing activities
    -       22,750  
Net effect of currency translation on cash
    0       0  
Cash and cash equivalents at the beginning of the period
    18,535       21  
Cash and cash equivalents at the end of the period
    12,131       18,557  
 
The increase in cash used in operating activities by 52% from CHF 4.2 million in the three months ended June 30, 2013 to CHF 6.4 million in the three months ended June 30, 2014 was mainly due to higher research and development and general and administrative expenses.
 
Net cash used in investing activities was insignificant in the three months ended June 30, 2014 and 2013.
 
The decrease in net cash from financing activities from CHF 22.7 million in the three months ended June 30, 2013 to CHF nil in the three months ended June 30, 2014 reflects completion of the first tranche of our Series C financing in April 2013.
 
 
6

 
 
Comparison of the six months ended June 30, 2014 and 2013
 
The table below summarizes our consolidated statement of cash flows for the six months ended June 30, 2014 and 2013:
 
   
Six months ended June 30,
 
   
2014
   
2013
 
   
(in thousands of CHF)
 
Cash used in operating activities
    (11,588 )     (5,717 )
Net cash used in investing activities
    (59 )     (18 )
Net cash from financing activities
    (87 )     24,228  
Net effect of currency translation on cash
    (0 )     1  
Cash and cash equivalents at the beginning of the period
    23,866       64  
Cash and cash equivalents at the end of the period
    12,131       18,557  
 
The increase in cash used in operating activities by 103% from CHF 5.7 million in the six months ended June 30, 2013 to CHF 11.6 million in the six months ended June 30, 2014 was mainly due to higher research and development and general and administrative expenses.
 
The increase in net cash used in investing activities by 227 % to CHF 0.1 million in the six months ended June 30, 2014 was due to higher investment in manufacturing equipment partially offset by higher interest income due to a higher cash base.
 
The decrease in net cash from financing activities from CHF 24.2 million in the six months ended June 30, 2013 to CHF (0.1) million in the six months ended June 30, 2014 reflects the completion of the first tranche of the Series C financing in April 2013 as well as stamp duties paid on the conversion of the convertible loan and exercise of stock options in January 2014, which was partially offset by the proceeds received through the exercise of said stock options.
 
Cash and funding sources
 
During the three and six months ended June 30, 2014, we did not obtain new financing except from the exercise of stock options.  As of June 30, 2014, we had no long term debt and had no ongoing material financial commitments, such as lines of credit or guarantees that are expected to affect our liquidity over the next five years, other than leases.
 
Funding requirements
 
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least 24 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:
 
 
·
the scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and other related activities;
 
 
·
the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop;
 
 
·
the number and characteristics of product candidates that we pursue;
 
 
·
the cost, timing, and outcomes of regulatory approvals;
 
 
·
the cost and timing of establishing sales, marketing, and distribution capabilities; and
 
 
·
the terms and timing of any collaborative, licensing, and other arrangements that we may establish, including any required milestone and royalty payments thereunder.
 
 
 
7

 
 
 
We expect that we will require additional funding to advance our late-stage AM-111 clinical program. In addition, we expect that we will require additional capital to commercialize our product candidates AM-101 and AM-111. If we receive regulatory approval for AM-101 or AM-111, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also expect to incur additional costs associated with operating as a public company following this offering. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
 
For more information as to the risks associated with our future funding needs, see “Risk Factors” in the Final Prospectus.
 
Contractual Obligations and Commitments
 
There have been no material changes to our contractual obligations outside the ordinary course of our business from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments” in the Final Prospectus.
 
Off-balance sheet arrangements
 
As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements except for the Operating Lease mentioned in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments” in the Final Prospectus.
 
Significant Accounting Policies and Use of Estimates and Judgment
 
There have been no material changes to the significant accounting policies and estimates described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Significant accounting policies and use of estimates and judgment” in the Final Prospectus.
 
Recent Accounting Pronouncements
 
Except for IFRS 9 for which the impact cannot be determined with sufficient reliability, there are no IFRS standards as issued by the IASB or interpretations issued by the IFRS interpretations committee that
 
 
8

 
 
are effective for the first time for the financial year beginning on or after January 1, 2014 that would be expected to have a material impact on our financial position.
 
JOBS Act Exemption
 
On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting.  This exemption will apply for a period of five years following the completion of our initial public offering or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than $1.0 billion in annual revenue, have more than $700 million in market value of our common shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.
 
Cautionary Statement Regarding Forward Looking Statements
 
Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in the Final Prospectus. These risks and uncertainties include factors relating to:
 
 
·
our operation as a development stage company with limited operating history and a history of operating losses;
 
 
·
our need for substantial additional funding before we can expect to become profitable from sales of our products;
 
 
·
our dependence on the success of AM-101 and AM-111, which are still in clinical development and may eventually prove to be unsuccessful;
 
 
·
the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage;
 
 
·
uncertainty surrounding whether any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized;
 
 
·
if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview;
 
 
·
enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization;
 
 
·
the chance that we do not obtain orphan drug exclusivity for AM-111, which would allow our competitors to sell products that treat the same conditions;
 
 
·
dependence on governmental authorities and health insurers establishing adequate reimbursement levels and pricing policies;
 
 
9

 
 
 
·
our products may not gain market acceptance, in which case we may not be able to generate product revenues;
 
 
·
our reliance on our current strategic relationships with INSERM or Xigen and the potential failure to enter into new strategic relationships;
 
 
·
our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates; and
 
 
·
other risk factors discussed under “Risk Factors” included in the Final Prospectus
 
  Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.
 
 
10 


Exhibit 99.3
 
 
 
 
Auris Medical News Release

Auris Medical Holding AG Reports Second Quarter 2014 Financial Results and Provides Business Update

Zug, Switzerland, September 15, 2014 Auris Medical Holding AG (NASDAQ: EARS) today provided an update on the Company’s business and announced financial results for the second quarter ended June 30, 2014.
 
Recent Business Highlights
 
·
Auris Medical raised net proceeds (after underwriting discounts) of approximately $56.4 million in its initial public offering (IPO), selling 10,113,235 of its common shares, including 713,235 common shares sold pursuant to the underwriters' exercise of their over-allotment option. On August 6, 2014, Auris Medical's shares began trading on the NASDAQ Global Market under the symbol "EARS".
 
·
The AM-101 Phase 3 clinical program in acute inner ear tinnitus remains on track. Ramp-up of clinical trial sites in North America and Europe progressed with approximately 100 sites initiated at the end of August 2014. As previously announced, Auris Medical expects to enroll a total of 930 patients: 630 in the acute stage (i.e. up to three months from onset) and 300 in the post acute stage (i.e. onset between 4 and 12 months). The first patients that completed the TACTT trials rolled over into the open label AMPACT trials in April and May 2014.
 
·
In May 2014, Auris Medical presented data on the determination of clinically meaningful change in subjective tinnitus loudness at the XI. International Tinnitus Seminar in Berlin, Germany. Anchor- and distribution-based statistical analyses of clinical data support the use of a 2 point reduction on a 0-10 numerical rating scale as a responder definition. Improvement in subjective tinnitus loudness is the primary endpoint in the TACTT clinical trials.
 
·
Auris Medical filed additional patent applications in the US relating to the use of inhibitors of the c-Jun N-Terminal Kinase (JNK) such as AM-111 for the treatment of tinnitus or Menière’s Disease. In addition the Company filed a continuation to its earlier US application relating to the use of polymer-based formulations in the treatment of disorders of the middle and inner ear.
 
·
Preparations for the AM-111 late stage clinical program in ASHNL are underway. Following discussions with the European Medicines Agency on the design for a pivotal Phase 3 trial, Auris Medical expects further regulatory feedback from a pre-IND meeting with the FDA in September 2014. Based on that feedback, the Company expects to finalize the design of the late-stage AM-111 clinical program.
 
 
Auris Medical Holding AG · Bahnhofstrasse 21 · CH-6300 Zug · Tel. +41 41 729 71 94 · www.aurismedical.com
 
 
Page 1 of 4

 
 
 
"During the second quarter Auris Medical has made significant progress, both financially and operationally," said Thomas Meyer, Auris Medical’s founder, Chairman and CEO. "With the successful completion of our recent IPO, we have obtained the means to complete the Phase 3 clinical development of AM-101 for the treatment of patients with acute inner ear tinnitus and to further advance our other research and development programs.”
 
Financial Results
 
As of June 30, 2014, the Company had CHF 12.1 million in cash and cash equivalents. Operating expenses for the three months ended June 30, 2014 were CHF 5.0 million, with CHF 4.2 million attributable to research and development. This compares to operating expenses of CHF 4.9 million and research and development expenses of CHF 4.4 million for the same period in 2013. The Company reported a net loss for the quarter ended June 30, 2014 of CHF 5.0 million, or CHF 0.27 per share. This compares to a net loss of CHF 4.8 million, or CHF 0.33 per share, for the same period in 2013.
 
For the six month period ended June 30, 2014, operating expenses were CHF 10.9 million, with CHF 8.4 million attributable to research and development. This compares to operating expenses of CHF 7.1 million and research and development expenses of CHF 6.4 million for the same period in 2013. The Company reported a net loss for the six months ended June 30, 2014 of CHF 10.9 million, or CHF 0.59 per share. This compares to a net loss of CHF 7.1 million, or CHF 0.52 per share, for the same period in 2013.
 
The increases in operating expenses, and resulting increases in net loss, for the three- and six-month periods ended June 30, 2014 over the comparable periods in 2013 reflect primarily the progression of the AM-101 Phase 3 clinical development program, preparations for the late stage AM-111 clinical program, headcount expansion and higher legal and auditing expenses related to the IPO preparations.
 
Conference Call / Webcast Information
 
Auris Medical will host a live conference call and webcast to discuss the Company's financial results and provide a general business update. The call is scheduled for September 15, 2014 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 1877 280 2342 (USA) or +1 718 354 1158 (International), and enter passcode 3215731. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Auris Medical website at: www.aurismedical.com. A replay will be available approximately two hours following the live call also on the Company’s website.
 
About Auris Medical
 
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland.
 
Forward-looking Statements
 
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 fact 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,” and 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, 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. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s prospectus relating to its Registration Statement on Form F-1, as amended, and future filings with the Securities and Exchange Commission. 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. All forward-looking statements are qualified in their entirety by this cautionary statement.
 
 
 
Page 2 of 4

 
 

 
Auris Medical Holding AG
Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income (unaudited)
(in CHF thousands, except per share data)

   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2014
   
2013
   
2014
   
2013
 
Research and development expenses
    (4,201 )     (4,411 )     (8,350 )     (6,384 )
General and administrative expenses
    (845 )     (462 )     (2,554 )     (732 )
Operating loss
    (5,046 )     (4,873 )     (10,904 )     (7,117 )
Finance expense
    (17 )     (1 )     (68 )     (11 )
Finance income
    71       27       121       51  
Loss before tax
    (4,991 )     (4,846 )     (10,851 )     (7,077 )
Net loss attributable to owners of the Company
    (4,991 )     (4,846 )     (10,851 )     (7,077 )
Other comprehensive income:
                               
Items that will never be reclassified to profit or loss
                               
Remeasurements of defined benefits liability
    (407 )     49       (424 )     92  
Items that are or may reclassified to profit or loss
                               
Foreign currency translation differences
    (3 )     4       3       (26 )
Other comprehensive income
    (410 )     53       (421 )     66  
Total comprehensive loss attributable to owners
of the Company
    (5,401 )     (4,793 )     (11,272 )     (7,011 )
Loss per share, basic and diluted
    (0.27 )     (0.33 )     (0.59 )     (0.52 )
Weighted average common shares outstanding, basic and diluted
    18,841,275       15,651,157       18,448,274       13,616,303  
Currency rate CHF / USD
    0.8888       0.9425       0.8907       0.9362  
 

 
 
Page 3 of 4

 

Auris Medical Holding AG
Condensed Consolidated Interim Statement of Financial Position (unaudited)
(in CHF thousands)

   
June 30, 2014
   
December 31, 2013
 
Assets
           
Non-current assets
           
Property and equipment
    215       196  
Intangible assets
    1,483       1,483  
Total non-current assets
    1,734       1,678  
Current assets
               
Current financial assets and other receivables
    694       525  
Prepayments
    714       183  
Cash and cash equivalents
    12,131       23,866  
Total current assets
    13,539       24,574  
Total assets
    15,273       26,252  
Equity and Liabilities
               
Equity
               
Share capital
    7,537       6,487  
Share premium
    48,233       35,608  
Foreign currency translation reserve
    57       54  
Accumulated deficit
    (44,295 )     (33,116 )
Total shareholders’ equity attributable to owners of the Company
    11,530       9,034  
Non-current liabilities
               
Employee benefits
    745       328  
Deferred tax liabilities
    328       328  
Total non-current liabilities
    1,073       656  
Current liabilities
               
Convertible loans
    -       13,711  
Trade and other payables
    1,105       954  
Accrued expenses
    1,564       1,897  
Total current liabilities
    2,669       16,562  
Total liabilities
    3,742       17,219  
Total equity and liabilities
    15,273       26,252  
Currency rate CHF / USD
    0.8867       0.8894  


Contact:
Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94, ear@aurismedical.com
 
 
Page 4 of 4

 
 


Second Quarter 2014 Earnings and Business Update

September 15, 2014

 

 
 

Forward Looking Statements / Safe Harbor

This presentation and the accompanying oral commentary contain
"forward-looking" statements that involve substantial risks and uncertainties.
All statements other than statements of historical facts contained in this
presentation and the accompanying oral commentary, including statements
regarding our future financial condition, business strategy and plans and
objectives of management for future operations, are forward looking statements.
In some cases, you can identify forward-looking statements by terminology such
as "believe," "will," "may," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "might," "approximately," "expect," "predict," "could,"
"potentially" or the negative of these terms or other similar expressions.
Forward looking statements appear in a number of places throughout this
presentation and the accompanying oral commentary and include statements
regarding our intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things, our ongoing and planned
preclinical development and clinical trials, the timing of and our ability to
make regulatory filings and obtain and maintain regulatory approvals for our
product candidates AM-101 and AM-111, our intellectual property position, our
ability to develop commercial functions, expectations regarding clinical trial
data, our results of operations, cash needs, spending of the proceeds from this
offering, financial condition, liquidity, prospects, growth and strategies, the
industry in which we operate and the trends that may affect the industry or us.


Forward-looking statements involve known and unknown risks, uncertainties,
assumptions and other factors that may cause our actual results, performance or
achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements.
Forward-looking statements represent our management's beliefs and assumptions
only as of the date of this presentation. Except as required by law, we assume
no obligation to update these forward-looking statements publicly, or to update
the reasons why actual results could differ materially from those anticipated
in the forward-looking statements, even if new information becomes available in
the future.

 

 
 

Business Update

 

 
 

AM-101 Phase 3 Program Update

[] AM-101  Phase 3 clinical program in acute inner ear tinnitus remains on
track

[] Ramp-up  of TACTT trial sites progressing

-- Approximately 100 sites initiated by the end of August 2014 (target 140)

-- Poland and Czech Republic getting started

[] As expected, Stratum B (post-acute  tinnitus) in European TACTT3 trial
enrolling faster than Stratum A (acute tinnitus)

-- Stratum B futility analysis early 2015 at midpoint of enrolment

[] AMPACT open-label  trials

-- First patients rolled over in April and May 2014 to receive first treatment
cycle

-- First patients rolled over in July and August 2014 to receive second
treatment cycle

 

 
 

Tinnitus Loudness Responder Definition

[] Primary efficacy endpoint in Phase 3 = improvement of subjective loudness
from baseline to the last follow-up  visit at Day 84 on a 0-10  numerical
rating scale


[] What represents a clinically meaningful reduction in tinnitus loudness / how
is a responder defined?

[] Data analyzed from 200 TACTT0 and TACTT1 patients (AAT or OM)

[] Mean tinnitus loudness at baseline = 5.2  points (SD 2.1)

 

 
 

Responder Data Presented at ITS 2014

[] Results presented at XI.  International Tinnitus Seminar in Berlin, Germany,
May 21-24, 2014

[] Anchor-based  approach suggesting 2 point reduction as clinically meaningful


-- Pattern of TLQ response compared to patient global impression of change
(PGIC) in tinnitus severity

-- Patients reporting either "very much improved" or "much improved" tinnitus
severity reported change scores of at least 2 points, with those rating their
change as "somewhat improved" reported less than a 2-point  change

-- Patients endorsing the largest amount of change on the global rating also
reported the largest amount of improvement on the TLQ

-- Pattern of response very similar for uni-  and bilateral cases

[] Supported by distribution-based  approach:

-- One-half  standard deviation of the baseline scores approach

-- Clinically meaningful = 1.1  points

 

 
 

Cumulative Distribution Function for [] TLQ

[] For all points  0, the curve for AM-101  0.81  mg/mL is shifted to the
right of the others

[] At 2 points change in TLQ, AM-101  0.81  mg/mL clearly separates from
placebo and AM- 101 0.27  mg/mL, providing further support for responder
definition

 

 
 

Auris Medical at the AAO Annual Meeting

[] Annual Meeting of the American Association for Otolaryngology -- Head and
Neck Surgery

[] Orlando FL, September 21-24

[] World's largest gathering of ENTs

[] Auris Medical hosting satellite symposium September 23

 

 
 

AM-101 Primary Market Research

[] 53 US ENT doctors surveyed(1)

-- 41 general ENTs

-- 12 otologists

[] Seeing an average of 43.5  tinnitus patients in an average month

[] 37.7%  of their tinnitus patients seek treatment during the acute stage (up
to 3 months from onset)

[] Consistent with survey by Hall et al. , 2011

[] 73.6%  of respondents expect their monthly tinnitus patient volume to
increase if an approved i. t.  treatment of acute tinnitus were available

[] 42.6%  of their tinnitus patients considered as candidates for a product
with the profile of AM-101

[] Rating

-- Tolerability 7.5

-- Efficacy 6.9

 (1=not at all attractive, 10=extremely attractive)

(1) Online survey conducted by MedaCorp, Inc. in April 2014

 

 
 

AM-111 Program Update

[] Preparations for the AM-111  late stage clinical program in ASHNL
progressing

[] Pivotal HEALOS Phase 3 trial planned in ISSNHL

-- 240 patients with severe to profound hearing loss

-- AM-111  0.4  or 0.8  mg/mL or placebo

-- Up to 72 hours from onset

-- Europe and Asia

[] Protocol Assistance from European Medicines Agency (EMA)

[] Pre-IND  meeting with the FDA scheduled for second half of September 2014

[] Based on FDA feedback, design of the late-stage  AM-111  clinical program to
be finalized and communicated

 

 
 

AM-111 Primary Market Research

[] 53 US ENT doctors surveyed(1)

-- 41 general ENTs

-- 12 otologists

[] Seeing an average of 11.2  patients with ISSNHL and 6.3  patients with AAT
in an average month

[] 39.9%  show up for treatment within first 3 days

[] 43.3%  of their ASNHL patients have severe to profound hearing loss

[] 64.2% of respondents expect their monthly ASNHL patient volume to increase
if an approved i.t. treatment of ASNHL were available

[] 59.9% of their ASNHL patients considered as candidates for product with the
profile of AM-111

[] Rating

-- Tolerability 7.8

-- Efficacy 7.2

 (1=not at all attractive, 10=extremely attractive)

(1) Online survey conducted by MedaCorp, Inc. in April 2014

 

 
 

Intellectual Property Update

[] Additional patent applications filed in US relating to the use of inhibitors
of the c- Jun N-Terminal  Kinase (JNK) such as AM-111  -- for the treatment of
tinnitus -- for the treatment of Meni[]re's Disease

[] Continuation to earlier US application filed relating to the use of
polymer-based  formulations in the treatment of disorders of the middle and
inner ear

-- Allowed by European Patent Office, covering compositions containing Ketamine
or derivatives and biocompatible hyaluronic acid gel for treatment of inner ear
disorders

-- Priority date = September 28, 2005

 

 
 

Financial Update

 

 
 

First Half 2014 Financial Highlights

[] Cash and cash equivalents as of June 30, 2014, were CHF 12.1  m compared to
CHF 18.5  m at March 31, 2014 and CHF 23.9  m at December 31, 2013

[] Research and development expenses increased from CHF 6.4  m in the six
months ended June 30, 2013 to CHF 8.4  m in the six months ended June 30, 2014.


-- Progression of our AM-101  Phase 3 clinical development program

-- Preparatory activities related to the late-stage  AM-111  clinical program


[] General and administrative expenses increased from CHF 0.7  m in the six
months ended June 30, 2013 to CHF 2.6  m in the six months ended June 30, 2014


-- Increase primarily related to higher legal and auditing expenses in relation
to the IPO preparations

[] Net loss for the first half 2014 was CHF 10.9  m compared with CHF 7.0  m in
the same period in 2013.

 

 
 

Financial Overview

Financial Position

[] Cash at end of H1 2014 = $13.7   m [] $60.7   m raised in IPO in early
August 2014 ($56.4    m after underwriting discount)

-- 10,113,235 common shares sold at $6  per share (incl.  713,235 shares under
over-allotment  option) -- Trading on the NASDAQ Global Market started August
6, 2014
[] Means to fund

-- AM-101  clinical program beyond Phase 3 read-out  -- Advance further
projects, incl.  AM-111
[] Runway mid 2016

Shareholder Structure

Founder            Sofinnova Ventures
Sofinnova Partners ZKB / Adamant
Idinvest           Other investors under lock-up
Public investors

 

 
 

Questions and Answers

 

 
 

Take care of your ears