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 May, 2015


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: May 28, 2015

 

 

 

 

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 May 28, 2015

 

 

 

 


Exhibit 99.1

 

Unaudited Condensed Consolidated Interim Financial Information as of March 31, 2015 and for the Three Months Ended March 31, 2015 and 2014

 

 

Condensed Consolidated Interim Statement of Profit or Loss

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 (unaudited)
For the Three Months Ended March 31, 2015 and 2014 (in CHF)


 

  Note THREE MONTHS ENDED MARCH 31, 2015  THREE MONTHS ENDED MARCH 31, 2014
Research and development     -6,229,896    -4,149,230 
General and administrative     -929,919    -1,709,065 
Operating loss     -7,159,815    -5,858,295 
Finance income/expense (net)     -892,296    -1,666 
Loss before tax     -8,052,111    -5,859,961 
Net loss attributable to owners of the Company     -8,052,111    -5,859,961 
Other comprehensive loss:            
Items that will never be reclassified to profit or loss            
Remeasurements of defined benefit liability     -228,865    -16,511 
Items that are or may be reclassified to profit or loss            
Foreign currency translation differences     18,361    5,490 
Other comprehensive loss     -210,504    -11,021 
Total comprehensive loss attributable to owners of the Company     -8,262,615    -5,870,982 
Basic and diluted loss per share     -0.28    -0.32 
 
 

 

AURIS MEDICAL HOLDING AG

Condensed Consolidated Interim Statement of Financial Position (unaudited)

As of March 31, 2015 and December 31, 2014

(in CHF)


 

  

Note

 

MARCH 31,
2015

 

DECEMBER 31,
2014

ASSETS             
Non-current assets             
Property and equipment       214,374    235,427 
Intangible assets       1,482,520    1,482,520 
Deferred tax asset       —      32,761 
Total non-current assets       1,696,894    1,750,708 
              
Current assets             
Other receivables       501,481    542,538 
Prepayments       190,036    265,170 
Cash and cash equivalents       49,653,975    56,934,325 
Total current assets       50,345,492    57,742,033 
              
Total assets       52,042,386    59,492,741 
EQUITY AND LIABILITIES             
Equity             
Share capital   3   11,605,656    11,604,156 
Share premium       93,871,671    93,861,171 
Foreign currency translation reserve       -32,747    -51,108 
Accumulated deficit       -60,358,724    -52,131,426 
Total shareholders’ equity attributable to owners of the Company       45,085,856    53,282,793 
              
Non-current liabilities             
Employee benefits   4   1,630,538    1,410,598 
Deferred tax liabilities       327,637    360,398 
Total non-current liabilities       1,958,175    1,770,996 
              
Current liabilities             
Trade and other payables       3,106,204    3,234,384 
Accrued expenses       1,892,151    1,204,568 
Total current liabilities       4,998,354    4,438,952 
              
Total liabilities       6,656,530    6,209,948 
              
Total equity and liabilities       52,042,386    59,492,741 
 
 

 

AURIS MEDICAL HOLDING AG

Condensed Consolidated Interim Statement of Cash Flows (unaudited)

For the Three Months Ended March 31, 2015 and 2014 (in CHF)


 

   Note  THREE MONTHS ENDED MARCH 31, 2015  THREE MONTHS ENDED MARCH 31, 2014
Cash flows from operating activities             
Net loss      -8,052,111    -5,859,961 
Adjustments for:             
Depreciation       21,054    14,904 
Unrealized net foreign currency exchange (gains) loss       979,506    5,880 
Net interest (income)expense       -5,059    26,496 
Share option costs       53,677    40,602 
Employee benefits       -8,923    -268 
Changes in net working capital      675,580    1,710,651 
              
Cash used in operating activities       -6,336,276    -4,061,696 
              
Cash flows from investing activities             
Purchase of property and equipment       —      -79,836 
Purchase of intangibles       —      -1,125,000 
Interest received       5,059    23,139 
Net cash used in investing activities       5,059    -1,181,697 
              
Cash flows from financing activities             
Proceeds from exercise of options   3   12,000    49,600 
Share issuance costs       —      -136,699 
Net cash from financing activities       12,000    -87,099 
              
Net decrease in cash and cash equivalents       -6,319,217    -5,330,492 
Cash and cash equivalents at beginning of the period       56,934,325    23,865,842 
Net effect of currency translation on cash       -961,133    -327 
Cash and cash equivalents at end of the period       49,653,975    18,535,023 
 
 

 

AURIS MEDICAL HOLDING AG

Additional Information to the Consolidated Financial Information

as of March 31, 2015 and for the Three Months Ended March 31, 2015 and 2014 (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. This consolidated interim financial information comprises 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 herein is not intended to fully comply with IFRS, and in particular with IAS 34. New accounting standards that were 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 herein has not been reviewed or audited by our auditors. Quarterly 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.

 

3.Capital and reserves

 

Share capital

The issued share capital of the Company consisted of:


 

   March 31, 2015  December 31, 2014
  

Number

  

CHF

  

Number

  

CHF 

 
Common shares with a nominal value of CHF 0.40 each    29,014,141    11,605,656    29,010,391    11,604,156 
Total    29,014,141    11,605,656    29,010,391    11,604,156 

 

All shares are fully paid in.

 
 


AURIS MEDICAL HOLDING AG

Additional Information to the Consolidated Financial Information
as of March 31, 2015 and for the Three Months Ended March 31, 2015 and 2014 (in CHF


   Common Shares (Number)  Preferred Shares (Number)
   2015  2014  2015  2014
As of January 1    29,010,391    72,600    —      16,145,225 
Common share stock options with a nominal value of CHF 0.40 each    3,750    15,500    —      —   
Preferred shares C issued for conversion of convertible loans with a nominal value of CHF 0.40 each    —      —      —      2,607,950 
Total, as at March 31, 2015 and March 31, 2014    29,014,141    88,100    —      18,753,175 

 


 

Issue of common shares upon exercise of option

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.

 

On January 23, 2015, one beneficiary of Option Plan A exercised his 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 3,750 and an increase in the share capital of CHF 1,500. Total proceeds from the exercise to the company were CHF 12,000.

 

IPO on NASDAQ Global Market

 

In August 2014 the Company completed its initial public offering of common shares (“IPO”) issuing 10,113,235 shares, including the underwriter’s overallotment option, yielding total net proceeds of CHF 51.3 million (USD 56.4 million). Following the IPO there were 28,954,510 common shares of the Company outstanding. At December 31, 2014 there were 29,010,391 shares outstanding due to exercise of options.

 

Pursuant to agreements with holders of the pre-IPO preferred shares, all preferred shares outstanding at the time of the IPO converted automatically into common shares at the ratio of 1:1 upon consummation of the IPO.

 

Issuance of preferred shares

 

In January 2014, a convertible loan was converted into 2,607,950 preferred shares Series C with a nominal value of CHF 0.40 at a conversion price of CHF 5.28 each.

 

4.Employee benefits

 


  

THREE MONTHS ENDED MARCH 2015

 

THREE MONTHS ENDED MARCH 2014

Salaries    603,984    461,230 
Pension costs    30,642    29,218 
Other social benefits    30,031    35,947 
Share option costs    53,677    40,602 
Other    40,059    15,814 
Total employee benefits    758,394    582,811 


 

 
 

 

AURIS MEDICAL HOLDING AG

Additional Information to the Consolidated Financial Information
as of March 31, 2015 and for the Three Months Ended March 31, 2015 and 2014 (in CHF

 

Accelerated Vesting for Stock Option Plan A

Option Plan A provided for the accelerated vesting of options under the plan in the case of an IPO, merger or change of control on the closing date of the respective transaction. The remaining share option expense for Option Plan A on the date of the closing of our IPO in August 2014 was included in the share option cost for the twelve months ending December 31, 2014.

 

5.Events after the balance sheet date

 

On May 20, 2015, the Company completed a public offering of common shares, issuing an aggregate of 5,275,000 common shares, yielding net proceeds of CHF 21.4 million (USD 22.9 million) after underwriting discounts and estimated offering expenses. Following the offering there were 34,293,891 common shares of the Company outstanding.

 

 


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 and for the three month periods ended March 31, 2015 and 2014 included as Exhibit 99.1 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 the notes thereto, which appear in our Annual Report on Form 20-F (the ”Annual Report”), filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the U.S. Securities Exchange Act of 1934, 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.

 

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 May 28, 2015.

 

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 an 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 the first quarter of 2016. We are also developing AM-111 for acute inner ear hearing loss. We are preparing two pivotal clinical trials of AM-111 in the treatment of idiopathic sudden sensorineural hearing loss, or ISSNHL, titled HEALOS and ASSENT. We expect to start enrollment in HEALOS in the third quarter of 2015 and in ASSENT in the first quarter of 2016. In addition, we are preparing a Phase 2 trial titled REACH in order to test AM-111 in the treatment of surgery-induced hearing loss following cochlear implantation. We expect to start enrollment in REACH in the third quarter of 2016. 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 public offerings 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. As of March 31, 2015, we had cash and cash equivalents of CHF 49.7 million. 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 18.2 million and CHF 15.0 million for the years ended December 31, 2014 and 2013, respectively. As of March 31, 2015, we had an accumulated deficit of CHF 60.4 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 May 20, 2015 we completed a public offering of common shares pursuant to a Registration Statement on Form F-1, as amended (Registration No. 333-203554). Under the registration statement, we sold an aggregate of 5,275,000 common shares, yielding net proceeds of $22.9 million (CHF 21.4 million) after underwriting discounts and estimated offering expenses.

 

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 Annual Report.

 

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 are conducting a Phase 3 program with AM-101 for acute inner ear tinnitus comprising of 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 TACTT2 and TACTT3 in early 2016. We anticipate that our research and development expenses in connection with these clinical trials will be substantially higher in 2015 than in the previous financial year.

 

·         AM-111. We are preparing two pivotal clinical trials of AM-111 in the treatment of idiopathic sudden sensorineural hearing loss, or ISSNHL, titled HEALOS and ASSENT. We expect to start enrollment in HEALOS in the third quarter of 2015 and in ASSENT in the first quarter of 2016. In addition, we are preparing a Phase 2 trial titled REACH in order to test AM-111 in the treatment of surgery-induced hearing loss following cochlear implantation. We expect to start enrollment in REACH in the third quarter of 2016. We anticipate that our research and development expenses will increase substantially in connection with commencement of these clinical trials.

 

·Other development programs. Other research and development expenses mainly relate to our preclinical studies with AM-102 and AM-123, including 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 Annual Report.

 

Results of Operations

 

The numbers below have been derived from our unaudited condensed consolidated interim financial information as of and for the three month periods ended March 31, 2015 and 2014. The discussion below should be read along with this financial information, and it is qualified in its entirety by reference to it.

 

 

 

 

Comparison of the three months ended March 31, 2015 and 2014

 

  

Three months ended March 31,

  

2015

 

2014

 

Change

   (in thousands of CHF)  %
Research and development    (6,230)   (4,149)   50%
General and administrative    (930)   (1,709)   (46)%
Operating loss    (7,160)   (5,858)   22%
Finance income/expense, net    (892)   (1)     
Loss before tax    (8,052)   (5,859)   37%
Net loss attributable to owners of the company    (8,052)   (5,859)   37%
Other comprehensive income:               
Items that will never be reclassified to profit or loss               
Remeasurements of defined benefits liability    (229)   (16)   1,286%
Items that are or may be reclassified to profit or loss               
Foreign currency translation differences    18    5    234%
Other comprehensive income   (211)   (11)   1,810%
Total comprehensive loss attributable to owners of the company    (8,263)   (5,870)   41%

 

Research and development expense

 

  

Three months ended March 31,

Research and development expense 

2015

 

2014

 

Change

   (in thousands of CHF)  %
Clinical Projects    (5,298)   (2,404)   120%
Pre-clinical projects    (129)   (564)   (77)%
Drug manufacture and substance    (148)   (625)   (76)%
Employee benefits    (457)   (370)   23%
Other research and development expenses    (198)   (186)   7%
Total    (6,230)   (4,194)   41%
                

 

Research and development expense increased 50% from CHF 4.1 million in the three months ended March 31, 2014 to CHF 6.2 million in the three months ended March 31, 2015. The variances in expense between the three months ended March 31, 2015 and the corresponding period in 2014 are mainly due to the following projects:

 

·Clinical Projects. In the three months ended March 31, 2015 we incurred higher clinical expenses than in the three months ended March 31, 2014 primarily due to higher service and milestone costs charged by contracted service providers in connection to the late stage AM-101 clinical trials, reflecting higher patient enrollment rates and trial progress when compared to the 2014 period.

 

·Pre-clinical projects. In the three months ended March 31, 2015, pre-clinical expenses decreased primarily due to fewer ongoing preclinical studies.

 

·Drug manufacture and substance. In the three months ended March 31, 2015 we incurred lower costs primarily due to fluctuations in the timing of raw material purchases across financial quarters and the manufacture of clinical trial supplies.

 

·Employee Benefits. Employee expenses were significantly higher in the three months ended March 31, 2015 due to higher headcount.

 

General and administrative expense

 

General and administrative expense decreased 46% from CHF 1.7 million in the three months ended March 31, 2014 to CHF 0.9 million in the three months ended March 31, 2015. While employee

 

 

 

 

costs increased over the previous reporting period, legal and auditing expenses were substantially lower. In the three months ending March 31, 2014 substantial costs had been incurred in connection with preparations for our initial public offering.

 

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.

 

Net Finance income/expense

 

Finance expense increased significantly to CHF 0.9 million in the three months ended March 31, 2015 primarily due to the marked appreciation of the Swiss Franc against the U.S. Dollar and the Euro, which resulted in substantial unrealized currency losses on cash and cash equivalents held in foreign currency.

 

Cash flows

 

Comparison of the three months ended March 31, 2015 and 2014

 

The table below summarizes our consolidated statement of cash flows for the three months ended March 31, 2015 and 2014:

 

   Three months ended
March, 31
   2015  2014
   (in thousands of CHF)
Cash used in operating activities   (6,336)   (4,062)
Net cash used in investing activities    5    (1,182)
Net cash from financing activities   12    (87)
Net effect of currency translation on cash   (961)   0 
Cash and cash equivalents at the beginning of the period    56,934    23,866 
Cash and cash equivalents at the end of the period    49,654    18,535 

 

The increase in cash used in operating activities from CHF 4.1 million in the three months ended March 31, 2014 to CHF 6.3 million in the three months ended March 31, 2015 was mainly due to higher research and development expenses, which more than offset the increase in accrued liabilities and lower general and administrative expenses.

 

Net cash used in investing activities was insignificant in the three months ended March 31, 2015. In the three months ended March 31, 2014, net cash used in investing was comprised mainly of a milestone payment to Xigen S.A.

 

Net cash from financing activities of CHF 12,000 in the three months ended March 31, 2015 represents proceeds from the exercise of employee stock options. In the three months ended March 31, 2014 net cash used in financing activities was CHF 87,099, reflecting the net effect of proceeds from the exercise of stock options that were more than offset by payment of stamp duties in relation to the conversion of the convertible loan from our pre-initial public offering Series C shareholders.

 

Cash and funding sources

 

As of March 31, 2015, 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 after the closing of our public offering on May 20, 2015, our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements at least until fall 2017. 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.

 

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. 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.

 

We may raise additional capital through the sale of equity or convertible debt securities. In such an event, your ownership interest will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect your rights as a holder of our common shares.

 

For more information as to the risks associated with our future funding needs, see “Risk Factors” in the Annual Report.

 

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 Annual Report.

 

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 Annual Report.

 

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 Annual Report.

 

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 are effective for the first time for the financial year beginning on or after January 1, 2015 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 (2019) 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 Annual Report. 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;

 

·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 Annual Report

 

  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.

 

 

 


 

Exhibit 99.3

https://cdn.kscope.io/b3630c72c5a880f87a45c2478def512c-logo_farb.jpg

 

Auris Medical News Release

 

Auris Medical Holding AG Reports First Quarter 2015 Financial Results and Provides Business Update

 

Zug, Switzerland, May 28, 2015 – Auris Medical Holding AG (NASDAQ: EARS) today provided an update on the Company’s business and announced financial results for the first quarter ended March 31, 2015.

 

"Auris Medical continued to make strong progress in the first months of 2015," commented Thomas Meyer, the Company’s founder, Chairman and CEO. "Enrollment into our AM-101 Phase 3 trials in the treatment of acute inner ear tinnitus advanced well, and through our recent equity raise we laid the groundwork for moving forward with an expanded AM-111 late-stage clinical development program. The treatment of acute inner ear hearing loss with AM-111 addresses an important unmet medical need and represents a substantial commercial opportunity for Auris Medical.”

 

Recent Business Highlights

 

·Based on further discussions with clinicians and feedback obtained from regulatory agencies, the Company refined and strengthened its development program for AM-111 in the treatment of acute sensorineural hearing loss (ASNHL). In addition to the HEALOS trial (to be performed in Europe and Asia), Auris Medical will conduct a second Phase 3 trial (ASSENT), to be performed in the U.S., to test AM-111 in patients suffering from idiopathic sudden sensorineural hearing loss (ISSNHL). Based on market research, the Company believes ISSNHL to be the most frequent type of ASNHL. In both trials, a single intratympanic dose of AM-111 0.4 mg/mL or 0.8 mg/mL will be tested against placebo; participants in ASSENT may receive an oral corticosteroid as a background therapy. Auris Medical expects to begin enrollment in the HEALOS trial in the third quarter of 2015 and in the ASSENT trial in the first quarter of 2016. In addition, the Company is preparing a Phase 2 trial (REACH) with AM-111 in the treatment of surgery-induced hearing loss. Auris Medical expects to begin enrollment in REACH in the third quarter of 2016.

 

·To fund the late-stage AM-111 clinical development program, Auris Medical raised $25 million in additional equity in May through a public offering of 5,275,000 of its common shares at $4.75 per share. After deducting the underwriting discounts and estimated offering expenses, the net proceeds of the public offering were approximately $22.9 million. As a result of the offering, the Company extended its cash runway to Fall 2017 (excluding funding needs for preparation of AM-101’s commercialization).

 

·The AM-101 Phase 3 clinical program in acute inner ear tinnitus progressed further. In May, close to 50% of the target patient number was enrolled in the TACTT2 trial (primarily conducted in North America) and more than 50% in the TACTT3 trial (conducted in Europe). Following the interim analysis and based on recommendations from the Independent Data Review Committee, enrollment in the post-acute tinnitus stratum of the TACTT3 trial continued with patients with tinnitus onset between 3 and 6 months prior to enrollment.

 

Auris Medical Holding AG · Bahnhofstrasse 21 · CH-6300 Zug · Tel. +41 41 729 71 94 ·

www.aurismedical.com

 

 

 

post-acute tinnitus stratum of the TACTT3 trial continued with patients with tinnitus onset between 3 and 6 months prior to enrollment.

 

·Two recent publications in peer-reviewed scientific and medical journals released additional preclinical and clinical data on AM-101. One of the articles, appearing in Cellular Physiology and Biochemistry, presented experimental data from an animal model of noise-induced tinnitus. The authors showed a significant reduction in the loss of inner hair cell ribbons and superior preservation of the amplitudes of centrally generated auditory brainstem response waves in AM-101 treated animals compared to controls. The second article, published in Audiology & Neurotology, presented the results from the TACTT1 trial with AM-101 and detailed how the most appropriate dose regimen for the Phase 3 was determined based on Phase 2 clinical outcomes.

 

·Scientific and clinical data from the AM-101 program were presented in a well-attended corporate symposium at the Annual Congress of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery in Berlin. The symposium was chaired by Prof. Markus Suckfüll, Munich, and featured presentations by Prof. Marlies Knipper, Tübingen, and Guido Mühlmeier, MD, Ulm.

 

·The Company further strengthened its intellectual property portfolio. The U.S. Patent and Trademark Office (“USPTO”) issued a Notice of Allowance for a patent relating to methods of treating inner or middle ear diseases with intratympanic injections of fluoroquinolone antibiotics in poloxamer 407 compositions under certain specifications. Auris Medical continues to seek to obtain broad coverage for its intellectual property around polymer-based ear therapeutics.

 

Financial Results

 

As of March 31, 2015, the Company had CHF 49.7 million in cash and cash equivalents. Operating expenses for the three months ended March 31, 2015 were CHF 7.2 million, with CHF 6.2 million attributable to research and development. This compares to operating expenses of CHF 5.9 million and research and development expenses of CHF 4.1 million for the same period in 2014. Net finance expenses were CHF 0.9 million primarily due to the strengthening of the Swiss Franc against the U.S. dollar and the Euro, which resulted in substantially higher unrealized losses on foreign currency positions. The Company reported a net loss for the quarter ended March 31, 2015 of CHF 8.1 million, or CHF 0.28 per share. This compares to a net loss of CHF 5.9 million, or CHF 0.32 per share, for the same period in 2014.

 

The increase in operating expenses, and resulting increase in operating loss, for the three-month period ended March, 2015 over the comparable period in 2014 primarily reflect 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 being a public company.

 

The Company expects operating expenses for the 2015 financial year to be in the range of CHF 30.0 to 35.0 million, including spending on advancing the AM-111 late-stage program. This outlook is based on management’s current expectations and beliefs.

 

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 May 28, 2015 at 8:00 a.m. Eastern Time (2:00 p.m. Central European Time).

 

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To participate in this conference call, dial 1 855 217 7942 (USA) or +1 646 254 3372 (International), and enter passcode 5198101. 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. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS".

 

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, 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, 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.

 

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Auris Medical Holding AG

Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income (unaudited)

(in CHF thousands, except share and currency data)

 

   Three Months Ended
March 31,
   2015  2014
Research and development expenses   (6,230)   (4,149)
General and administrative expenses   (930)   (1,709)
Operating loss   (7,160)   (5,858)
Finance income / expense (net)   (892)   (2)
Loss before tax   (8,052)   (5,860)
Net loss attributable to owners of the Company   (8,052)   (5,860)
Other comprehensive income:          
Items that will never be reclassified to profit or loss:          
Remeasurements of defined benefits liability   (229)   (17)
Items that are or may reclassified to profit or loss:          
Foreign currency translation differences   18    5 
Other comprehensive income   (211)   (11)
Total comprehensive loss attributable to owners
of the Company
   (8,263)   (5,871)
Loss per share, basic and diluted   (0.28)   (0.32)
Weighted average common shares outstanding, basic and diluted     29,013,214    18,055,273 
Currency rate CHF / USD   0.9526    0.8928 

 

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Auris Medical Holding AG

Condensed Consolidated Statement of Financial Position (unaudited)

(in CHF thousands)

 

   March 31, 2015  December 31, 2014
Assets          
Non-current assets          
Property and equipment   214    235 
Intangible assets   1,483    1,483 
Deferred tax asset   —      33 
Total non-current assets   1,697    1,751 
Current assets          
Current financial assets and other receivables   501    543 
Prepayments   190    265 
Cash and cash equivalents   49,654    56,934 
Total current assets   50,345    57,742 
Total assets   52,042    59,493 
Equity and Liabilities          
Equity          
Share capital   11,606    11,604 
Share premium   93,872    93,861 
Foreign currency translation reserve   (33)   (51)
Accumulated deficit   (60,359)   (52,131)
Total shareholders’ equity attributable to owners of the Company   45,086    53,283 
Non-current liabilities          
Employee benefits   1,631    1,411 
Deferred tax liabilities   328    360 
Total non-current liabilities   1,958    1,771 
Current liabilities          
Convertible loans   —      —   
Trade and other payables   3,106    3,234 
Accrued expenses   1,892    1,205 
Total current liabilities   4,998    4,439 
Total liabilities   6,957    6,210 
Total equity and liabilities   52,042    59,493 
Currency rate CHF / USD   0.9720    0.8841 

 

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Auris Medical Holding AG

Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income (unaudited)

(convenience presentation in USD thousands, except share data)

 

   Three Months Ended
March 31,
   2015  2014
Research and development expenses   (6,409)   (4,269)
General and administrative expenses   (957)   (1,758)
Operating loss   (7,366)   (6,029)
Finance income / expense (net)   (918)   (2)
Loss before tax   (8,284)   (6,029)
Net loss attributable to owners of the Company   (8,284)   (6,029)
Other comprehensive income:          
Items that will never be reclassified to profit or loss:          
Remeasurements of defined benefits liability   (235)   (17)
Items that are or may reclassified to profit or loss:          
Foreign currency translation differences   19    6 
Other comprehensive income   (217)   (11)
Total comprehensive loss attributable to owners
of the Company
   (8,501)   (6,040)
Loss per share, basic and diluted   (0.29)   (0.33)
Weighted average common shares outstanding, basic and diluted     29,013,214    18,046,442 

 

Solely for the convenience of the reader, unless otherwise indicated, all Swiss Franc amounts stated in the Condensed Consolidated Statement of Profit and Loss for the 3 months ended March 31, 2015 and March 31, 2014, have been translated into U.S. dollars at the rate on March 31, 2015 of USD 1.0288 / CHF 1.00. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

 

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Auris Medical Holding AG

Condensed Consolidated Statement of Financial Position (unaudited)

(convenience presentation in USD thousands)

 

   March 31, 2015  December 31, 2014
Assets          
Non-current assets          
Property and equipment   221    242 
Intangible assets   1,525    1,525 
Deferred tax asset   —      34 
Total non-current assets   1,746    1,801 
Current assets          
Current financial assets and other receivables   516    558 
Prepayments   196    273 
Cash and cash equivalents   51,084    58,574 
Total current assets   51,796    59,405 
Total assets   53,542    61,207 
Equity and Liabilities          
Equity          
Share capital   11,940    11,938 
Share premium   96,576    96,565 
Foreign currency translation reserve   (34)   (53)
Accumulated deficit   (62,097)   (53,633)
Total shareholders’ equity attributable to owners of the Company   46,385    54,818 
Non-current liabilities          
Employee benefits   1,678    1,451 
Deferred tax liabilities   337    371 
Total non-current liabilities   2,015    1,822 
Current liabilities          
Convertible loans   —      —   
Trade and other payables   3,196    3,328 
Accrued expenses   1,947    1,239 
Total current liabilities   5,142    4,567 
Total liabilities   7,157    6,389 
Total equity and liabilities   53,542    61,207 

 

Solely for the convenience of the reader, unless otherwise indicated, all Swiss Franc amounts stated in the Condensed Consolidated Statement of Financial Position as at March 31, 2015 and December 31, 2014, have been translated into U.S. dollars at the rate on March 31, 2015 of USD 1.0288 / CHF 1.00. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

 

Company: Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94, ear@aurismedical.com

Investors: Matthew P. Duffy, Managing Director, LifeSci Advisors, 212-915-0685, matthew@lifesciadvisors.com

 

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