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 August, 2016
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 | o |
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 | o | 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 | o | No | x | |
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-206710) and Form S-8 (Registration Numbers 333-198037 and 333-200805) of Auris Medical Holding AG and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibits 99.3 and 99.4 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
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: August 18, 2016
EXHIBIT INDEX
Exhibit Number | Description |
99.1 | Unaudited Condensed Consolidated Interim Financial Statements |
99.2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
99.3 | Press Release dated August 18, 2016 |
99.4 | Press Release dated August 18, 2016 |
Exhibit 99.1
Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2016 and December 31, 2015 and for the Three and Six Months Ended June 30, 2016 and 2015
Condensed Consolidated Interim Statement of Profit or Loss and
Other Comprehensive Loss
Condensed Consolidated Interim Statement of Financial Position
Condensed Consolidated Interim Statement of Changes in Equity
Condensed Consolidated Interim Statement of Cash Flows
Notes to the Condensed Consolidated Interim Financial Statements
Condensed Consolidated Interim Statement of Profit or Loss
and Other Comprehensive Loss (unaudited)
For the Three and Six Months Ended June 30, 2016 and 2015 (in CHF)
THREE MONTHS ENDED JUNE 30 | SIX MONTHS ENDED JUNE 30 | |||||||||||||||||
Note | 2016 | 2015 | 2016 | 2015 | ||||||||||||||
Research and development | -7,278,563 | -8,750,891 | -13,418,738 | -14,980,787 | ||||||||||||||
General and administrative | -1,725,114 | -980,187 | -2,947,146 | -1,910,106 | ||||||||||||||
Operating loss | -9,003,677 | -9,731,078 | -16,365,884 | -16,890,893 | ||||||||||||||
Interest income | 15,281 | 5,210 | 26,166 | 10,268 | ||||||||||||||
Interest expense | -2,514 | -2,540 | -5,259 | -4,604 | ||||||||||||||
Foreign currency exchange gain/(loss), net | 558,908 | -1,230,018 | -985,937 | -2,125,308 | ||||||||||||||
Loss before tax | -8,432,002 | -10,958,426 | -17,330,914 | -19,010,537 | ||||||||||||||
Income tax expense | - | - | - | - | ||||||||||||||
Net loss attributable to owners of the Company | -8,432,002 | -10,958,426 | -17,330,914 | -19,010,537 | ||||||||||||||
Other comprehensive loss: | ||||||||||||||||||
Items that will never be reclassified to profit or loss | ||||||||||||||||||
Remeasurements of defined benefit liability, net of taxes of CHF 0 | -347,398 | -306 | -607,867 | -229,170 | ||||||||||||||
Items that are or may be reclassified to profit or loss | ||||||||||||||||||
Foreign currency translation differences, net of taxes of CHF 0 | -15,856 | 38,501 | 25,964 | 56,863 | ||||||||||||||
Other comprehensive (loss)/income, net of taxes of CHF 0 | -363,254 | 38,195 | -581,903 | -172,307 | ||||||||||||||
Total comprehensive loss attributable to owners of the Company | -8,795,256 | -10,920,231 | -17,912,817 | -19,182,844 | ||||||||||||||
Basic and diluted loss per share | 6 | -0.25 | -0.34 | -0.50 | -0.62 |
| ||||||||||||
The accompanying notes form an integral part of these condensed consolidated interim financial statements
Condensed Consolidated Interim Statement of Financial Position
(unaudited)
As of June 30, 2016 and December 31, 2015 (in CHF)
Note | JUNE 30, 2016 | DECEMBER 31, | ||||||||
ASSETS | ||||||||||
Non-current assets | ||||||||||
Property and equipment | 185,324 | 222,570 | ||||||||
Intangible assets | 1,482,520 | 1,482,520 | ||||||||
Other non-current receivables | 38,066 | 38,066 | ||||||||
Total non-current assets | 1,705,910 | 1,743,156 | ||||||||
Current assets | ||||||||||
Other receivables | 1,387,380 | 650,716 | ||||||||
Prepayments | 17,789 | 181,044 | ||||||||
Cash and cash equivalents | 32,780,841 | 50,237,300 | ||||||||
Total current assets | 34,186,010 | 51,069,060 | ||||||||
Total assets | 35,891,920 | 52,812,216 | ||||||||
EQUITY AND LIABILITIES | ||||||||||
Equity | ||||||||||
Share capital | 13,731,881 | 13,721,556 | ||||||||
Share premium | 112,838,815 | 112,662,910 | ||||||||
Foreign currency translation reserve | -37,858 | -63,821 | ||||||||
Accumulated deficit | -99,440,625 | -81,578,733 | ||||||||
Total shareholders’ equity attributable to owners of the Company | 27,092,213 | 44,741,912 | ||||||||
Non-current liabilities | ||||||||||
Employee benefits | 2,245,431 | 1,575,833 | ||||||||
Deferred tax liabilities | 327,637 | 327,637 | ||||||||
Total non-current liabilities | 2,573,068 | 1,903,470 | ||||||||
Current liabilities | ||||||||||
Trade and other payables | 660,341 | 1,205,522 | ||||||||
Accrued expenses | 5,566,298 | 4,961,312 | ||||||||
Total current liabilities | 6,226,639 | 6,166,834 | ||||||||
Total liabilities | 8,799,707 | 8,070,304 | ||||||||
Total equity and liabilities | 35,891,920 | 52,812,216 |
The accompanying notes form an integral part of these condensed consolidated interim financial statements
Condensed Consolidated Interim Statement of Changes in Equity
(unaudited)
As of June 30, 2016 and 2015 (in CHF)
Attributable to Owners of the Company | ||||||||||||||||||||||
Note | Share Capital | Share Premium | Foreign Currency Translation Reserve | Accumulated Deficit | Total Equity | |||||||||||||||||
Balance as of January 1, 2015 | 11,604,156 | 93,861,171 | -51,109 | -52,131,426 | 53,282,792 | |||||||||||||||||
Total comprehensive loss | ||||||||||||||||||||||
Net loss | - | - | - | -19,010,537 | -19,010,537 | |||||||||||||||||
Other comprehensive income/(loss) | - | - | 56,863 | -229,170 | -172,307 | |||||||||||||||||
Total comprehensive loss | - | - | 56,863 | -19,239,707 | -19,182,844 | |||||||||||||||||
Transactions with owners of the Company | ||||||||||||||||||||||
Capital increase from follow-on offering | 2,110,000 | 19,604,877 | - | - | 21,714,877 | |||||||||||||||||
Share issuance costs | - | -210,675 | - | - | -210,675 | |||||||||||||||||
Transaction costs | - | -643,796 | - | - | -643,796 | |||||||||||||||||
Share based payments | 4 | - | - | - | 127,993 | 127,993 | ||||||||||||||||
Share options exercised | 3 | 3,400 | 23,800 | - | - | 27,200 | ||||||||||||||||
Balance as of June 30, 2015 | 13,717,556 | 112,635,377 | 5,754 | -71,243,140 | 55,115,547 | |||||||||||||||||
Balance as of January 1, 2016 | 13,721,556 | 112,662,910 | -63,821 | -81,578,733 | 44,741,912 | |||||||||||||||||
Total comprehensive loss | ||||||||||||||||||||||
Net loss | - | - | - | -17,330,914 | -17,330,914 | |||||||||||||||||
Other comprehensive loss | - | - | 25,964 | -607,867 | -581,904 | |||||||||||||||||
Total comprehensive loss | - | - | 25,964 | -17,938,781 | -17,912,818 | |||||||||||||||||
Transactions with owners of the Company | ||||||||||||||||||||||
Share issuance costs | - | -1,862 | - | - | -1,862 | |||||||||||||||||
Share based payments | 5 | - | - | - | 76,889 | 76,889 | ||||||||||||||||
Issue of bonus shares | 3 | 10,325 | 177,767 | - | - | 188,092 | ||||||||||||||||
Balance as of June 30, 2016 | 13,731,881 | 112,838,815 | -37,858 | -99,440,625 | 27,092,213 |
The accompanying notes form an integral part of these condensed consolidated interim financial statements
Condensed Consolidated Interim Statement of Cash Flows (unaudited)
For the Six Months Ended June 30, 2016 and 2015 (in CHF)
Note | SIX MONTHS ENDED JUNE 30, 2016 | SIX MONTHS ENDED JUNE 30, 2015 | ||||||||
Cash flows from operating activities | ||||||||||
Net loss | -17,330,914 | -19,010,537 | ||||||||
Adjustments for: | ||||||||||
Depreciation | 48,720 | 44,551 | ||||||||
Unrealized net foreign currency exchange loss, net | 1,051,376 | 2,272,314 | ||||||||
Net interest income | -26,166 | -10,096 | ||||||||
Share option costs | 5 | 76,889 | 127,993 | |||||||
Employee benefits | 61,731 | 60,611 | ||||||||
Changes in: | ||||||||||
Other receivables | -736,665 | 14,059 | ||||||||
Prepayments | 163,255 | 245,377 | ||||||||
Trade and other payables | -545,181 | -1,124,859 | ||||||||
Accrued expenses | 793,079 | 2,827,018 | ||||||||
Net cash used in operating activities | -16,443,876 | -14,553,569 | ||||||||
Cash flows from investing activities | ||||||||||
Purchase of property and equipment | -11,474 | -53,249 | ||||||||
Interest received | 26,166 | 10,096 | ||||||||
Net cash from investing activities | 14,692 | -43,153 | ||||||||
Cash flows from financing activities | ||||||||||
Proceeds from share capital increase | 3 | - | 27,200 | |||||||
Share issuance costs | -1,862 | -210,675 | ||||||||
Proceeds from follow-on offering | 3 | - | 21,071,081 | |||||||
Net cash from financing activities | -1,862 | 20,887,606 | ||||||||
Net (decrease)/increase in cash and cash equivalents | -16,431,046 | 6,290,884 | ||||||||
Cash and cash equivalents at beginning of the period | 50,237,300 | 56,934,325 | ||||||||
Net effect of currency translation on cash | -1,025,413 | -2,215,353 | ||||||||
Cash and cash equivalents at end of the period | 32,780,841 | 61,009,855 |
The accompanying notes form an integral part of these condensed consolidated interim financial statements
AURIS MEDICAL HOLDING AG
Notes to the Condensed Consolidated Interim Financial Statements
as of June 30, 2016 and December 31, 2015 and for the Three and Six Months Ended June 30, 2016 and 2015 (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 condensed consolidated interim financial statements 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%) |
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 |
Statement of compliance
These condensed consolidated interim financial statements as of June 30, 2016 and December 31, 2015 and for the three and six months ended June 30, 2016 have been prepared in accordance with International Accounting Standard Interim Financial Reporting (“IAS 34”) and should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2015.
These condensed consolidated interim financial statements include all adjustments, that are necessary to fairly state the results of the interim period and the Group believes that the disclosures are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected for the full year. Management does not consider the business to be seasonal or cyclical.
Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board, have been condensed or omitted as permitted by IAS 34. The condensed consolidated statement of financial position as of December 31, 2015 was derived from the audited consolidated financial statements.
The interim condensed consolidated financial statements were authorized for issuance by the Company’s Audit Committee on August 17, 2016.
Functional and reporting currency
These interim condensed consolidated financial statements are presented in Swiss Francs (“CHF”), which is the Company’s functional currency (“functional currency”) and the Group’s reporting currency.
Significant accounting policies
The accounting policies applied by the Group in these condensed consolidated interim financial statements are the same as those applied by the Group in its audited consolidated financial statements as of and for the year ended December 31, 2015 and have been applied consistently to all periods presented in these condensed consolidated interim financial statements, unless otherwise indicated.
New standards, amendments and interpretations adopted by the Group
The Group has not early adopted any standard, interpretation or amendment that was issued, but is not yet effective.
A number of new standards, amendments to standards and interpretations are effective for the Group’s 2016 reporting year, and have not been applied in preparing these condensed consolidated interim financial statements. Management does not believe that the adoption of these standards, interpretations, or amendments will have a material impact on the financial statements of the Group.
3. | Capital and reserves |
Share capital
The issued share capital of the Company consisted of:
COMMON SHARES (NUMBER) | ||||||||
2016 | 2015 | |||||||
As of January 1 | 34,303,891 | 29,010,391 | ||||||
Common shares issued for stock option exercises with a nominal value of CHF 0.40 each | — | 8,500 | ||||||
Common shares issued for the follow-on offering with a nominal value of CHF 0.40 each | — | 5,275,000 | ||||||
Common shares issued for restricted share awards with a nominal value of CHF 0.40 each | 25,813 | — | ||||||
Total, as of June 30, 2016 and June 30, 2015 | 34,329,704 | 34,293,891 |
All shares have a nominal value of CHF 0.40 and are fully paid in. As of June 30, 2016, the nominal value of the 34,329,704 issued shares amounted to CHF 13,731,881.60 (as of December 31, 2015, the nominal value of 34,303,891 issued shares amounted to CHF 13,721,556.40).
Issue of common shares upon exercise of options
During the six months ended June 30, 2015, beneficiaries of the 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 8,500 and an increase in the nominal value of the share capital of CHF 3,400. Total proceeds from the exercise to the Company were CHF 27,200.
During the six months ended June 30, 2016, no options were exercised.
On January 7, 2016, the Company granted 25,813 restricted shares to employees under the Equity Incentive Plan as a compensation bonus for 2015. These shares vested upon grant and have a sales restriction of 3 years. The Company recorded a corresponding payroll charge of CHF 188,092 in 2015. As a result of the grant, the nominal share capital increased by CHF 10,325.
Follow-On Offering on NASDAQ Global Market
On May 20, 2015, the Company completed a public offering of 5,275,000 shares, yielding net proceeds after underwriting discounts of US$ 23.6 million (CHF 21.7 million). As at June 30, 2015, following the offering (and settlement of the aforementioned employee options) there were 34,293,891 common shares of the Company outstanding.
Controlled Equity Offering
On June 1, 2016, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), pursuant to which the Company may offer and sell, from time to time common shares, with a nominal value of CHF 0.40 per share, having an aggregate offering price of up to US$ 35 million through Cantor. Any common shares offered and sold will be issued pursuant to the Company’s shelf registration statement on Form F-3 (Registration No. 333-206710) as supplemented by a prospectus supplement, dated June 1, 2016. In the second quarter of 2016, the Company did not offer or sell any common shares under the Sales Agreement.
4. | Employee benefits |
SIX MONTHS ENDED | SIX MONTHS ENDED | |||||||
JUNE 30, 2016 | JUNE 30, 2015 | |||||||
Salaries | 1,836,098 | 1,222,644 | ||||||
Pension costs | 169,700 | 140,103 | ||||||
Share based compensation expense | 76,889 | 127,993 | ||||||
Other employee costs and social benefits | 365,737 | 87,484 | ||||||
Total employee benefits | 2,448,424 | 1,578,224 |
5. | Share based compensation expense |
Share based compensation expense of CHF 76,889 was recognized for the six months ended June 30, 2016 (for the six months ended June, 2015: CHF 127,993).
A total of 148,150 options were granted in the six months ended June 30, 2016. The exercise price of the options granted is US$ 3.92 (CHF 3.76). The methodology for computation of share based compensation expense for the period is consistent with the methodology used in 2015.
6. | Loss per share |
THREE MONTHS ENDED JUNE 30, 2016 | THREE MONTHS ENDED JUNE 30, 2015 | SIX MONTHS ENDED JUNE 30, 2016 | SIX MONTHS ENDED JUNE 30, 2015 | |||||||||||||
Loss attributable to owners of the Company | (8,432,002 | ) | (10,958,426 | ) | (17,330,914 | ) | (19,010,537 | ) | ||||||||
Weighted average number of shares outstanding | 34,329,704 | 32,121,477 | 34,328,711 | 30,569,142 | ||||||||||||
Basic and diluted loss per share | (0.25 | ) | (0.34 | ) | (0.50 | ) | (0.62 | ) |
For the six months ended June 30, 2016 and June 30, 2015 basic and diluted loss per share are calculated based on the weighted average number of shares issued and outstanding and excludes shares to be issued under the stock option plans, as they would be anti-dilutive. As of the date hereof, the Company has 755,910 options outstanding under its stock option plans, of which 103,260 are considered forfeited due to the termination of the beneficiaries’ employment relationships. The average number of options outstanding between January 1, 2016 and June 30, 2016 was 640,830 (462,635 for the period between January 1, 2015 and June 30, 2015).
7. | Events after the Reporting Period |
On July 19, 2016 the Company entered into a Loan and Security Agreement for a secured term loan facility of up to US$20.0 million with Hercules Capital, Inc. as administrative agent (“Hercules”) and the lenders party thereto. An initial tranche of US$12.5 million was drawn on July 19, 2016, concurrently with the execution of the loan agreement. An additional US$7.5 million may be drawn, at the Company’s option, subject to certain milestones described in the loan agreement. The loan matures on January 2, 2020 and bears interest at a minimum rate of 9.55% per annum, and is subject to the variability of the prime interest rate as reported by the Wall Street Journal. In connection with the loan facility, the Company issued Hercules a warrant to purchase up to 241,111 of its common shares at an exercise price of US$3.94 per share. As of July 19, 2016, the warrant is exercisable for 156,726 common shares. Upon Hercules making the second advance under the loan facility, the warrant shall become exercisable for the additional 84,391 common shares. The warrant forfeits on July 19, 2023. The loan is secured by a pledge of the shares of Auris Medical AG owned by the Company, all intercompany receivables owed to the Company by its Swiss subsidiaries and a security assignment of the Company’s bank accounts.
The trial (Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2; TACTT2), the first of two pivotal Phase 3 clinical trials with KeyzilenTM, did not meet the two co-primary endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo. Data from the TACTT2 trial support the positive safety profile established in the Phase 2 trials. The Company expects to have top-line results from the second Phase 3 trial for KeyzilenTM (TACTT3) in the fourth quarter of 2016 and intends to discuss TACTT2 outcomes and its plans for a path forward with regulatory agencies prior to the readout from TACTT3.
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 statements as of and for the three and six months ended June 30, 2016 and 2015 included as Exhibit 99.1 to this Report on Form 6-K, which have been prepared in accordance with International Accounting Standard (“IAS”) 34, Interim Financial Reporting. 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 for the year ended December 31, 2015 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the U.S. Securities and 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 Holding AG and its subsidiaries.
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 August 18, 2016.
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 candidates are in Phase 3 clinical development. KeyzilenTM (AM-101) is being developed for the treatment of acute inner ear tinnitus under a special protocol assessment, or SPA, from the FDA and has received fast track designation from the FDA. In two Phase 2 clinical trials, KeyzilenTM demonstrated a favorable safety profile and statistically significant improvement in tinnitus loudness and other patient reported outcomes. The trial (Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2; TACTT2), the first of two pivotal Phase 3 clinical trials with KeyzilenTM, did not meet the two co-primary endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo. Data from the TACTT2 trial support the positive safety profile established in the Phase 2 trials. We expect to have top-line results from the second Phase 3 trial for KeyzilenTM (TACTT3) in the fourth quarter of 2016 and intend to discuss TACTT2 outcomes and our plans for a path forward with regulatory agencies prior to the readout from TACTT3.
We are also developing AM-111 for acute inner ear hearing loss. We are conducting two pivotal Phase 3 trials in the treatment of idiopathic sudden sensorineural hearing loss, titled HEALOS and ASSENT. HEALOS is enrolling 255 patients in Europe and Asia and ASSENT is enrolling 300 patients in the U.S., Canada, and South Korea. In addition, we are planning a Phase 2 trial, entitled Efficacy and Safety of AM-111 in the Treatment of Surgery-Induced Hearing Loss (REACH) in the U.S. Provided that we obtain grant or other funding, REACH could be initiated at the earliest in the first half of 2017.
To date, we have financed our operations through public offerings of our common shares, private placements of equity securities and loans. We have no products approved for commercialization and have never generated any revenues from royalties or product sales. As of June 30, 2016, we had cash and cash equivalents of CHF 32.8 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, KeyzilenTM, AM-111 or any of our other product candidates.
As of June 30, 2016, we had an accumulated deficit of CHF 99.4 million. We expect to continue incurring losses as we continue our clinical and pre-clinical 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.
Thomas Jung, MD, PhD, has been appointed Chief Development Officer. In this newly created position, Dr. Jung will lead the Company’s clinical, preclinical and pharmaceutical development activities. He will join the Company in September 2016. Dr. Jung previously served as the Chief Medical Officer at Delenex Therapeutics AG and spent 13 years at Novartis, most recently as Head, Translational Medicine for the European Union.
There have been no developments in the previously disclosed patent interference involving our issued patent No. 9,066,865 and Otonomy Inc.’s patent application No. 13/848,636.
Collaboration and License Agreements
There have been no material changes to our collaboration and license agreements from those reported in “Item 5—Operating and Financial Review and Prospects–Operating results—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:
· | KeyzilenTM (AM-101). We are conducting a Phase 3 clinical development program with KeyzilenTM comprising two Phase 3 studies (TACTT2 and TACTT3) and two open label follow-on studies (AMPACT1 and AMPACT2). TACTT2 has been completed and top-line results have been announced earlier today. AMPACT1 is expected to complete enrollment in the first quarter of 2017. TACTT3 completed enrollment in June 2016 and we expect top-line results of the TACTT3 trial in the fourth quarter 2016. AMPACT2 is expected to complete enrollment in the fourth quarter 2016. We anticipate that our research and development expenses in connection with these clinical trials will be lower in 2016 than in the preceding year, but remain at a substantial level. |
· | AM-111. We are conducting two pivotal Phase 3 trials in the treatment of ISSNHL, titled HEALOS and ASSENT. HEALOS initiated enrollment in Europe and Asia in the fourth quarter of 2015 and ASSENT started enrollment in the U.S. in the second quarter of 2016 and is expected to also include Canadian and South Korean sites. We anticipate that our research and development expenses in connection with the two AM-111 trials will substantially increase in 2016 compared to the previous year. |
Other research and development expenses mainly relate to our pre-clinical studies of AM-102 (second generation tinnitus treatment) and AM-123 (rhinology indication). The expenses mainly consist of costs for production of the pre-clinical compounds and costs paid to academic research institutions in conjunction with pre-clinical testing.
For a discussion of our other key financial statement line items, please see “Item 5—Operating and Financial Review and Prospects–Operating results—Financial Operations Overview” in the Annual Report.
Results of Operations
The numbers below have been derived from our unaudited condensed consolidated interim financial statements as of and for the three and six months ended June 30, 2016 and 2015. The discussion below should be read along with this financial information, and it is qualified in its entirety by reference to them.
Page 2 of 9
Comparison of the three months ended June 30, 2016 and 2015
Three months ended June 30, | ||||||||||||
2016 | 2015 | Change | ||||||||||
(in thousands of CHF) | % | |||||||||||
Research and development | (7,278 | ) | (8,751 | ) | (17 | %) | ||||||
General and administrative | (1,725 | ) | (980 | ) | 76 | % | ||||||
Operating loss | (9,003 | ) | (9,731 | ) | (7 | %) | ||||||
Interest income | 15 | 5 | 200 | % | ||||||||
Interest expense | (3 | ) | (2 | ) | 50 | % | ||||||
Foreign currency exchange gain/(loss), net | 559 | (1,230 | ) | (145 | %) | |||||||
Loss before tax | (8,432 | ) | (10,958 | ) | (23 | %) | ||||||
Income tax expense | — | — | ||||||||||
Net loss attributable to owners of the Company | (8,432 | ) | (10,958 | ) | (23 | %) | ||||||
Other comprehensive loss: | ||||||||||||
Items that will never be reclassified to profit or loss | ||||||||||||
Remeasurements of defined benefits liability | (347 | ) | (0 | ) | 1,134 | % | ||||||
Items that are or may be reclassified to profit or loss | ||||||||||||
Foreign currency translation differences | (16 | ) | 38 | (142 | %) | |||||||
Other comprehensive (loss)/gain | (363 | ) | 38 | (1,051 | %) | |||||||
Total comprehensive loss attributable to owners of the Company | (8,795 | ) | (10,920 | ) | (19 | %) |
Research and development expense
Three months ended June 30, | ||||||||||||
Research and development expense | 2016 | 2015 | Change | |||||||||
(in thousands of CHF) | % | |||||||||||
Clinical projects | (5,223 | ) | (7,642 | ) | (32 | %) | ||||||
Pre-clinical projects | (118 | ) | (122 | ) | (3 | %) | ||||||
Drug manufacture and substance | (700 | ) | (339 | ) | 106 | % | ||||||
Employee benefits | (864 | ) | (440 | ) | 96 | % | ||||||
Other research and development expenses | (373 | ) | (208 | ) | 79 | % | ||||||
Total | (7,278 | ) | (8,751 | ) | (17 | %) |
Research and development expenses amounted to CHF 7.3 million in the three months ended June 30, 2016. This represents a decrease of about CHF 1.5 million over the CHF 8.8 million research and development expenses accrued for the three months ended June 30, 2015. The decrease is mainly due to the following:
· | Clinical projects. In the three months ended June 30, 2016 we incurred lower clinical expenses than in the three months ended June 30, 2015, due to lower service and milestone costs charged by contracted service providers in connection with the Phase 3 KeyzilenTM trials (TACTT2, TACTT3, AMPACT1 and AMPACT2) mainly reflecting their progression towards completion (related costs were CHF 6.6 million in the second quarter of 2015 and CHF 3.1 million in the second quarter of 2016). The decrease in KeyzilenTM related costs was partially offset by higher AM-111 related expenses due to the initiation of the Phase 3 ASSENT trial. |
· | Pre-clinical projects. In the three months ended June 30, 2016, pre-clinical expenses decreased primarily due to the completion of AM-101 and AM-111 related pre-clinical projects partially offset by higher expenses for our AM-102 pre-clinical project. |
· | Drug manufacture and substance. Compared to the three months ended June 30, 2015, expenses for drug manufacturing and substance increased by CHF 0.4 million in the three months ended June 30, 2016. This increase is due to higher costs related to raw material purchases and expenses for process validation. |
· | Employee benefits. Employee expenses were higher in the three months ended June 30, 2016 than in the same period in 2015 (CHF 0.9 million vs CHF 0.4 million) due to an increased headcount and higher compensation expenses. |
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Other research and development expenses.
· | Other research and development expenses increased by CHF 0.2 million in the three months ended June 30, 2016 compared with the corresponding period in 2015 due to higher regulatory expenses partially offset by lower lease and intellectual property related expenses. |
General and administrative expense
General and administrative expense was CHF 1.7 million in the three months ended June 30, 2016 compared to CHF 1.0 million in the same period in the previous year, as a result of higher administration costs (CHF 1.1 million vs CHF 0.6 million) as well as higher employee benefits due to higher headcount and increased compensation expenses (CHF 0.6 million vs CHF 0.4 million).
We expect that general and administrative expense will increase in the future as our business expands and we continue to incur costs associated with operating as a public company and protecting our intellectual property portfolio.
Interest income
Interest income increased from the three months ended June 30, 2015 to the three months ended June 30, 2016, due to a higher return on short-term deposits.
Interest expense
Interest expense did not substantially change in the three months ended June 30, 2016 to the three months ended June 30, 2015, and mainly consists of bank charges.
Foreign currency exchange losses, net
For the three months ended June 30, 2016 the appreciation of the U.S. dollar against the Swiss Franc triggered a net foreign unrealized currency gain on the U.S. dollar denominated cash and cash equivalents compared to the unrealized losses due the depreciation of the U.S. dollar against the Swiss Franc in the three months’ period ended June 30, 2015.
Comparison of the six months ended June 30, 2016 and 2015
Six months ended June 30, | ||||||||||||
2016 | 2015 | Change | ||||||||||
(in thousands of CHF) | % | |||||||||||
Research and development | (13,419 | ) | (14,981 | ) | (10 | %) | ||||||
General and administrative | (2,947 | ) | (1,910 | ) | 54 | % | ||||||
Operating loss | (16,366 | ) | (16,891 | ) | (3 | %) | ||||||
Interest income | 26 | 10 | 160 | % | ||||||||
Interest expense | (5 | ) | (5 | ) | 0 | % | ||||||
Foreign currency exchange losses, net | (986 | ) | (2,125 | ) | (54 | %) | ||||||
Loss before tax | (17,331 | ) | (19,011 | ) | (9 | %) | ||||||
Income tax expense | — | — | ||||||||||
Net loss attributable to owners of the Company | (17,331 | ) | (19,011 | ) | (9 | %) | ||||||
Other comprehensive loss: | ||||||||||||
Items that will never be reclassified to profit or loss | ||||||||||||
Remeasurements of defined benefits liability | (608 | ) | (229 | ) | 166 | % | ||||||
Items that are or may be reclassified to profit or loss | ||||||||||||
Foreign currency translation differences | 26 | 57 | (54 | %) | ||||||||
Other comprehensive loss | (582 | ) | (172 | ) | 238 | % | ||||||
Total comprehensive loss attributable to owners of the Company | (17,913 | ) | (19,183 | ) | (7 | %) |
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Research and development expense
Six months ended June 30, | ||||||||||||
Research and development expense | 2016 | 2015 | Change | |||||||||
(in thousands of CHF) | % | |||||||||||
Clinical projects | (9,392 | ) | (12,940 | ) | (27 | %) | ||||||
Pre-clinical projects | (199 | ) | (250 | ) | (20 | %) | ||||||
Drug manufacture and substance | (1,102 | ) | (488 | ) | 126 | % | ||||||
Employee benefits | (1,430 | ) | (896 | ) | 60 | % | ||||||
Other research and development expenses | (1,296 | ) | (407 | ) | 218 | % | ||||||
Total | (13,419 | ) | (14,981 | ) | (10 | %) |
Research and development expenses amounted to CHF 13.4 million in the six months ended June 30, 2016. This represents a decrease of about CHF 1.6 million over the CHF 15.0 million accrued for the six months ended June 30, 2015. The decrease is mainly due to the following:
· | Clinical projects. In the six months ended June 30, 2016, we incurred lower clinical expenses than in the six months ended June 30, 2015, due to lower service and milestone costs charged by contracted service providers in connection with the Phase 3 KeyzilenTM clinical trials (TACTT2, TACTT3, AMPACT1 and AMPACT2) reflecting their progression towards completion (related costs were CHF 10.7 million in the first half of 2015 and CHF 5.6 million in the first half of 2016). The decrease in KeyzilenTM related costs was partially offset by higher AM-111 related expenses for the start of enrollment into the Phase 3 ASSENT trial in the six months ended June 30, 2016. |
· | Pre-clinical projects. In the six months ended June 30, 2016, pre-clinical expenses decreased primarily due to the completion of KeyzilenTM and AM-111 related pre-clinical projects partially offset by higher expenses for our AM-102 pre-clinical project. |
· | Drug manufacture and substance. Compared to the six months ended June 30, 2015, costs for drug manufacture and substance increased by CHF 0.6 million in the six months ended June 30, 2016. The increase is mainly due to higher expenses related to raw material purchases and process validation. |
· | Employee benefits. Employee expenses were higher in the six months ended June 30, 2016 than in the same period in 2015 (CHF 1.4 million vs CHF 0.9 million) due to an increased headcount and higher compensation expenses. |
· | Other research and development expenses increased by CHF 0.9 million in the six months ended June 30, 2016 compared with the corresponding period in 2015 due to higher regulatory and intellectual property related expenses. |
General and administrative expense
General and administrative expense was CHF 2.9 million in the six months ended June 30, 2016, compared to CHF 1.9 million in the six months ended June 30, 2015, as a result of higher administration costs (CHF 1.9 million vs CHF 1.2 million) as well as higher employee benefits due to higher headcount and increased compensation expenses (CHF 1.0 million vs CHF 0.7 million).
We expect that general and administrative expense will increase in the future as our business expands and we continue to incur costs associated with operating as a public company and protecting our intellectual property portfolio.
Interest income
Interest income increased from the six months ended June 30, 2015 to the six months ended June 30, 2016, due to a higher return on short-term deposits.
Interest expense
Interest expense did not substantially change in the six months ended June 30, 2015 to the six months ended June 30, 2016, and mainly consists of bank charges.
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Foreign currency exchange losses, net
Net Foreign currency exchange losses, decreased from the six months ended June 30, 2015 to the six months ended June 30, 2016, due to lower unrealized foreign exchange losses on the Company’s U.S. dollar denominated cash and cash equivalents.
Cash flows
Comparison of the six months ended June 30, 2016 and 2015
The table below summarizes our cash flows for the six months ended June 30, 2016 and 2015:
Six months ended June, 30 | ||||||||
2016 | 2015 | |||||||
(in thousands of CHF) | ||||||||
Net cash used in operating activities | (16,444 | ) | (14,554 | ) | ||||
Net cash from investing activities | 15 | (43 | ) | |||||
Net cash from financing activities | (2 | ) | 20,888 | |||||
Net effect of currency translation on cash | (1,025 | ) | (2,215 | ) | ||||
Cash and cash equivalents at the beginning of the period | 50,237 | 56,934 | ||||||
Cash and cash equivalents at the end of the period | 32,781 | 61,010 |
The increase in net cash used in operating activities from CHF 14.6 million in the six months ended June 30, 2015, to CHF 16.4 million in the six months ended June 30, 2016, was mainly due to higher general and administrative expenses partially offset by lower research and development expenses as well as a lower increase in accrued liabilities from December 31, 2015 to June 30, 2016, compared to the period from December 31, 2014 to June 30, 2015.
Net cash from investing activities increased in the six months ended June 30, 2016, compared to the six months ended June 30, 2015, and was comprised of interest received (higher in the period ended June 30, 2016, than in the prior year period) and purchases of equipment (lower in the period ended June 30, 2016, than in the prior year period).
Cash from financing activities in the six months ended June 30, 2015, includes the net proceeds of the public offering of 5,275,000 of our common shares at a price of US$4.75 per share, yielding net proceeds of US$23.6 million (CHF 21.7 million). The decrease in net cash from financing activities in the six months ended June 30, 2016 compared to the six months ended June 30, 2015 is reflective of the fact that no corresponding offering was made in 2016.
Cash and funding sources
As of June 30, 2016, 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.
On June 1, 2016, we entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), pursuant to which we may offer and sell, from time to time common shares, with a nominal value of CHF 0.40 per share, having an aggregate offering price of up to US$35 million through Cantor. Any common shares offered and sold will be issued pursuant to our shelf registration statement on Form F-3 (Registration No. 333-206710) as supplemented by a prospectus supplement, dated June 1, 2016. In the second quarter of 2016, we did not offer or sell any common shares under the Sales Agreement.
On July 19, 2016, we entered into a Loan and Security Agreement for a secured term loan facility of up to US$20.0 million with Hercules Capital, Inc. as administrative agent (“Hercules”) and the lenders party thereto. An initial tranche of US$12.5 million was drawn on July 19, 2016, concurrently with the execution of the loan agreement. An additional US$7.5 million may be drawn, at our option, subject to certain milestones described in the loan agreement. The loan matures on January 2, 2020 and bears interest at a minimum rate of 9.55% per annum, and is subject to the variability of the prime interest rate as reported by the Wall Street Journal. In connection with the loan facility, we issued Hercules a warrant to purchase up to 241,111 of our common shares at an exercise price of US$ 3.94 per share. As of July 19, 2016, the warrant is exercisable for 156,726 common shares. Upon Hercules making the second advance under the loan facility, the warrant shall become exercisable for the additional 84,391 common shares. The warrant forfeits on July 19, 2023. The loan is secured by a pledge of the shares of Auris Medical AG, our principal operating subsidiary, owned by us, all intercompany receivables owed to us by our Swiss subsidiaries and a security assignment of our bank accounts.
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Funding requirements
We believe that our existing cash and cash equivalents, including the proceeds from the term loan facility, will enable us to fund our operating expenses and capital expenditure requirements until year-end 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 KeyzilenTM and AM-111. If we receive regulatory approval for KeyzilenTM 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. Likewise, if we are unable to refinance amounts outstanding under our existing term loan facility before such amounts are due we may be unable to repay such amounts, which could result in foreclosure of the collateral pledged to secure such loan.
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 “Item 3—Key Information—Risk factors” in the Annual Report.
Contractual Obligations and Commitments
As of June 30, 2016, there had been no material changes to our contractual obligations outside the ordinary course of our business from those reported in “Item 5—Operating and Financial Review and Prospects—Tabular disclosure of contractual obligations” 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 “Item 5—Operating and Financial Review and Prospects—Tabular disclosure of contractual obligations” in the Annual Report.
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Significant Accounting Policies and Use of Estimates and Judgment
There have been no material changes to the significant accounting policies and estimates described in “Item 5—Operating and Financial Review and Prospects–Operating results—Significant accounting policies and use of estimates and judgment” in the Annual Report.
Recent Accounting Pronouncements
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, 2016 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 US$1.0 billion in annual revenue, have more than US$700 million in market value of our common shares held by non-affiliates or issue more than US$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 various factors, including, but not limited to, those identified under the section entitled “Item 3—Key Information—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 KeyzilenTM (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; |
· | the chance our clinical trials may not be completed on schedule, or at all, as a result of factors such as delayed enrollment or the identification of adverse effects; |
· | uncertainty surrounding whether and when 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; |
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· | 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; |
· | our ability to draw on the second tranche of financing under our term loan facility with Hercules and our ability to comply with the requirements of the term loan facility, including repayment of amounts outstanding when due; and |
· | other risk factors discussed under “Item 3—Key Information—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.
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Exhibit 99.3
Auris Medical News Release
Auris Medical Provides Business Update and Reports Second Quarter 2016 Financial Results
· | TACTT2 trial with KeyzilenTM for acute inner ear tinnitus did not meet efficacy endpoints |
· | Top-line results from TACTT3 trial with KeyzilenTM expected in the fourth quarter of 2016 |
· | AM-111 Phase 3 program for acute inner ear hearing loss is ongoing |
· | Conference call today at 8 am Eastern Time |
Zug, Switzerland, August 18, 2016 – Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today provided a business update and announced financial results for the second quarter ended June 30, 2016.
“As stated earlier today, we are disappointed with the top-line results from the TACTT2 trial with KeyzilenTM for acute inner ear tinnitus and we continue to assess the full dataset. We plan to complete this analysis and meet with the regulatory agencies prior to the TACTT3 readout, which is expected in the fourth quarter,” commented Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer. “Apart from this, we are pleased with the progress of our second Phase 3 asset, AM-111 for the treatment of acute sensorineural hearing loss, which is progressing with enrollment into the HEALOS and ASSENT trials. Furthermore, we have appointed Thomas Jung to our management team as Chief Development Officer to support our clinical, preclinical and pharmaceutical development activities.”
Development Program Updates
KeyzilenTM (AM-101) for Acute Inner Ear Tinnitus
· | Announced top-line results from the Phase 3 TACTT2 trial in acute inner ear tinnitus. The TACTT2 trial did not meet the two co-primary efficacy endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo. Data from the TACTT2 trial support the positive safety profile established in previous studies. |
· | Completed enrollment of the Phase 3 TACTT3 trial with more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). The trial, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled trial in acute and post-acute inner ear tinnitus following traumatic cochlear injury or otitis media. The primary endpoint is the change in tinnitus loudness from baseline to Day 84; the change in the TFI is the key secondary efficacy outcome. Top-line results from this trial are expected in the fourth quarter of 2016. |
· | Received fast track designation from the FDA for KeyzilenTM in acute peripheral (inner ear) tinnitus following traumatic cochlear injury or otitis media in adults, highlighting the seriousness of the condition as well as the unmet medical need. |
AM-111 for Acute Inner Ear Hearing Loss
· | Progressed with enrollment in the Phase 3 HEALOS trial, which is being conducted in several European and Asian countries. The trial aims to enroll approximately 255 patients with severe to profound idiopathic sudden sensorineural hearing loss. Top-line results from this trial are expected in the second half of 2017. |
Auris Medical Holding AG · Bahnhofstrasse 21 · CH-6300 Zug · Tel. +41 41 729 71 94 · www.aurismedical.com
· | Initiated the Phase 3 ASSENT trial, which is being conducted in the US, Canada and South Korea. The trial aims to enroll approximately 300 patients with severe to profound idiopathic sudden sensorineural hearing loss. Top-line results from this trial are expected in the first half of 2018. |
Other Developments
· | Appointed Thomas Jung, MD, PhD, as Chief Development Officer. In this newly created position, Dr. Jung will lead the Company’s clinical, preclinical and pharmaceutical development activities. He will join Auris Medical in September. Dr. Jung previously served as the Chief Medical Officer at Delenex Therapeutics AG and spent 13 years at Novartis, most recently as Head, Translational Medicine for the European Union. |
· | Received $12.5 million in financing from a loan facility agreement with Hercules Capital, Inc. |
Second Quarter 2016 Financial Results
• | Cash and cash equivalents at June 30, 2016, totaled CHF 32.8 million, which does not include the $12.5 million received in July 2016 as part of the loan facility. |
• | Total operating expenses for the second quarter of 2016 were CHF 9.0 million compared to CHF 9.7 million for the second quarter of 2015. |
• | Research and development expenses for the second quarter of 2016 were CHF 7.3 million compared to CHF 8.8 million for the second quarter of 2015. |
• | General and administrative expenses for the second quarter of 2016 were CHF 1.7 million compared to CHF 0.9 million for the second quarter of 2015. |
• | Net loss for the second quarter of 2016 was CHF 8.43 million, or CHF 0.25 per share, compared to CHF 10.96 million, or CHF 0.34 per share, for the second quarter of 2015. The net loss includes a net unrealized foreign currency exchange gain of CHF 0.6 million in the second quarter of 2016 compared to a foreign currency exchange loss of CHF 1.2 million in the second quarter of 2015. |
The Company continues to expect that its operating expenses in 2016 will be in the range of CHF 33.0 to 38.0 million and believes that existing cash and cash equivalents, including the $12.5 million loan, will enable the funding of operations until year-end 2017.
Today’s Conference Call & Webcast Information
Auris Medical will host a conference call and webcast to discuss the top-line results from the TACTT2 trial, the second quarter 2016 financial results and to provide a general business update today, August 18, 2016, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial 1-877-280-3459 (USA) or +1-646-254-3387 (International), and enter passcode 9451099. A live webcast of the conference call will be available in the Investor Relations section of the Auris Medical website at www.aurismedical.com and a replay of the conference call will be available following the live call.
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 Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration 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."
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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.
Company contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 13 50, investors@aurismedical.com
Media contact: David Schull, Russo Partners, 1-858-717-2310, david.schull@russopartnersllc.com
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Auris Medical Holding AG
Condensed Consolidated Interim Statement of Loss and Other Comprehensive Loss (unaudited)
(in CHF)
THREE MONTHS ENDED JUNE 30 | SIX MONTHS ENDED JUNE 30 | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Research and development | -7,278,563 | -8,750,891 | -13,418,738 | -14,980,787 | ||||||||||||
General and administrative | -1,725,114 | -980,187 | -2,947,146 | -1,910,106 | ||||||||||||
Operating loss | -9,003,677 | -9,731,078 | -16,365,884 | -16,890,893 | ||||||||||||
Interest income | 15,281 | 5,210 | 26,166 | 10,268 | ||||||||||||
Interest expense | -2,514 | -2,540 | -5,259 | -4,604 | ||||||||||||
Foreign currency exchange gain/(loss), net | 558,908 | -1,230,018 | -985,937 | -2,125,308 | ||||||||||||
Loss before tax | -8,432,002 | -10,958,426 | -17,330,914 | -19,010,537 | ||||||||||||
Income tax expense | - | - | - | - | ||||||||||||
Net loss attributable to owners of the Company | -8,432,002 | -10,958,426 | -17,330,914 | -19,010,537 | ||||||||||||
Other comprehensive loss: | ||||||||||||||||
Items that will never be reclassified to profit or loss | ||||||||||||||||
Remeasurements of defined benefit liability, net of taxes of CHF 0 | -347,398 | -306 | -607,867 | -229,170 | ||||||||||||
Items that are or may be reclassified to profit or loss | ||||||||||||||||
Foreign currency translation differences, net of taxes of CHF 0 | -15,856 | 38,501 | 25,964 | 56,863 | ||||||||||||
Other comprehensive (loss)/income, net of taxes of CHF 0 | -363,254 | 38,195 | -581,903 | -172,307 | ||||||||||||
Total comprehensive loss attributable to owners of the Company | -8,795,256 | -10,920,231 | -17,912,817 | -19,182,844 | ||||||||||||
Basic and diluted loss per share | -0.25 | -0.34 | -0.50 | -0.62 |
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Auris Medical Holding AG
Condensed Consolidated Interim Statement of Financial Position (unaudited)
(in CHF)
JUNE 30, | DECEMBER 31, | |||||||
ASSETS | ||||||||
Non-current assets | ||||||||
Property and equipment | 185,324 | 222,570 | ||||||
Intangible assets | 1,482,520 | 1,482,520 | ||||||
Other non-current receivables | 38,066 | 38,066 | ||||||
Total non-current assets | 1,705,910 | 1,743,156 | ||||||
Current assets | ||||||||
Other receivables | 1,387,380 | 650,716 | ||||||
Prepayments | 17,789 | 181,044 | ||||||
Cash and cash equivalents | 32,780,841 | 50,237,300 | ||||||
Total current assets | 34,186,010 | 51,069,060 | ||||||
Total assets | 35,891,920 | 52,812,216 | ||||||
Equity | ||||||||
Share capital | 13,731,881 | 13,721,556 | ||||||
Share premium | 112,838,815 | 112,662,910 | ||||||
Foreign currency translation reserve | -37,858 | -63,821 | ||||||
Accumulated deficit | -99,440,625 | -81,578,733 | ||||||
Total shareholders’ equity attributable to owners of the Company | 27,092,213 | 44,741,912 | ||||||
Non-current liabilities | ||||||||
Employee benefits | 2,245,431 | 1,575,833 | ||||||
Deferred tax liabilities | 327,637 | 327,637 | ||||||
Total non-current liabilities | 2,573,068 | 1,903,470 | ||||||
Current liabilities | ||||||||
Trade and other payables | 660,341 | 1,205,522 | ||||||
Accrued expenses | 5,566,298 | 4,961,312 | ||||||
Total current liabilities | 6,226,639 | 6,166,834 | ||||||
Total liabilities | 8,799,707 | 8,070,304 | ||||||
Total equity and liabilities | 35,891,920 | 52,812,216 |
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Exhibit 99.4
Auris Medical News Release
Auris Medical Reports Top-Line Results from TACTT2 Trial with KeyzilenTM in Acute Inner Ear Tinnitus
· | TACTT2 trial did not meet its co-primary efficacy endpoints |
· | Top-line results from the Phase 3 TACTT3 trial expected in the fourth quarter of 2016 |
· | Second quarter 2016 financial results and conference call scheduled for today |
Zug, Switzerland, August 18, 2016 – Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced top-line results from the Phase 3 TACTT2 trial with KeyzilenTM (AM-101) in acute inner ear tinnitus. The TACTT2 trial did not meet the two co-primary efficacy endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo. Data from the TACTT2 trial support the positive safety profile established in previous studies, and results from the second Phase 3 trial, TACTT3, are expected in the fourth quarter of 2016.
“We are disappointed that our TACTT2 trial did not reach its co-primary efficacy endpoints. The assessment of the trial data is ongoing and we intend to discuss outcomes and our plans for a path forward with regulatory agencies prior to the readout from the TACTT3 trial,” commented Thomas Meyer, founder, Chairman and Chief Executive Officer of Auris Medical. “We would like to sincerely thank all patients, investigators and study site staff participating in TACTT2 for their dedicated contribution to the trial. Acute inner ear tinnitus represents an important unmet medical need, and we remain committed to achieving our mission of providing tinnitus patients with effective and safe therapeutic options.”
TACTT2 was designed as a randomized, double-blind, placebo-controlled trial in acute inner ear tinnitus following traumatic cochlear injury or otitis media. The trial was conducted primarily in North America and randomized 343 patients to receive either KeyzilenTM 0.87 mg/mL or placebo in a 3:2 ratio. The co-primary endpoints were the improvement in subjective tinnitus loudness from baseline to Day 84 and the improvement in tinnitus burden from baseline to Day 84, measured by the Tinnitus Functional Index (TFI). Treatment with KeyzilenTM did not demonstrate a statistically significant difference in tinnitus improvement as compared to placebo for either endpoint. KeyzilenTM was well tolerated with no drug-related serious adverse events. The trial’s primary safety endpoint, incidence of clinically meaningful hearing deterioration, was low with no statistically significant difference from the placebo group, supporting the safety profile of KeyzilenTM.
TACTT3, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled trial in acute and post-acute inner ear tinnitus following traumatic cochlear injury or otitis media. The trial has enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). The primary endpoint is the change in tinnitus loudness from baseline to Day 84; the change in the TFI is the key secondary efficacy outcome.
Conference Call & Webcast Information
Auris Medical will host a conference call and webcast to discuss the top-line results from the TACTT2 trial, the second quarter 2016 financial results and to provide a general business update today, August 18, 2016, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial 1-877-280-3459 (USA) or +1-646-254-3387 (International), and enter passcode 9451099. A live webcast of the conference call will be available in the Investor Relations section of the Auris Medical website at www.aurismedical.com and a replay of the conference call will be available following the live call.
About Acute Inner Ear Tinnitus
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation. Tinnitus may be transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Inner ear tinnitus often has a serious impact on the ability to sleep, relax, or concentrate, and it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, neither a universal standard of care for acute inner ear tinnitus, nor a truly proven and effective treatment method is available.
Auris Medical Holding AG · Bahnhofstrasse 21 · CH-6300 Zug · Tel. +41 41 729 71 94 · www.aurismedical.com
About KeyzilenTM (AM-101)
KeyzilenTM is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel for intratympanic injection. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following acute injury to the inner ear, e.g. from exposure to excessive noise, infections, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. KeyzilenTM has received fast track designation from the FDA for the treatment of acute peripheral (inner ear) tinnitus following traumatic cochlear injury or otitis media in adults. The development of KeyzilenTM is based on research conducted at the INSERM Institute for Neurosciences, and patents have been granted in more than 40 countries worldwide so far.
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 Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration 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.
Contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, investors@aurismedical.com
Media contact: David Schull, Russo Partners, 1-858-717-2310, david.schull@russopartnersllc.com
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