EARS Auris Medical Holding AG

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 November, 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

 

 

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of Auris Medical Holding AG and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

 

 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: November 12, 2015

 

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 November 12, 2015

 

Exhibit 99.1

 

Unaudited Condensed Consolidated Interim Financial Statements as of September 30, 2015 and December 31, 2014 and for the Three and Nine Months Ended September 30, 2015 and 2014

 

Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income (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 Income (Loss) (unaudited)
For the Three and Nine Months Ended September 30, 2015 and 2014 (in CHF)

 

		THREE MONTHS ENDED SEPT. 30				NINE MONTHS ENDED SEPT. 30
		2015		2014		2015		2014
Research and development		-5,884,313		-4,686,442		-20,865,100		-13,036,450
General and administrative		-1,326,750		-997,733		-3,236,856		-3,552,021
Operating loss		-7,211,063		-5,684,175		-24,101,956		-16,588,471
Interest income		12,873		6,023		23,141		35,908
Interest expense		-1,608		-1,245		-6,212		-53,877
Foreign currency exchange gains/losses, net		1,988,870		2,318,569		-136,438		2,394,429
Net loss before tax and attributable to
owners of the Company		-5,210,928		-3,360,828		-24,221,465		-14,212,011
Other comprehensive income (loss):
Items that will never be reclassified to
profit or loss
Remeasurement of defined benefit liability,		-3,792		111,550		-232,962		-312,261
net of taxes of CHF 0.00
Items that are or may be reclassified to
profit or loss
Foreign currency translation differences,		-40,524		-74,115		16,339		-71,298
net of taxes of CHF 0.00
Other comprehensive income (loss),		-44,316		37,435		-216,623		-383,559
net of taxes of CHF 0.00
Total comprehensive loss attributable to owners of the Company		-5,255,244		-3,323,393		-24,438,088		-14,595,570
Basic and diluted loss per share	7	-0.15		-0.14		-0.76		-0.69

 

The accompanying notes form an integral part of these condensed consolidated interim financial statements

 

Condensed Consolidated Interim Statement of Financial Position (unaudited)
As of September 30, 2015 and December 31, 2014 (in CHF)

 

			SEPTEMBER 30, 2015		DECEMBER 31, 2014
	Note
ASSETS
Non-current assets
Property and equipment			247,129		235,427
Intangible assets			1,482,520		1,482,520
Deferred tax asset			-		32,761
Total non-current assets			1,729,649		1,750,708
Current assets
Other receivables			575,954		542,538
Prepayments			294,466		265,170
Cash and cash equivalents			55,400,708		56,934,325
Total current assets			56,271,128		57,742,033
Total assets			58,000,777		59,492,741
EQUITY AND LIABILITIES
Equity
Share capital	3		13,717,556		11,604,156
Share premium			112,645,019		93,861,171
Foreign currency translation reserve			-34,770		-51,108
Accumulated deficit			-76,378,540		-52,131,426
Total shareholders’ equity attributable to owners of the Company			49,949,265		53,282,793
Non-current liabilities
Employee benefits			1,758,770		1,410,598
Deferred tax liabilities			327,637		360,398
Total non-current liabilities			2,086,407		1,770,996
Current liabilities
Trade and other payables			2,822,445		3,234,384
Accrued expenses			3,142,660		1,204,568
Total current liabilities			5,965,105		4,438,952
Total liabilities			8,051,512		6,209,948
Total equity and liabilities			58,000,777		59,492,741

 

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 September 30, 2015 and 2014 (in CHF)

 

ATTRIBUTABLE TO OWNERS OF THE COMPANY
	NOTE	SHARE CAPITAL	SHARE PREMIUM	FX TRANSLATION RESERVE	ACCUMULATED DEFICIT	TOTAL EQUITY
Balance at January 1, 2014		6,487,130	35,608,210	53,995	-33,115,689	9,033,646
Total comprehensive loss
Net loss		-	-	-	-14,212,011	-14,212,011
Other comprehensive income/(-loss)		-	-	-71,298	-312,261	-383,559
Total comprehensive loss		-	-	-71,298	-14,524,272	-14,595,570
Transactions with owners of the Company
Capital increase from IPO		4,045,294	47,261,446	-	-	51,306,740
Share issuance costs		-	-682,860	-	-	-682,860
Transaction costs		-	-1,154,569	-	-	-1,154,569
Conversion of convertible loans		1,043,180	12,717,655	-	-	13,760,835
Share based payments	5	-	-	-	238,203	238,203
Share options exercised	3	6,200	43,400	-	-	49,600
Balance at September 30, 2014		11,581,804	93,793,282	-17,303	-47,401,758	57,956,025
Balance at January 1, 2015		11,604,156	93,861,171	-51,109	-52,131,426	53,282,792
Total comprehensive loss
Net loss		-	-	-	-24,221,465	-24,221,465
Other comprehensive income/(-loss)		-	-	16,339	-232,962	-216,623
Total comprehensive loss		-	-	16,339	-24,454,427	-24,438,088
Transactions with owners of the Company
Capital increase from follow-on offering		2,110,000	19,604,877	-	-	21,714,877
Transaction costs		-	-643,796	-	-	-643,796
Share issuance costs		-	-210,826	-	-	-210,826
Share based payments	5	-	-	-	207,313	207,313
Share options exercised	3	3,400	33,593	-	-	36,993
Balance at September 30, 2015		13,717,556	112,645,019	-34,770	-76,378,540	49,949,265

 

The accompanying notes form an integral part of these condensed consolidated interim financial statements

 

Condensed Consolidated Interim Statement of Cash Flows (unaudited)
For the Nine Months Ended September 30, 2015 and 2014 (in CHF)

 

	Note	NINE MONTHS ENDED SEPTEMBER 30, 2015		NINE MONTHS ENDED SEPTEMBER 30, 2014
Cash flows from operating activities
Net loss		-24,221,465		-14,212,011
Adjustments for:
Depreciation		68,217		53,291
Unrealized net foreign currency exchange gain/(loss)		168,232		-2,462,886
Net interest (income)/expense		-22,969		13,727
Share option compensation	5	207,313		238,202
Employee benefits		115,211		-13,338
Changes in:
Other receivables		-33,428		-187,147
Prepayments		-29,296		-150,258
Trade and other payables		-411,937		2,658,211
Accrued expenses		1,938,089		-301,141
Changes in net working capital		1,463,428		2,019,665
Cash used in operating activities		-22,222,033		-14,363,350
Cash flows from investing activities
Purchase of property and equipment		-79,917		-102,746
Interest received		22,969		35,908
Net cash used in investing activities		-56,948		-66,838
Cash flows from (used in) financing activities
Proceeds from share capital increase		36,993		49,600
Share issuance costs		-210,826		-682,860
Proceeds from IPO, net		-		50,698,334
Proceeds from follow-on offering, net		21,071,081		-
Net cash from (used in) financing activities		20,897,248		50,065,074
Net increase (decrease) in cash and cash equivalents		-1,381,733		35,634,886
Cash and cash equivalents at beginning of the period		56,934,325		23,865,842
Net effect of currency translation on cash		-151,885		2,391,932
Cash and cash equivalents at end of the period		55,400,707		61,892,660

 

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 September 30, 2015 and December 31, 2014 and for the Three and Nine Months Ended September 30, 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. 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 September 30, 2015 and for the three and nine months ended September 30, 2015 and the condensed consolidated financial statements as of December 31, 2014 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, 2014.

 

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 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, 2014 was derived from the audited consolidated financial statements.

 

The interim financial statements were authorized for issuance by the Company’s Audit Committee on November 9, 2015.

 

Functional and reporting currency

 

These 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.

 

Segment reporting

 

A segment is a distinguishable component of the Group that engages in business activities from which it may earn revenues and incur expenses, including revenues and expenses that relate to transactions with any of the Group’s other components. Management has determined that there is only one operating segment under the requirements of IFRS 8 (“Operating Segments”).

 

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, 2014 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 2015 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)			Preferred Shares (Number)
	2015	2014		2015	2014
As of January 1	29,010,391	72,600		—	16,145,225
Common shares issued for stock option exercises with a nominal value of CHF 0.40 each	8,500	15,500		—	—
Preferred shares “C” issued for conversion of convertible loan with a nominal value of CHF 0.40 each	—	—		—	2,607,950
Common shares issued for the IPO with a nominal value of CHF 0.40 each	—	10,113,235		—	—
Common shares resulting from conversion of Preferred Shares at the time of the IPO with a nominal value of CHF 0.40 each	—	18,753,175		—	-18,753,175
Common shares issued for the follow-on offering with a nominal value of CHF 0.40 each	5,275,000	—		—	—
Total, as of September 30	34,293,891	28,954,510		—	—

 

All shares have a nominal value of CHF 0.40 and are fully paid in. As of September 30, 2015, the nominal value of the 34,293,891 issued shares amounted to CHF 13,717,556 (as of December 31, 2014, the nominal value of 29,010,391 issued shares amounted to CHF 11,604,156).

 

Issue of common shares upon exercise of options

 

During the nine months ended September 30, 2014, three 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 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.

 

During the nine months ended September 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 share capital of CHF 3,400. Total proceeds from the exercise to the Company were CHF 27,200. The Company also recorded the difference of CHF 9,793 between the exercise price and market price at the day of exercise in the share premium.

 

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 USD 23.6 million (CHF 21.7 million). Following the offering (and settlement of the aforementioned employee options) there were 34,293,891 common shares of the Company outstanding.

 

IPO on NASDAQ Global Market

 

In August 2014, the Company completed its Initial Public Offering (“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 following the exercise of options.

 

Pursuant to agreements with holders of 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

 

	Nine months ended September 30, 2015		Nine months ended September 30, 2014
Salaries	1,920,616		1,542,359
Pension costs	239,247		89,612
Other social benefits	141,745		128,315
Share based compensation expense	207,313		238,202
Other	22,692		59,334
Total employee benefits	2,531,613		2,057,822

 

5.

Share based compensation expense

 

Share based compensation expense of CHF 207,313 was recognized during the nine month period ended September 30, 2015 (for the nine months ended September 30, 2014: CHF 238,202). A total of 234,750 options were granted in the nine month period ended September 30, 2015. The exercise price of the options granted was the average closing price in the 30 days preceding the grant date, which was USD 5.98 for 95,750 options granted in March 2015 and USD 4.68 for 139,000 options granted in September 2015. The methodology for computation of share based compensation expense for the period is consistent with the methodology used in 2014.

 

6.

Loss per share

 

		Three months ended September 30,		Nine months ended September 30,
		2015	2014	2015	2014
Loss attributable to owners of the Company		(5,210,928)	(3,360,828)	(24,221,465)	(14,212,011)
Weighted average number of shares outstanding		34,290,141	24,589,852	31,828,984	20,488,392
Basic and diluted loss per share		(0.15)	(0.14)	(0.76)	(0.69)

 

For the nine months ended September 30, 2015 and September 30, 2014 basic and diluted loss per share is 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 645,260 options outstanding under its stock option plans. The average number of options outstanding between January 1, 2015 and September 30, 2015 was 527,885 (262,500 for the period between January 1, 2014 and September 30, 2014). The average number of options outstanding between June 30, 2015 and September 30, 2015 was 575,760 (311,250 for the period between June 30, 2014 and September 30, 2014).

 

 

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 nine month periods ended September 30, 2014 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, 2014 (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 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 November 12, 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 a special protocol assessment, or SPA, from the FDA. In two 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 first top-line Phase 3 clinical data for AM-101 in the second quarter of 2016. We are also developing AM-111 for acute inner ear hearing loss. We are preparing two pivotal Phase 3 clinical trials in the treatment of idiopathic sudden sensorineural hearing loss, or ISSNHL, titled HEALOS and ASSENT. We expect to start enrollment in HEALOS in the fourth quarter of 2015 and in ASSENT in the first half of 2016. In addition, we are preparing a Phase 2 trial titled REACH in order to test AM-111 in the treatment of cochlear implantation surgery-induced hearing loss. We intend to seek grant funding for REACH and expect to start enrollment for the trial 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 September 30, 2015, we had cash and cash equivalents of CHF 55.4 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 September 30, 2015, we had an accumulated deficit of CHF 76.4 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.

 

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 at a price to the public of US$4.75 per share. The underwriting discounts and offering expenses totaled US$ 0.7 million. The offering expenses included SEC registration fees, FINRA filing fees, Nasdaq listing fees and expenses, legal fees and expenses, printing expenses, transfer agent fees and expenses, accounting fees and expenses, as well as other miscellaneous fees and expenses. In addition to offering expenses, the proceeds of the offering were subject to 1% stamp duty taxes. The net proceeds of the public offering after underwriting discounts were US$23.6 million (CHF 21.7 million).

 

On September 1, 2015, we filed a shelf registration statement on Form F-3 (333-206710) with the SEC to register for one or more offerings of common shares, senior debt securities, subordinated debt securities, warrants, purchase contracts or units with a maximum aggregate offering price of up to US$ 100 million. The shelf registration statement was declared effective on September 10, 2015.

 

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:

 

·

AM-101. We are conducting a Phase 3 program comprising two pivotal Phase 3 clinical trials (TACTT2 and TACTT3) as well as two open label extension studies (AMPACT1 and AMPACT2). We expect first top-line data from the TACTT trials in the second quarter of 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 Phase 3 clinical trials in the treatment of idiopathic sudden sensorineural hearing loss, or ISSNHL, titled HEALOS and ASSENT. We expect to start enrollment in HEALOS in the fourth quarter of 2015 and in ASSENT in the first half of 2016. In addition, we are preparing a Phase 2 trial titled REACH in order to test AM-111 in the treatment of cochlear implant surgery-induced hearing loss. We intend to seek grant funding for REACH and expect to start enrollment 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 pre-clinical studies with AM-102 and AM-123, including 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 nine month periods ended September 30, 2015 and 2014. The discussion below should be read along with this financial information, and it is qualified in its entirety by reference to them.

 

Comparison of three months ended September 30, 2015 and 2014

 

	Three months ended September 30,
	2015		2014		Change
	(in thousands of CHF)				%
Research and development	(5,884)		(4,686)		26%
General and administrative	(1,327)		(998)		33%
Operating loss	(7,211)		(5,684)		27%
Finance income/(expense), net	2,000		2,323		(14)%
Net loss before tax and attributable to owners of the Company	(5,211)		(3,361)		55%

 

Research and development expense

 

	Three months ended September 30,
	2015		2014		Change
	(in thousands of CHF)				%
Clinical projects	(4,292)		(3,396)		26%
Pre-clinical projects	(84)		(15)		458%
Drug manufacturing and substance	(570)		(571)		0%
Employee benefits	(538)		(412)		31%
Other research and development expenses	(401)		(292)		37%
Total	(5,884)		(4,686)		26%

 

Research and development expense increased 26% from CHF 4.7 million in the three months ended September 30, 2014 to CHF 5.9 million in the three months ended September 30, 2015. The variance in expense between the three months ended September 30, 2015 and the corresponding period in 2014 is mainly due to the following:

 

·

Clinical projects. In the three months ended September 30, 2015 we incurred higher clinical expenses than in the three months ended September 30, 2014, primarily due to higher service and milestone costs charged by contracted service providers in connection with the late stage AM-101 clinical trials, reflecting a higher number of enrolled patients when compared with the previous reporting period and trial progress. We also incurred higher costs as a result of payments for the initiation of our AM-111 Phase 3 HEALOS trial.

 

·

Pre-clinical projects. In the three months ended September 30, 2015, pre-clinical expenses increased primarily due to expenses related to our AM-102 pre-clinical project.

 

·

Drug manufacture and substance. In the three months ended September 30, 2015, we incurred generally the same amount of costs as in the three months ended September 30, 2014. Such costs typically depend on the timing of raw material purchases and the manufacture of clinical trial supplies.

 

·

Employee benefits. Employee expenses were higher in the three months ended September 30, 2015 than in the same period 2014 due to a higher headcount.

 

General and administrative expense

 

General and administrative expense was CHF 1.3 million in the three months ended September 30, 2015 compared to CHF 1.0 million in the three months ended September 30, 2014, as a result of higher administration costs (CHF 0.8 million vs 0.5 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.

 

Finance income/ expense net

 

Net finance income/expense decreased from CHF 2.3 million in the three months ended September 30, 2014 to CHF 2.0 million in the three month ended September 30, 2015 due to lower unrealized foreign currency exhange gains (CHF 2.1 million gain vs CHF 2.3 million gain) and higher realized foreign exchange losses (CHF 0.06 million loss vs CHF 0.03 million gain) in the three months to September 2015.

 

Comparison of nine months ended September 30, 2015 and 2014

 

	Nine months ended September 30,
	2015		2014		Change
	(in thousands of CHF)				%
Research and development	(20,865)		(13,036)		60%
General and administrative	(3,237)		(3,552)		(9)%
Operating loss	(24,102)		(16,588)		45%
Finance income/(expense), net	(120)		2,376		(105)%
Net loss before tax and attributable to
owners of the Company	(24,221)		(14,212)		70%

 

Research and development expense
	Nine months ended September 30,
	2015		2014		Change
	(in thousands of CHF)				%
Clinical projects	(17,232)		(8,558)		101%
Pre-clinical projects	(333)		(1,166)		(71)%
Drug manufacturing and substance	(1,058)		(1,355)		(22)%
Employee benefits	(1,434)		(1,210)		18%
Other research and development expenses	(808)		(747)		8%
Total	(20,865)		(13,036)		60%

 

Research and development expense increased 60% from CHF 13.0 million in the nine months ended September 30, 2014 to CHF 20.9 million in the nine months ended September 30, 2015. The variances in expense between the nine months ended September 30, 2015 and the corresponding period in 2014 are mainly due to the following:

 

·

Clinical projects. In the nine months ended September 30, 2015 we incurred significantly higher clinical expenses than in the nine months ended September 30, 2014, primarily due to higher service and milestone costs charged by contracted service providers in connection with the late stage AM-101 clinical trials, reflecting higher patient enrollment rates when compared with the previous reporting period and trial progress. We also incurred higher costs as a result of payments for the initiation of our AM-111 Phase 3 HEALOS trial.

 

·

Pre-clinical projects. In the nine months ended September 30, 2015, pre-clinical expenses decreased primarily due to fewer ongoing pre-clinical studies.

 

·

Drug manufacture and substance. In the nine months ended September 30, 2015, we incurred lower costs primarily due to fluctuations in the timing of raw material purchases and the manufacture of clinical trial supplies.

 

·

Employee benefits. Employee expenses increased in the nine months ended September 30, 2015 compared to the same period in 2014 due to an increase in headcount.

 

General and administrative expense

 

General and administrative expense decreased 9% from CHF 3.6 million in the nine months ended September 30, 2014 to CHF 3.2 million in the nine months ended September 30, 2015. While employee costs increased over the previous reporting period, administration expenses decreased from CHF 2.4 million to CHF 1.8 million as substantial costs incurred in connection with preparations for our initial public offering (legal and auditing expenses) were expensed in the nine months ended September 30, 2014.

 

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.

 

Finance income/expense net

 

Net finance income/expense decreased from an income of CHF 2.4 million in the nine months ended September 30, 2014 to an expense of CHF 0.1 million in the nine months ended September 30, 2015 due to substantially higher unrealized foreign currency exchange gains (CHF 2.4 million gain vs CHF 0.2 million loss ) partially offset by a non-cash interest charge (CHF 0.05 million) for our convertible bond in the nine months to September 2014.

 

Cash flow

 

Comparison of nine months ended September 30, 2015 and 2014

 

The table below summarizes our consolidated statement of cash flows for the nine months ended September 30, 2015 and 2014:

 

	Nine months ended September 30,
	2015		2014
	(in thousands of CHF)
Cash used in operating activities	(22,222)		(14,363)
Net cash used in investing activities	(57)		(67)
Net cash from financing activities	20,897		50,065
Net effect of currency translation on cash	(151)		2,392
Cash and cash equivalents at beginning of the period	56,934		23,866
Cash and cash equivalents at end of the period	55,401		61,893

 

The increase in cash used in operating activities from CHF 14.4 million in the nine months ended September 30, 2014 to CHF 22.2 million in the nine months ended September 30, 2015, was mainly due to higher research and development expenses and a decrease in net working capital (higher accrued expenses more than offset a decrease in payables).

 

Net cash used in investing activities decreased in the nine months ended September 30, 2015 due to lower expenditures for purchases of equipment and lower interest income.

 

Net cash from financing activities of CHF 20.9 million in the nine months ended September 30, 2015 represents proceeds from our public offering of 5,275,000 common shares at a price of US$4.75 per share. These proceeds were partially offset by issuance costs associated with the offering. In the nine months ended September 30, 2014 net cash from financing activities was CHF 50.0 million reflecting the net effect of proceeds from our initial public offering in August 2014.

 

Cash and funding sources

 

As of September 30, 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 “Item 3—Key Information—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 “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.

 

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

 

Except for IFRS 9 which we have not adopted yet, 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 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 of 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 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;

 

·

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 “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.

 

Exhibit 99.3

 

 

Auris Medical News Release

 

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

 

Zug, Switzerland, November 12, 2015 – Auris Medical Holding AG (NASDAQ: EARS) today provided an update on the Company’s business and announced financial results for the third quarter ended September 30, 2015.

 

"Auris Medical continued to make good progress in the third quarter of 2015," commented Thomas Meyer, the Company’s founder, Chairman and CEO. "Preparations for the three clinical trials in our AM-111 hearing loss program advanced well, with the first study expected to begin patient recruitment shortly. Importantly, our hearing loss program is generating considerable interest within the ENT community. At the same time, we reinforced our leadership in tinnitus research by taking our project AM-102 into the next stage of drug discovery. After several years of collaborative efforts together with our partners, we are very excited about AM-102’s potential of becoming a powerful second generation tinnitus treatment.”

 

Third Quarter and Recent Business Highlights

 

·

Progressed with enrolment into pivotal AM-101 trials. The Phase 3 clinical program with AM-101 in acute inner ear tinnitus continued to progress. The Company expects to have first top-line Phase 3 clinical data for AM-101 in the second quarter of 2016.

 

·

Launched HEALOS Phase 3 trial. In HEALOS, the first of two pivotal trials with AM-111 in the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL; a.k.a. “sudden deafness”), the first study sites in Europe and Asia were opened, and enrolment is expected to begin shortly. HEALOS will enroll 255 patients suffering from acute severe to profound hearing loss within 72 hours from ISSNHL onset. They will be randomized to receive a single intratympanic dose of either AM-111 at 0.4 mg/mL or 0.8 mg/mL or placebo, and will be followed for three months. The primary efficacy endpoint is the improvement of pure tone hearing threshold from baseline to day 28 at the average of the three most affected contiguous test frequencies.

 

·

Advanced preparations for ASSENT and REACH trials. Preparations for the two other planned AM-111 trials progressed further. For ASSENT, the second pivotal trial with AM-111 in ISSNHL, the design of the study protocol was completed, subject to final consultation with the FDA. The trial will be conducted primarily in North America, and is expected to begin enrolling patients in the first half of 2016. For REACH, a Phase 2 proof of concept study to assess AM-111’s otoprotective effects in cochlear implant surgery induced hearing loss, the study protocol was finalized based on additional FDA feedback. Contingent on securing grant funding, the trial could be initiated in the third quarter of 2016.

 

·

Provided medical education on acute hearing loss. In September 2015, Auris Medical organized a corporate symposium, “Rational Pharmacotherapy for Acute Hearing Loss – Recent Advances and Perspectives”, at the Annual Meeting of the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) in Dallas, TX. The symposium featured presentations from leading experts on hearing preservation following acute cochlear stress injury, inner ear drug delivery and the state of clinical research in acute hearing loss. The event highlighted the significant unmet medical need in the treatment of acute hearing loss, and laid out key considerations for the design of clinical trials. A Webcast of the event is available on Auris Medical’s website in the “Events” section.

 

·

Expanded research collaboration with King’s College London. Auris Medical initiated a drug discovery collaboration with the Institute of Pharmaceutical Science of King’s College London, which expands on earlier work by the Wolfson Centre for Age-Related Diseases at King’s. Under the collaboration, King’s will develop and optimize a range of specific small molecules for Auris Medical’s AM-102 project. The AM-102 compounds bind to a novel, undisclosed drug target that is different from AM-101’s target, and has been previously validated in collaboration with another research institution. From the AM-102 research project, Auris Medical aims to select a lead compound for further preclinical and subsequent clinical development as a second generation tinnitus treatment.

 

Financial Results

 

As of September 30, 2015, the Company had CHF 55.4 million in cash and cash equivalents. Operating expenses for the three months ended September 30, 2015 were CHF 7.2 million, with CHF 5.9 million attributable to research and development. This compares to operating expenses of CHF 5.7 million and research and development expenses of CHF 4.7 million for the same period in 2014. The Company reported a net loss for the quarter ended September 30, 2015 of CHF 5.2 million, or CHF 0.15 per share. This compares to a net loss of CHF 3.4 million, or CHF 0.14 per share, for the same period in 2014.

 

For the nine month period ended September 30, 2015, operating expenses were CHF 24.1 million, with CHF 20.9 million attributable to research and development. This compares to operating expenses of CHF 16.6 million and research and development expenses of CHF 13.0 million for the same period in 2014. The Company reported a net loss for the nine months ended September 30, 2015 of CHF 24.2 million, or CHF 0.76 per share. This compares to a net loss of CHF 14.2 million, or CHF 0.69 per share, for the same period in 2014.

 

The increases in operating expenses, and resulting increases in net loss, for the three- and nine-month periods ended September 30, 2015 over the comparable periods in 2014 reflect primarily the progression of the AM-101 Phase 3 clinical development program and preparations for the late stage AM-111 clinical program.

 

The Company expects its operating expenses for the 2015 financial year to be in line with previous guidance of CHF 30.0 to 35.0 million.

 

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 November 12, 2015 at 8:00 a.m. Eastern Time (2:00 p.m. Central European Time). To participate in this conference call, dial 1 855 217 7942 (USA) or +1 646 254 3369 (International), and enter passcode 4621688. 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, the prospectus dated May 14, 2015 relating to its Registration Statement on Form F-1 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: 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

 

Auris Medical Holding AG

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

(in CHF thousands, except share and currency data)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2015				2014				2015				2014
Research and development expenses			(5,884	)			(4,686	)			(20,865	)			(13,036	)
General and administrative expenses			(1,327	)			(998	)			(3,237	)			(3,552	)
Operating loss			(7,211	)			(5,684	)			(24,102	)			(16,588	)
Finance income/(expense), net			2,000				2,323				(120	)			2,376
Loss before tax			(5,211	)			(3,361	)			(24,221	)			(14,212	)
Net loss attributable to owners of the Company			(5,211	)			(3,361	)			(24,221	)			(14,212	)
Other comprehensive income:
Items that will never be reclassified to profit or loss:
Remeasurements of defined benefits liability			(4	)			112				(233	)			(312	)
Items that are or may reclassified to profit or loss:
Foreign currency translation differences			(41	)			(74	)			16				(71	)
Other comprehensive income			(44	)			37				(217	)			(384	)
Total comprehensive loss attributable to owners of the Company			(5,255	)			(3,323	)			(24,438	)			(14,596	)
Loss per share, basic and diluted			(0.15	)			(0.14	)			(0.76	)			(0.69	)
Weighted average common shares outstanding, basic and diluted			34,290,141				24,589,852				31,828,984				20,488,392
Currency rate CHF / USD			0.9525				0.9134				0.9507				0.8960

 

Auris Medical Holding AG

Condensed Consolidated Interim Statement of Financial Position (unaudited)

(in CHF thousands)

 

		September 30, 2015				December 31, 2014
Assets
Non-current assets
Property and equipment			247				235
Intangible assets			1,483				1,483
Deferred tax asset			-				33
Total non-current assets			1,730				1,751
Current assets
Current financial assets and other receivables			576				543
Prepayments			294				265
Cash and cash equivalents			55,401				56,934
Total current assets			56,271				57,742
Total assets			58,001				59,493
Equity and Liabilities
Equity
Share capital			13,718				11,604
Share premium			112,645				93,861
Foreign currency translation reserve			(35	)			(51	)
Accumulated deficit			(76,379	)			(52,131	)
Total shareholders’ equity attributable to owners of the Company			49,949				53,283
Non-current liabilities
Employee benefits			1,759				1,411
Deferred tax liabilities			328				360
Total non-current liabilities			2,086				1,771
Current liabilities
Trade and other payables			2,822				3,234
Accrued expenses			3,143				1,205
Total current liabilities			5,965				4,439
Total liabilities			8,052				6,210
Total equity and liabilities			58,001				59,493
Currency rate CHF / USD			0.9739				0.8841

 

Auris Medical Holding AG

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

(convenience presentation in USD thousands, except share data)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2015				2014				2015				2014
Research and development expenses			(6,042	)			(4,812	)			(21,424	)			(13,386	)
General and administrative expenses			(1,362	)			(1,024	)			(3,324	)			(3,647	)
Operating loss			(7,404	)			(5,837	)			(24,748	)			(17,033	)
Finance income/(expense), net			2,054				2,386				(123	)			2,440
Loss before tax			(5,351	)			(3,451	)			(24,871	)			(14,593	)
Net loss attributable to owners of the Company			(5,351	)			(3,451	)			(24,871	)			(14,593	)
Other comprehensive income:
Items that will never be reclassified to profit or loss:
Remeasurements of defined benefits liability			(4	)			115				(239	)			(321	)
Items that are or may reclassified to profit or loss:
Foreign currency translation differences			(42	)			(76	)			17				(73	)
Other comprehensive income			(46	)			38				(222	)			(394	)
Total comprehensive loss attributable to owners of the Company			(5,396	)			(3,412	)			(25,093	)			(14,987	)
Loss per share, basic and diluted			(0.16	)			(0.14	)			(0.78	)			(0.71	)
Weighted average common shares outstanding, basic and diluted			34,290,141				24,589,852				31,828,984				20,488,392

 

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 and 9 months ended September 30, 2015 and September 30, 2014, have been translated into U.S. dollars at the rate on September 30, 2015 of USD 1.0268 / 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.

 

Auris Medical Holding AG

Condensed Consolidated Interim Statement of Financial Position (unaudited)

(convenience presentation in USD thousands)

 

		September 30, 2015				December 31, 2014
Assets
Non-current assets
Property and equipment			254				242
Intangible assets			1,522				1,522
Deferred tax asset			-				34
Total non-current assets			1,776				1,798
Current assets			-
Current financial assets and other receivables			591				557
Prepayments			302				272
Cash and cash equivalents			56,885				58,460
Total current assets			57,779				59,289
Total assets			59,555				61,087
Equity and Liabilities			-
Equity			-
Share capital			14,085				11,915
Share premium			115,664				96,377
Foreign currency translation reserve			(36	)			(52	)
Accumulated deficit			(78,425	)			(53,529	)
Total shareholders’ equity attributable to owners of the Company			51,288				54,711
Non-current liabilities			-
Employee benefits			1,806				1,448
Deferred tax liabilities			336				370
Total non-current liabilities			2,142				1,818
Current liabilities			-
Trade and other payables			2,898				3,321
Accrued expenses			3,227				1,237
Total current liabilities			6,125				4,558
Total liabilities			8,267				6,376
Total equity and liabilities			59,555				61,087

 

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 September 30, 2015 and December 31, 2014, have been translated into U.S. dollars at the rate on September 30, 2015 of USD 1.0268 / 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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