SEC Filing - Altamira Therapeutics

Auris Medical Holding AG

/s/ Thomas Meyer

Thomas Meyer

Chief Executive Officer

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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 December, 2014

Commission File Number: 001-36582

Auris Medical Holding AG

(Exact name of registrant as specified in its charter)

Bahnhofstrasse 21

6300 Zug, Switzerland

(Address of principal executive office)

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

Form 20-F

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

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

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.

Date: December 3, 2014

EXHIBIT INDEX

Exhibit Number	Description
99.1	Unaudited Condensed Consolidated Interim Financial Information

99.2	Management’s Discussion and Analysis of Financial Condition and Results of Operations

99.3	Press Release dated December 3, 2014

Exhibit 99.1

Unaudited Condensed Consolidated Interim Financial Information as of September 30, 2014 and for the Nine Months Ended September 30, 2014 and 2013

Condensed Consolidated Interim Statement of Profit or Loss

Condensed Consolidated Interim Statement of Financial Position

Condensed Consolidated Interim Statement of Cash Flows

Selected Additional Information to the Consolidated Financial Information

AURIS MEDICAL HOLDING AG

Condensed Consolidated Interim Statement of Profit or Loss (unaudited)

For the Nine Months Ended September 30, 2014 and 2013 (in CHF)

	Note	NINE MONTHS ENDED SEPT. 30, 2014		NINE MONTHS ENDED SEPT. 30, 2013
Research and development			-13,036,450		-10,327,366
General and administrative			-3,552,021		-1,010,096
Operating loss			-16,588,471		-11,337,462
Finance income / expense (net)			2,376,460		-168,260
Loss before tax			-14,212,011		-11,505,722
Net loss for the period attributable to owners of the Company			-14,212,011		-11,505,722
Other comprehensive income
Items that will never be reclassified to profit or loss
Remeasurements of defined benefit liability			-312,261		95,466
Items that are or may be reclassified to profit or loss
Foreign currency translation differences			-71,298		13,314
Other comprehensive income for the period, net of tax			-383,559		108,780
Total comprehensive loss for the period attributable to owners of the Company			-14,595,570		-11,396,942
Basic and diluted loss per share			-0.69		-0.79

AURIS MEDICAL HOLDING AG

Condensed Consolidated Interim Statement of Financial Position (unaudited)

As of September 30, 2014 and December 31, 2013

(in CHF)

	Note		September. 30, 2014		December 31, 2013
ASSETS
Non-current assets
Property and equipment				245,369		195,915
Intangible assets				1,482,520		1,482,520

Total non-current assets				1,727,889		1,678,435

Current assets
Other receivables				712,051		524,786
Prepayments				333,395		183,137
Cash and cash equivalents				61,892,660		23,865,842

Total current assets				62,938,106		24,573,765


Total assets				64,665,995		26,252,200

EQUITY AND LIABILITIES
Equity
Share capital		3		11,581,804		6,487,130
Share premium				93,793,282		35,608,210
Foreign currency translation reserve				-17,303		53,995
Accumulated deficit				-47,401,761		-33,115,689
Total shareholders' equity attributable to owners of the Company				57,956,022		9,033,646

Non-current liabilities
Employee benefits		5		627,265		328,342
Deferred tax liabilities				327,637		327,637

Total non-current liabilities				954,902		655,979

Current liabilities
Convertible loans		4		–		13,711,200
Trade and other payables				3,612,930		954,257
Accrued expenses				2,142,141		1,897,118

Total current liabilities				5,755,071		16,562,575

Total liabilities				6,709,973		17,218,554

Total equity and liabilities				64,665,995		26,252,200

AURIS MEDICAL HOLDING AG

Condensed Consolidated Interim Statement of Cash Flows (unaudited)

For the Nine Months Ended September 30, 2014 and 2013 (in CHF)

	Note		NINE MONTHS ENDED		NINE MONTHS ENDED
			SEPT. 30, 2014		SEPT. 30, 2013
Cash flows from operating activities
Net loss				-14,212,011		-11,505,722
Adjustments for:
Depreciation				53,291		24,414
Unrealized exchange differences				-2,462,886		14,281
Net interest income				13,727		-15,181
Share based payments		5		238,202		78,236
Employee benefits				-13,338		26,685

Change in Net Working Capital				2,019,665		1,602,383

Cash used in operating activities				-14,363,350		-9,774,904

Net cash used in investing activities				-66,838		-40,420

Net cash from financing activities				50,065,074		24,252,444

Net increase/(decrease) in cash and cash equivalents				35,634,886		14,437,120
Cash and cash equivalents at beginning of the period				23,865,842		63,967
Net effect of currency translation on cash				2,391,932		-390

Cash and cash equivalents at end of the period				61,892,660		14,500,697

AURIS MEDICAL HOLDING AG

Additional Information to the Consolidated Financial Information

as of September 30, 2014 and for the Nine Months Ended September 30, 2013 (in CHF)

1.	Reporting entity

Auris Medical Holding AG (the “Company”) is domiciled in Switzerland. The Company’s registered address is at Bahnhofstrasse 21, 6300 Zug. This consolidated interim financial information comprises the Company and its subsidiaries (together referred to as the “Group” and individually as “Group entities”). The Company is the ultimate parent of the following Group entities:

Auris Medical AG, Basel, Switzerland (100%)

Otolanum AG, Zug, Switzerland (100%)

Auris Medical Inc., Chicago, United States (100%)

Auris Medical Ltd., Dublin, Ireland (100%)

On April 22, 2014, we changed our name from Auris Medical AG to Auris Medical Holding AG and transferred our operational business to our newly incorporated subsidiary Auris Medical AG, which is now our main operating subsidiary. The Group is primarily involved in the development of pharmaceutical products for the treatment of inner ear disorders, in particular tinnitus and hearing loss. Its most advanced projects are in the late stage of clinical development.

2.	Basis of preparation

This interim financial information has been prepared using the same accounting policies and methods of computation as compared with the most recent annual financial statements. The financial information included here-in is not intended to fully comply with IFRS, and in particular with IAS 34. New accounting standards, which have been applied in 2014 for the first time, did not have an impact on the Company’s financial position, results or cash flows.

The financial information included in this quarterly release and shareholder information has not been reviewed or audited by our auditors. Quarterly results are not necessarily indicative of results to be expected for the full year.

The Group has not early adopted any standard, interpretation or amendment that was issued but is not yet effective.

3.	Capital and reserves

Share capital

The issued share capital of Auris Medical Holding AG consisted of:

	AS OF SEPTEMBER 30, 2014				AS OF DECEMBER 31 2013
	NUMBER		CHF		NUMBER		CHF
Common shares with a nominal value of CHF 0.40 each		28,954,510		11,581,804		72,600		29,040
Preferred shares Series A with a nominal value of CHF 0.40 each		–		–		5,999,750		2,399,900
Preferred shares Series B with a nominal value of CHF 0.40 each		–		–		5,509,100		2,203,640
Preferred shares Series C with a nominal value of CHF 0.40 each		–		–		4,636,375		1,854,550
		28,954,510		11,581,804		16,217,825		6,487,130

All shares are fully paid in. All disclosed numbers and nominal value of shares in these interim financial statements are adjusted for the 25:1 stock split effected in December 2013 unless otherwise indicated.

	Common shares				Preferred shares
	2014		2013		2014		2013
As of January 1		72,600		72,600		16,145,225		11,508,850
Common shares stock options with a nominal value of CHF 0.40 each		15,500		–		–		–
Preferred shares Series A with a nominal value of CHF 0.40 each		–		–		2,607,950		4,636,375
Common shares issued for IPO with a nominal value of CHF 0.40 each		10,113,235		–		–		–
Common shares with a nominal value of CHF 0.40 each resulting from conversion of preference shares at the IPO		18,753,175		–		-18,753,175		–
As at September 30, 2014, and September 30, 2013		28,954,510		72,600		–		16,145,225

AURIS MEDICAL HOLDING AG

Additional Information to the Consolidated Financial Information

as of September 30, 2014 and for the Nine Months Ended September 30, 2013 (in CHF)

Issue of common shares upon exercise of options

On January 21, 2014, three beneficiaries of Option Plan A exercised their right to acquire common shares of the Company at CHF 3.20 per share. This resulted in an increase in the number of outstanding common shares of 15,500 and an increase in the share capital of CHF 6,200. Total proceeds from the exercise to the company were CHF 49,600.

IPO on NASDAQ Global Market

On August 11, 2014, the Company completed its initial public offering of common shares, selling an aggregate of 10,113,235 common shares, which included 713,235 common shares sold on August 19, 2014 pursuant to an over-allotment option granted to the underwriters. All of these common shares were sold at a price to the public of USD 6.00 per share yielding gross proceeds (before underwriting fees and IPO costs) of USD 60.7 million. Following the IPO, there are 28,954,510 common shares of the Company outstanding. All 18,753,175 preferred shares outstanding at the time of the IPO were converted into common shares.

4.	Convertible loans

On December 9, 2013, the Company issued non-interest bearing convertible loans to two shareholders with a nominal value of CHF 13,769,976 and a maximum term of 12 months. On January 27, 2014, the loans were converted into 2,607,950 new preferred shares Series C with nominal value of CHF 0.40 each for CHF 5.28 per share.

On the conversion date of the loan, the liability was derecognized and CHF 1,043,180 was recognized as share capital and CHF 12,717,655 as share premium.

Convertible loans from shareholders

	Sept. 30, 2014
Convertible loans as at December 31		13,711,200
Loss on derecognition		9,141
Imputed interest expense for the period		49,635
Derecognition of liability at conversion into		13,769,976
Convertible loans at September 30, 2014		–

5.	Employee benefits

Employee benefits

	NINE MONTHS ENDED SEPT. 30, 2014		NINE MONTHS ENDED SEPT. 30, 2013
Salaries		1,542,359		533,783
Pension costs		89,612		59,187
Other social benefits		128,315		46,189
Share option costs		238,202		78,236
Other employee costs		59,334		73,899
Total employee benefits		2,057,822		791,294

Accelerated Vesting for Stock Option Plan A

Stock Option Plan A provided for the accelerated vesting of options under the plan on the closing of an IPO, merger or change of control event. As a result, the remaining share option expense for Stock Option Plan A on the date of the closing of our IPO in August 2014 was included in the share option cost for the nine months ending 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 information as of and for the nine month periods ended September 30, 2014 and 2013 included as Exhibit 1 to this Report on Form 6-K. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements, and the notes thereto, which appear in our prospectus (our “Final Prospectus”) relating to our Registration Statement on Form F-1, as amended (Registration No. 333-197105), filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to Rule 424(b) under the U.S. Securities Act of 1933, as amended.

Unless otherwise indicated or the context otherwise requires, all references to “Auris Medical” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to Auris Medical AG and its subsidiaries prior to the completion of our corporate reorganization in connection with our initial public offering (“IPO”), and Auris Medical Holding AG and its subsidiaries as of the completion of our corporate reorganization and thereafter. See “Prospectus Summary—Corporate Information” in the Final Prospectus.

We prepare and report our audited 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 December 3, 2014.

Overview

We are a clinical-stage biopharmaceutical company focused on the development of novel products for the treatment of inner ear disorders. Our most advanced product candidate, AM-101, is in Phase 3 clinical development for acute inner ear tinnitus under a special protocol assessment, or SPA, from the FDA. In two recently completed Phase 2 clinical trials, AM-101 demonstrated a favorable safety profile and statistically significant improvement in tinnitus loudness and other patient reported outcomes. We expect to have top-line Phase 3 clinical data for AM-101 in early 2016. We are also developing AM-111 for acute inner ear hearing loss (acute sensorineural hearing loss, or ASNHL). Following feedback from a pre-IND meeting with the FDA in September 2014, we are in the process of finalizing the design of the late-stage AM-111 clinical program and if all goes well and we obtain sufficient funding, we intend to start a placebo-controlled pivotal trial around mid-2015. Both acute inner ear tinnitus and hearing loss are conditions for which there is high unmet medical need, and we believe that we have the potential to be the first to market in these indications.

To date, we have financed our operations through our initial public offering of our common shares, private placements of equity securities and short term loans. We have no products approved for commercialization and have never generated any revenues from royalties or product sales. Based on our current plans, we do not expect to generate royalty or product revenues unless and until we obtain marketing approval for, and commercialize, AM-101, AM-111 or any of our other product candidates.

Since inception, we have incurred significant operating losses. We incurred net losses (defined as net losses attributable to the owners of the company) of CHF 15.0 million and CHF 4.6 million for the years ended December 31, 2013 and 2012, respectively. For the nine months ended September 30, 2014

and 2013, we incurred net losses of CHF 14.2 million and CHF 11.5 million, respectively. As of September 30, 2014, we had an accumulated deficit of CHF 47.4 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.

Recent Developments

On August 11, 2014, we completed our initial public offering of common shares pursuant to a Registration Statement on Form F-1, as amended (Registration No. 333-197105) that was declared effective on August 5, 2014. Under the registration statement, we sold an aggregate of 10,113,235 common shares, which included 713,235 common shares sold on August 19, 2014 pursuant to an over-allotment option granted to the underwriters. All of these common shares were sold at a price to the public of US$6.00 per share. Our common shares are listed on the NASDAQ Global Market under the symbol “EARS.”

Collaboration and License Agreements

There have been no material changes to our collaboration and license agreements from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Collaboration and License Agreements” in the Final Prospectus.

Research and Development Expense

Our research and development expense is highly dependent on the development phases of our research projects and therefore may fluctuate substantially from period to period. Our research and development expense mainly relates to the following key programs:

AM-101. We have commenced a Phase 3 program of AM-101 comprising two Phase 3 clinical trials (TACTT2 and TACTT3) as well as two open label extension studies (AMPACT1 and AMPACT2). We expect top-line data from the TACTT trials in early 2016. We anticipate that our research and development expenses will increase substantially in connection with these clinical trials.

AM-111. Following feedback from a pre-IND meeting with the FDA in September 2014, we are in the process of finalizing the design of our late-stage AM-111 clinical program for ASNHL. Implementation of the late-stage AM-111 clinical program may require additional funding. We anticipate that our research and development expenses will increase substantially with the continuation of AM-111’s clinical development program.

Other development programs. Other research and development expenses mainly relate to our pre-clinical studies of AM-102 and AM-123. 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 “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Financial Operations Overview” in the Final Prospectus.

Results of Operations

The discussion below should be read along with our unaudited condensed consolidated interim financial information as of and for the nine month periods ended September 30, 2014 and 2013, and is qualified in its entirety by reference to it.

Comparison of three months ended September 30, 2014 and 2013

	Three months ended September 30,
	2014			2013			Change
	(in thousands of CHF)						%
Research and development		(4,686	)		(3,943	)		19	%
General and administrative		(998	)		(278	)		259	%
Operating loss		(5,684	)		(4,221	)		35	%
Finance income / expense (net)		2,323			(208	)
Loss before tax		(3,361	)		(4,429	)		(24	)%
Net loss attributable to owners of the company		(3,361	)		(4,429	)		(24	)%

Research and development expense

	Three months ended September 30,
	2014			2013			Change
	(in thousands of CHF)						%
Clinical projects		(3,396	)		(2,739	)		24	%
Pre-clinical projects		(15	)		(886	)		(98	)%
Drug manufacture and substance		(571	)		(61	)		832	%
Employee benefits		(412	)		(189	)		119	%
Other research and development expenses		(292	)		(68	)		331	%
Total		(4,686	)		(3,943	)		19	%

Research and development expense increased 19% from CHF 3.9 million in the three months ended September 30, 2013 to CHF 4.7 million in the three months ended September 30, 2014. The variances in expense between the three months ended September 30, 2013 and the corresponding period in 2014 are mainly due to the following projects:

Clinical Projects. In the three months ended September 30, 2014 we incurred higher clinical expenses than in the three months ended September 30, 2013 primarily due to higher service and pass-through costs charged by contracted service providers in connection with our AM-101 Phase 3 program.

Pre-clinical projects. In the three months ended September 30, 2014, pre-clinical expenses were lower than in the three months ended September 30, 2013 as expenses for AM-111 were lower due to the completion of several pre-clinical studies and the timing of expenses for AM-101 studies.

Drug manufacture and substance. In the three months ended September 30, 2014, we incurred significantly higher costs related to process development and the manufacture of clinical supplies compared to the three months ended September 30, 2013.

Employee Benefits. Employee expenses were significantly higher in the three months ended September 30, 2014 than in the three months ended September 30, 2013 due to higher headcount and expenses recognized in connection with the accelerated vesting of options outstanding at the time of the IPO under one of our stock option plans.

General and administrative expense

General and administrative expense increased 259% from CHF 0.3 million in the three months ended September 30, 2013 to CHF 1.0 million in the three months ended September 30, 2014. The increase was

primarily related to higher legal and auditing expenses in connection with the preparation for the IPO and expenses associated with operating as a public company.

We expect that compared to the three months ended September 30, 2014 (less the IPO preparation expenses), general and administrative expense will increase in the future as our business expands and we incur additional costs associated with operating as a public company.

Net finance income/expense

Net finance income swung from a CHF 0.3 million expense in the three months ended September 30, 2013 to income of CHF 2.3 million in the three months ended September 30, 2014 due to higher unrealized foreign exchange gains on a significantly higher U.S. dollar cash position at the end of September 30, 2014 as a result of the IPO.

Comparison of nine months ended September 30, 2014 and 2013

	Nine months ended September 30,
	2014			2013			Change
	(in thousands of CHF)						%
Research and development		(13,036	)		(10,327	)		26	%
General and administrative		(3,552	)		(1,010	)		252	%
Operating loss		(16,588	)		(11,337	)		46	%
Finance income / expense (net)		2,376			(168	)
Loss before tax		(14,212	)		(11,506	)		24	%
Net loss attributable to owners of the company		(14,212	)		(11,506	)		24	%

Research and development expense

	Nine months ended September 30,
	2014			2013			Change
	(in thousands of CHF)						%
Clinical projects		(8,558	)		(7,037	)		22	%
Pre-clinical projects		(1,166	)		(1,587	)		(27	)%
Drug manufacture and substance		(1,355	)		(955	)		42	%
Employee benefits		(1,210	)		(537	)		125	%
Other research and development expenses		(747	)		(211	)		254	%
Total		(13,036	)		(10,327	)		26	%

Research and development expense increased 26% from CHF 10.3 million in the nine months ended September 30, 2013 to CHF 13.0 million in the nine months ended September 30, 2014. The variances in expense between the nine months ended September 30, 2013 and the corresponding period in 2014 are mainly due to the following projects:

Clinical Projects. In the nine months ended September 30, 2014 we incurred higher clinical expenses due to the progression of our AM-101 Phase 3 clinical development program. In addition, we conducted preparatory activities related to our late stage AM-111 clinical program, whereas in the nine months ended September 30, 2013 the AM-111 Phase 2 trial had been completed with a concomitant decline in spending.

Pre-clinical projects. In the nine months ended September 30, 2014, pre-clinical expenses were lower than in the nine months ended September 30, 2013 due to the conclusion of certain pre-clinical studies.

Drug manufacture and substance. Expenses in the nine months ended September 30, 2014 were higher than in the nine months ended September 30, 2013, primarily due to higher costs for analytical and process development as well as the manufacture of clinical supplies.

Employee Benefits. Employee expenses were significantly higher in the nine months ended September 30, 2014 than in the nine months ended September 30, 2013, primarily due to higher headcount and expenses recognized in connection with the accelerated vesting of options outstanding at the time of the IPO under one of our stock option plans.

General and administrative expense

General and administrative expense increased nearly two-and-a-half times from CHF 1.0 million in the nine months ended September 30, 2013 to CHF 2.5 million in the nine months ended September 30, 2014. The increase was primarily related to higher legal and auditing expenses in connection with preparation for the IPO.

We expect that general and administrative expense compared to the nine months ended September 30, 2014 (less the IPO preparation expenses), will increase in the future as our business expands and we incur additional costs associated with operating as a public company.

Net finance income/expense

Net finance income swung from a CHF 0.2 million expense in the nine months ended September 30, 2013 to an income of CHF 2.4 million in the nine months ended September 30, 2014 due to higher unrealized foreign exchange gains on a significantly higher U.S. dollar cash position at the end of September 30, 2014 as a result of the IPO.

Liquidity and Capital Resources

Since inception, we have incurred significant operating losses. To date, we have not generated any product sale revenue. We have financed our operations primarily through our initial public offering of our common shares, private placements of equity securities and loans from existing shareholders.

Cash flows

Comparison of the three months ended September 30, 2014 and 2013

The table below summarizes our consolidated statement of cash flows for the three months ended September 30, 2014 and 2013:

	Three months ended September 30,						Change
	2014			2013			%
Cash used in operating activities		(2,775	)		(4,058	)		(32	)%
Net cash used in investing activities		(8	)		(22	)		(66	)%
Net cash from financing activities		50,152			24
Net effect of currency translation on cash		2,392			(1	)
Cash and cash equivalents at the beginning of the period		12,131			18,557
Cash and cash equivalents at the end of the period		61,893			14,501			327	%

The decrease in cash used in operating activities by 32% from CHF 4.1 million in the three months ended September 30, 2013 to CHF 2.8 million in the three months ended September 30, 2014 was mainly due to an increase in trade and other payables in the three months ended September 30, 2014.

Net cash used in investing activities was insignificant in the three months ended September 30, 2014 and was CHF 0.2 million in the same period in 2013.

The increase in net cash from financing activities of CHF 50.2 million from the three months ended September 30, 2013 to the three months ended September 30, 2014 reflects the net proceeds of the IPO.

The significant increase in the net effect of currency translations on cash from the three months ended September 30, 2013 to the three months ended September 30, 2014 is due to unrealized gains on cash positions held in U.S. dollars due to a favorable move in the USD/CHF exchange rate in the three months ended September 30, 2014.

Comparison of the nine months ended September 30, 2014 and 2013

The table below summarizes our consolidated statement of cash flows for the nine months ended September 30, 2014 and 2013:

	Nine months ended September 30,						Change
	2014			2013			%
Cash used in operating activities		(14,363	)		(9,775	)		47	%
Net cash used in investing activities		(67	)		(40	)		65	%
Net cash from financing activities		50,065			24,252			106	%
Net effect of currency translation on cash		2,392			(0	)
Cash and cash equivalents at the beginning of the period		23,866			64
Cash and cash equivalents at the end of the period		61,893			14,501			327	%

The increase in cash used in operating activities by 47% from CHF 9.8 million in the nine months ended September 30, 2013 to CHF 14.3 million in the nine months ended September 30, 2014 was mainly due to higher research and development and general and administrative expenses, which was partly offset by an increase in trade and other payables in the three months ended September 30, 2014.

The increase in net cash used in investing activities by 65% from the nine months ended September 30, 2013 to CHF 0.1 million in the nine months ended September 30, 2014 was due to higher investment in manufacturing equipment.

The increase in net cash from financing activities to CFH 50.1 million in the nine months ended September 30, 2014 reflects the net proceeds of the IPO.

The significant increase in the net effect of currency translations on cash from the nine months ended September 30, 2013 to the nine months ended September 30, 2014 is due to unrealized gains on cash positions held in U.S. dollars due to a favorable move in the USD/CHF exchange rate in the three months ended September 30, 2014.

Cash and funding sources

During the three and nine months ended September 30, 2014, we raised gross proceeds of US$ 60.7 million from the sale of 10.1 million common shares in the IPO. As of September 30, 2014, we had no long term debt and had no ongoing material financial commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, other than leases.

Funding requirements

We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until at least mid-2016. 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, pre-clinical 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 funding to advance our late-stage AM-111 clinical program in 2015. In addition, we expect that we will require additional capital to commercialize our product candidates AM-101 and AM-111. If we receive regulatory approval for AM-101 or AM-111, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also expect to incur additional costs associated with operating as a public company following this offering. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

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

Contractual Obligations and Commitments

There have been no material changes to our contractual obligations outside the ordinary course of our business from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments” in the Final Prospectus.

Off-balance sheet arrangements

As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements except for the Operating Lease mentioned in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments” in the Final Prospectus.

Significant Accounting Policies and Use of Estimates and Judgment

There have been no material changes to the significant accounting policies and estimates described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Significant accounting policies and use of estimates and judgment” in the Final Prospectus.

Recent Accounting Pronouncements

Except for IFRS 9 for which the impact cannot be determined with sufficient reliability, there are no IFRS standards as issued by the IASB or interpretations issued by the IFRS interpretations committee that

are effective for the first time for the financial year beginning on or after January 1, 2014 that would be expected to have a material impact on our financial position.

JOBS Act Exemption

On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. This exemption will apply for a period of five years following the completion of our initial public offering or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than $1.0 billion in annual revenue, have more than $700 million in market value of our common shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.

Cautionary Statement Regarding Forward Looking Statements

Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in the Final Prospectus. These risks and uncertainties include factors relating to:

·	our operation as a development stage company with limited operating history and a history of operating losses;

·	our need for substantial additional funding before we can expect to become profitable from sales of our products;

·	our dependence on the success of AM-101 and AM-111, which are still in clinical development and may eventually prove to be unsuccessful;

·	the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage;

·	uncertainty surrounding whether any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized;

·	if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview;

·	enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization;

·	the chance that we do not obtain orphan drug exclusivity for AM-111, which would allow our competitors to sell products that treat the same conditions;

·	dependence on governmental authorities and health insurers establishing adequate reimbursement levels and pricing policies;

·	our products may not gain market acceptance, in which case we may not be able to generate product revenues;

·	our reliance on our current strategic relationships with INSERM or Xigen and the potential failure to enter into new strategic relationships;

·	our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates; and

·	other risk factors discussed under “Risk Factors” included in the Final Prospectus

Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

Exhibit 99.3

Auris Medical News Release

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

Zug, Switzerland, December 3, 2014 – 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, 2014.

"We made great progress on clinical and operational fronts in the third quarter," commented Thomas Meyer, the Company’s founder, Chairman and CEO. "We transitioned from a privately held to a publicly traded company, secured the funding to complete our important AM-101 development program in tinnitus, advanced our development projects and significantly raised our visibility among investors and inner ear specialists.“

Recent Business Highlights

·	Completion of the initial public offering (IPO) in August 2014 raising net proceeds (after underwriting discounts) of $56.4 million. At the close of the third quarter 2014 (September 30, 2014), Auris Medical’s cash and cash equivalents stood at CHF 61.9 million.

The AM-101 Phase 3 clinical program in acute inner ear tinnitus remains on track. Ramp-up of clinical trial sites in North America and Europe is expected to be completed in the first quarter of 2015. Enrolment into the post-acute arm (“Stratum B”; tinnitus onset between 3 and 12 months) of the TACTT3 trial continued to progress, with the goal of an interim analysis for futility testing in the first quarter of 2015, as previously announced.

In September 2014, Auris Medical organized a satellite symposium “Rational Pharmacotherapy for Tinnitus – Recent Advances and Perspectives” at the Annual Meeting of the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) in Orlando FL. The symposium featured talks from leading experts on scientific research, clinical endpoints, intratympanic drug delivery and clinical research in the field of tinnitus. The event was well attended and well received, and further raised awareness about our projects and therapeutic approaches within the otolaryngology community.

·	In September 2014, Auris Medical completed a Pre-IND meeting with the FDA on the AM-111 development program. The FDA provided formal feedback and guidance on the Company’s pre-clinical and CMC development and specifically on the planned AM-111 late stage clinical program

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

in acute sensorineural hearing loss (ASHNL). The Agency’s feedback was sought in addition to protocol assistance obtained earlier from the European Medicines Agency. Based on the FDA’s guidance and a general review of the development program by the Board of Directors, the Company is currently finalizing the design of the late-stage AM-111 clinical program. In parallel, Auris Medical is evaluating various non-dilutive financing options to secure comprehensive funding for the program.

·	During the third quarter, Auris Medical continued to strengthen and expand its intellectual property position. In Europe, the Company was granted European Patent 1928405 “Pharmaceutical compositions for the treatment of inner ear disorders” and filed a divisional application.

Financial Results

As of September 30, 2014, the Company had CHF 61.9 million in cash and cash equivalents. Operating expenses for the three months ended September 30, 2014 were CHF 5.6 million, with CHF 4.7 million attributable to research and development. This compares to operating expenses of CHF 4.2 million and research and development expenses of CHF 3.9 million for the same period in 2013. The Company reported a net loss for the quarter ended September 30, 2014 of CHF 3.4 million, or CHF 0.14 per share. This compares to a net loss of CHF 4.4 million, or CHF 0.27 per share, for the same period in 2013.

For the nine month period ended September 30, 2014, operating expenses were CHF 16.6 million, with CHF 13.0 million attributable to research and development. This compares to operating expenses of CHF 11.3 million and research and development expenses of CHF 10.3 million for the same period in 2013. The Company reported a net loss for the nine months ended September 30, 2014 of CHF 14.2 million, or CHF 0.69 per share. This compares to a net loss of CHF 11.5 million, or CHF 0.79 per share, for the same period in 2013.

The increases in operating expenses, and resulting increases in net loss, for the three- and nine-month periods ended September 30, 2014 over the comparable periods in 2013 reflect primarily the progression of the AM-101 Phase 3 clinical development program, preparations for the late stage AM-111 clinical program, headcount expansion and higher legal and auditing expenses related to the IPO preparations.

The Company expects the operating loss for the entire 2014 financial year to be in the range of CHF 22.5 to 24.5 million. This outlook is based on management’s current expectations and beliefs.

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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 December 3, 2014 at 8:00 a.m. Eastern Time (2:00 p.m. Central European Time). To participate in this conference call, dial 1877 280 2296 (USA) or +1 646 254 3364 (International), and enter passcode 9517081. 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 prospectus relating to its Registration Statement on Form F-1, as amended, and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Auris Medical Holding AG

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

(in CHF thousands, except per share data)

	Three Months Ended September 30,		Nine Months Ended September 30,
	2014	2013	2014	2013
Research and development expenses	(4,686)	(3,943)	(13,036)	(10,327)
General and administrative expenses	(998)	(278)	(3,522)	(1,010)
Operating loss	(5,684)	(4,221)	(16,588)	(11,337)
Finance income / expense (net)	2,323	(208)	2,376	(168)
Loss before tax	(3,361)	(4,429)	(14,212)	(11,506)
Net loss attributable to owners of the Company	(3,361)	(4,429)	(14,212)	(11,506)
Other comprehensive income:
Items that will never be reclassified to profit or loss
Remeasurements of defined benefits liability	112	3	(312)	95
Items that are or may reclassified to profit or loss
Foreign currency translation differences	(74)	39	(71)	13
Other comprehensive income	37	43	(384)	109
Total comprehensive loss attributable to owners of the Company	(3,323)	(4,386)	(14,596)	(11,397)
Loss per share, basic and diluted	(0.14)	(0.27)	(0.69)	(0.79)
Weighted average common shares outstanding, basic and diluted	24,589,852	16,217,825	20,488,392	14,496,230
Currency rate CHF / USD	0.9134	0.9326	0.8960	0.9330

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Auris Medical Holding AG

Condensed Consolidated Interim Statement of Financial Position (unaudited)

(in CHF thousands)

	September 30, 2014	December 31, 2013
Assets
Non-current assets
Property and equipment	245	196
Intangible assets	1,483	1,483
Total non-current assets	1,728	1,678
Current assets
Current financial assets and other receivables	712	525
Prepayments	333	183
Cash and cash equivalents	61,893	23,866
Total current assets	62,938	24,574
Total assets	64,666	26,252

Equity and Liabilities
Equity
Share capital	11,582	6,487
Share premium	93,793	35,608
Foreign currency translation reserve	(17)	54
Accumulated deficit	(47,402)	(33,116)
Total shareholders’ equity attributable to owners of the Company	57,956	9,034
Non-current liabilities
Employee benefits	627	328
Deferred tax liabilities	328	328
Total non-current liabilities	955	656
Current liabilities
Convertible loans	-	13,711
Trade and other payables	3,613	954
Accrued expenses	2,142	1,897
Total current liabilities	5,755	16,562
Total liabilities	6,710	17,219
Total equity and liabilities	64,666	26,252
Currency rate CHF / USD	0.9574	0.8894

Contact:

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

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