Form 20-F
|
X
|
Form 40-F
|
Yes
|
No
|
X
|
Yes
|
No
|
X
|
Auris Medical Holding AG
|
||||
By:
|
/s/ Thomas Meyer
|
|||
Name:
|
Thomas Meyer
|
|||
Title:
|
Chief Executive Officer
|
Exhibit Number
|
Description
|
99.1
|
Unaudited Condensed Consolidated Interim Financial Information
|
99.2
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
99.3
|
Press Release dated September 15, 2014
|
99.4
|
Second Quarter 2014 Earnings and Business Update Presentation dated September 15, 2014 |
Condensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Income
|
Condensed Consolidated Interim Statement of Financial Position
|
Condensed Consolidated Interim Statement of Cash Flows
|
Selected Additional Information to the Consolidated Financial Information
|
Note
|
SIX MONTHS ENDED JUNE 30 2014
|
SIX MONTHS ENDED JUNE 30 2013
|
|||||||
Research and development
|
-8,350,008 | -6,384,347 | |||||||
General and administrative
|
-2,554,288 | -732,210 | |||||||
Operating loss
|
-10,904,296 | -7,116,557 | |||||||
Finance expense
|
-68,031 | -11,366 | |||||||
Finance income
|
121,144 | 51,119 | |||||||
Loss before tax
|
-10,851,183 | -7,076,804 | |||||||
Net loss for the period attributable to owners of the Company
|
-10,851,183 | -7,076,804 | |||||||
Other comprehensive income:
|
|||||||||
Items that will never be reclassified to profit or loss
|
|||||||||
Remeasurements of defined benefit liability
|
-423,811 | 91,981 | |||||||
Items that are or may be reclassified to profit or loss
|
|||||||||
Foreign currency translation differences
|
2,817 | -25,915 | |||||||
Other comprehensive income for the period, net of tax
|
-420,994 | 66,066 | |||||||
Total comprehensive loss for the period attributable to owners of the Company
|
-11,272,177 | -7,010,738 | |||||||
Basic and diluted loss per share
|
6
|
-0.59 | -0.52 |
June 30,
|
December 31,
|
|||||||||||
Note
|
2014
|
2013
|
||||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property and equipment
|
251,095 | 195,915 | ||||||||||
Intangible assets
|
1,482,520 | 1,482,520 | ||||||||||
Total non-current assets
|
1,733,615 | 1,678,435 | ||||||||||
Current assets
|
||||||||||||
Other receivables
|
694,396 | 524,786 | ||||||||||
Prepayments
|
713,889 | 183,137 | ||||||||||
Cash and cash equivalents
|
12,130,954 | 23,865,842 | ||||||||||
Total current assets
|
13,539,239 | 24,573,765 | ||||||||||
Total assets
|
15,272,854 | 26,252,200 | ||||||||||
EQUITY AND LIABILITIES
|
||||||||||||
Equity
|
||||||||||||
Share capital
|
7,536,510 | 6,487,130 | ||||||||||
Share premium
|
48,232,566 | 35,608,210 | ||||||||||
Foreign currency translation reserve
|
56,812 | 53,995 | ||||||||||
Accumulated deficit
|
-44,295,487 | -33,115,689 | ||||||||||
Total shareholders’ equity attributable to owners of the Company
|
11,530,401 | 9,033,646 | ||||||||||
Non-current liabilities
|
||||||||||||
Employee benefits
|
5 | 745,440 | 328,342 | |||||||||
Deferred tax liabilities
|
327,637 | 327,637 | ||||||||||
Total non-current liabilities
|
1,073,077 | 655,979 | ||||||||||
Current liabilities
|
||||||||||||
Convertible loans
|
4 | - | 13,711,200 | |||||||||
Trade and other payables
|
1,105,180 | 954,257 | ||||||||||
Accrued expenses
|
1,564,196 | 1,897,118 | ||||||||||
Total current liabilities
|
2,669,376 | 16,562,575 | ||||||||||
Total liabilities
|
3,742,453 | 17,218,554 | ||||||||||
Total equity and liabilities
|
15,272,854 | 26,252,200 |
Note
|
SIX MONTHS ENDED JUNE 30 2014
|
SIX MONTHS ENDED JUNE 30 2013
|
||||||||||
Cash flows from operating activities
|
||||||||||||
Net loss
|
-10,851,183 | -7,076,804 | ||||||||||
Adjustments for:
|
||||||||||||
Depreciation
|
34,006 | 13,562 | ||||||||||
Unrealized exchange differences
|
2,835 | -25,686 | ||||||||||
Net interest income
|
19,750 | -2,181 | ||||||||||
Share based payments
|
5 | 95,197 | 51,325 | |||||||||
Employee benefits
|
-6,713 | 17,995 | ||||||||||
Changes in:
|
||||||||||||
Other receivables
|
-169,492 | -17,091 | ||||||||||
Prepayments
|
-530,752 | 72,325 | ||||||||||
Trade and other payables
|
150,901 | 139,438 | ||||||||||
Accrued expenses
|
-332,923 | 1,110,023 | ||||||||||
Cash used in operating activities
|
-11,588,374 | -5,717,094 | ||||||||||
Cash flows from investing activities
|
||||||||||||
Purchase of property and equipment
|
-89,185 | -30,233 | ||||||||||
Sale of financial assets
|
- | - | ||||||||||
Interest received
|
29,885 | 12,096 | ||||||||||
Net cash used in investing activities
|
-59,300 | -18,137 | ||||||||||
Cash flows from financing activities
|
||||||||||||
Proceeds from share capital increase
|
49,600 | 24,480,060 | ||||||||||
Share issuance costs
|
-136,699 | -242,115 | ||||||||||
Interest paid
|
- | -9,915 | ||||||||||
Net cash from financing activities
|
-87,099 | 24,228,030 | ||||||||||
Net increase/(decrease) in cash and cash equivalents
|
-11,734,773 | 18,492,799 | ||||||||||
Cash and cash equivalents at beginning of the period
|
23,865,842 | 63,967 | ||||||||||
Net effect of currency translation on cash
|
-115 | 614 | ||||||||||
Cash and cash equivalents at end of the period
|
12,130,954 | 18,557,380 |
1.
|
Reporting entity
|
§
|
Auris Medical AG, Basel, Switzerland (100%)
|
§
|
Otolanum AG, Zug, Switzerland (100%)
|
§
|
Auris Medical Inc., Chicago, United States (100%)
|
§
|
Auris Medical Ltd., Dublin, Ireland (100%)
|
2.
|
Basis of preparation
|
3.
|
Capital and reserves
|
AS OF JUNE 30, 2014 | AS OF DECEMBER 31, 2013 | ||||||||||||||
NUMBER | CHF | NUMBER | CHF | ||||||||||||
Common shares with a nominal value of CHF 0.40 each
|
88,100 | 35,240 | 72,600 | 29,040 | |||||||||||
Preferred shares Series A with a nominal value of CHF 0.40 each
|
5,999,750 | 2,399,900 | 5,999,750 | 2,399,900 | |||||||||||
Preferred shares Series B with a nominal value of CHF 0.40 each
|
5,509,100 | 2,203,640 | 5,509,100 | 2,203,640 | |||||||||||
Preferred shares Series C with a nominal value of CHF 0.40 each
|
7,244,325 | 2,897,730 | 4,636,375 | 1,854,550 | |||||||||||
18,841,275 | 7,536,510 | 16,217,825 | 6,487,130 |
Common shares | Preferred shares | ||||
2014 | 2013 | 2014 | 2013 | ||
As of January 1
|
72,600
|
72,600
|
16,145,225
|
11,508,850
|
|
Common shares with a nominal value of CHF 0.40 each
|
15,500
|
-
|
2,607,950
|
-
|
|
As at June 30, 2014, and June 30, 2013 |
88,100
|
72,600
|
18,753,175
|
11,508,850
|
|
4.
|
Convertible loans
|
JUNE 30,
2014
|
|
Convertible loans as at December 31
|
13,711,200
|
Loss on derecognition
|
9,141 |
Imputed interest expense for the period
|
49,635 |
Derecognition of liability at conversion into equity | 13,769,976 |
Convertible loans at June 30, 2014
|
-
|
|
5.
|
Employee benefits
|
SIX MONTHS
ENDED JUNE 30,
2014
|
SIX MONTHS
ENDED JUNE 30,
2013
|
|
Salaries
|
980,518 | 356,110 |
Pension costs | 59,547 | 39,387 |
Other social benefits | 82,149 | 30,425 |
Share option cost | 95,197 | 51,325 |
Other employee cost | 97,871 | 44,774 |
Total employee benefits
|
1,315,280 | 522,021 |
6.
|
Loss per share
|
|
SIX MONTHS
ENDED JUNE 30,
2014
|
SIX MONTHS
ENDED JUNE 30,
2013
|
Loss attributable to owners of the Company | -10,851,183 | -7,076,804 |
Weighted average number of shares outstanding | 18,448,274 | 13,616,303 |
Basic and diluted loss per share | -0.59 | -0.52 |
7.
|
Related party transactions
|
8.
|
Events after the balance sheet date
|
|
·
|
AM-101. We have commenced a Phase 3 program of AM-101 comprising two Phase 3 clinical trials (TACTT2 and TACTT3) as well as two open label extension studies (AMPACT1 and AMPACT2). We expect top-line data from the TACTT trials in early 2016. We anticipate that our research and development expenses will increase substantially in connection with these clinical trials.
|
|
·
|
AM-111. Following feedback from a pre-IND meeting with the FDA in September 2014, we plan to finalize the design of our late-stage AM-111 clinical program for ASNHL. Implementation of the late-stage AM-111 clinical program may require additional funding . We anticipate that our research and development expenses will increase substantially with the continuation of AM-111’s clinical development program.
|
|
·
|
Other development programs. Other research and development expenses mainly relate to our preclinical studies of AM-102 and AM-123. The expenses mainly consist of costs for production of the preclinical compounds and costs paid to academic research institutions in conjunction with preclinical testing.
|
Three months ended June 30,
|
||||||||||||
2014
|
2013
|
Change
|
||||||||||
(in thousands of CHF)
|
%
|
|||||||||||
Research and development
|
(4,201 | ) | (4,411 | ) | (5) | % | ||||||
General and administrative
|
(845 | ) | (462 | ) | 83 | % | ||||||
Operating loss
|
(5,046 | ) | (4,873 | ) | 4 | % | ||||||
Finance expense
|
(17 | ) | (1 | ) | ||||||||
Finance income
|
71 | 27 | 164 | % | ||||||||
Loss before tax
|
(4,991 | ) | (4,847 | ) | 3 | % | ||||||
Net loss attributable to owners of the company
|
(4,991 | ) | (4,847 | ) | 3 | % | ||||||
Other comprehensive income:
|
||||||||||||
Items that will never be reclassified to profit or loss
|
||||||||||||
Remeasurements of defined benefits liability
|
(407 | ) | 49 | |||||||||
Items that are or may be reclassified to profit or loss
|
||||||||||||
Foreign currency translation differences
|
(3 | ) | 4 | |||||||||
Other comprehensive income
|
(410 | ) | 53 | |||||||||
Total comprehensive loss attributable to owners of the company
|
(5,401 | ) | (4,794 | ) | 13 | % |
Three months ended June 30,
|
||||||||||||
Research and development expense
|
2014
|
2013
|
Change
|
|||||||||
(in thousands of CHF)
|
%
|
|||||||||||
Clinical Projects
|
(2,757 | ) | (3,235 | ) | (15) | % | ||||||
Pre-clinical projects
|
(587 | ) | (301 | ) | 95 | % | ||||||
Drug manufacture and substance
|
(159 | ) | (665 | ) | (76) | % | ||||||
Employee benefits
|
(428 | ) | (125 | ) | 242 | % | ||||||
Other research and development expenses
|
(269 | ) | (85 | ) | 217 | % | ||||||
Total
|
(4,201 | ) | (4,411 | ) | (5) | % |
|
·
|
Clinical Projects. In the three months ended June 30, 2014 we incurred lower clinical expenses than in the three months ended June 30, 2013 primarily due to fluctuations in upfront and milestone costs charged by contracted service providers.
|
|
·
|
Pre-clinical projects. In the three months ended June 30, 2014, pre-clinical expenses were higher than in the three months ended June 30, 2013 as additional studies for AM-111 were ongoing.
|
|
·
|
Drug manufacture and substance. In the three months ended June 30, 2014 we incurred lower costs related to the manufacture, and storage of supplies for clinical material compared to the three months ended June 30, 2013, primarily due to fluctuations in the timing of raw material purchases and the manufacture of clinical trial supplies.
|
|
·
|
Employee Benefits. Employee expenses were significantly higher in the three months ended June 30,2014 than in the three months ended June 30, 2013 due to a higher headcount.
|
Six months ended June 30,
|
||||||||||||
2014
|
2013
|
Change
|
||||||||||
(in thousands of CHF)
|
%
|
|||||||||||
Research and development
|
(8,350 | ) | (6,384 | ) | 31 | % | ||||||
General and administrative
|
(2,554 | ) | (732 | ) | 248 | % | ||||||
Operating loss
|
(10,904 | ) | (7,117 | ) | 53 | % | ||||||
Finance expense
|
(68 | ) | (11 | ) | 499 | % | ||||||
Finance income
|
121 | 51 | 137 | % | ||||||||
Loss before tax
|
(10,851 | ) | (7,077 | ) | 53 | % | ||||||
Net loss attributable to owners of the company
|
(10,851 | ) | (7,077 | ) | 53 | % | ||||||
Other comprehensive income:
|
||||||||||||
Items that will never be reclassified to profit or loss
|
||||||||||||
Remeasurements of defined benefits liability
|
(424 | ) | 92 | |||||||||
Items that are or may be reclassified to profit or loss
|
||||||||||||
Foreign currency translation differences
|
3 | (26 | ) | |||||||||
Other comprehensive income
|
(421 | ) | 66 | |||||||||
Total comprehensive loss attributable to owners of the company
|
(11,272 | ) | (7,011 | ) | 61 | % |
Six months ended June 30,
|
||||||||||||
Research and development expense
|
2014
|
2013
|
Change
|
|||||||||
(in thousands of CHF)
|
%
|
|||||||||||
Clinical Projects
|
(5,161 | ) | (4,298 | ) | 20 | % | ||||||
Pre-clinical projects
|
(1,152 | ) | (701 | ) | 64 | % | ||||||
Drug manufacture and substance
|
(784 | ) | (894 | ) | (12) | % | ||||||
Employee benefits
|
(797 | ) | (349 | ) | 129 | % | ||||||
Other research and development expenses
|
(455 | ) | (143 | ) | 218 | % | ||||||
Total
|
(8,350 | ) | (6,384 | ) | 31 | % |
|
·
|
Clinical Projects. In the six months ended June 30, 2014 we incurred higher clinical expenses due to the progression of our AM-101 Phase III clinical development program. In addition, we conducted preparatory activities related to our late stage AM-111 clinical program, whereas in the six months ended June 30, 2013 the Phase II had been completed with a concomitant decline in spending.
|
|
·
|
Pre-clinical projects. In the six months ended June 30, 2014, pre-clinical expenses were higher than in the six months ended June 30, 2013 as more pre-clinical projects were ongoing related to the AM-101 and AM-111 projects.
|
·
|
Drug manufacture and substance. In the six months ended June 30, 2014 we continued to incur substantial costs related to the manufacture, packaging and distribution of clinical trial supplies. However, expense levels decreased compared to the six months ended June 30, 2013 primarily due to fluctuations in the timing of purchases of raw material and the manufacture of clinical trial supplies.
|
|
·
|
Employee Benefits. Employee expenses were significantly higher in the six months ended June 30, 2014 than in the six months ended June 30, 2013 due to a higher headcount.
|
Three months ended
June 30,
|
||||||||
2014
|
2013
|
|||||||
(in thousands of CHF)
|
||||||||
Cash used in operating activities
|
(6,402 | ) | (4,208 | ) | ||||
Net cash used in investing activities
|
(3 | ) | (7 | ) | ||||
Net cash from financing activities
|
- | 22,750 | ||||||
Net effect of currency translation on cash
|
0 | 0 | ||||||
Cash and cash equivalents at the beginning of the period
|
18,535 | 21 | ||||||
Cash and cash equivalents at the end of the period
|
12,131 | 18,557 |
Six months ended June 30,
|
||||||||
2014
|
2013
|
|||||||
(in thousands of CHF)
|
||||||||
Cash used in operating activities
|
(11,588 | ) | (5,717 | ) | ||||
Net cash used in investing activities
|
(59 | ) | (18 | ) | ||||
Net cash from financing activities
|
(87 | ) | 24,228 | |||||
Net effect of currency translation on cash
|
(0 | ) | 1 | |||||
Cash and cash equivalents at the beginning of the period
|
23,866 | 64 | ||||||
Cash and cash equivalents at the end of the period
|
12,131 | 18,557 |
|
·
|
the 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.
|
|
·
|
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
|
·
|
Auris Medical raised net proceeds (after underwriting discounts) of approximately $56.4 million in its initial public offering (IPO), selling 10,113,235 of its common shares, including 713,235 common shares sold pursuant to the underwriters' exercise of their over-allotment option. On August 6, 2014, Auris Medical's shares began trading on the NASDAQ Global Market under the symbol "EARS".
|
·
|
The AM-101 Phase 3 clinical program in acute inner ear tinnitus remains on track. Ramp-up of clinical trial sites in North America and Europe progressed with approximately 100 sites initiated at the end of August 2014. As previously announced, Auris Medical expects to enroll a total of 930 patients: 630 in the acute stage (i.e. up to three months from onset) and 300 in the post acute stage (i.e. onset between 4 and 12 months). The first patients that completed the TACTT trials rolled over into the open label AMPACT trials in April and May 2014.
|
·
|
In May 2014, Auris Medical presented data on the determination of clinically meaningful change in subjective tinnitus loudness at the XI. International Tinnitus Seminar in Berlin, Germany. Anchor- and distribution-based statistical analyses of clinical data support the use of a 2 point reduction on a 0-10 numerical rating scale as a responder definition. Improvement in subjective tinnitus loudness is the primary endpoint in the TACTT clinical trials.
|
·
|
Auris Medical filed additional patent applications in the US relating to the use of inhibitors of the c-Jun N-Terminal Kinase (JNK) such as AM-111 for the treatment of tinnitus or Menière’s Disease. In addition the Company filed a continuation to its earlier US application relating to the use of polymer-based formulations in the treatment of disorders of the middle and inner ear.
|
·
|
Preparations for the AM-111 late stage clinical program in ASHNL are underway. Following discussions with the European Medicines Agency on the design for a pivotal Phase 3 trial, Auris Medical expects further regulatory feedback from a pre-IND meeting with the FDA in September 2014. Based on that feedback, the Company expects to finalize the design of the late-stage AM-111 clinical program.
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
Research and development expenses
|
(4,201 | ) | (4,411 | ) | (8,350 | ) | (6,384 | ) | ||||||||
General and administrative expenses
|
(845 | ) | (462 | ) | (2,554 | ) | (732 | ) | ||||||||
Operating loss
|
(5,046 | ) | (4,873 | ) | (10,904 | ) | (7,117 | ) | ||||||||
Finance expense
|
(17 | ) | (1 | ) | (68 | ) | (11 | ) | ||||||||
Finance income
|
71 | 27 | 121 | 51 | ||||||||||||
Loss before tax
|
(4,991 | ) | (4,846 | ) | (10,851 | ) | (7,077 | ) | ||||||||
Net loss attributable to owners of the Company
|
(4,991 | ) | (4,846 | ) | (10,851 | ) | (7,077 | ) | ||||||||
Other comprehensive income:
|
||||||||||||||||
Items that will never be reclassified to profit or loss
|
||||||||||||||||
Remeasurements of defined benefits liability
|
(407 | ) | 49 | (424 | ) | 92 | ||||||||||
Items that are or may reclassified to profit or loss
|
||||||||||||||||
Foreign currency translation differences
|
(3 | ) | 4 | 3 | (26 | ) | ||||||||||
Other comprehensive income
|
(410 | ) | 53 | (421 | ) | 66 | ||||||||||
Total comprehensive loss attributable to owners
of the Company
|
(5,401 | ) | (4,793 | ) | (11,272 | ) | (7,011 | ) | ||||||||
Loss per share, basic and diluted
|
(0.27 | ) | (0.33 | ) | (0.59 | ) | (0.52 | ) | ||||||||
Weighted average common shares outstanding, basic and diluted
|
18,841,275 | 15,651,157 | 18,448,274 | 13,616,303 | ||||||||||||
Currency rate CHF / USD
|
0.8888 | 0.9425 | 0.8907 | 0.9362 |
June 30, 2014
|
December 31, 2013
|
|||||||
Assets
|
||||||||
Non-current assets
|
||||||||
Property and equipment
|
215 | 196 | ||||||
Intangible assets
|
1,483 | 1,483 | ||||||
Total non-current assets
|
1,734 | 1,678 | ||||||
Current assets
|
||||||||
Current financial assets and other receivables
|
694 | 525 | ||||||
Prepayments
|
714 | 183 | ||||||
Cash and cash equivalents
|
12,131 | 23,866 | ||||||
Total current assets
|
13,539 | 24,574 | ||||||
Total assets
|
15,273 | 26,252 | ||||||
Equity and Liabilities
|
||||||||
Equity
|
||||||||
Share capital
|
7,537 | 6,487 | ||||||
Share premium
|
48,233 | 35,608 | ||||||
Foreign currency translation reserve
|
57 | 54 | ||||||
Accumulated deficit
|
(44,295 | ) | (33,116 | ) | ||||
Total shareholders’ equity attributable to owners of the Company
|
11,530 | 9,034 | ||||||
Non-current liabilities
|
||||||||
Employee benefits
|
745 | 328 | ||||||
Deferred tax liabilities
|
328 | 328 | ||||||
Total non-current liabilities
|
1,073 | 656 | ||||||
Current liabilities
|
||||||||
Convertible loans
|
- | 13,711 | ||||||
Trade and other payables
|
1,105 | 954 | ||||||
Accrued expenses
|
1,564 | 1,897 | ||||||
Total current liabilities
|
2,669 | 16,562 | ||||||
Total liabilities
|
3,742 | 17,219 | ||||||
Total equity and liabilities
|
15,273 | 26,252 | ||||||
Currency rate CHF / USD
|
0.8867 | 0.8894 |
Second Quarter 2014 Earnings and Business Update September 15, 2014 |
Forward Looking Statements / Safe Harbor This presentation and the accompanying oral commentary contain "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary, including statements regarding our future financial condition, business strategy and plans and objectives of management for future operations, are forward looking statements. In some cases, you can identify forward-looking statements by terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "might," "approximately," "expect," "predict," "could," "potentially" or the negative of these terms or other similar expressions. Forward looking statements appear in a number of places throughout this presentation and the accompanying oral commentary and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates AM-101 and AM-111, our intellectual property position, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, spending of the proceeds from this offering, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our management's beliefs and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. |
Business Update |
AM-101 Phase 3 Program Update [] AM-101 Phase 3 clinical program in acute inner ear tinnitus remains on track [] Ramp-up of TACTT trial sites progressing -- Approximately 100 sites initiated by the end of August 2014 (target 140) -- Poland and Czech Republic getting started [] As expected, Stratum B (post-acute tinnitus) in European TACTT3 trial enrolling faster than Stratum A (acute tinnitus) -- Stratum B futility analysis early 2015 at midpoint of enrolment [] AMPACT open-label trials -- First patients rolled over in April and May 2014 to receive first treatment cycle -- First patients rolled over in July and August 2014 to receive second treatment cycle |
Tinnitus Loudness Responder Definition [] Primary efficacy endpoint in Phase 3 = improvement of subjective loudness from baseline to the last follow-up visit at Day 84 on a 0-10 numerical rating scale [] What represents a clinically meaningful reduction in tinnitus loudness / how is a responder defined? [] Data analyzed from 200 TACTT0 and TACTT1 patients (AAT or OM) [] Mean tinnitus loudness at baseline = 5.2 points (SD 2.1) |
Responder Data Presented at ITS 2014 [] Results presented at XI. International Tinnitus Seminar in Berlin, Germany, May 21-24, 2014 [] Anchor-based approach suggesting 2 point reduction as clinically meaningful -- Pattern of TLQ response compared to patient global impression of change (PGIC) in tinnitus severity -- Patients reporting either "very much improved" or "much improved" tinnitus severity reported change scores of at least 2 points, with those rating their change as "somewhat improved" reported less than a 2-point change -- Patients endorsing the largest amount of change on the global rating also reported the largest amount of improvement on the TLQ -- Pattern of response very similar for uni- and bilateral cases [] Supported by distribution-based approach: -- One-half standard deviation of the baseline scores approach -- Clinically meaningful = 1.1 points |
Cumulative Distribution Function for [] TLQ [] For all points 0, the curve for AM-101 0.81 mg/mL is shifted to the right of the others [] At 2 points change in TLQ, AM-101 0.81 mg/mL clearly separates from placebo and AM- 101 0.27 mg/mL, providing further support for responder definition |
Auris Medical at the AAO Annual Meeting [] Annual Meeting of the American Association for Otolaryngology -- Head and Neck Surgery [] Orlando FL, September 21-24 [] World's largest gathering of ENTs [] Auris Medical hosting satellite symposium September 23 |
AM-101 Primary Market Research [] 53 US ENT doctors surveyed(1) -- 41 general ENTs -- 12 otologists [] Seeing an average of 43.5 tinnitus patients in an average month [] 37.7% of their tinnitus patients seek treatment during the acute stage (up to 3 months from onset) [] Consistent with survey by Hall et al. , 2011 [] 73.6% of respondents expect their monthly tinnitus patient volume to increase if an approved i. t. treatment of acute tinnitus were available [] 42.6% of their tinnitus patients considered as candidates for a product with the profile of AM-101 [] Rating -- Tolerability 7.5 -- Efficacy 6.9 (1=not at all attractive, 10=extremely attractive) (1) Online survey conducted by MedaCorp, Inc. in April 2014 |
AM-111 Program Update [] Preparations for the AM-111 late stage clinical program in ASHNL progressing [] Pivotal HEALOS Phase 3 trial planned in ISSNHL -- 240 patients with severe to profound hearing loss -- AM-111 0.4 or 0.8 mg/mL or placebo -- Up to 72 hours from onset -- Europe and Asia [] Protocol Assistance from European Medicines Agency (EMA) [] Pre-IND meeting with the FDA scheduled for second half of September 2014 [] Based on FDA feedback, design of the late-stage AM-111 clinical program to be finalized and communicated |
AM-111 Primary Market Research [] 53 US ENT doctors surveyed(1) -- 41 general ENTs -- 12 otologists [] Seeing an average of 11.2 patients with ISSNHL and 6.3 patients with AAT in an average month [] 39.9% show up for treatment within first 3 days [] 43.3% of their ASNHL patients have severe to profound hearing loss [] 64.2% of respondents expect their monthly ASNHL patient volume to increase if an approved i.t. treatment of ASNHL were available [] 59.9% of their ASNHL patients considered as candidates for product with the profile of AM-111 [] Rating -- Tolerability 7.8 -- Efficacy 7.2 (1=not at all attractive, 10=extremely attractive) (1) Online survey conducted by MedaCorp, Inc. in April 2014 |
Intellectual Property Update [] Additional patent applications filed in US relating to the use of inhibitors of the c- Jun N-Terminal Kinase (JNK) such as AM-111 -- for the treatment of tinnitus -- for the treatment of Meni[]re's Disease [] Continuation to earlier US application filed relating to the use of polymer-based formulations in the treatment of disorders of the middle and inner ear -- Allowed by European Patent Office, covering compositions containing Ketamine or derivatives and biocompatible hyaluronic acid gel for treatment of inner ear disorders -- Priority date = September 28, 2005 |
Financial Update |
First Half 2014 Financial Highlights [] Cash and cash equivalents as of June 30, 2014, were CHF 12.1 m compared to CHF 18.5 m at March 31, 2014 and CHF 23.9 m at December 31, 2013 [] Research and development expenses increased from CHF 6.4 m in the six months ended June 30, 2013 to CHF 8.4 m in the six months ended June 30, 2014. -- Progression of our AM-101 Phase 3 clinical development program -- Preparatory activities related to the late-stage AM-111 clinical program [] General and administrative expenses increased from CHF 0.7 m in the six months ended June 30, 2013 to CHF 2.6 m in the six months ended June 30, 2014 -- Increase primarily related to higher legal and auditing expenses in relation to the IPO preparations [] Net loss for the first half 2014 was CHF 10.9 m compared with CHF 7.0 m in the same period in 2013. |
Financial Overview Financial Position [] Cash at end of H1 2014 = $13.7 m [] $60.7 m raised in IPO in early August 2014 ($56.4 m after underwriting discount) -- 10,113,235 common shares sold at $6 per share (incl. 713,235 shares under over-allotment option) -- Trading on the NASDAQ Global Market started August 6, 2014 [] Means to fund -- AM-101 clinical program beyond Phase 3 read-out -- Advance further projects, incl. AM-111 [] Runway mid 2016 Shareholder Structure Founder Sofinnova Ventures Sofinnova Partners ZKB / Adamant Idinvest Other investors under lock-up Public investors |
Questions and Answers |
Take care of your ears |