News & Events
Otonomy Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
- OTO-313 Phase 2 trial in tinnitus fully enrolled ahead of schedule with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosing
- OTO-413 Phase 2a cohort in hearing loss fully enrolled with top-line results expected early in second quarter of 2022; enrollment ongoing for higher dose evaluation
- OTO-825 IND-enabling activities ongoing with IND filing expected first half of 2023
- Current capital funds operations through multiple clinical readouts and into second half of 2023
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“We are very pleased to have completed enrollment in both the OTO-313 Phase 2 and OTO-413 Phase 2a trials ahead of schedule and look forward to reporting the results from these trials in the coming months,” said
Otonomy Program Updates
- OTO-313: Phase 2 trial in tinnitus is fully enrolled with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosing.
Otonomy has completed the enrollment of 153 patients with persistent, unilateral tinnitus of at least moderate severity in a Phase 2 trial of OTO-313 (target enrollment was 140 patients). Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (0.32 mg) or placebo and are being followed for four months. The primary endpoint is the same as reported for the successful Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in the Tinnitus Functional Index (TFI) from baseline to Months 1 and 2 following treatment. To assess durability of the OTO-313 treatment effect, the follow-up period has been extended out to four months. Top-line results for all timepoints are expected to be available in mid-2022. Additionally,Otonomy is initiating a one-month safety study for bilateral and higher (0.64 mg) dosing of OTO-313 with results expected in the second half of 2022. Together, these clinical data are expected to support an End-of-Phase 2 meeting with the FDA and inform the design of the OTO-313 Phase 3 clinical program planned to start in the first half of 2023. - OTO-413: Phase 2a cohort in hearing loss is fully enrolled with top-line results expected early in the second quarter of 2022; clinical evaluation of higher dosing ongoing.
Otonomy has also completed enrollment in a Phase 2a cohort for the highest OTO-413 dose (0.3 mg) evaluated in the initial Phase 1/2 trial cohorts. A total of 33 patients with hearing loss were randomized 2:1 to receive a single intratympanic injection of OTO-413 or placebo. Patients are being followed for three months and assessed using three clinically-validated speech-in-noise hearing tests. In addition,Otonomy is enrolling patients to evaluate at least one higher dose of OTO-413 (starting with 0.75 mg). Each dose cohort is expected to enroll approximately 12 hearing loss patients randomized 2:1 to OTO-413 or placebo with patients evaluated as in the Phase 2a. Based on results from the Phase 2a and higher-dose evaluation,Otonomy expects to initiate a full dose-ranging Phase 2 efficacy trial by the end of 2022. - OTO-825: preclinical studies validate therapeutic potential of GJB2 gene therapy for congenital hearing loss with Investigational New Drug (IND) filing expected in first half of 2023. OTO-825 is an AAV-based gene therapy to restore hearing in patients with a mutation in the gap junction beta-2 (GJB2) gene, the most common cause of congenital hearing loss. Preclinical proof-of-concept results, which have been presented at multiple scientific meetings, demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two preclinical models representing a range of hearing loss severity caused by GJB2 deficiency. A Pre-IND meeting has been completed with the FDA and IND-enabling activities are ongoing.
- OTO-510: preclinical development ongoing for novel and proprietary otoprotection molecule. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children, however, it is commonly associated with severe adverse effects including cisplatin-induced hearing loss (CIHL).
Otonomy has identified a novel series of molecules with improved otoprotection in preclinical CIHL studies compared to other agents in development. The goal of the OTO-510 program is otoprotection without tumor protection. - OTO-6XX: preclinical development ongoing for severe hearing loss program.
Otonomy is evaluating therapeutic approaches to repair or regenerate cochlear hair cells that are damaged due to noise, aging or exposure to ototoxic chemicals. This mechanism is expected to be complementary to repair of cochlear synapses, which is addressed by OTO-413.
Anticipated Upcoming Milestones
- Early second quarter 2022, announce top-line results for OTO-413 Phase 2a cohort.
- In mid-2022, announce top-line results for OTO-313 Phase 2 clinical trial.
- In second half of 2022, announce safety results for OTO-313 bilateral and higher dosing.
- In second half of 2022, announce top-line results for OTO-413 higher dose evaluation.
- By end of 2022, initiate Phase 2 dose-ranging efficacy trial for OTO-413 in hearing loss.
- In first half of 2023, initiate Phase 3 clinical program for OTO-313 in tinnitus.
- In first half of 2023, file IND for OTO-825 in hearing loss associated with GJB2 gene mutation.
Fourth Quarter and Full Year 2021 Financial Highlights
- Cash Position: Cash, cash equivalents, and short-term investments totaled
$77.4 million as ofDecember 31, 2021 , compared to$86.3 million as ofDecember 31, 2020 . - Operating Expenses: GAAP operating expenses were
$13.2 million for the fourth quarter of 2021, compared to$10.1 million for the fourth quarter of 2020. For the full year 2021, GAAP operating expenses were$49.4 million compared to$42.6 million for 2020. Non-GAAP operating expenses, which exclude stock-based compensation, were$11.3 million for the fourth quarter of 2021, compared to$8.5 million for the fourth quarter of 2020. For the full year 2021, non-GAAP operating expenses were$42.0 million compared to$36.5 million for 2020. - Research and Development Expenses: GAAP research and development (R&D) expenses for the fourth quarter of 2021 were
$9.7 million , compared to$6.4 million for the fourth quarter of 2020. The increase for the quarter was primarily due to higher development expenses for OTO-313 and OTO-413. For the full year 2021, GAAP R&D expenses were$34.7 million compared to$28.0 million for 2020. - Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the fourth quarter of 2021 were
$3.5 million , compared to$3.7 million for the fourth quarter of 2020. For the full year 2021, GAAP SG&A expenses were$14.7 million compared to$14.6 million for 2020. - Financial Guidance:
- 2022 Operating Expenses:
Otonomy expects that GAAP operating expenses will be in the range of$52-$54 million , and that non-GAAP operating expenses will be in the range of$42-$44 million . - Cash Runway:
Otonomy expects that its current cash, cash equivalents, and short-term investments will be sufficient to fund company operations into the second half of 2023.
- 2022 Operating Expenses:
Non-GAAP Operating Expenses
In this press release, Otonomy’s operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in
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Contacts:
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Spectrum Science
Account Director
205.910.4443
ccullen@spectrumscience.com
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858.356.5932
robert.uhl@westwicke.com
Condensed Balance Sheet Data | |||||||
(in thousands) | |||||||
As of |
As of |
||||||
2021 | 2020 | ||||||
Cash and cash equivalents | $ | 77,412 | $ | 30,767 | |||
Short-term investments | — | 55,576 | |||||
Right-of-use assets | 12,696 | 14,082 | |||||
Total assets | 95,637 | 106,265 | |||||
Long-term debt, net | 15,997 | 15,158 | |||||
Leases, net of current | 12,400 | 13,847 | |||||
Total liabilities | 40,730 | 39,999 | |||||
Accumulated deficit | (555,805 | ) | (504,624 | ) | |||
Total stockholders’ equity | 54,907 | 66,266 | |||||
Condensed Statements of Operations | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Three Months Ended | Years Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(unaudited) | ||||||||||||||||
Product sales, net | $ | — | $ | 53 | $ | 125 | $ | 273 | ||||||||
Costs and operating expenses: | ||||||||||||||||
Cost of product sales | — | 274 | 370 | 1,188 | ||||||||||||
Research and development | 9,678 | 6,374 | 34,673 | 27,997 | ||||||||||||
Selling, general and administrative | 3,494 | 3,692 | 14,707 | 14,575 | ||||||||||||
Total costs and operating expenses | 13,172 | 10,340 | 49,750 | 43,760 | ||||||||||||
Loss from operations | (13,172 | ) | (10,287 | ) | (49,625 | ) | (43,487 | ) | ||||||||
Other expense, net | (407 | ) | (360 | ) | (1,556 | ) | (1,244 | ) | ||||||||
Net loss | $ | (13,579 | ) | $ | (10,647 | ) | $ | (51,181 | ) | $ | (44,731 | ) | ||||
Net loss per share, basic and diluted | $ | (0.20 | ) | $ | (0.20 | ) | $ | (0.81 | ) | $ | (1.10 | ) | ||||
Weighted-average shares used to compute net loss per share, | ||||||||||||||||
basic and diluted | 67,807,995 | 52,257,321 | 63,441,330 | 40,845,844 | ||||||||||||
Reconciliation of GAAP to Non-GAAP Operating Expenses | ||||||||||||||||
(in thousands) | ||||||||||||||||
Three Months Ended | Years Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(unaudited) | ||||||||||||||||
GAAP operating expenses | ||||||||||||||||
Research and development | $ | 9,678 | $ | 6,374 | $ | 34,673 | $ | 27,997 | ||||||||
Selling, general and administrative | 3,494 | 3,692 | 14,707 | 14,575 | ||||||||||||
Total GAAP operating expenses | 13,172 | 10,066 | 49,380 | 42,572 | ||||||||||||
Non-GAAP adjustments | ||||||||||||||||
R&D stock-based compensation expense | (915 | ) | (632 | ) | (3,355 | ) | (2,456 | ) | ||||||||
SG&A stock-based compensation expense | (942 | ) | (950 | ) | (4,039 | ) | (3,642 | ) | ||||||||
Total non-GAAP adjustments | (1,857 | ) | (1,582 | ) | (7,394 | ) | (6,098 | ) | ||||||||
Non-GAAP operating expenses | $ | 11,315 | $ | 8,484 | $ | 41,986 | $ | 36,474 | ||||||||
Reconciliation of 2022 GAAP to Non-GAAP Operating Expense Guidance | ||
(in millions) | ||
GAAP operating expenses | ||
Non-GAAP adjustments | ||
Stock-based compensation expense | ||
Non-GAAP operating expenses | ||

Source: Otonomy, Inc.