OTIC Otonomy Inc.

2.23
+0.03  (+1%)
Previous Close 2.2
Open 2.23
52 Week Low 1.9
52 Week High 6.983
Market Cap $107,751,303
Shares 48,318,970
Float 45,902,927
Enterprise Value $52,228,734
Volume 1,272,358
Av. Daily Volume 1,311,072
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Upcoming Catalysts

Drug Stage Catalyst Date
OTO-313
Tinnitus
Phase 2
Phase 2
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OTO-413
Hearing loss
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
OTIVIDEX
Ménière's disease
Phase 3
Phase 3
Phase 3 trial did not achieve the primary endpoint.
OTIPRIO
Acute otitis externa
Approved
Approved
Approval announced March 2, 2018.
OTO-104 AVERTS-1
Meniere's disease
Phase 3
Phase 3
Phase 3 data released August 30 failed to meet primary and key secondary endpoints.
OTIPRIO (ciprofloxacin otic suspension)
Ear Tube Placement Surgery
Approved
Approved
Approved December 11, 2015

Latest News

  1. SAN DIEGO, April 07, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the pricing of an underwritten public offering of 6,288,890 shares of its common stock at a price to the public of $2.25 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 7,111,110 shares of its common stock at a purchase price of $2.249 per each pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately…

    SAN DIEGO, April 07, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the pricing of an underwritten public offering of 6,288,890 shares of its common stock at a price to the public of $2.25 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 7,111,110 shares of its common stock at a purchase price of $2.249 per each pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately $30.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by Otonomy. In addition, Otonomy has granted the underwriters a 30-day option to purchase up to an additional 2,010,000 shares of its common stock in connection with the public offering at the public offering price per share, less underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants are being sold by Otonomy. The offering is expected to close on or about April 12, 2021, subject to customary closing conditions.

    Cowen and Piper Sandler are acting as joint book-running managers in the offering.

    A shelf registration statement (File No. 333-227269) was previously filed with the Securities and Exchange Commission (SEC) on September 10, 2018 and became effective on September 21, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on April 7, 2021. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting one of the following: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Piper Sandler & Co., by mail at 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the federal securities laws. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Otonomy will be able to consummate the offering, the satisfaction of customary closing conditions, prevailing market conditions, the anticipated use of the proceeds of the offering which could change as a result of market conditions or for other reasons, and the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to the offering, Otonomy and its business can be found under the heading "Risk Factors" in Otonomy's most recent current, quarterly and annual reports filed with the SEC and in the preliminary prospectus supplement and accompanying prospectus relating to the offering to be filed with the SEC. Otonomy assumes no duty or obligation to update or revise any forward-looking statements for any reason.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    408.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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  2. SAN DIEGO, April 07, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by Otonomy. Otonomy may, in lieu of common stock, offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in the underwritten public offering. In addition, Otonomy expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in this public offering. The offering is subject to market and other conditions, and…

    SAN DIEGO, April 07, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by Otonomy. Otonomy may, in lieu of common stock, offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in the underwritten public offering. In addition, Otonomy expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in this public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Cowen and Piper Sandler are acting as joint book-running managers in the offering.

    A shelf registration statement (File No. 333-227269) was previously filed with the Securities and Exchange Commission (SEC) on September 9, 2018 and became effective on September 21, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting one of the following: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, by telephone at (800) 747-3924, or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the federal securities laws, including, but not limited to, statements Otonomy makes regarding its intention to conduct an offering and sale of securities, the grant of the option to purchase additional shares and the ability to complete this offering. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Otonomy will be able to raise capital through the sale of shares of common stock and pre-funded warrants or consummate the offering, the final terms of the offering, the satisfaction of customary closing conditions, prevailing market conditions, the anticipated use of the proceeds of the offering which could change as a result of market conditions or for other reasons, and the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to the offering, Otonomy and its business can be found under the heading "Risk Factors" in Otonomy's most recent current, quarterly and annual reports filed with the SEC and in the preliminary prospectus supplement and accompanying prospectus relating to the offering to be filed with the SEC. Otonomy assumes no duty or obligation to update or revise any forward-looking statements for any reason.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    408.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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  3. SAN DIEGO, April 06, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced its participation in the 20th Annual Needham Virtual Healthcare Conference. David A. Weber, Ph.D., president and CEO of Otonomy, will present a company overview on Tuesday, April 13, 2021 at 4:30 p.m. ET (1:30 p.m. PT).

    A live audio webcast of the presentation will be available through the Events page of the company's website (www.otonomy.com). An archived webcast of the presentation will also be available on the same web page shortly after the live event.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative…

    SAN DIEGO, April 06, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced its participation in the 20th Annual Needham Virtual Healthcare Conference. David A. Weber, Ph.D., president and CEO of Otonomy, will present a company overview on Tuesday, April 13, 2021 at 4:30 p.m. ET (1:30 p.m. PT).

    A live audio webcast of the presentation will be available through the Events page of the company's website (www.otonomy.com). An archived webcast of the presentation will also be available on the same web page shortly after the live event.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs with a focus on hearing loss and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



    Primary Logo

    View Full Article Hide Full Article
  4. SAN DIEGO, April 05, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the presentation of previously disclosed clinical results from the successful OTO-313 Phase 1/2 trial at the upcoming American Neurotology Society's 56th Annual Spring Meeting, which is part of the Combined Otolaryngology Spring Meeting (COSM), to be held virtually April 7-11, 2021. The oral presentation will be delivered on April 10, 2021 at 5:07 p.m. EDT by Kenneth Maxwell, M.D., a Neurotologist at Piedmont Ear Nose & Throat Associates in Winston-Salem, North Carolina. Dr. Maxwell was an investigator in the trial.

    "We are pleased to have the opportunity…

    SAN DIEGO, April 05, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the presentation of previously disclosed clinical results from the successful OTO-313 Phase 1/2 trial at the upcoming American Neurotology Society's 56th Annual Spring Meeting, which is part of the Combined Otolaryngology Spring Meeting (COSM), to be held virtually April 7-11, 2021. The oral presentation will be delivered on April 10, 2021 at 5:07 p.m. EDT by Kenneth Maxwell, M.D., a Neurotologist at Piedmont Ear Nose & Throat Associates in Winston-Salem, North Carolina. Dr. Maxwell was an investigator in the trial.

    "We are pleased to have the opportunity to present clinical results from the OTO-313 Phase 1/2 trial to the neurotology community during the COSM conference," said David A. Weber, Ph.D., president and CEO of Otonomy. "Tinnitus is a common condition seen by neurotologists who unfortunately have no approved drug treatments to offer patients. The Phase 2 trial we recently initiated builds on the encouraging Phase 1/2 results and is a significant step forward for this important program."

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs with a focus on hearing loss and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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    • Phase 2 study design based on successful Phase 1/2 trial including use of Tinnitus Functional Index (TFI) responder analysis for primary efficacy endpoint
    • Patient enrollment criteria refined to enrich study population
    • Top-line results expected in mid-2022

    SAN DIEGO, March 25, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 2 clinical trial of OTO-313 in patients with unilateral tinnitus. The randomized, double-blind, placebo-controlled Phase 2 study will enroll approximately 140 patients with persistent, early onset tinnitus of at least moderate severity. Following the successful Phase 1/2 trial…

    • Phase 2 study design based on successful Phase 1/2 trial including use of Tinnitus Functional Index (TFI) responder analysis for primary efficacy endpoint

    • Patient enrollment criteria refined to enrich study population
    • Top-line results expected in mid-2022

    SAN DIEGO, March 25, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 2 clinical trial of OTO-313 in patients with unilateral tinnitus. The randomized, double-blind, placebo-controlled Phase 2 study will enroll approximately 140 patients with persistent, early onset tinnitus of at least moderate severity. Following the successful Phase 1/2 trial, the primary efficacy endpoint will be a responder analysis based on the proportion of patients reporting a clinically meaningful improvement in TFI from baseline to both Month 1 and Month 2 following treatment. Top-line results are expected in mid-2022.

    "Tinnitus is a common problem that negatively impacts millions of people by disrupting their ability to sleep, concentrate at work, and enjoy leisure activities. This often leads to anxiety and depression that can be quite severe, as sadly reported in a recent case of a prominent post-COVID patient experiencing unrelenting tinnitus," said David A. Weber, Ph.D., president and CEO of Otonomy. "Unfortunately, there are no approved drug treatments for tinnitus and current therapy focuses on coping and masking mechanisms. OTO-313 was designed to address the underlying pathology producing the false perception of sound, with the Phase 1/2 trial demonstrating a clinically meaningful reduction in tinnitus severity in a group of responders. We are excited to be initiating the trial and advancing the OTO-313 program for this important unmet need."

    The Phase 2 trial will be conducted at approximately 50 clinical sites in the U.S. and Europe. Following a lead-in period, patients will be randomized to a single intratympanic injection of OTO-313 or placebo and then followed for four months. Consistent with the Phase 1/2 trial results, the primary endpoint will be a responder analysis based on the reduction in TFI score from baseline to both Month 1 and Month 2 following treatment. In order to assess durability of the treatment benefit, patients will be followed for an additional two months. Other measures of efficacy include tinnitus loudness, tinnitus annoyance, and patient global impression of change.

    About Tinnitus

    Tinnitus is the medical term for the perception of noise when there is no sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Tinnitus is often caused by cochlear injury due to excessive noise, physical trauma, persistent ear infection or exposure to an ototoxic agent, leading to over-activation of auditory nerve fibers and the perception of noise in the absence of an external stimulus. Approximately 10 percent of U.S. adults suffer from the condition, which can severely impact daily activities and result in anxiety and depression. Tinnitus also accounts for the most prevalent service-connected disability among veterans with an estimated cost exceeding $2 billion. There are currently no FDA approved drug treatments for tinnitus.

    About OTO-313

    OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. We believe that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea and their connections. OTO-313 utilizes a novel, patent-protected formulation technology to provide several weeks of gacyclidine drug exposure in the inner ear following a single intratympanic injection. In 2020, we reported positive results from a Phase 1/2 trial of OTO-313 in patients with unilateral tinnitus of at least moderate severity. This trial demonstrated a positive clinical response for OTO-313 using the Tinnitus Functional Index (TFI) that was correlated with improvements in tinnitus loudness, tinnitus annoyance and patient global impression of change measures.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Cautionary Note Regarding Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements related to plans and expectations regarding OTO-313, including with respect to patient populations and the Phase 2 trial of OTO-313; anticipated timing of topline results of the Phase 2 clinical trial of OTO-313; and statements by Otonomy's president and CEO.

    Otonomy's expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: delays and disruption resulting from the COVID-19 pandemic and governmental and site responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment, conduct and compliance in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could impact the performance under or give rise to the termination of Otonomy's collaboration, co-promotion or license agreements, or that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world and to ensure compliance with various laws and regulations in countries in which it conducts clinical trials; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 11, 2021, and Otonomy's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



    Primary Logo

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