AKUS Akouos Inc.

9.51
-0.25  -3%
Previous Close 9.76
Open 9.77
52 Week Low 9.45
52 Week High 23.49
Market Cap $327,906,788
Shares 34,480,209
Float 21,420,307
Enterprise Value $235,857,652
Volume 32,593
Av. Daily Volume 89,157
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Drug Pipeline

Drug Stage Notes
AK-OTOF
Hearing loss
Phase 1/2
Phase 1/2
Phase 1/2 IND filing to be submitted 1H 2022.

Latest News

  1. BOSTON, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos, will participate in a presentation at the Jefferies Gene Therapy/Editing Summit on Wednesday, October 27 at 9:30 a.m. EDT.

    A live webcast of the presentation will be accessible through the investors section of www.akouos.com. To access the webcast, please go to the Akouos website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. An archived…

    BOSTON, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos, will participate in a presentation at the Jefferies Gene Therapy/Editing Summit on Wednesday, October 27 at 9:30 a.m. EDT.

    A live webcast of the presentation will be accessible through the investors section of www.akouos.com. To access the webcast, please go to the Akouos website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. An archived replay will be available on Akouos's website for 30 days following the conference.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Contacts

    Media:

    Katie Engleman, 1AB

    katie@1abmedia.com

    Investors:

    Courtney Turiano, Stern Investor Relations

    Courtney.Turiano@sternir.com



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  2. BOSTON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos, will present at two upcoming virtual investor conferences in September:

    • H.C. Wainwright 23rd Annual Global Investment Conference. Pre-recorded fireside chat available for on-demand viewing starting on Monday, September 13 at 7:00 a.m. EDT
    • Morgan Stanley Virtual Global Healthcare Conference. Fireside chat on Monday, September 13 at 5:00 p.m. EDT

    An on-demand webcast of the H.C. Wainwright fireside chat and…

    BOSTON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos, will present at two upcoming virtual investor conferences in September:

    • H.C. Wainwright 23rd Annual Global Investment Conference. Pre-recorded fireside chat available for on-demand viewing starting on Monday, September 13 at 7:00 a.m. EDT
    • Morgan Stanley Virtual Global Healthcare Conference. Fireside chat on Monday, September 13 at 5:00 p.m. EDT

    An on-demand webcast of the H.C. Wainwright fireside chat and a live webcast of the Morgan Stanley fireside chat will be accessible through the investors section of www.akouos.com. To access the webcasts, please go to the Akouos website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. An archived replay will be available on Akouos's website for 90 days following the conference.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Contacts

    Media:

    Katie Engleman, 1AB

    katie@1abmedia.com 

    Investors:

    Courtney Turiano, Stern Investor Relations 

    Courtney.Turiano@sternir.com 



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  3. - Announced European Commission designation of AK-OTOF as an orphan drug for the treatment of otoferlin gene-mediated hearing loss

    - Advanced both AK-OTOF and AK-antiVEGF towards planned IND submissions in the first half of 2022 and in 2022, respectively

    - Continued to broaden application of genetic medicines platform to treat additional inner ear conditions

    BOSTON, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reports financial results for the second quarter ended June 30, 2021 and provides business highlights.

    "During the past quarter, we have continued to advance the…

    - Announced European Commission designation of AK-OTOF as an orphan drug for the treatment of otoferlin gene-mediated hearing loss

    - Advanced both AK-OTOF and AK-antiVEGF towards planned IND submissions in the first half of 2022 and in 2022, respectively

    - Continued to broaden application of genetic medicines platform to treat additional inner ear conditions

    BOSTON, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reports financial results for the second quarter ended June 30, 2021 and provides business highlights.

    "During the past quarter, we have continued to advance the development of our two lead programs," said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos. "All IND-enabling activities for both AK-OTOF and AK-antiVEGF remain on track to support our planned submissions in 2022, including the completion of dosing in the GLP toxicology study for AK-antiVEGF. We also continue to strengthen our precision genetic medicine platform and progress our earlier stage programs towards the announcement of a product candidate for the treatment of GJB2-mediated hearing loss and targets for hair cell regeneration and autosomal dominant hearing loss, planned for later this year. Our team's exceptional expertise in neurotology, genetics, inner ear drug delivery, and AAV gene therapy has helped establish our leadership in the field of inner ear genetic medicine, and enables us to drive forward the development of gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide."

    Business Highlights

    • AK-OTOF is on track for planned IND submission in the first half of 2022 – All IND-enabling activities for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene (OTOF)-mediated hearing loss, continue to advance as planned.



      • Along with the Orphan Drug Designation and Rare Pediatric Disease Designation previously granted by FDA, the orphan drug designation for AK-OTOF in the European Union could accelerate our development and provide other potential benefits
      • Following the Hearing Loss Association of America-sponsored Patient-Focused Drug Development meeting for people and families living with sensorineural hearing loss, the Company convened a community advisory board of families affected by OTOF-mediated hearing loss to learn about their experiences living with the condition and gain their input on the clinical development plan for AK-OTOF
    • Advanced AK-antiVEGF toward planned IND submission in 2022 – IND-enabling activities for AK-antiVEGF, a gene therapy intended for the treatment of vestibular schwannoma, continue to make progress, including completion of dosing for the good laboratory practice (GLP) toxicology study.
    • Applying genetic medicines platform beyond lead programs to address broader range of inner ear conditions – In 2021, the Company plans to announce a product candidate for its GJB2 program, and targets for its hair cell regeneration and autosomal dominant hearing loss programs.

    Second Quarter 2021 Financial Results

    • Cash Position – Cash, cash equivalents, and marketable securities were $271.8 million as of June 30, 2021, as compared to $308.0 million as of December 31, 2020. Akouos expects its cash balance to fund operations for at least the next two years.
    • Research and Development (R&D) Expenses – R&D expenses were $17.1 million for the second quarter ended June 30, 2021, compared to $9.9 million for the same period in 2020. The increase was primarily due to the increased efforts in IND-enabling studies and increased manufacturing costs for AK-OTOF and AK-antiVEGF and the growth in the number of R&D employees and their related activities, as well as the expense allocated to R&D related to Akouos's leased facilities.
    • General and Administrative (G&A) Expenses – G&A expenses were $5.7 million for the second quarter ended June 30, 2021, compared to $2.7 million for the same period in 2020. The increase was primarily due to the growth in the number of G&A employees and other administrative expenses related to operating as a public company, as well as the expense allocated to G&A related to Akouos's leased facilities.
    • Net Loss – Net loss was $22.7 million, or $0.66 per share, for the second quarter ended June 30, 2021, compared to $12.5 million, or $11.14 per share, for the same period in 2020.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation, plans, and timing of our future clinical trials and our research and development programs, the timing of our IND submissions for AK-OTOF and AK-antiVEGF, the potential receipt of exclusivity and other benefits from Orphan Drug Designation in the European Union and Orphan Drug Designation and Rare Pediatric Disease Designation in the United States, and the period over which we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our limited operating history; uncertainties inherent in the development of product candidates, including the initiation and completion of nonclinical studies and clinical trials; whether results from nonclinical studies will be predictive of results or success of clinical trials; the timing of and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates; our expectations regarding our regulatory strategy; our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents, and marketable securities; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential addressable patient population for our product candidates; our commercialization, marketing, and manufacturing capabilities and strategy; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with our commercial objectives; the impact of government laws and regulations and any changes in such laws and regulations; risks related to competitive programs; the potential that our internal manufacturing capabilities and/or external manufacturing supply may experience delays; the impact of the COVID-19 pandemic on our business, results of operations, and financial condition; our ability to maintain and establish collaborations or obtain additional funding; and other factors discussed in the "Risk Factors" included in the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2021 filed with the Securities and Exchange Commission, and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.



    Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (in thousands)

           
      June 30, 2021 December 31, 2020
          
    Cash, cash equivalents and marketable securities $271,751 $308,010
    Total assets  316,583  333,350
    Total liabilities  40,055  22,736
    Total stockholders' equity  276,528  310,614



    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands, except share and per share data)

                
     Three Months Ended  Six Months Ended
     June 30,  June 30, 
     2021  2020  2021  2020 
            
    Operating expenses:           
    Research and development$17,119  $9,937  $28,377  $17,971 
    General and administrative 5,665   2,664   10,555   5,168 
    Total operating expenses 22,784   12,601   38,932   23,139 
    Loss from operations (22,784)  (12,601)  (38,932)  (23,139)
    Other income (expense):           
    Interest income 554   80   1,063   180 
    Other expense, net (510)  (2)  (957)  (4)
    Total other income, net 44   78   106   176 
    Net loss$(22,740) $(12,523) $(38,826) $(22,963)
    Net loss per share attributable to common stockholders

    basic and diluted
    $(0.66) $(11.14) $(1.13) $(25.05)
    Weighted‑average common shares outstanding, basic

    and diluted
     34,372,262   1,124,251   34,324,477   916,521 
    Other comprehensive income (loss):           
    Unrealized gain (loss) on marketable securities (23)     5    
    Total other comprehensive income (loss) (23)     5    
    Total comprehensive loss$(22,763) $(12,523) $(38,821) $(22,963)
                

    Contacts

    Media:

    Katie Engleman, 1AB

    katie@1abmedia.com

    Investors:

    Courtney Turiano, Stern Investor Relations

    Courtney.Turiano@sternir.com



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  4. BOSTON, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company's application for orphan drug designation for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss. The positive opinion was subsequently adopted by the European Commission. AK-OTOF was previously granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration for this same indication…

    BOSTON, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company's application for orphan drug designation for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss. The positive opinion was subsequently adopted by the European Commission. AK-OTOF was previously granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration for this same indication.

    Otoferlin gene (OTOF)-mediated hearing loss is a form of sensorineural hearing loss caused by mutations in the OTOF gene. The OTOF gene encodes otoferlin, a protein that enables the inner hair cells of the cochlea to release neurotransmitter vesicles in response to stimulation by sound to activate auditory neurons. Most individuals with OTOF-mediated hearing loss have Severe to Profound sensorineural hearing loss from birth and approximately 20,000 individuals are affected in the United States and Europe. AK-OTOF is designed to treat the underlying cause of OTOF-mediated hearing loss through delivery of a transgene using a dual vector technology that results in expression of normal, functional otoferlin protein in the affected cells, namely inner hair cells, in the cochlea.

    "Severe to Profound sensorineural hearing loss from birth caused by mutations in the OTOF gene is a high unmet need, especially given that there are currently no approved pharmacologic treatment options available," said Katie Wachtel, M.S. and vice president of regulatory affairs of Akouos. "The orphan drug designation granted by the European Commission is an important step towards advancing the global development of AK-OTOF, a gene therapy with potential to restore physiologic hearing and provide long-lasting benefit to individuals with OTOF-mediated hearing loss. Along with the ODD and RPDD designations previously granted by FDA, the orphan drug designation for AK-OTOF in the European Union could accelerate our development of AK-OTOF and our progress towards our mission of healthy hearing available to all."

    Orphan drug designation in the European Union is granted by the European Commission based on an opinion issued by the EMA COMP. An orphan drug designation provides a number of benefits, including fee reductions, regulatory assistance, and the possibility to apply for a centralized European Union marketing authorization. Marketing authorization for an orphan drug can lead to a ten-year period of market exclusivity.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation, plans, and timing of our future clinical trials and our research and development programs, and the potential receipt of exclusivity and other benefits from Orphan Drug Designation in the European Union and Orphan Drug Designation and Rare Pediatric Disease Designation in the United States. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our limited operating history; uncertainties inherent in the development of product candidates, including the initiation and completion of nonclinical studies and clinical trials; whether results from nonclinical studies will be predictive of results or success of clinical trials; the timing of and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates; our expectations regarding our regulatory strategy; our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents, and marketable securities; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential addressable patient population for our product candidates; our commercialization, marketing, and manufacturing capabilities and strategy; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with our commercial objectives; the impact of government laws and regulations and any changes in such laws and regulations; risks related to competitive programs; the potential that our internal manufacturing capabilities and/or external manufacturing supply may experience delays; the impact of the COVID-19 pandemic on our business, results of operations, and financial condition; our ability to maintain and establish collaborations or obtain additional funding; and other factors discussed in the "Risk Factors" included in the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2021 filed with the Securities and Exchange Commission, and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Contacts

    Media:

    Katie Engleman, 1AB

    katie@1abmedia.com

    Investors:

    Courtney Turiano, Stern Investor Relations

    Courtney.Turiano@sternir.com



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  5. - Leadership team expanded with appointment of Kathy Reape, M.D. as chief development officer

    - AK-OTOF granted both Orphan Drug Designation and Rare Pediatric Disease Designation by FDA and is on track for planned IND submission in first half of 2022

    - Nonclinical data supporting future clinical development of AK-OTOF and AK-antiVEGF presented at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting

    - Construction for an internal cGMP manufacturing facility completed, and expansion of laboratory footprint underway, contributing to continued infrastructure build to support future development activities

    BOSTON, May 13, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company…

    - Leadership team expanded with appointment of Kathy Reape, M.D. as chief development officer

    - AK-OTOF granted both Orphan Drug Designation and Rare Pediatric Disease Designation by FDA and is on track for planned IND submission in first half of 2022

    - Nonclinical data supporting future clinical development of AK-OTOF and AK-antiVEGF presented at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting

    - Construction for an internal cGMP manufacturing facility completed, and expansion of laboratory footprint underway, contributing to continued infrastructure build to support future development activities

    BOSTON, May 13, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reports financial results for the first quarter ended March 31, 2021 and provides business updates.

    "We continue to demonstrate our leadership in the field of inner ear genetic medicines. Recently, FDA granted AK-OTOF, our lead product candidate, what we believe are the first Orphan Drug and Rare Pediatric Disease designations for a genetic form of hearing loss. At the ASGCT Annual Meeting, our team presented nonclinical data demonstrating the unique applicability of our genetic medicine platform to potentially restore, improve, and preserve physiologic hearing for a monogenic condition and a condition of complex etiology," said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos. "These accomplishments have been made possible by our team of leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy, including the recent addition of Dr. Kathy Reape as chief development officer. We continue to build our team's capabilities, infrastructure, and facilities to support our planned IND submissions for AK-OTOF and AK-antiVEGF in 2022, and are progressing our earlier stage programs towards candidate selection or target announcement."

    Business Highlights

    • Appointment of Kathy Reape, M.D. as chief development officer Dr. Kathy Reape joined Akouos as chief development officer and brings over 20 years of experience in clinical drug development and medical affairs to Akouos, most notably from her recent role as chief medical officer of Spark Therapeutics.
    • Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) granted by FDA for AK-OTOF – AK-OTOF is a gene therapy intended for the treatment of otoferlin gene (OTOF)-mediated hearing loss, a condition that often results in Severe to Profound sensorineural hearing loss from birth and does not currently have any pharmacologic treatment options available. The receipt of these designations could support acceleration of development of AK-OTOF.
    • Presented nonclinical data at the ASGCT 24th Annual Meeting reflecting broad applicability of genetic medicine platform to treat inner ear conditions In May 2021, Akouos presented nonclinical data that support the future clinical development for both AK-OTOF and AK-antiVEGF, a gene therapy intended for the treatment of vestibular schwannoma, at the ASGCT 24th Annual Meeting. The digital presentations are located at https://akouos.com/gene-therapy-resources/.
    • Continued advancement of both AK-OTOF and AK-antiVEGF towards expected IND submissions in 2022 – Akouos continues to make progress towards an investigational new drug application (IND) submission for AK-OTOF planned in the first half of 2022. The Company expects to submit an IND for AK-antiVEGF in 2022. Both programs utilize key components of Akouos's genetic medicine platform, which incorporates a proprietary AAVAnc capsid library, including AAVAnc80, and a novel delivery approach that leverages minimally-invasive surgical techniques familiar to otologic surgeons.
    • Building infrastructure to support future development – Akouos expanded its facility at 645 Summer Street in Boston, MA to support additional research, development, and manufacturing activities. In 2021, the Company plans to complete build of infrastructure and capabilities to enable internal cGMP manufacturing expected to support clinical development of product candidates, at the anticipated commercial scale.

    First Quarter 2021 Financial Results

    • Cash Position – Cash, cash equivalents, and marketable securities were $286.6 million as of March 31, 2021, as compared to $308.0 million as of December 31, 2020. Akouos expects its cash balance to fund operations for at least the next two years.
    • Research and Development (R&D) Expenses – R&D expenses were $11.3 million for the first quarter ended March 31, 2021, compared to $8.0 million for the same period in 2020. The increase was primarily due to the increased efforts in IND-enabling studies for AK-OTOF and AK-antiVEGF and the growth in the number of R&D employees and their related activities, as well as the expense allocated to R&D related to Akouos's leased facilities.
    • General and Administrative (G&A) Expenses – G&A expenses were $4.9 million for the first quarter ended March 31, 2021, as compared to $2.5 million for the same period in 2020. The increase was primarily due to the growth in the number of G&A employees and other administrative expenses related to operating as a public company, as well as the expense allocated to G&A related to Akouos's leased facilities.
    • Net Loss – Net loss was $16.1 million, or $0.47 loss per share, for the first quarter ended March 31, 2021, compared to $10.4 million, or $14.74 loss per share, for the same period in 2020.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation, plans, and timing of our future clinical trials and our research and development programs, the timing of our IND submissions for AK-OTOF and AK-antiVEGF, our expectations regarding our manufacturing capabilities and timelines, and the period over which we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our limited operating history; uncertainties inherent in the development of product candidates, including the initiation and completion of nonclinical studies and clinical trials; whether results from nonclinical studies will be predictive of results or success of clinical trials; the timing of and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates; our expectations regarding our regulatory strategy; our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents, and marketable securities; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential addressable patient population for our product candidates; our commercialization, marketing, and manufacturing capabilities and strategy; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with our commercial objectives; the impact of government laws and regulations; risks related to competitive programs; the potential that our internal manufacturing capabilities and/or external manufacturing supply may experience delays; the impact of the COVID-19 pandemic on our business, results of operations, and financial condition; our ability to maintain and establish collaborations or obtain additional funding; and other factors discussed in the "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission, and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. 





    Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (in thousands)

      March 31, 2021 December 31, 2020
           
    Cash, cash equivalents and marketable securities $286,619  $308,010 
    Total assets  321,859   333,350 
    Total liabilities  25,057   22,736 
    Total stockholders' equity  296,802   310,614 





    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands, except share and per share data)

      Three months ended March 31,

      2021  2020 
           
    Operating expenses:      
    Research and development $11,258  $8,034 
    General and administrative  4,890   2,504 
    Total operating expenses  16,148   10,538 
    Loss from operations  (16,148)  (10,538)
    Other income (expense):      
    Interest income  509   100 
    Other expense, net  (447)  (2)
    Total other income, net  62   98 
    Net loss $(16,086) $(10,440)
    Weighted‑average common shares outstanding, basic and diluted  34,284,419   708,204 
    Net loss per share attributable to common stockholders, basic and diluted $(0.47) $(14.74)
           

    Contacts

    Media:

    Katie Engleman, 1AB

    katie@1abmedia.com

    Investors:

    Courtney Turiano, Stern Investor Relations

    Courtney.Turiano@sternir.com



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