FREQ Frequency Therapeutics Inc.

28.7
-0.02  -0%
Previous Close 28.72
Open 29.08
52 Week Low 14.5
52 Week High 29.71
Market Cap $968,185,660
Shares 33,734,692
Float 30,636,476
Enterprise Value $746,870,354
Volume 468,287
Av. Daily Volume 184,644
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Upcoming Catalysts

Drug Stage Catalyst Date
FX-322
Acquired Sensorineural Hearing Loss (SNHL)
Phase 2a
Phase 2a
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FX-322
Age-Related Hearing Loss
Phase 1b
Phase 1b
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FX-322
Severe Sensorineural Hearing Loss (SNHL)
Phase 1b
Phase 1b
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Latest News

  1. Day-90 Analysis of FX-322 Phase 2a Study for Acquired Sensorineural Hearing Loss (SNHL) Planned for Late Q1 2021; End of Study Readout Planned in Late Q2 2021

    Commenced Phase 1b Study of FX-322 in Patients with Age-Related Hearing Loss; Additional Phase 1b Study in Patients with Severe SNHL to Start Before Year End

    Company Ends Quarter with $224.2M in Cash, Cash Equivalents and Short-Term Investments

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced business updates and financial results for the third quarter ended September 30, 2020.

    The Company has continued to…

    Day-90 Analysis of FX-322 Phase 2a Study for Acquired Sensorineural Hearing Loss (SNHL) Planned for Late Q1 2021; End of Study Readout Planned in Late Q2 2021

    Commenced Phase 1b Study of FX-322 in Patients with Age-Related Hearing Loss; Additional Phase 1b Study in Patients with Severe SNHL to Start Before Year End

    Company Ends Quarter with $224.2M in Cash, Cash Equivalents and Short-Term Investments

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced business updates and financial results for the third quarter ended September 30, 2020.

    The Company has continued to advance the clinical development program for FX-322, its lead product candidate for the treatment of acquired SNHL, announcing last month a detailed update that includes an upcoming analysis of day-90 data from its Phase 2a study in late Q1 2021. This readout will assess all efficacy and safety endpoints following single or multiple doses of FX-322, or placebo. The Company also reiterated its plan to share end of Phase 2a data in late Q2 2021, evaluating the same metrics as at day-90, as well as the durability of the effect of FX-322 over seven months.

    Further, Frequency is expanding its FX-322 development program to evaluate FX-322's clinical profile in other SNHL patient types, including those with age-related hearing loss and severe SNHL, in order to identify the broadest population that may benefit from the product candidate. The Company expects to share results from its Phase 1b age-related hearing loss study in Q2 2021 and its Phase 1b severe SNHL study in Q3 2021. SNHL is the most common form of hearing loss, impacting more than 40 million people in the US alone.

    "This past quarter we continued to gain momentum, completing study enrollment and moving toward a day-90 readout of the Phase 2a study of FX-322, while expanding our development program by adding additional studies to further our understanding of the potential of FX-322 to help the broadest SNHL patient population. The analysis of day-90 data will enable us to evaluate our key goals for the Phase 2a study and provide a comparison to the hearing improvement signal we observed in our Phase 1/2 study. These data are also expected to provide critical insights as we look ahead to the end-of-study readout late in the second quarter of next year and enable us to plan our longer-term development and regulatory strategies," said Frequency Therapeutics Chief Executive Officer David L. Lucchino. "We also expect these studies to provide us with a deeper understanding of the potential impact of FX-322 on intelligibility or clarity measures. Intelligibility of speech, which is critical for daily activities, especially in noisy environments, is the primary unmet need for tens of millions of people with hearing loss and is not effectively addressed by the current standard of care.

    "We look forward to an eventful 2021, with multiple FX-322 data readouts. We also expect to move our therapeutic candidate for remyelination in multiple sclerosis to the clinic in the second half of next year and further our exploration of additional opportunities for our progenitor cell activation approach."

    Recent Program and Business Updates

    FX-322 Phase 2a Study and Pending Clinical Readouts: The FX-322 Phase 2a study is a double-blind, placebo-controlled single and repeat dose study in patients aged 18 to 65 with acquired SNHL. The study includes four dose cohorts, with hearing function being regularly tested in all patients over the course of the full seven months following the first dosing.

    The key efficacy objectives of the study are to evaluate the potential of FX-322 to improve hearing clarity or intelligibility, as measured by improvements in tests of word recognition (WR) or words-in-noise (WIN). Data will also be analyzed for the impact of FX-322 on pure tone audiometry in the standard frequencies (0.25-8 kHz), at higher frequencies (up to 16k Hz) and on tinnitus and quality of life measures. Frequency expects to share day-90 study results in late Q1 2021 and end of study results in late Q2 2021.

    In its previously disclosed Phase 1/2 study, Frequency observed improvements in key measures of hearing function, specifically speech intelligibility, following a single dose of FX-322 in patients with moderate to moderately severe acquired SNHL. The evaluation period for the Phase 1/2 study was 90 days.

    At the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) annual meeting in September 2020, Frequency presented clinical results from a follow-up durability study of patients who had shown statistically significant improvements in word recognition scores in the Phase 1/2 study. These data showed that three of four patients maintained statistically significant improvements in word recognition at time points between 13 - 21 months following initial dosing, while a fourth patient maintained some improvement. A fifth patient that had shown non-statistically significant improvements had returned to baseline.

    The results of the Phase 2a end of study analysis, as well as anticipated results from the age-related hearing loss and severe SNHL studies, are expected to provide the basis for an end of Phase 2 meeting with the US Food and Drug Administration regarding potential pivotal studies of FX-322.

    FX-322 Phase 1b Study for Age-Related Hearing Loss: In October, the Company announced that the first patient was dosed in a Phase 1b safety study of FX-322 for age-related hearing loss. The study is a double-blind, placebo-controlled, randomized multicenter safety study of up to 30 patients aged 66-85 with mild to moderately severe age-related hearing loss. The primary objectives of the Phase 1b study are to assess the local and systemic safety of a single dose of FX-322 and evaluate the hearing response. Study participants are being randomized 4:1 to receive either FX-322 or placebo in one ear. The study is using validated measures of hearing function including WR, WIN and pure tone audiometry to assess the effect of FX-322. Safety, otologic and audiologic assessments will be conducted at days 30 and 90 following administration. Frequency expects to share these study results in Q2 2021.

    FX-322 Phase 1b Study of Severe SNHL: Frequency plans to start a Phase 1b study in patients aged 18-65 with severe SNHL before year-end. Severe SNHL is defined as a pure tone average deficit between 71-90 dB. Many patients with this clinical profile typically would be candidates for cochlear implants. This study is expected to employ a similar design to the age-related Phase 1b study that is currently underway. Frequency expects to share results from this study in Q3 2021.

    Continued Progress on Earlier Stage Pipeline: The Company continued to make progress in its program for remyelination in multiple sclerosis, advancing the program from discovery into the pre-clinical phase. The program remains on track for an anticipated regulatory submission in H2 2021.

    Cynthia Feldmann Appointed to Board of Directors: In September, Cynthia Feldmann joined the Company's Board of Directors. Ms. Feldmann is an experienced finance and accounting professional who brings to Frequency several decades of experience in life sciences and public company board leadership. She was formerly a partner at KPMG LLP, where she held leadership roles in the firm's medical technology and health care and life sciences industry groups, and was the lead partner in the life sciences practice for Coopers & Lybrand (now PricewaterhouseCoopers LLP) during her 19-year career there. Currently, she is a member of the board of directors at STERIS PLC (NYSE:STE) and at UFP Technologies (NASDAQ:UFPT).

    New England Innovation Awards Life Science Winner: In October, Frequency was named the winner in the life sciences category of the New England Innovation Awards for its research into and development of FX-322 for sensorineural hearing loss. The award recognizes companies for their efforts to develop transformative innovations that can have a positive impact on patients, industry and society.

    Boston Patent Law Association (BPLA) Honoree: In November, Frequency Therapeutics scientific co-founders Dr. Robert Langer of the Massachusetts Institute of Technology and Dr. Jeff Karp of Harvard Medical School, along with their co-inventors Dr. Xiaolei Yin and Dr. Nitin Joshi, were recognized by the BPLA for U.S. Patent No. 10,568,883 titled "Compositions, Systems, and Methods for Generating Inner Ear Hair Cells For Treatment Of Hearing Loss," work that was foundational for some of Frequency's drug discovery programs.

    Third Quarter 2020 Financial Results

    Cash Position: Cash, cash equivalents and short-term investments on Sept. 30, 2020 were $224.2 million, as compared to $217.4 million on December 31, 2019. In July, the Company completed a private placement, resulting in $40.1 million in net proceeds, after deducting placement agent fees and other offering expenses.

    Based on current plans and assumptions, the Company expects its existing cash and cash equivalents, and short-term investments will be sufficient to fund its operations into 2023. This guidance does not include potential future milestones which could be received from Astellas Pharma for continued FX-322 development.

    Revenue: Revenue was $11.2 million and $27.0 million for the three- and nine-month periods ended Sept. 30, 2020, respectively. The Company had revenue of $24.2 million in each of the comparable periods of 2019.

    Research & Development Expenses: Research and development expenses were $10.2 million and $25.6 million for the three- and nine-month periods ended Sept. 30, 2020, respectively, as compared to $5.2 million and $12.6 million for the comparable periods of 2019. The increases are due to increased costs related to the Company's lead product candidate, FX-322, including external development costs related to the Company's ongoing Phase 2a clinical trial, as well as increased personnel-related costs due to additional headcount to support the growth of Frequency's research and development organization.

    General and Administrative Expenses: General and administrative expenses were $6.5 million and $18.7 million for the three- and nine-month periods ended Sept. 30, 2020, respectively, as compared to $4.3 million and $9.8 million for the comparable periods of 2019. The increases are primarily due to an increase in personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company as well as costs associated with being a public company, primarily comprised of insurance, consulting and professional fees.

    Net Loss: Net loss was $5.3 million and $16.3 million for the three- and nine-month periods ended Sept. 30, 2020, respectively, as compared to $0.6 million and $13.3 million for the comparable periods of 2019. The increase in net loss in 2020 reflects the increase in research and development costs associated with the growth of Frequency's research and development organization and the increase in general and administrative expenses required to support the growth of the Company and the cost associated with operating as a public company.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Cambridge Enterprises Limited, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Phase 2a clinical trial, the Phase 1b study of age-related hearing loss, the Phase 1b study of severe SNHL, including timing of commencement thereof, design, pace and timing of enrollment and results for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completion of analysis of Phase 2 clinical trial data and data readouts from the Phase 2a clinical trial and the Phase 1b studies in age-related hearing loss and severe SNHL, the expected insights of such readouts and resulting developments, the effectiveness of the current standard of care to address the primary unmet need of patients with acquired SNHL, the timing of a regulatory submission of a product candidate for remyelination in MS and commencement of clinical trials, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Company's on-going and planned clinical trials and business, increases in headcount, future milestone and royalty payments under the license and collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company's ability to advance its hearing program and further diversify its portfolio, the potential application of the PCA platform to other diseases and expectations regarding cash, cash equivalents and short-term investments.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company's ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company's offices and laboratory facilities, the Company's business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company's need for additional funding to complete development and commercialization of any product candidate; the Company's dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

    These and other important factors discussed under the caption "Risk factors" in the Company's Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 16, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

    Frequency Therapeutics, Inc.

    Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

    (unaudited)

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue

     

    $

    11,247

     

     

    $

    24,238

     

     

    $

    27,034

     

     

    $

    24,238

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Royalty

     

     

     

     

     

    16,000

     

     

     

     

     

     

    16,000

     

    Research and development

     

     

    10,153

     

     

     

    5,221

     

     

     

    25,587

     

     

     

    12,588

     

    General and administrative

     

     

    6,512

     

     

     

    4,269

     

     

     

    18,720

     

     

     

    9,837

     

    Total operating expenses

     

     

    16,665

     

     

     

    25,490

     

     

     

    44,307

     

     

     

    38,425

     

    Loss from operations

     

     

    (5,418

    )

     

     

    (1,252

    )

     

     

    (17,273

    )

     

     

    (14,187

    )

    Interest income

     

     

    74

     

     

     

    624

     

     

     

    962

     

     

     

    842

     

    Realized gain on investments

     

     

     

     

     

    62

     

     

     

    65

     

     

     

    88

     

    Foreign exchange gain (loss)

     

     

    18

     

     

     

    (9

    )

     

     

    27

     

     

     

    4

     

    Loss before income taxes

     

     

    (5,326

    )

     

     

    (575

    )

     

     

    (16,219

    )

     

     

    (13,253

    )

    Income taxes

     

     

    (15

    )

     

     

    -

     

     

     

    (60

    )

     

     

    -

     

    Net loss

     

     

    (5,341

    )

     

     

    (575

    )

     

     

    (16,279

    )

     

     

    (13,253

    )

    Cumulative Series C convertible preferred stock dividends

     

     

    -

     

     

     

    (1,014

    )

     

     

    -

     

     

     

    (1,014

    )

    Net loss attributable to common stockholders

     

    $

    (5,341

    )

     

    $

    (1,589

    )

     

    $

    (16,279

    )

     

    $

    (14,267

    )

    Net loss per share attributable to common stockholders- basic and diluted

     

    $

    (0.16

    )

     

    $

    (0.73

    )

     

    $

    (0.51

    )

     

    $

    (7.17

    )

    Weighted-average shares of common stock outstanding- basic and diluted

     

     

    33,073,889

     

     

     

    2,163,289

     

     

     

    31,729,702

     

     

     

    1,990,106

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Frequency Therapeutics, Inc.

    Consolidated Balance Sheet Data

    (in thousands)

    (unaudited)

     
     

     

     

    September 30, 2020

     

     

    December 31, 2019

     

    Cash, cash equivalents and short-term investments

     

    $

    224,231

     

     

    $

    217,355

     

    Working capital

     

     

    194,424

     

     

     

    168,575

     

    Total assets

     

     

    234,320

     

     

     

    223,218

     

    Total liabilities

     

     

    34,728

     

     

     

    55,860

     

    Accumulated deficit

     

     

    (85,167

    )

     

     

    (68,888

    )

    Total stockholders' equity

     

     

    199,592

     

     

     

    167,358

     

     

    View Full Article Hide Full Article
  2. Company Will Report Data from Phase 2a Sensorineural Hearing Loss (SNHL) Study in Late Q1 2021

    First Patient Dosed in Phase 1b Study of Age-Related Hearing Loss; Additional Phase 1b Study for Severe SNHL Patients to Start This Quarter

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today provided an update to its strategy and clinical development program for FX-322, its lead product candidate for the treatment of acquired sensorineural hearing loss (SNHL). SNHL is the primary cause of more than 90 percent of all hearing loss.

    The Company announced today plans to report an analysis…

    Company Will Report Data from Phase 2a Sensorineural Hearing Loss (SNHL) Study in Late Q1 2021

    First Patient Dosed in Phase 1b Study of Age-Related Hearing Loss; Additional Phase 1b Study for Severe SNHL Patients to Start This Quarter

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today provided an update to its strategy and clinical development program for FX-322, its lead product candidate for the treatment of acquired sensorineural hearing loss (SNHL). SNHL is the primary cause of more than 90 percent of all hearing loss.

    The Company announced today plans to report an analysis of day-90 data from its Phase 2a study of FX-322 in late Q1 2021. In its previously disclosed Phase 1/2 study, Frequency observed improvements in key measures of hearing function, following a single dose of FX-322, in patients with moderate to moderately severe acquired SNHL. The evaluation period for the Phase 1/2 study was 90 days.

    The primary objectives of the FX-322 Phase 2a study are to: 1) further establish the hearing signal observed in the Phase 1/2 study; 2) evaluate the impact of multiple doses; and 3) characterize exploratory endpoints to inform future studies.

    Frequency also is expanding its clinical development program to evaluate FX-322's clinical profile in other SNHL patient groups, including age-related and severe SNHL patients, in order to identify the broadest population that may benefit from its potentially restorative therapeutic approach.

    Summary of FX-322 clinical studies and anticipated milestones:

    • FX-322 Phase 2a study of patients with mild to moderately severe acquired SNHL (ages 18-65): The Phase 2a study completed enrollment with 95 patients in September 2020. The Company today announced plans to provide a complete analysis of day-90 Phase 2a study data, which is anticipated late in Q1 2021. The Phase 2a end-of-study (seven month) readout is anticipated late in Q2 2021.
    • FX-322 Phase 1b study of patients with age-related hearing loss (ages 66 – 85): The first patient in this study was dosed in October 2020 and the complete data readout is anticipated in Q2 2021.
    • FX-322 Phase 1b study in patients with severe SNHL (ages 18-65): This study is expected to start this quarter and the complete data readout is anticipated in Q3 2021.

    "The first half of 2021 will be an important period for Frequency in which we will obtain multiple clinical datasets that will guide and potentially accelerate our future regulatory and later stage development activities," said David L. Lucchino, Frequency's chief executive officer. "Improved clarity of sound and speech remains the critical unmet need for the tens of millions of individuals in the US with hearing loss, and we look forward to sharing key insights from our Phase 2a study early next year."

    FX-322 Phase 2a Study

    The Phase 2a day-90 readout will assess all efficacy and safety endpoints following single or multiple doses of FX-322, or placebo. This evaluation period is consistent with the prior Phase 1/2 study of FX-322, in which the Company observed improvements in word recognition scores following a single intratympanic dose of FX-322 in patients with moderate to moderately severe acquired SNHL.

    The end of Phase 2a data readout will evaluate the same metrics as at day-90, as well as the durability of the effect of FX-322 over seven months.

    The Phase 2a study is a double-blind, placebo-controlled, single and repeat dose study of FX-322 in patients aged 18 to 65 with mild to moderately severe acquired SNHL. The FX-322 Phase 2a study has four dose cohorts and hearing function is regularly tested in all patients over the course of seven months. The study is being conducted at private ear, nose and throat clinics across the US.

    Efficacy measures include speech intelligibility (clarity), as measured by standard, validated word recognition (WR) and words-in-noise (WIN) testing. Exploratory efficacy measures include pure tone audiometry at extended high frequencies (up to 16kHz) that are known to contribute to speech intelligibility, as well as assessments of tinnitus and quality of life measures.

    At the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) annual meeting in September 2020, Frequency presented clinical results from a follow-up durability study of patients who had shown statistically significant improvements in word recognition scores in the Phase 1/2 study. These data showed that three of four patients maintained statistically significant improvements in word recognition between 13 - 21 months following initial dosing, while a fourth patient maintained some improvement. A fifth patient that had shown non-statistically significant improvements had returned to baseline.

    The results of the Phase 2a end of study analysis, as well as those reported from the age-related hearing loss and severe SNHL studies, are expected to provide the basis for an end of Phase 2 meeting with the US Food and Drug Administration regarding potential registrational studies of FX-322.

    New FX-322 Clinical Studies:

    • FX-322 Phase 1b Study for Age-Related Hearing Loss: Frequency announced today that the first patient has been dosed in a Phase 1b safety study of FX-322 for age-related hearing loss. The study is a double-blind, placebo-controlled, randomized multicenter safety study of up to 30 individuals aged 66-85 with mild to moderately severe age-related hearing loss. In the Phase 1/2 study of FX-322, which enrolled patients with sudden SNHL and noise-induced hearing loss, the mean age of study participants was in the mid 50's.



      The primary objectives of the Phase 1b study are to assess the local and systemic safety of a single dose of FX-322 and evaluate hearing responses in an older adult cohort. Study participants will be randomized 4:1 to receive either FX-322 or placebo in one ear. Validated measures of hearing including WR, WIN and pure tone audiometry will be used. Safety, otologic and audiologic assessments will be conducted at day 30 and 90 following administration of FX-322 or placebo. Frequency expects to share results from this study in Q2 2021.
    • FX-322 Phase 1b Study of Severe SNHL: Frequency plans to start a Phase 1b study in patients aged 18-65 with severe SNHL this quarter. Severe SNHL is defined as a pure tone average deficit between 71-90 dB. Many patients with this clinical profile typically would be candidates for cochlear implants. This study is expected to employ a similar design to the age-related Phase 1b study that is currently underway. Frequency expects to share results from this study in Q3 2021.

    "Over this past year we shared results from clinical research that built on our original Phase 1/2 data. These recent findings have given us additional confidence that FX-322 reaches the site of action in the cochlea at therapeutic levels, that the treatment may be durable and disease modifying and that it continues to show a favorable safety profile," added Carl LeBel, Ph.D., Frequency's chief development officer. "We look forward to the Phase 2a day-90 analysis of FX-322, and we expect that these data will enable us to refine the design and endpoints of future studies and provide a fuller understanding of the effects of FX-322 on hearing clarity."

    About Sensorineural Hearing Loss

    Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to auditory sensory hair cells in the inner ear. These cells convert sound waves to a signal sent to the brain. Sensory hair cells may be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. This type of damage impacts hundreds of millions of individuals in the U.S. and worldwide.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a pre-clinical program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Cambridge Enterprises Limited, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Phase 2a clinical trial, the Phase 1b study of age-related hearing loss, the Phase 1b study of severe SNHL, design, pace and timing of enrollment for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completeness of data readouts from the Phase 2a clinical trial and the Phase 1b studies in age-related hearing loss and severe SNHL, the therapeutic levels of FX-322 predicted in the exploratory pharmacokinetic study, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Company's on-going and planned clinical trials and business, increases in headcount, future milestone and royalty payments under the license and collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company's ability to advance its hearing program and further diversify its portfolio and the potential application of the PCA platform to other diseases.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company's ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company's offices and laboratory facilities, the Company's business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company's need for additional funding to complete development and commercialization of any product candidate; the Company's dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

    These and other important factors discussed under the caption "Risk factors" in the Company's Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  3. Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced the appointment of Cynthia Feldmann to its Board of Directors.

    Ms. Feldmann is an experienced finance and accounting professional who brings to Frequency several decades of experience in life sciences and public company board leadership. She was formerly a partner at KPMG LLP, where she held leadership roles in the firm's medical technology and health care and life sciences industry groups, and was the lead partner in the life sciences practice for Coopers & Lybrand (now PricewaterhouseCoopers LLP) during her 19-year career…

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced the appointment of Cynthia Feldmann to its Board of Directors.

    Ms. Feldmann is an experienced finance and accounting professional who brings to Frequency several decades of experience in life sciences and public company board leadership. She was formerly a partner at KPMG LLP, where she held leadership roles in the firm's medical technology and health care and life sciences industry groups, and was the lead partner in the life sciences practice for Coopers & Lybrand (now PricewaterhouseCoopers LLP) during her 19-year career there. Currently, she is a member of the board of directors at STERIS PLC (NYSE:STE) and at UFP Technologies (NASDAQ:UFPT).

    "Cynthia's financial expertise and deep public board experience will be of tremendous value to our organization as we continue to scale Frequency," said David L. Lucchino, Frequency's chief executive officer. "We look forward to her contributions as we work to advance a therapy to potentially treat the millions of people with hearing loss and move toward development of our remyelination program for patients with multiple sclerosis."

    "I am thrilled to join Frequency's board and to be part of a company working to solve such a profoundly complex challenge as hearing restoration," said Ms. Feldmann. "I have been deeply impressed both with the strength and vision of leadership, the commitment of the team to pursue this audacious objective and their focus on building a world-class research and development organization. It's exciting to join the company at this time to be part of something so potentially groundbreaking."

    Ms. Feldmann has served on the STERIS board for more than fifteen years and chaired its audit committee for eight years. She has also been a director at Atrius Health, Hanger Inc. (NYSE:HNGR), a provider of orthotic and prosthetic services and products and Heartware International, Inc., a medical device company that was acquired by Medtronic.

    "Cynthia is a great addition and will provide tremendous perspective having worked as an independent board member for newly-public companies and contributing to their success over time," said Marc A. Cohen, chairman of the board of directors at Frequency Therapeutics. "Her breadth of experience will further strengthen the organization, and I look forward to her partnership during this important time for the company and its growth."

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In an FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in an ongoing Phase 2a clinical study in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a discovery program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Cambridge Enterprises Limited (the commercialization arm of the University of Cambridge), Massachusetts Eye and Ear, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  4. Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced the completion of enrollment of its Phase 2a study of FX-322 for sensorineural hearing loss (SNHL). The company anticipates obtaining full results for the study, in which 95 patients were enrolled, in the second quarter of 2021.

    "We are pleased to have completed an important next step toward offering a potential breakthrough medicine for millions of people with acquired sensorineural hearing loss and look forward to sharing the full results of the Phase 2a study next year," said Frequency Therapeutics Chief Executive Officer…

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced the completion of enrollment of its Phase 2a study of FX-322 for sensorineural hearing loss (SNHL). The company anticipates obtaining full results for the study, in which 95 patients were enrolled, in the second quarter of 2021.

    "We are pleased to have completed an important next step toward offering a potential breakthrough medicine for millions of people with acquired sensorineural hearing loss and look forward to sharing the full results of the Phase 2a study next year," said Frequency Therapeutics Chief Executive Officer David L. Lucchino. "A critical need for patients with hearing loss is improving the clarity of sound, a basic function that is essential for day-to-day engagement with family and colleagues, and even more so today as many of us communicate remotely. Hearing health is essential for overall health, and our hope is that our new potential restorative therapy also may help address the risks of depression, isolation and dementia associated with long-term hearing loss."

    Lucchino continued, "We deeply appreciate the commitment and compliance of all of the patients that participated in this study, as well as the efforts of our clinical partners, particularly given the challenges posed by the pandemic."

    FX-322 is Frequency's lead product candidate for the treatment of acquired SNHL, which impacts more than 40 million people in the U.S. and hundreds of millions of people globally. SNHL is the primary cause of more than 90 percent of all cases of hearing loss. FX-322 is designed to regenerate auditory sensory hair cells located in the cochlea within the inner ear and to potentially restore hearing in patients with SNHL.

    Acquired SNHL results from damage to the hair cells in the inner ear that normally convert sound waves from the inner ear into signals that are sent to the brain. These auditory sensory hair cells may be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear.

    The Phase 2a study is a randomized, double blind, placebo-controlled, single- and repeat-dose study which enrolled 95 patients, aged 18 to 65, with stable SNHL. Patients in the study were randomized into four dose cohorts and hearing function is being regularly tested over the course of seven months following the first dosing. FX-322 Phase 2a study subjects are randomized to receive either FX-322 or placebo in one ear, with the untreated ear acting as an additional measure of control.

    The objectives of the Phase 2a study are to further establish the hearing signal observed in the completed Phase 1/2 study, evaluate the impact of multiple doses and provide deeper insights on endpoints and the appropriate patient population for future studies. The study is using validated measures of hearing function including word recognition, words-in-noise and pure tone audiometry. Tinnitus and quality-of-life measures will also be evaluated using the Tinnitus Functional Index and the Hearing Handicap Inventory for Adults, respectively.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In an FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in an ongoing Phase 2a clinical study in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a discovery program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Cambridge Enterprises Limited, Massachusetts Eye and Ear, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Phase 2a clinical trial, the timing of top-line data from the Phase 2a clinical trial, the potential of FX-322 to help address the risks of depression, isolation and dementia associated with long-term hearing loss, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Company's on-going and planned clinical trials and business, future milestone and royalty payments under the license and collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company's ability to advance its hearing program and further diversify its portfolio and the potential application of the PCA platform to other diseases.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company's ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company's offices and laboratory facilities, the Company's business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company's need for additional funding to complete development and commercialization of any product candidate; the Company's dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

    These and other important factors discussed under the caption "Risk factors" in the Company's Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  5. Evidence of Durable Hearing Improvements in Follow-Up with Patients from Phase 1/2 Study; Speech Intelligibility and Audibility Sustained for Up to 21 Months After Initial Dosing

    Data Highlighted at the 2020 American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) Annual Meeting

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today presented clinical results from a longer-term durability study of FX-322, showing that some patients with chronic sensorineural hearing loss had significant improvement in key measures of hearing that were sustained for up to 21 months.

    These…

    Evidence of Durable Hearing Improvements in Follow-Up with Patients from Phase 1/2 Study; Speech Intelligibility and Audibility Sustained for Up to 21 Months After Initial Dosing

    Data Highlighted at the 2020 American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) Annual Meeting

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today presented clinical results from a longer-term durability study of FX-322, showing that some patients with chronic sensorineural hearing loss had significant improvement in key measures of hearing that were sustained for up to 21 months.

    These new data build upon Phase 1/2 study results previously detailed at the 2019 AAO-HNS conference that showed, for the first time, statistically significant improvements in word recognition (WR) scores in patients with chronic moderate to moderately severe SNHL. These patients had received a single intratympanic dose of FX-322 in a double-blind, placebo-controlled study, and had been evaluated for 90 days. Subsequent testing of a subset of these patients between 13 and 21 months after initial dosing, showed sustained improvements in measures of speech intelligibility (clarity), and in some patients, increased audibility (volume) threshold values at a higher frequency. Susan King, M.D., FACS, the lead investigator on both studies, detailed results today at the AAO-HNSF 2020 Virtual Annual Meeting & OTO Experience.

    "Historically, patients with acquired chronic SNHL do not regain their lost hearing. The FX-322 Phase 1/2 study has provided promising evidence of clinically meaningful improvements in word recognition, and based on the recent longer-term follow-up data, we believe that this benefit may be sustained for many months following a single dose of this investigational treatment," said Dr. King, co-founder of the Ear Medical Group in San Antonio and Clinical Professor, Department of Otolaryngology, Head and Neck Surgery, The University of Texas Health Science Center at San Antonio. "It is exciting to see sustained clinical benefits in these individuals, and while still early, also to see the potential for a therapeutic that may provide sustained speech intelligibility improvement, which remains an unmet need for hearing loss patients."

    Four of the patients that were observed to have statistically significant WR scores during the Phase 1/2 study had maintained those improvements in the follow up assessment. Three of these patients remained at statistically significant levels, maintaining an average increase of 87 percent in WR scores from their original baseline levels. The other patient maintained a 71 percent increase from their initial baseline, though that sustained improvement fell outside the range of statistical significance. An additional patient who did not achieve statistically significant change in WR during the Phase 1/2 study was also retested, and it was observed that their WR score had returned to baseline.

    Moreover, three of the patients that maintained statistically significant WR scores also showed 10-15dB improvements at 8000Hz compared to their original threshold values at this frequency. The safety profile observed in the FX-322 Phase 1/2 study was favorable and no additional safety findings were observed in the follow-up period. Together, these longer-term clinical data demonstrate the potential for FX-322 to have a durable positive impact both on measures of hearing clarity and volume.

    "Today's announcement is another important building block as we further our understanding of FX-322's drug potential and the patient populations we hope to treat. In addition to a favorable safety profile, we have generated compelling cochlear drug delivery data, and these newly presented results show that the FX-322 benefit to hearing loss may provide individuals with a long-lasting clinical benefit," said David L. Lucchino, Frequency's chief executive officer. "Furthermore, we believe this provides additional evidence supporting the regenerative mechanism of our novel therapeutic approach and a potentially disease modifying treatment. We look forward to sharing data from our ongoing Phase 2a study and to a better understanding of the impact of FX-322 on sound clarity and word recognition that is so critical to hearing health and overall health."

    About FX-322 and Sensorineural Hearing Loss

    FX-322 is Frequency's lead product candidate for the treatment of acquired SNHL. SNHL impacts more than 40 million people in the U.S. and hundreds of millions of people globally and is the primary cause of more than 90 percent of all hearing loss. Acquired SNHL typically results from damage to the hair cells of the inner ear into signals that are sent to the brain. These auditory sensory hair cells may be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. FX-322 is designed to activate progenitor cells (pre-programmed stem cells) and regenerate auditory hair cells in the inner ear (cochlea) to restore hearing function.

    FX-322 is currently being evaluated in a Phase 2a study. The FX-322 Phase 2a study is a randomized, double blind, placebo-controlled, single- and repeat-dose study in which the Company plans to enroll up to 96 patients aged 18 to 65 with SNHL. The objectives of the Phase 2a study are to further establish the hearing signal observed in the completed Phase 1/2 study, evaluate the impact of multiple doses and provide deeper insights on endpoints and the appropriate patient population for future studies. FX-322 Phase 2a study subjects are randomized to receive either FX-322 or placebo in one ear, with the untreated ear acting as an additional measure of control. The study is using validated measures of hearing function including word recognition (WR), words-in-noise and pure tone audiometry. Tinnitus and quality-of-life measures will also be evaluated using the Tinnitus Functional Index and the Hearing Handicap Inventory for Adults, respectively. The Phase 2a study has four dose cohorts, and hearing function will be regularly tested over the course of seven months following the first dosing.

    The FX-322 Phase 2a study remains ongoing and the Company is expected to report study data in the second quarter of 2021.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in an ongoing Phase 2a clinical study in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a discovery program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Phase 2a clinical trial, pace and timing of enrollment for the Phase 2a clinical trial, the timing of top-line data from the Phase 2a clinical trial, the results and implications of the Phase 1/2 durability of response data, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Company's on-going and planned clinical trials and business, increases in headcount, future milestone and royalty payments under the license and collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company's ability to advance its hearing program and further diversify its portfolio and the potential application of the PCA platform to other diseases.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company's ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company's offices and laboratory facilities, the Company's business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company's need for additional funding to complete development and commercialization of any product candidate; the Company's dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

    These and other important factors discussed under the caption "Risk factors" in the Company's Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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