1. 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 that Chief Executive Officer David L. Lucchino will present at the following investor conferences:

    • H.C. Wainwright 23rd Annual Global Investment Conference: On-demand viewing will start Monday, September 13, 2021 at 7:00 a.m. ET
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: Wednesday, September 22, 2021 at 8:15 a.m. ET

    A webcast of the presentations may be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of each presentation will be posted to the Frequency…

    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 that Chief Executive Officer David L. Lucchino will present at the following investor conferences:

    • H.C. Wainwright 23rd Annual Global Investment Conference: On-demand viewing will start Monday, September 13, 2021 at 7:00 a.m. ET
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: Wednesday, September 22, 2021 at 8:15 a.m. ET

    A webcast of the presentations may be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of each presentation will be posted to the Frequency website following the event.

    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. 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 Lexington, 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 Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  2. Company Plans to Commence New FX-322 Phase 2 Study in Q4 2021 in a Refined Population of Individuals with Sensorineural Hearing Loss (SNHL)

    Will Host R&D Event on November 9th to Provide Detailed Insights into FX-322 Clinical Data, Plans for Continued FX-322 Development and New Pipeline Advancements for Hearing Loss and Multiple Sclerosis

    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 second quarter ended June 30, 2021.

    "We have made important progress in our efforts to advance FX-322, our lead program for SNHL, toward…

    Company Plans to Commence New FX-322 Phase 2 Study in Q4 2021 in a Refined Population of Individuals with Sensorineural Hearing Loss (SNHL)

    Will Host R&D Event on November 9th to Provide Detailed Insights into FX-322 Clinical Data, Plans for Continued FX-322 Development and New Pipeline Advancements for Hearing Loss and Multiple Sclerosis

    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 second quarter ended June 30, 2021.

    "We have made important progress in our efforts to advance FX-322, our lead program for SNHL, toward its next step in clinical development. We are now completing a thorough analysis of our FX-322 exploratory clinical studies, which has served to increase our understanding of the etiologies and severities where hearing benefits have been observed in study subjects. Based on the overall learnings from multiple completed studies, we plan to initiate a randomized and well-controlled Phase 2 trial in the fourth quarter of this year, using a single administration of FX-322 in a refined population of subjects with SNHL. In addition, this trial will incorporate several novel study design elements that we believe will help address previously observed study bias," said David L. Lucchino, Frequency's Chief Executive Officer. "In the fourth quarter, we also intend to share topline data from our FX-322 Phase 1b learning study of subjects with severe SNHL (FX-322-113). Our plan is to maintain flexibility in the design of the new Phase 2 trial so we may also incorporate insights from the study of severe SNHL subjects."

    "This November, we will host an R&D event for investors where we will detail findings from all of our FX-322 clinical studies. These insights have provided the basis for our enthusiasm in the program and have informed the design of our upcoming Phase 2 clinical trial. In addition, we plan to discuss other potential near-term and longer-term areas of pipeline expansion, including continued advancements in hair cell regeneration, as well as the progress we have made in our preclinical program for remyelination in multiple sclerosis (MS), our scientific approach toward compound selection and the in vivo data that we believe supports our MS program," Mr. Lucchino concluded.

    Clinical Study Overview and Recent Corporate Highlights

    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 signals sent to the brain. Sensory hair cells may be lost due to noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear.

    Frequency's lead clinical development program has included numerous learning studies that have examined different SNHL severities and etiologies, as well as durability of benefit and the impact of various delivery approaches to best understand target populations and administration approaches for continued FX-322 development. In a Phase 1/2 study of subjects with mild to moderately severe SNHL (FX-322-201) the Company observed statistically significant and clinically meaningful improvements in key measures of hearing loss. In March 2021, the Company shared data from an open-label study of FX-322 (FX-322-111), that, similar to the Phase 1/2 study, showed an improvement in word recognition scores, including a near doubling of these scores in certain patients with stable SNHL.

    FX-322-113 Phase 1b Study in Severe SNHL: In November 2020, Frequency commenced a Phase 1b study in patients aged 18-65 with severe SNHL (FX-322-113). The study is fully enrolled with 31 subjects. The primary objectives of the study are to assess the local and systemic safety of a single dose of FX-322 and evaluate hearing responses in a more severe adult cohort. Study participants are randomized 4:1 to receive either FX-322 or placebo in one ear. Validated measures of hearing function including speech perception and pure tone audiometry are utilized in the study. Safety, otologic and audiologic assessments are being conducted at days 30 and 90 following administration of FX-322 or placebo. Frequency expects to share topline results from this study in Q4 2021.

    Remyelination in Multiple Sclerosis: Frequency continues to advance its preclinical research efforts designed to repair neurological damage in patients with MS. Research efforts are underway to optimize lead compounds with potent remyelination activity that have favorable brain penetration and pharmacokinetic properties. The Company plans to provide additional details on its MS preclinical program at its November 2021 R&D event.

    Support for Patient-Focused Drug Development Event on Sensorineural Hearing Loss: In May 2021, the Company issued a statement of support for the Hearing Loss Association of America's externally led Patient-Focused Drug Development (PFDD) meeting held to address the patient experience in sensorineural hearing loss. The meeting was designed to provide the U.S. Food and Drug Administration (FDA) with an opportunity to hear directly from patients, their families and caregivers, and advocates on the impact of hearing loss on daily life and their experiences with currently available interventions in order to inform the FDA's decisions and oversight both during drug development and review of marketing applications for new drugs.

    Second Quarter 2021 Financial Results

    Cash Position: Cash, cash equivalents and marketable securites as of June 30, 2021 were $175.5 million, as compared to $220.3 million as of December 31, 2020. Based on current plans and assumptions, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into 2023. This guidance does not include potential future milestones which could be received from Astellas for continued FX-322 development.

    Revenue: Revenue was $9.4 million and $14.1 million for the three and six month periods ended June 30, 2021, respectively. The Company had revenue of $8.5 million and $15.8 million in the comparable periods of 2020.

    Research & Development Expenses: Research and development expenses were $17.4 million and $32.5 million for the three and six month periods ended June 30, 2021, respectively, as compared to $8.8 million and $15.4 million for the comparable periods of 2020. The increase was due to increased costs related to the Company's lead product candidate, FX-322, including external development costs related to the Company's ongoing trials for FX-322, as well as increased personnel-related costs due to additional headcount to support the growth of Frequency's research and development organization. Excluding stock-based compensation expense of $3.1 million for the three months ended June 30, 2021 and $4.6 million for the six months ended June 30, 2021, research and development expenses for the three and six months ended June 30, 2021 were $14.3 million and $27.9 million, respectively.

    General and Administrative Expenses: General and administrative expenses were $9.5 million and $19.2 million for the three and six months ended June 30, 2021, respectively, as compared to $6.0 million and $12.2 million for the comparable periods of 2020. The increase was 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 professional fees. Excluding stock-based compensation expense of $3.0 million for the three months ended June 30, 2021 and $6.1 million for the six months ended June 30, 2021, general and administrative expenses for the three and six months ended June 30, 2021 were $6.5 million and $13.1 million, respectively.

    Net Loss: Net loss was $17.7 million and $38.0 million for the three and six months ended June 30, 2021, respectively, as compared to $6.0 million and $10.9 million for the comparable periods of 2020. The increase in net loss reflects the increase in research and development costs associated with the growth of Frequency's research and development organization as well as the increase in general and administrative expenses required to support the growth of Frequency 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. 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 Lexington, 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 Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. 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 initiation, timing and design of the new Phase 2 trial of FX-322, including the ability of study design to address study bias, the interpretation and implications of the results of the Phase 2a, FX-322-111, FX-322-201 and FX-322-112 data, the timing and results of top-line data from the Phase 1b study (FX-322-113) in severe SNHL, the design and timing of future studies of and clinical development path of FX-322, the treatment potential of FX-322, and our program to develop a product candidate for the treatment of multiple sclerosis; the ability of our technology platform to provide patient benefit, the ability to continue to develop our PCA platform and identify additional product candidates, the timing of and content to be disclosed during the R&D event, the timing and progress of the Company's remyelination program, the sufficiency of the Company's capital resources, the implementation of our strategic plans for our business, product candidates and technology, the license and collaboration agreements, including with Astellas Pharma Inc., 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, 2021 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 June 30,

     

     

    Six Months Ended June 30,

     

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Revenue

     

    $

    9,417

     

     

    $

    8,523

     

     

    $

    14,068

     

     

    $

    15,787

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    17,401

     

     

     

    8,764

     

     

     

    32,507

     

     

     

    15,434

     

    General and administrative

     

     

    9,499

     

     

     

    5,959

     

     

     

    19,243

     

     

     

    12,208

     

    Total operating expenses

     

     

    26,900

     

     

     

    14,723

     

     

     

    51,750

     

     

     

    27,642

     

    Loss from operations

     

     

    (17,483

    )

     

     

    (6,200

    )

     

     

    (37,682

    )

     

     

    (11,855

    )

    Interest income

     

     

    118

     

     

     

    178

     

     

     

    143

     

     

     

    888

     

    Interest (expense)

     

     

    (182

    )

     

     

     

     

     

    (400

    )

     

     

     

    Realized (loss) gain on investments

     

     

    (10

    )

     

     

    (4

    )

     

     

    (14

    )

     

     

    65

     

    Foreign exchange (loss) gain

     

     

    (1

    )

     

     

    8

     

     

     

    20

     

     

     

    9

     

    Other (expense), net

     

     

    (88

    )

     

     

     

     

     

    (88

    )

     

     

     

    Loss before income taxes

     

     

    (17,646

    )

     

     

    (6,018

    )

     

     

    (38,021

    )

     

     

    (10,893

    )

    Income taxes

     

     

    (10

    )

     

     

    (7

    )

     

     

    (10

    )

     

     

    (45

    )

    Net loss

     

    $

    (17,656

    )

     

    $

    (6,025

    )

     

    $

    (38,031

    )

     

    $

    (10,938

    )

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

     

    $

    (0.52

    )

     

    $

    (0.19

    )

     

    $

    (1.11

    )

     

    $

    (0.35

    )

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

     

     

    34,238,394

     

     

     

    31,066,686

     

     

     

    34,177,262

     

     

     

    30,967,453

     

    Frequency Therapeutics, Inc.

    Consolidated Balance Sheet Data

    (in thousands)

    (unaudited)

     

     

    June 30, 2021

     

     

    December 31, 2020

     

    Cash, cash equivalents and marketable securities

     

    $

    175,524

     

     

    $

    220,341

     

    Working capital

     

     

    163,333

     

     

     

    198,430

     

    Total assets

     

     

    220,213

     

     

     

    264,722

     

    Total liabilities

     

     

    54,173

     

     

     

    72,231

     

    Accumulated deficit

     

     

    (133,430

    )

     

     

    (95,399

    )

    Total stockholders' equity

     

     

    166,040

     

     

     

    192,491

     

     

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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 that Chief Executive Officer David L. Lucchino will present at two upcoming investor conferences:

    • Jefferies Virtual Healthcare Conference on June 2, 2021 at 2:30 p.m. EDT
    • Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021 at 8:00 a.m. EDT

    A live webcast of the presentations can be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of the presentations will be posted on the Frequency website following the event.

    About Frequency Therapeutics

    Frequency…

    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 that Chief Executive Officer David L. Lucchino will present at two upcoming investor conferences:

    • Jefferies Virtual Healthcare Conference on June 2, 2021 at 2:30 p.m. EDT
    • Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021 at 8:00 a.m. EDT

    A live webcast of the presentations can be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of the presentations will be posted on the Frequency website following the event.

    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. 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 Lexington, 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 Massachusetts Eye and Ear, Mass General Brigham, Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  4. Frequency Therapeutics, Inc., (NASDAQ:FREQ) today shared a statement from David L. Lucchino, Frequency's Chief Executive Officer, in support of the Hearing Loss Association of America (HLAA) and its efforts to advance the voice of the patient in leading the first-ever Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting on sensorineural hearing loss (SNHL).

    Patient-Focused Drug Development meetings are designed to provide the U.S. Food and Drug Administration (FDA) an opportunity to hear directly from patients, their families, caregivers and advocates on the impact of disease on daily life and their experiences with currently available interventions. This input helps inform the FDA's decisions and oversight both during drug development…

    Frequency Therapeutics, Inc., (NASDAQ:FREQ) today shared a statement from David L. Lucchino, Frequency's Chief Executive Officer, in support of the Hearing Loss Association of America (HLAA) and its efforts to advance the voice of the patient in leading the first-ever Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting on sensorineural hearing loss (SNHL).

    Patient-Focused Drug Development meetings are designed to provide the U.S. Food and Drug Administration (FDA) an opportunity to hear directly from patients, their families, caregivers and advocates on the impact of disease on daily life and their experiences with currently available interventions. This input helps inform the FDA's decisions and oversight both during drug development and review of marketing applications for new drugs. This is the first program focused specifically on SNHL, the most common form of hearing loss.

    SNHL typically results from damage to the inner ear, also called the cochlea. This damage may occur 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 worldwide.

    "HLAA has been empowering patients with hearing loss for decades and continues to be at the forefront of championing the needs of individuals impacted by hearing loss. Their efforts are essential to elevating the voice of patients and caregivers by building awareness of the need for greater access to treatment and to advance new areas of innovation. As ongoing research and development progresses for a wide range of therapeutics and modalities to potentially repair or restore hearing, understanding the benefits and gaps in the current standard of care will be crucial in helping inform future discussions on the role of new treatment options for patients and providers. HLAA's impact is evident by the breadth of organizations they have convened for this meeting, spotlighting the extent of the need for new advances in the field of hearing and the impact of hearing health on overall health. Their work to drive this EL-PFDD meeting will provide a crucial window into the lives of individuals who struggle with sensorineural hearing loss, the impact of the condition on their quality of life and the need to bring new solutions to patients in this underserved area of medicine."

    The Externally-Led Patient Focused Drug Development meeting on SNHL will be held on Tuesday, May 25, from 10 a.m. to 3 p.m. ET. Interested parties may register for the virtual interactive meeting through HLAA's website, www.hearingloss.org.

    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. 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 Lexington, 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 Massachusetts Eye and Ear, Mass General Brigham, Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  5. Data From Recent FX-322 Clinical Readouts, Including New Data from Phase 1b Study in Presbycusis (Age-Related Hearing Loss), Further Clarify Acquired Sensorineural Hearing Loss Target Patient Populations and Future Study Design

    Company Anticipates Initiation of New FX-322 Phase 2 Study in H2 2021

    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 first quarter ended March 31, 2021.

    "As we work to develop a novel medicine for the treatment of the most common form of hearing loss, our initial focus has been to investigate…

    Data From Recent FX-322 Clinical Readouts, Including New Data from Phase 1b Study in Presbycusis (Age-Related Hearing Loss), Further Clarify Acquired Sensorineural Hearing Loss Target Patient Populations and Future Study Design

    Company Anticipates Initiation of New FX-322 Phase 2 Study in H2 2021

    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 first quarter ended March 31, 2021.

    "As we work to develop a novel medicine for the treatment of the most common form of hearing loss, our initial focus has been to investigate the broadest set of potential conditions and severities through a comprehensive series of probing studies. With data from all of our single administration studies, we have been able to better define the groups of patients that we believe are responding to FX-322, while also informing the optimal study design for new placebo-controlled Phase 2 trials," said David L. Lucchino, Frequency's Chief Executive Officer.

    Most recently, Frequency completed a Phase 1b study (FX-322-112) in subjects with presbycusis (age-related hearing loss). No subjects enrolled in the 112 study had either noise-induced or sudden sensorineural hearing loss (SSNHL), conditions where FX-322 associated hearing benefits were observed in prior studies. In the 112 study, the Company observed no significant treatment effect with FX-322 administration compared to placebo. Results showed a favorable safety and tolerability profile and, importantly, that the inclusion of multiple baseline hearing tests prior to treatment mitigated the impact of potential study bias (e.g. placebo response) previously observed in Frequency's Phase 2a study (FX-322-202). This lead-in approach was also used in the Company's recently reported open-label study of subjects with mild-to-severe SNHL (FX-322-111). The Company expects to utilize study lead-in measures, and other approaches, to minimize potential bias in future clinical studies.

    "To date, Frequency has shown statistically significant hearing benefits in multiple, independent FX-322 studies and these hearing benefits have been observed in subjects diagnosed with sudden sensorineural or noise-induced hearing loss. Based on the available clinical data, we are able to continue to refine the targeted patient populations we expect to include in our next set of clinical studies, populations that include millions of individuals," Mr. Lucchino concluded.

    Clinical Study Overview and Recent Corporate Highlights

    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.

    In February, findings from Frequency's Phase 1/2 study of FX-322 were published in the journal Otology & Neurotology, which showed statistically significant increases in word recognition (WR) and words-in-noise (WIN) scores. Individuals with stable SNHL that received a single dose of FX-322 showed improvements in the number of words recognized in quiet from baseline to day 90 in the WR test and the level of background noise in which words could be identified in the WIN test.

    These effects also were observed to be durable in four out of the five responders in the study 13 – 21 months following initial administration. In the study, there were no meaningful changes in the WR and WIN scores of the placebo group and FX-322 was also shown to be well tolerated. The publication also includes data demonstrating consistent cochlear drug delivery in both preclinical and human studies.

    The Company's clinical development strategy has been to build off these data and subsequent findings regarding delivery and durability, conducting exploratory studies in subjects with different etiologies and severities of SNHL in order to best understand the population that may be best treated by FX-322.

    FX-322-112 Phase 1b Study in Presbycusis (Age-Related Hearing Loss or ARHL): The recently completed study was a double-blind, placebo-controlled, randomized, multicenter safety study of 30 individuals aged 66-85 with age-related hearing loss. The primary objectives of the study were 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 were randomized 4:1 to receive either FX-322 or placebo in one ear. Validated hearing measures, as well as safety, otologic and audiologic assessments were also evaluated in the study. By design, the study recruited subjects with no medical history of noise-induced or sudden sensorineural hearing loss (SSNHL), etiologies where FX-322 associated hearing benefits were observed in prior studies. This was done as the Company continues to separately evaluate subjects with specific forms of hearing loss to better refine cohorts for future studies. While the treatment effect was not significant compared to placebo, results from the FX-322-112 study showed a favorable safety and tolerability profile, no treatment-related serious adverse events were reported and no meaningful improvements in the placebo group were observed.

    FX-322-111 Phase 1b Study (Open-Label Administration Study): In March 2021, Frequency announced data from a multi-center, randomized open-label study of subjects with mild to severe SNHL (n=33) designed to evaluate the impact of injection conditions on tolerability. Subjects were injected in one ear with FX-322, with the untreated ear as the control. Hearing function was tested over the course of 90 days following dosing. At day 90, thirty-four percent (34%) of the 32 subjects that completed the study achieved a ten percent (10%) or greater absolute improvement in WR scores in the treated ear, which was statistically significant compared to the untreated ear. This included a subset of subjects that more than doubled their WR scores. The single dose had a favorable safety profile and was well tolerated.

    FX-322-202 Phase 2a Study in Mild to Moderately Severe SNHL: In March 2021, the Company announced interim day-90 topline study results. No treatment-related serious adverse events were observed in the study. While WR scores increased across all groups, repeated weekly injections appeared to dampen the hearing benefit observed compared to other single-injection studies and there was no discernible hearing benefit of FX-322 over placebo. The Phase 2a interim results also showed an unexpected apparent level of hearing benefit in the placebo group that did not occur in previous trials and exceeded well-established published standards, potentially suggesting bias due to trial design. The Company expects to utilize lead-in hearing measures, and other study design approaches, in future studies to minimize the risk of study bias. The Company expects to report complete results of the study in late Q2 2021.

    FX-322-113 Phase 1b Study in Severe SNHL: In November 2020, Frequency commenced a Phase 1b study in patients aged 18-65 with severe SNHL. Enrollment remains ongoing. The primary objectives of the study are to assess the local and systemic safety of a single dose of FX-322 and evaluate hearing responses in a more severe adult cohort. Study participants are randomized 4:1 to receive either FX-322 or placebo in one ear. Validated measures of hearing including WR, the Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) test and pure tone audiometry are utilized in the study. Safety, otologic and audiologic assessments are being conducted at days 30 and 90 following administration of FX-322 or placebo. Frequency expects to obtain topline results from this study in the second half of 2021.

    Expanded Clinical Development Team: In April 2021, the Company announced the expansion of its clinical development team with the addition of Jeffery T. Lichtenhan, Ph.D., a leading expert in hearing diagnostics and measurement. He joins Frequency from the Washington University School of Medicine in St. Louis, where he was Assistant Professor of Otolaryngology and Audiology and Communication Sciences. In February 2021, Frequency previously announced the appointment of Kevin Franck, Ph.D., who joined the Company as Senior Vice President of Strategic Marketing and New Product Planning from Massachusetts Eye and Ear, where he served as Director of Audiology and was on the Harvard Medical School Faculty of the Department of Otolaryngology-Head and Neck Surgery.

    Multiple Sclerosis Preclinical Program: Frequency continues to advance preclinical research efforts designed to repair neurological damage in patients with multiple sclerosis. Research efforts remain underway to confirm the optimal candidate for a future clinical program.

    First Quarter 2021 Financial Results

    Cash Position: Cash, cash equivalents and short-term investments on March 31, 2021 were $194.9 million, as compared to $220.3 million on December 31, 2020. Excluding cash payments of approximately $2.0 million made during the first quarter ended March 31, 2021 related to fixed assets and the buildout of the Company's new Lexington facility, cash, cash equivalents, and short-term investments at March 31, 2021 would have been $196.9 million. Based on current plans and assumptions, the Company expects its existing cash, 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 for continued FX-322 development.

    Revenue: Revenue was $4.7 million for the first quarter of 2021. The Company had revenue of $7.3 million in the comparable period of 2020.

    Research & Development Expenses: Research and development expenses were $15.1 million for the first quarter of 2021, as compared to $6.7 million for the first quarter of 2020. The increase was due to increased costs related to the Company's lead product candidate, FX-322, including external development costs related to the Company's ongoing trials for FX-322, as well as increased personnel-related costs due to additional headcount to support the growth of Frequency's research and development organization. Excluding stock-based compensation expense of $1.5 million, research and development expenses for the three months ended March 31, 2021 were $13.6 million.

    General and Administrative Expenses: General and administrative expenses were $9.7 million for the first quarter of 2021, as compared to $6.2 million for the first quarter of 2020. The increase was 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 professional fees. Excluding stock-based compensation expense of $3.1 million, general and administrative expenses for the three months ended March 31, 2021 were $6.6 million.

    Net Loss: Net loss was $20.4 million for the first quarter of 2021, as compared to $4.9 million for the first quarter of 2020. The increase in net loss reflects the increase in research and development costs associated with the growth of Frequency's research and development organization as well as the increase in general and administrative expenses required to support the growth of Frequency 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. 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 Lexington, 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 Massachusetts Eye and Ear, Mass General Brigham, Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. 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 interpretation and implications of the results of the interim day-90 Phase 2a data, the FX-322-112 data and the FX-322-111 data, including advancing FX-322 as a single-dose regimen and re-treatment at longer intervals, the impact of the trial design of the Phase 2a study on clinical data, the timing of results of the Company's clinical studies, including timing of initiation of additional planned studies in FX-322, the treatment potential of FX-322, the ability of our technology platform to provide patient benefit, 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 timing of the Company's remyelination program, the sufficiency of the Company's capital resources, the license and collaboration with Astellas Pharma Inc., 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 May 13, 2021 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

    March 31,

     

     

     

    2021

     

     

    2020

     

    Revenue

     

    $

    4,651

     

     

    $

    7,264

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Research and development

     

     

    15,106

     

     

     

    6,670

     

    General and administrative

     

     

    9,744

     

     

     

    6,249

     

    Total operating expenses

     

     

    24,850

     

     

     

    12,919

     

    Loss from operations

     

     

    (20,199

    )

     

     

    (5,655

    )

    Interest income

     

     

    25

     

     

     

    710

     

    Interest (expense)

     

     

    (218

    )

     

     

     

    Realized (loss) gain on investments

     

     

    (4

    )

     

     

    69

     

    Foreign exchange gain

     

     

    21

     

     

     

    1

     

    Loss before income taxes

     

    $

    (20,375

    )

     

    $

    (4,875

    )

    Income taxes

     

     

     

     

     

    (38

    )

    Net loss

     

    $

    (20,375

    )

     

    $

    (4,913

    )

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

     

    $

    (0.60

    )

     

    $

    (0.16

    )

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

     

     

    34,115,682

     

     

     

    30,868,220

     

     

     

     

     

     

     

     

     

     

    Frequency Therapeutics, Inc.

    Consolidated Balance Sheet Data

    (in thousands)

    (unaudited)

     

     

     

    March 31, 2021

     

     

    December 31, 2020

     

    Cash, cash equivalents and short-term investments

     

    $

    194,909

     

     

    $

    220,341

     

    Working capital

     

     

    181,159

     

     

     

    198,430

     

    Total assets

     

     

    241,511

     

     

     

    264,722

     

    Total liabilities

     

     

    64,104

     

     

     

    72,231

     

    Accumulated deficit

     

     

    (115,774

    )

     

     

    (95,399

    )

    Total stockholders' equity

     

     

    177,407

     

     

     

    192,491

     

     

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  6. Company Announces Appointment of Jeffery Lichtenhan, Ph.D., to Lead Efforts in Hearing Diagnostics and Measurement; Joins Frequency from Washington University Medical School in St. Louis

    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 expansion of its clinical development team with the addition of Jeffery T. Lichtenhan, Ph.D., a leading expert in hearing diagnostics and measurement.

    Dr. Lichtenhan, an auditory neuroscientist, will help to advance the Company's hearing clinical development programs, including its lead program, FX-322, which aims to regenerate sensory…

    Company Announces Appointment of Jeffery Lichtenhan, Ph.D., to Lead Efforts in Hearing Diagnostics and Measurement; Joins Frequency from Washington University Medical School in St. Louis

    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 expansion of its clinical development team with the addition of Jeffery T. Lichtenhan, Ph.D., a leading expert in hearing diagnostics and measurement.

    Dr. Lichtenhan, an auditory neuroscientist, will help to advance the Company's hearing clinical development programs, including its lead program, FX-322, which aims to regenerate sensory hair cells to potentially restore hearing for individuals with sensorineural hearing loss (SNHL). He joins Frequency from the Washington University School of Medicine in St. Louis, where he was Assistant Professor of Otolaryngology and Audiology and Communication Sciences. Dr. Lichtenhan's laboratory has aimed to develop novel, clinically relevant measures of auditory dysfunction and he has published more than 25 peer-reviewed studies on this topic.

    At Frequency, Dr. Lichtenhan will develop strategies to turn laboratory and clinical observations into new, increasingly sensitive diagnostic methodologies to support development of new therapeutics for acquired sensorineural hearing loss, the most common form of hearing loss.

    "We are excited to continue welcoming world-class experts to Frequency and extending our field-leading expertise in hearing science. Jeff's focus on diagnostics and inner ear dysfunction will support our advancement of the FX-322 hearing restoration program into new clinical studies, and more broadly build upon our novel regenerative medicine platform," said David L. Lucchino, Frequency's President and Chief Executive Officer.

    Dr. Lichtenhan's appointment further broadens the Company's internal audiology and hearing science expertise, as Frequency continues to build out its hearing research and development efforts, while working to define specific patient populations where its lead treatment candidate, FX-322, may have the greatest impact. In February, Frequency announced the appointment of Kevin Franck, Ph.D., who joined the Company as Senior Vice President of Strategic Marketing and New Product Planning from Massachusetts Eye and Ear, where he served as Director of Audiology and was on the Harvard Medical School Faculty of the Department of Otolaryngology-Head and Neck Surgery.

    "I am honored to join the team at Frequency and to have the opportunity to align my research expertise with the Company's focus on restoring hearing function," said Dr. Lichtenhan, who joins Frequency in the role of Principal Scientist, Translational Science. "I am thrilled to now build upon the decades of research focused on cellular regeneration and hearing diagnostics and apply it to the Company's mission of transforming treatment for patients with sensorineural hearing loss."

    Dr. Lichtenhan earned his B.S.G. in Speech-Language and Hearing Science, his M.A. in Audiology and his Ph.D. in Speech-Language and Hearing Science from the University of Kansas. He later completed a postdoctoral fellowship in Auditory Physiology at Massachusetts Eye and Ear/Harvard Medical School in the Eaton-Peabody Laboratories. He holds editorial responsibilities at the Journal of the American Academy of Audiology and the American Journal of Audiology. He is also a board-certified audiologist.

    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. 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 Lexington, 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 Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  7. 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 that Chief Executive Officer David L. Lucchino will present a company overview at the 20th Annual Needham Virtual Healthcare Conference.

    Mr. Lucchino's presentation will take place on Wednesday, April 14 at 8:00 a.m. EDT.

    A live webcast of the presentation can be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of the presentation will be posted on the Frequency website following the event.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development…

    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 that Chief Executive Officer David L. Lucchino will present a company overview at the 20th Annual Needham Virtual Healthcare Conference.

    Mr. Lucchino's presentation will take place on Wednesday, April 14 at 8:00 a.m. EDT.

    A live webcast of the presentation can be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of the presentation will be posted on the Frequency website following the event.

    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. 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 Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  8. Recent FX-322 Study Readouts Support Single-Dose Administration as Part of Future Trial Designs; Company Planning Additional Single Injection Studies

    Results from Exploratory FX-322 Phase 1b Studies in Patients with Age-Related and Severe Hearing Loss Anticipated in Q2 and Q3 Respectively

    Company Ends Year with $220 Million in Unrestricted Cash Providing Runway Into 2023

    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 fourth quarter and year ended December 31, 2020.

    "We recently obtained valuable data from two clinical…

    Recent FX-322 Study Readouts Support Single-Dose Administration as Part of Future Trial Designs; Company Planning Additional Single Injection Studies

    Results from Exploratory FX-322 Phase 1b Studies in Patients with Age-Related and Severe Hearing Loss Anticipated in Q2 and Q3 Respectively

    Company Ends Year with $220 Million in Unrestricted Cash Providing Runway Into 2023

    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 fourth quarter and year ended December 31, 2020.

    "We recently obtained valuable data from two clinical studies in patients with sensorineural hearing loss that have provided us with important learnings that already are informing our future development plans for FX-322, specifically around trial design and using a single administration approach in our studies," said David L. Lucchino, Frequency's President and CEO. "Combined with data from our published Phase 1/2 results, we have now shown statistically significant and clinically meaningful improvements in speech intelligibility from two independent, single injection studies that we believe provide encouraging support for FX-322 as a potential novel treatment option as we drive forward in this new area of regenerative medicine."

    Mr. Lucchino continued: "Upcoming readouts from our ongoing studies will be further clarifying, and we will use these insights as we plan for future placebo-controlled FX-322 clinical studies using a single administration regimen. We have utilized a multi-study development approach that enables us to continually learn more about the clinical profile of FX-322, its potential application in different potential populations, as well as how to carry out trials most effectively in this emerging therapeutic area. In Q2, we anticipate results of a FX-322 Phase 1b study in patients with age-related hearing loss and in Q3 results of a FX-322 Phase 1b study of patients with severe sensorineural hearing loss, which will further inform our path forward. There is a tremendous need to advance the standard of care for people with sensorineural hearing loss, and we are grateful to the patient community and all of those that have participated in our clinical studies for their continued support as we work to advance a medicine for hearing restoration."

    FX-322 Day-90 Study Detail and Ongoing Program

    • FX-322 Phase 2a Study Day 90 Topline Results: The Company recently shared interim data from its four-arm, Phase 2a study of FX-322 conducted in 95 subjects aged 18-65 with mild to moderately severe sensorineural hearing loss (SNHL). In the study, all subjects were administered a total of four weekly intratympanic injections comprised of zero, one, two, or four doses of FX-322 with the balance of injections comprised of placebo doses. Subjects were evaluated for hearing improvement using Word Recognition (WR), Words-In-Noise (WIN), pure tone audiometry and additional exploratory measures. While WR scores increased across all groups, repeated weekly injections appeared to dampen the hearing benefit observed compared to other single-injection studies. The Phase 2a interim results also showed an unexpected apparent level of hearing benefit in the placebo group that did not occur in previous trials and exceeded well-established published standards, suggesting bias due to trial design. Given these challenges observed in the Phase 2a study design, there was no discernible hearing benefit of FX-322 over placebo. No treatment-related serious adverse events were observed in the study.
    • FX-322 - 111 Phase 1b: The Company also shared preliminary data from a recently completed open-label, single-dose study of FX-322 (FX-322-111) designed to evaluate the impact of injection conditions on tolerability. In the multi-center, randomized study, subjects with mild to severe SNHL (n=33) were injected in one ear with FX-322, with the untreated ear as the control. Hearing function was tested over the course of 90 days following dosing. At day 90 following dosing, thirty-four percent (34%) of subjects achieved a ten percent (10%) or greater absolute improvement in WR scores in the treated ear, which was clinically meaningful and statistically significant compared to the untreated ear (p <0.05). This included a subset of subjects that more than doubled their WR scores. These data were based on results from 32 of 33 subjects that completed the 90-day clinical assessment period. The single dose had a favorable safety profile and was well tolerated.
    • FX-322 - 112 Phase 1b Study in Age-Related Hearing Loss: In October 2020, Frequency commenced a Phase 1b safety study of FX-322 (FX-322-112) for individuals with age-related hearing loss. The study, which has completed enrollment, is a double-blind, placebo-controlled, randomized, multicenter safety study of 30 individuals aged 66-85 with 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 hearing responses in an older adult cohort. Study participants were randomized 4:1 to receive either FX-322 or placebo in one ear. Validated measures of hearing including WR, WIN and pure tone audiometry are being evaluated. Safety, otologic and audiologic assessments are also being conducted at day 30 and 90 following administration of FX-322 or placebo. Frequency expects to obtain topline results from this study in Q2 2021.
    • FX-322 - 113 Phase 1b Study in Severe SNHL: In November 2020, Frequency commenced a Phase 1b study in patients aged 18-65 with severe SNHL (FX-322-113). Enrollment is continuing for the study of up to 30 individuals. This study employs a similar design and endpoints to the ongoing age-related Phase 1b study. Frequency expects to obtain topline results from this study in Q3 2021.

    Other FX-322 Program Highlights

    • FX-322 Phase 1/2 Publication and Presentation: In February 2021, the results from the completed FX-322 Phase 1/2 study were published in Otology & Neurotology, a leading peer-reviewed journal focused on disorders of the ear. The data demonstrate hearing improvements in adults with acquired SNHL, and the first known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy. The Phase 1/2 study data were also presented at the leading international hearing research conference, the Association for Research in Otolaryngology (ARO) 44th Annual Midwinter Meeting on February 22, 2021.
    • Key Opinion Leader Webcast on Potential for Restorative Treatments for SNHL: In January 2021, Company management and leading hearing loss researchers and clinicians held an investor event to discuss current interventions for the treatment of acquired sensorineural hearing loss (SNHL), unmet medical needs for hearing loss patients and the potential of FX-322 to transform the current standard of care.
    • FX-322 Phase 1/2 Durability Data: In September 2020 at the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) Annual Meeting, data from a Phase 1/2 follow-up study showed that some patients with chronic SNHL had maintained significant improvements in key measures of hearing following a single injection of FX-322. Susan King, M.D., FACS, the lead investigator on both studies, outlined data which showed sustained improvements 13 – 21 months after initial dosing in measures of speech intelligibility (clarity) and in some patients, increased audibility (volume) threshold values at the highest tested frequency.
    • Clinical Data from Exploratory Study Confirming Delivery of FX-322 to the Cochlea: In May 2020, the Company announced top-line data from an exploratory clinical study designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the approach, study results showed measurable concentrations of FX-322 in every sample analyzed and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment.

    2020 and Recent Business Activity:

    • Expanded Leadership Team: The Company recently has made several important leadership hires, building out its finance, manufacturing and pre-commercial functions:
      • Peter P. Pfreundschuh was appointed to the role of Chief Financial Officer in December 2020 to oversee the Company's financial strategy and activities related to accounting, investor relations, business development and business operations. He joined Frequency from UroGen Pharma Ltd., where he served as Chief Financial Officer, Chief Compliance Officer and Corporate Secretary.
      • Quentin McCubbin, Ph.D. was appointed as Chief Manufacturing Officer in January 2021. Dr. McCubbin is overseeing Company technical operations, leading drug product formulation, chemistry manufacturing and controls (CMC) and supply chain, to support the development of Frequency's pipeline of product candidates. He joined Frequency from Cerevel Therapeutics, a clinical-stage biotechnology company where he served as Head of Technical Operations.
      • Kevin Franck, Ph.D. was appointed to the role Senior Vice President of Strategic Marketing and New Product Planning in February 2021. Dr. Franck will lead pre-commercial strategy and launch planning for Frequency's clinical pipeline. A licensed audiologist, Dr. Franck joined Frequency from Massachusetts Eye and Ear, where he served as Director of Audiology and was on the Harvard Medical School faculty in the Department of Otolaryngology-Head and Neck Surgery.
    • Progress on Remyelination Program for Multiple Sclerosis: The Company continues to advance preclinical programs to support the advancement of a therapeutic candidate for remyelination in multiple sclerosis into the clinic.

    Fourth Quarter 2020 Financial Results

    Cash Position: Cash, cash equivalents and short-term investments on Dec. 31, 2020 were $220.3 million. 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 $10.0 million and $37.0 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively. The Company had revenue of $4.7 million and $28.9 million in each of the comparable periods of 2019.

    Research & Development Expenses: Research and development expenses were $11.8 million and $37.4 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively, as compared to $6.2 million and $18.8 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 $8.4 million and $27.1 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively, as compared to $5.0 million and $14.8 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 $10.2 million and $26.5 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively, as compared to $5.5 million and $18.7 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. 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 Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. 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 interpretation and implications of the results of the interim day-90 Phase 2a data and the FX-322-111 data, including advancing FX-322 as a single-dose regimen and re-treatment at longer intervals, the impact of the trial design of the Phase 2a study on clinical data, the timing of results of the Company's clinical studies, the treatment potential of FX-322, the ability of our technology platform to provide patient benefit, 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 timing of the Company's remyelination program, the sufficiency of the Company's capital resources, the license and collaboration with Astellas Pharma Inc., 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-K filed with the Securities and Exchange Commission (SEC) on March 29, 2021 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)

     

     

     

    Three Months Ended December 31,

     

     

    Year Ended December 31,

     

     

    2020

     

     

    2019

     

     

    2020

    2019

    Revenue

     

    $

    9,950

     

     

    $

    4,709

     

     

    $

    36,984

     

     

    $

    28,947

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Royalty

     

     

     

     

     

     

     

     

     

     

     

    16,000

     

    Research and development

     

     

    11,828

     

     

     

    6,196

     

     

     

    37,415

     

     

     

    18,784

     

    General and administrative

     

     

    8,399

     

     

     

    5,001

     

     

     

    27,119

     

     

     

    14,838

     

    Total operating expenses

     

     

    20,227

     

     

     

    11,197

     

     

     

    64,534

     

     

     

    49,622

     

    Loss from operations

     

     

    (10,277

    )

     

     

    (6,488

    )

     

     

    (27,550

    )

     

     

    (20,675

    )

    Interest income

     

     

    32

     

     

     

    942

     

     

     

    994

     

     

     

    1,784

     

    Realized gain on investments

     

     

    19

     

     

     

    50

     

     

     

    84

     

     

     

    138

     

    Foreign exchange gain (loss)

     

     

    (31

    )

     

     

    3

     

     

     

    (4

    )

     

     

    7

     

    Loss before income taxes

     

     

    (10,257

    )

     

     

    (5,493

    )

     

     

    (26,476

    )

     

     

    (18,746

    )

    Income taxes

     

     

    25

     

     

     

    -

     

     

     

    (35

    )

     

     

    -

     

    Net loss

     

     

    (10,232

    )

     

     

    (5,493

    )

     

     

    (26,511

    )

     

     

    (18,746

    )

    Cumulative Series C convertible preferred stock

    dividends

     

     

    -

     

     

     

    (40

    )

     

     

    -

     

     

     

    (1,054

    )

    Net loss attributable to common stockholders

     

    $

    (10,232

    )

     

    $

    (5,533

    )

     

    $

    (26,511

    )

     

    $

    (19,800

    )

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

     

    $

    (0.30

    )

     

    $

    (0.19

    )

     

    $

    (0.82

    )

     

    $

    (2.29

    )

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

     

     

    33,807,943

     

     

     

    28,409,518

     

     

     

    32,253,227

     

     

     

    8,649,245

     

     

    Frequency Therapeutics, Inc.

    Consolidated Balance Sheet Data

    (in thousands)

     

     

     

    December 31, 2020

     

     

    December 31, 2019

     

    Cash, cash equivalents and short-term investments

     

    $

    220,341

     

     

    $

    217,355

     

    Working capital

     

     

    198,430

     

     

     

    168,575

     

    Total assets

     

     

    264,722

     

     

     

    223,218

     

    Total liabilities

     

     

    72,231

     

     

     

    55,860

     

    Accumulated deficit

     

     

    (95,399

    )

     

     

    (68,888

    )

    Total stockholders' equity

     

     

    192,491

     

     

     

    167,358

     

     

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  9. Interim FX-322 Phase 2a Results Show Four Injection Schedule Had No Discernible Hearing Benefit

    Separate FX-322 Phase 1b Study Confirms Hearing Improvement from Single Injection

    Conference call at 8:30am ET today

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), today announced topline, day-90 data from its FX-322 Phase 2a study (FX-322-202). The interim results show that four weekly injections in subjects with mild to moderately severe sensorineural hearing loss (SNHL) did not demonstrate improvements in hearing measures versus placebo. No treatment-related serious adverse events were observed in the study. Frequency also announced new data from a parallel study demonstrating hearing improvement from a single injection of FX-322. The Company…

    Interim FX-322 Phase 2a Results Show Four Injection Schedule Had No Discernible Hearing Benefit

    Separate FX-322 Phase 1b Study Confirms Hearing Improvement from Single Injection

    Conference call at 8:30am ET today

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), today announced topline, day-90 data from its FX-322 Phase 2a study (FX-322-202). The interim results show that four weekly injections in subjects with mild to moderately severe sensorineural hearing loss (SNHL) did not demonstrate improvements in hearing measures versus placebo. No treatment-related serious adverse events were observed in the study. Frequency also announced new data from a parallel study demonstrating hearing improvement from a single injection of FX-322. The Company plans to advance further development of FX-322 as a single dose regimen.

    FX-322 is Frequency's lead product candidate, designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients with SNHL.

    In the four-arm Phase 2a study, 95 subjects aged 18-65 were evaluated for hearing improvement using Word Recognition (WR), Words-In-Noise (WIN), pure tone audiometry and additional exploratory measures. All subjects were administered a total of four weekly intratympanic injections comprised of zero, one, two, or four doses of FX-322 with the balance of injections comprised of placebo doses.

    While WR scores increased across all groups, repeated weekly injections appeared to dampen the hearing benefit observed compared to other single-injection studies. The Phase 2a interim results also showed an unexpected apparent level of hearing benefit in the placebo group that did not occur in previous trials and exceeded well-established published standards, potentially suggesting bias due to trial design. Given these challenges observed in the Phase 2a study design, there was no discernible hearing benefit of FX-322 over placebo.

    "Our FX-322 interim Phase 2a clinical results were unexpected, especially given our prior published Phase 1/2 data. We have already gained important learnings from this study that will inform our future development efforts. The results clearly demonstrated that a treatment regimen using four weekly injections is unfavorable and we will continue to move ahead with single-dose administrations in future studies. We believe in the potential of FX-322 given the demonstrated hearing signal and favorable safety profile observed with a single dose and in the future, we may evaluate re-treatment at longer intervals," said David L. Lucchino, Frequency's President and Chief Executive Officer.

    The Company also announced preliminary results today from a recently completed open-label, single-dose study of FX-322 (FX-322-111) designed to evaluate the impact of injection conditions on tolerability. In the multi-center, randomized study, subjects with mild to severe SNHL (n=33) were injected in one ear with FX-322, with the untreated ear as the control. Hearing function was tested over the course of 90 days following dosing.

    At day 90 following dosing, thirty-four percent (34%) of subjects achieved a ten percent (10%) or greater absolute improvement in WR scores in the treated ear, which was clinically meaningful and statistically significant compared to the untreated ear (p <0.05). This included a subset of subjects that more than doubled their WR scores. The single dose had a favorable safety profile and was well tolerated. These latest results are supportive of the data reported in the prior single dose Phase 1/2 (FX-322-201) study, recently published in the peer-reviewed journal Otology & Neurotology.

    "We now have two independent, single-dose studies showing a hearing signal with FX-322 and with statistically significant improvements in speech intelligibility. More single dose studies are underway to further understand the potential benefit of FX-322 in additional patient populations. Frequency is well resourced, and with the support of our collaborator Astellas Pharma, we will continue to advance development of potential hearing restoration therapeutics for the millions of individuals impacted by sensorineural hearing loss," added Mr. Lucchino. "We are very thankful to the people who participated in our studies and to the staff at all of the sites for their contributions and continued engagement, especially during the pandemic."

    FX-322 Ongoing Development Activities

    Clinical development activities are ongoing to evaluate FX-322's clinical profile in patients with age-related hearing loss (ARHL) and severe SNHL, to identify additional patient populations that may benefit from this potentially restorative therapeutic approach.

    This includes a double-blind, placebo-controlled Phase 1b study (FX-322-112) of subjects with ARHL (ages 66-85), which is fully enrolled with 30 subjects. The primary objectives of the Phase 1b ARHL 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 were randomized 4:1 to receive either FX-322 or placebo in one ear. Validated measures of hearing including WR, WIN and pure tone audiometry were used. Safety, otologic and audiologic assessments were conducted at days 30 and 90 following administration of FX-322 or placebo. Frequency expects to share results from this study in Q2 2021.

    Frequency is also conducting an FX-322 Phase 1b study of up to 30 subjects ages 18-65 with severe SNHL (FX-322-113). This study, which has a similar study design as the ARHL study, is continuing to enroll subjects and results are anticipated in Q3 2021.

    The Company plans to report final results of the Phase 2a study in late Q2 2021.

    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.

    Webcast Details

    Webcast details can be found on the Frequency Therapeutics' investor relations site at https://investors.frequencytx.com/events-and-presentations, or by clicking here to enter the webcast directly.

    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. FX-322 is being evaluated in multiple ongoing clinical studies in subjects with sensorineural hearing loss. The Company is also 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 Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, the Scripps Research Institute and Cambridge Enterprises Limited. 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 interpretation and implications of the results of the interim day-90 Phase 2a data and the FX-322-111 data, including advancing FX-322 as a single-dose regimen and re-treatment at longer intervals, the impact of the trial design of the Phase 2a study on clinical data, the timing of results of the Company's clinical studies, the treatment potential of FX-322, the ability of our technology platform to provide patient benefit, 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 Company's capital resources, the license and collaboration with Astellas Pharma Inc., 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 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.

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  10. Results Published in Leading Peer-Reviewed Otolaryngology Journal, Otology & Neurotology

    Statistically Significant Improvements Observed in Word Recognition Tests in Quiet and in Noise; Suggests Potential to Improve Speech Intelligibility, a Major Unmet Need for Individuals with Hearing Loss

    Company Expects Interim FX-322 Phase 2a Study Data Later 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 announced the publication of its FX-322 Phase 1/2 study results in Otology & Neurotology, a leading peer-reviewed journal focused on disorders of the ear. The data show…

    Results Published in Leading Peer-Reviewed Otolaryngology Journal, Otology & Neurotology

    Statistically Significant Improvements Observed in Word Recognition Tests in Quiet and in Noise; Suggests Potential to Improve Speech Intelligibility, a Major Unmet Need for Individuals with Hearing Loss

    Company Expects Interim FX-322 Phase 2a Study Data Later 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 announced the publication of its FX-322 Phase 1/2 study results in Otology & Neurotology, a leading peer-reviewed journal focused on disorders of the ear. The data show hearing improvements in adults with acquired sensorineural hearing loss (SNHL) and the first-known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy.

    Findings from the Phase 1/2 study of FX-322, the company's lead product candidate to treat SNHL, showed statistically significant increases in word recognition (WR) and words-in-noise (WIN) scores. Individuals with stable SNHL that received a single dose of FX-322 showed improvements in the number of words recognized in quiet from baseline to day 90 in the WR test (p=0.029) and the level of background noise in which words could be identified in the WIN test (p=0.012). There were no meaningful changes in the WR and WIN scores of the placebo group. FX-322 was also shown to be well tolerated. The publication includes data demonstrating consistent cochlear drug delivery in both preclinical and human studies. FX-322 is currently being evaluated in a larger Phase 2a study, with results anticipated later this quarter.

    The study data will be presented today at the leading international hearing research conference, the Association for Research in Otolaryngology 44th Annual MidWinter Meeting.

    "Healthy hearing is not just about the volume of sound, but about the broader ability to communicate. The most frequent complaint from patients with hearing loss is their inability to understand speech, which is due to a lack of clarity and loss of intelligibility where patients can't recognize words and follow conversations, particularly in background noise," said Christina Runge, Ph.D., a professor in the Department of Otolaryngology and Communication Sciences at the Medical College of Wisconsin, Director of the Koss Cochlear Implant Program, a member of the Company's clinical advisory board and an author on the publication. "These Phase 1/2 data are the first to show a potential therapeutic solution to address intelligibility, a key unmet need for those with SNHL."

    SNHL accounts for more than 90 percent of all hearing loss and results from damage to auditory sensory hair cells due to chronic noise exposure, aging, certain viral infections or from toxic medications. SNHL impacts more than 40 million people in the U.S. and hundreds of millions of people globally.

    "Having a treatment that regenerates sensory hair cells would have a profound impact on the field, providing physicians with a meaningful intervention for restoring hearing loss," said Ravi N. Samy, M.D., FACS, Professor of Otolaryngology & Neurosurgery and Chief of the Division of Otology/Neurotology at the University of Cincinnati / Cincinnati Children's. "These exciting early clinical data begin to show the potential of a localized approach to repairing the cochlea, the ability to deliver a treatment to an area of the body that historically has been impossible to access and restore, and above all, clinically meaningful hearing improvements in patients."

    Hearing loss typically begins in higher frequencies and often impacts the ability to hear and distinguish between certain consonants, making it difficult to understand words, especially in noise. Hearing aids amplify sound but do not improve hearing clarity in higher frequencies or repair the underlying damage to the inner ear. FX-322, an injectable treatment candidate made up of two small molecules, is designed to activate progenitor cells (pre-programmed stem cells) to regenerate auditory hair cells in the cochlea and restore hearing function.

    "These Phase 1/2 study data build upon the favorable word recognition performances that we previously reported, while bolstering the trends we saw in words-in-noise scores," said Will McLean, Ph.D., Frequency's Vice President of Biology and Regenerative Medicine, a Company co-founder and the lead author on the paper. "Increases in speech intelligibility and improvements when listening in noisy environments can have a significant impact on quality of life, and we are excited about the potential of our approach for patients and to advance the field of hearing restoration."

    FX-322 Development Program

    FX-322 is Frequency's lead product candidate for the treatment of acquired SNHL. The Phase 1/2 study was a randomized, double-blind, placebo-controlled, single-dose, multi-center study to assess the safety of FX-322 in 23 patients with stable SNHL. Patients received an intratympanic injection of FX-322 or placebo in one ear during an office-based procedure. In the study, 15 patients received a single dose of FX-322 in one ear while eight patients received placebo.

    Of the six patients treated with FX-322 who had baseline word recognition in quiet scores of below 90 percent, four showed clinically meaningful improvements. Also, when assessed at the group level, patients treated with FX-322 outperformed the placebo group in word recognition in a quiet background when averaged across all time points.

    The FX-322 Phase 2a study is a randomized, double-blind, placebo-controlled, single- and repeat-dose study in which the Company enrolled 95 patients aged 18 to 65 with mild to moderately severe SNHL. The study uses validated measures of hearing function including WR, WIN and pure tone audiometry.

    Tinnitus and quality-of-life measures will be evaluated using the Tinnitus Functional Index and the Hearing Handicap Inventory for Adults, respectively, and the study also includes testing of extended high frequencies (up to 16 kHz). 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 Company is conducting Phase 1b clinical studies to evaluate the potential of FX-322 in additional patient groups, including patients with age-related hearing loss and with severe SNHL. The Company is also conducting an open-label safety study looking at the administration conditions for FX-322.

    A link to the publication, Improved Speech Intelligibility in Subjects with Stable Sensorineural Hearing Loss Following Intratympanic Dosing of FX-322 in a Phase 1b Study (W.J. McLean, et. al.) can be found here. The Editor-in-Chief of Otology and Neurotology is Lawrence Lustig, M.D., Chair, Department of Otolaryngology - Head & Neck Surgery at Columbia University.

    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. 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 Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. 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 timing and results of top-line data from the Phase 1b studies in age-related hearing loss and severe SNHL, the implications of the results of the Phase 1/2 data, the timing and results of the open-label safety study evaluating the administration conditions for FX-322, the ability of our technology platform to provide patient benefit, 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 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.

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  11. Dr. Franck joins from Massachusetts Eye and Ear, where he was Director of Audiology and Harvard Medical School Faculty in the Department of Otolaryngology-Head and Neck Surgery

    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 Kevin Franck, Ph.D., as Senior Vice President of Strategic Marketing and New Product Planning. Dr. Franck will lead pre-commercial strategy and launch planning for Frequency's clinical pipeline, including its lead program aimed at developing a restorative treatment for sensorineural hearing loss (SNHL), the most common form of…

    Dr. Franck joins from Massachusetts Eye and Ear, where he was Director of Audiology and Harvard Medical School Faculty in the Department of Otolaryngology-Head and Neck Surgery

    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 Kevin Franck, Ph.D., as Senior Vice President of Strategic Marketing and New Product Planning. Dr. Franck will lead pre-commercial strategy and launch planning for Frequency's clinical pipeline, including its lead program aimed at developing a restorative treatment for sensorineural hearing loss (SNHL), the most common form of hearing loss.

    Dr. Franck is a leader in the hearing field with 25 years of experience including the development and commercialization of medical devices for people with hearing loss. A licensed audiologist, Dr. Franck joins Frequency from Massachusetts Eye and Ear, where he served as Director of Audiology and Harvard Medical School Faculty of the Department of Otolaryngology-Head and Neck Surgery. Prior to Mass Eye and Ear, he was Head of Marketing for Bose Hear, a division of Bose Corporation, where he led new product management and channel marketing of an emerging category of business focused on hearing loss. Dr. Franck co-founded Ear Machine, a startup funded by the National Institutes of Health before it was acquired by Bose in 2014. He has held senior roles at Cochlear Ltd., Artisan Healthcare Consulting and BiOM and worked as a clinician at the University of Michigan and the Children's Hospital of Philadelphia.

    "We are thrilled to have Kevin join Frequency. He has dedicated his career to improving the lives of those with hearing loss by advancing innovative technologies to market, through his work in research, commercial marketing, advocacy and as a clinician," said David Lucchino, Frequency's President and Chief Executive Officer. "Our objective is to help hundreds of millions of people globally with sensorineural hearing loss to more clearly hear speech and sound and to better communicate. Kevin's leadership will be critical as we advance our lead candidate FX-322 in pivotal clinical trials and prepare for potential commercialization in the US, and with our partner Astellas in the rest of the world."

    Dr. Franck holds an MBA in Healthcare Management from the Wharton School of the University of Pennsylvania, a Ph.D. in hearing science from the University of Washington, an MSE in biomedical engineering from Johns Hopkins University and a B.A. in engineering from Dartmouth College. He is the incoming Board Chair of the Hearing Loss Association of America.

    "I'm excited to join Frequency at this important time and contribute to advancing the field toward hearing regeneration," said Dr. Franck. "Currently available hearing devices have been an incomplete solution and many patients continue to struggle to understand speech and with sound clarity. Repairing the underlying damage that is the primary cause of acquired hearing loss has always been the ultimate objective, and Frequency may be on the cusp of addressing this ambitious goal."

    Frequency's lead product candidate FX-322 is designed to treat the underlying cause of SNHL by regenerating sensory hair cells through activation of progenitor cells already present in the cochlea. Sensory hair cells are responsible for amplifying, filtering, tuning and converting sounds, enabling people to clearly understand sounds and speech. The Company plans to share interim day-90 group-level data from its Phase 2a study of FX-322 late in Q1 2021, and is planning an end-of-study data read-out in late Q2 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 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 Massachusetts Eye and Ear, Mass General Brigham and the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited, Cambridge University, UK. . For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  12. 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 Quentin McCubbin, Ph.D., as chief manufacturing officer. Dr. McCubbin will oversee Company technical operations, leading drug product formulation, chemistry manufacturing and controls (CMC) and supply chain, to support the development of Frequency's pipeline of product candidates.

    Dr. McCubbin joins Frequency from Cerevel Therapeutics, a clinical-stage biotechnology company where he served as head of technical operations. Prior to Cerevel, he spent 19 years at Takeda/Millennium Pharmaceuticals in various…

    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 Quentin McCubbin, Ph.D., as chief manufacturing officer. Dr. McCubbin will oversee Company technical operations, leading drug product formulation, chemistry manufacturing and controls (CMC) and supply chain, to support the development of Frequency's pipeline of product candidates.

    Dr. McCubbin joins Frequency from Cerevel Therapeutics, a clinical-stage biotechnology company where he served as head of technical operations. Prior to Cerevel, he spent 19 years at Takeda/Millennium Pharmaceuticals in various roles progressing in responsibility, including six years as vice president of pharmaceutical sciences and global head of process chemistry.

    "Quentin's background and leadership in technical operations will be critical as we prepare for larger studies in support of our lead FX-322 program that aims to treat the most common form of hearing loss, and as we look to diversify and expand our clinical pipeline with a program for remyelination in multiple sclerosis," said David Lucchino, Frequency's President and Chief Executive Officer. "I am excited to have Quentin join our leadership team and believe his operational and technical expertise will play an essential role as we look to advance and commercialize a medicine for the tens of millions of patients in the U.S. with sensorienural hearing loss, and aim to leverage the broad potential of our progenitor cell activation platform."

    Frequency's lead product candidate FX-322 is designed to treat the underlying cause of sensorineural hearing loss (SNHL) by regenerating sensory hair cells by activating progenitor cells already present in the cochlea. Sensory hair cells are responsible for filtering, tuning and converting sounds, enabling people to clearly understand sounds and speech. The Company plans to share interim day-90 group-level data from its Phase 2a study of FX-322 late in Q1 2021, and is planning an end-of-study data read-out in late Q2 2021.

    Dr. McCubbin began his career as a chemist, completing a post-doctoral fellowship at Imperial College in London. He earned his B.S. and Ph.D. in chemistry from Monash University in Australia. He is an inventor on several patents and has published numerous peer-reviewed articles.

    "I'm excited to join Frequency at this critical point in the Company's evolution and to have an opportunity to play a role in advancing potential novel treatments for such profoundly vexing medical conditions," said Dr. McCubbin. "Frequency's platform and small molecule approach provides a unique opportunity to pursue a broad range of degenerative diseases and I'm thrilled to be a part of something with the potential to improve quality of life for so many."

    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.

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  13.  Company to Review FX-322 Clinical Development Program, Progress and Upcoming Milestones for the First Potential Medicine to Treat Sensorineural Hearing Loss

    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 that Chief Executive Officer David L. Lucchino will present a Company overview at the 39th annual J.P. Morgan Healthcare conference.

    Mr. Lucchino's presentation will take place on Wednesday, January 13th at 7:30 a.m. ET. The presentation will be followed by a question and answer session to be held at 8:00 a.m. ET. A live webcast of both the presentation and the breakout…

     Company to Review FX-322 Clinical Development Program, Progress and Upcoming Milestones for the First Potential Medicine to Treat Sensorineural Hearing Loss

    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 that Chief Executive Officer David L. Lucchino will present a Company overview at the 39th annual J.P. Morgan Healthcare conference.

    Mr. Lucchino's presentation will take place on Wednesday, January 13th at 7:30 a.m. ET. The presentation will be followed by a question and answer session to be held at 8:00 a.m. ET. A live webcast of both the presentation and the breakout session can be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of the presentation will be posted on the Frequency website following the event.

    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.

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  14. Event to be Held January 19, 2021 at 8:00 am ET; Will Feature Prominent Otolaryngology and Audiology Key Opinion Leaders

    Phase 2a Day-90 Readout for FX-322, Frequency's Lead Product Candidate, for Acquired Sensorineural Hearing Loss Anticipated in Late Q1 2021; End of Study Readout in Late Q2 2021

    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 plans to host a virtual event and live Q&A session on Tuesday, January 19, 2021 at 8:00 am ET.

    Leading researchers and clinicians, along with Company executives, will discuss current interventions for the treatment of acquired…

    Event to be Held January 19, 2021 at 8:00 am ET; Will Feature Prominent Otolaryngology and Audiology Key Opinion Leaders

    Phase 2a Day-90 Readout for FX-322, Frequency's Lead Product Candidate, for Acquired Sensorineural Hearing Loss Anticipated in Late Q1 2021; End of Study Readout in Late Q2 2021

    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 plans to host a virtual event and live Q&A session on Tuesday, January 19, 2021 at 8:00 am ET.

    Leading researchers and clinicians, along with Company executives, will discuss current interventions for the treatment of acquired sensorineural hearing loss (SNHL), unmet medical needs for hearing loss patients and the potential of FX-322 to transform the current standard of care.

    Presenters to include:

    • Robert S. Langer, Sc.D., Scientific Co-Founder; Member of Frequency's Board of Directors; David H. Koch Institute Professor, Massachusetts Institute of Technology
    • Lawrence R. Lustig, M.D., Chair, Department of Otolaryngology – Head and Neck Surgery, Columbia University
    • René H. Gifford, Ph.D., Professor, Hearing and Speech Sciences, Director, Cochlear Implant Program, Vanderbilt University
    • Frank Lin, M.D., Ph.D., Director, Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health

    FX-322 is being evaluated in an ongoing double-blind, placebo-controlled, single and repeat dose Phase 2a study in patients aged 18 to 65 with mild to moderately severe acquired SNHL. Frequency expects to share day-90 results from the study in late Q1 2021 and end of study results in late Q2 2021. Acquired SNHL is the primary cause of more than 90 percent of all hearing loss, impacting more than 40 million people in the US alone. Efficacy measures for the Phase 2a study 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.

    The Company is also conducting two Phase 1b clinical studies to evaluate the potential of FX-322 to provide benefit to additional patient groups, including patients with age-related hearing loss, and individuals with severe SNHL. Clinical study results are also expected in Q2 2021 for a Phase 1b study of FX-322 in patients with age-related hearing loss and in Q3 2021 for the Phase 1b study in patients with severe SNHL.

    Event Details:

    To join the webcast and live Q&A on Tuesday, January 19, 2021 at 8:00 a.m. ET, please visit the "Investors & Media" section of the Frequency website at www.investors.frequencytx.com. A webcast replay will be archived on the Frequency Therapeutics website for up to 60 days following the event.

    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 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 impact of COVID-19 on the Company's on-going and planned clinical trials and business, 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 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.

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  15. 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 that it has named Peter P. Pfreundschuh as its new chief financial officer. Mr. Pfreundschuh will oversee the Company's financial strategy and activities related to accounting, investor relations, business development and business operations.

    Mr. Pfreundschuh joins Frequency from UroGen Pharma Ltd., a commercial-stage biopharma company, where he served as chief financial officer, chief compliance officer and corporate secretary. He brings to Frequency more than 20 years of finance, business development, commercial and…

    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 that it has named Peter P. Pfreundschuh as its new chief financial officer. Mr. Pfreundschuh will oversee the Company's financial strategy and activities related to accounting, investor relations, business development and business operations.

    Mr. Pfreundschuh joins Frequency from UroGen Pharma Ltd., a commercial-stage biopharma company, where he served as chief financial officer, chief compliance officer and corporate secretary. He brings to Frequency more than 20 years of finance, business development, commercial and public company leadership experience in the life sciences and medical device industries. Prior to joining UroGen, Mr. Pfreudschuh was the CFO of Sucampo Pharmaceuticals Inc., where he co-led the sale of the company to Mallinckrodt, was EVP and CFO of Immunomedics Inc., and was CFO of the heart pump maker, CircuLite Inc. He has also held senior roles across finance, commercial operations and business development within the pharmaceutical industry at AstraZeneca and Johnson & Johnson. Mr. Pfreundschuh started his career as an auditor at Ernst & Young, LLP.

    "We're thrilled to have Peter join us as we drive toward several important milestones in the coming year for our lead product candidate, FX-322, for the treatment of hearing loss, as well as the anticipated expansion of our clinical pipeline with a program for remyelination in multiple sclerosis," said David Lucchino, Frequency's president and chief executive officer. "Peter's background and broad range of life sciences industry experience will be key as we advance our clinical-stage programs, our novel regenerative medicine platform and plans for future growth."

    Mr. Pfreundschuh comes to Frequency as the Company aims to advance development of FX-322, a potential therapeutic for the treatment of sensorineural hearing loss, the most common form of the condition accounting for more that 90 percent of all hearing loss. Frequency anticipates multiple FX-322 study readouts in 2021, including a day-90 readout of all patients in its Phase 2a study late in Q1 2021 and a full Phase 2a study readout late in Q2 2021.

    "I'm excited to join Frequency at this pivotal point in its evolution and to be a part of this dynamic team to pursue the first therapeutic to potentially restore hearing loss," Mr. Pfreundschuh said. "The opportunity to be part of Frequency, and working to address such a prevalent condition and large market, is extraordinary. I'm thrilled to be a part of something so potentially groundbreaking."

    Mr. Pfeundschuh is a certified public accountant and holds a Master of Business Administration in finance from Rider University. He has completed master's coursework in strategic marketing from Northwestern University's Kellogg School of Management and received his Bachelor of Science in accounting from Rutgers University. Mr. Pfreundschuh is currently on the Boards of Speratus Therapeutics Inc., and GitBasic.

    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.

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  16. 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

     

     

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  17. 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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  18. 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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  19. 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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  20. 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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  21. 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 that Company management will be presenting at the following investor conferences and medical meetings:

    • American Academy of Otolaryngology – Head & Neck Surgery (AAO-HNS) 2020 Virtual Annual Meeting & OTO Experience, September 13, 2020, 3:00 p.m. ET
    • Cantor Fitzgerald Global Virtual Global Healthcare Conference, September 17, 2020, 4:00 p.m. ET
    • Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit, September 22, 2020, 10:00 a.m. ET

    The Cantor Fitzgerald and Oppenheimer investor presentations will be available…

    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 that Company management will be presenting at the following investor conferences and medical meetings:

    • American Academy of Otolaryngology – Head & Neck Surgery (AAO-HNS) 2020 Virtual Annual Meeting & OTO Experience, September 13, 2020, 3:00 p.m. ET
    • Cantor Fitzgerald Global Virtual Global Healthcare Conference, September 17, 2020, 4:00 p.m. ET
    • Oppenheimer Virtual Fall Healthcare Life Sciences & MedTech Summit, September 22, 2020, 10:00 a.m. ET

    The Cantor Fitzgerald and Oppenheimer investor presentations will be available via webcast and may be viewed on the Investors & Media section of the Frequency website. A replay of the presentations will be posted on the Frequency website and made available for at least 30 days following each event.

    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, Partners Healthcare and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  22. Expects to Complete Enrollment of FX-322 Phase 2a Study for Sensorineural Hearing Loss by Early Q4 2020; Study Readout Anticipated in Q2 2021

    Recently Announced Clinical Data Show FX-322 Delivery to the Cochlea and Preliminary Evidence of a Durable Clinical Benefit; Plans New Studies in Additional Patient Populations

    Raised $42.3 Million Private Placement, Providing Company Runway into 2023

    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 second quarter ended June 30, 2020.

    "We are pleased with the steady progress…

    Expects to Complete Enrollment of FX-322 Phase 2a Study for Sensorineural Hearing Loss by Early Q4 2020; Study Readout Anticipated in Q2 2021

    Recently Announced Clinical Data Show FX-322 Delivery to the Cochlea and Preliminary Evidence of a Durable Clinical Benefit; Plans New Studies in Additional Patient Populations

    Raised $42.3 Million Private Placement, Providing Company Runway into 2023

    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 second quarter ended June 30, 2020.

    "We are pleased with the steady progress in our Phase 2a study, despite the challenges of the pandemic, and we anticipate completing enrollment early in the fourth quarter of 2020 and sharing data from the study in the second quarter of 2021," said Frequency Therapeutics Chief Executive Officer David L. Lucchino. "In the last quarter, we generated compelling cochlear drug delivery data for FX-322, as well as important durability data suggesting that some patients who were given a single injection of FX-322 in our original Phase 1/2 study maintained statistically significant improvements in word recognition between 12 and 21 months following administration. We believe that these clinical advances are important building blocks as we work to further our understanding of FX-322 drug activity and the patient populations we hope to treat.

    "I also want to thank the medical professionals and patients who have enabled the study to move forward in these difficult conditions. Their commitment, and compliance, gives us great confidence in the quality of data that will be produced."

    Recent Program and Business Updates

    FX-322 Phase 2a Study for Sensorineural Hearing Loss: Patient enrollment for Frequency's FX-322 Phase 2a study has been steady over the second quarter of 2020 and based on current projections, the Company expects to achieve target enrollment by early in the fourth quarter of 2020. Based on this timeline, the Company expects to report study data in the second quarter of 2021. The study is a randomized, double blind, placebo-controlled, single- and repeat-dose study in which the Company may enroll up to 96 patients aged 18 to 65 with stable sensorineural hearing loss (SNHL). In addition, in order to evaluate additional potential patient populations that FX-322 may treat, later this year the Company plans to commence a safety study of FX-322 in patients with age-related hearing loss, and also is evaluating other potential studies.

    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.

    FX-322 Phase 1/2 Durability of Clinical Response Data: In June 2020, the Company shared preliminary findings from a longer-term, follow-up study of five patients that had been treated with FX-322 in the randomized portion of the Phase 1/2 study, and where the Company observed improvement in certain key measures of hearing loss. WR tests were performed for five patients at timepoints between 12- and 21-months following FX-322 administration.

    Four of the patients that were observed to have statistically significant WR scores during the Phase 1/2 study were observed to have maintained the hearing benefit, three of which remained at statistically significant levels. An additional patient who did not achieve a statistically significant improvement in WR during the Phase 1/2 study was also retested and it was observed that the WR score had returned to baseline. The Company plans to share results of this follow-up study at the upcoming American Academy of Otolaryngology – Head & Neck Surgery meeting in September 2020.

    Exploratory Clinical Pharmacokinetic Study Data: In May 2020, Frequency announced top-line data from an exploratory clinical study designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the drug delivery approach, study results showed measurable concentrations of FX-322 in all samples measured and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment, based on computer models.

    Private Placement: In July 2020, the Company completed the issuance and sale of 2,350,108 shares of its common stock in a private placement to institutional and accredited investors, including Wasatch Global, Federated Hermes Kaufmann Funds, RTW Investments, Perceptive Advisors, Driehaus Capital Management, Maven Investment Partners US and Alexandria Venture Investments. The transaction resulted in gross proceeds of $42.3 million and net proceeds to the Company of $40.1 million, after deducting placement agent fees and other offering expenses.

    Update of COVID-19 Impact on Operations: Frequency's offices are located in states that are currently operating under a phased re-opening plan in response to the COVID-19 pandemic. At present, the majority of employees continue to work from home, while nearly a quarter of Frequency's workforce, consisting of mainly laboratory personnel, have periodically worked in rotating teams to ensure the continuation of essential experiments. The Company's Farmington, CT research site, co-located with the University of Connecticut, has resumed activity at a 50 percent level after a period of paused activity due to state lock down orders. Thus, while the Company has resumed experiments at its Farmington site, certain key experiments have been transitioned to its offices in Woburn, MA, while third party and contract research organizations also have been engaged to advance certain projects. The Company also has taken steps consistent with the FDA's updated industry guidance for conducting clinical trials.

    Upcoming Conferences and Investor Events: Frequency executives plan to present at the following upcoming (virtual) events:

    • American Academy of Otolyrangology – Head and Neck Surgery 2020 Meeting and OTO Experience: September 13 – 16, 2020
    • Cantor Fitzgerald Virtual Global Healthcare Conference: September 15 – 17, 2020
    • Oppenheimer Healthcare Fall Summit: September 22 – 23, 2020
    • 2020 Cell and Gene Meeting on the Mesa: October 12 – 16, 2020

    Second Quarter 2020 Financial Results

    Cash Position: Cash, cash equivalents and short-term investments on June 30, 2020 were $195.4 million, as compared to $217.4 million on December 31, 2019. Subsequent to the end of the second quarter, the Company completed a private placement, resulting in $42.3 million in gross proceeds and $40.1 million in net proceeds to the Company, after deducting placement agent fees and other offering expenses.

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

    Revenue: Revenue was $8.5 million and $15.8 million for the three- and six-month periods ended June 30, 2020, respectively. The Company had no revenue in the comparable periods of 2019.

    Research & Development Expenses: Research and development expenses were $8.8 million and $15.4 million for the three- and six-month periods ended June 30, 2020, respectively, as compared to $3.9 million and $7.4 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 $6.0 million and $12.2 million for the three- and six-month periods ended June 30, 2020, respectively, as compared to $3.1 million and $5.6 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 $6.0 million and $10.9 million for the three- and six-month periods ended June 30, 2020, respectively, as compared to $6.9 million and $12.7 million for the comparable periods of 2019. The decrease in net loss in 2020 reflects the recognition of revenue under the agreement with Astellas partially offset by the increase in operating expenses.

    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, Partners Healthcare 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 novelty of the exploratory pharmacokinetic study, the implications of the results of the exploratory pharmacokinetic study in combination with our other trials, the results and implications of the Phase 1/2 durability of response data, expected presentation of such results, the therapeutic levels of FX-322 predicted in the exploratory pharmacokinetic study, the timing of the FX-322 clinical study in patients with age related 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, 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 expected use of proceeds from the private placement, the sufficiency of the Company's cash, cash equivalents, short-term investments and private placement funds, 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 May 14, 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 June 30,

     

    Six Months Ended June 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenue

     

    $

    8,523

     

     

    $

     

     

    $

    15,787

     

     

    $

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    8,764

     

     

     

    3,921

     

     

     

    15,434

     

     

     

    7,367

     

    General and administrative

     

     

    5,959

     

     

     

    3,098

     

     

     

    12,208

     

     

     

    5,568

     

    Total operating expenses

     

     

    14,723

     

     

     

    7,019

     

     

     

    27,642

     

     

     

    12,935

     

    Loss from operations

     

     

    (6,200

    )

     

     

    (7,019

    )

     

     

    (11,855

    )

     

     

    (12,935

    )

    Interest income

     

     

    178

     

     

     

    119

     

     

     

    888

     

     

     

    218

     

    Realized (loss) gain on investments

     

     

    (4

    )

     

     

    26

     

     

     

    65

     

     

     

    26

     

    Foreign exchange gain

     

     

    8

     

     

     

    22

     

     

     

    9

     

     

     

    13

     

    Loss before income taxes

     

    $

    (6,018

    )

     

    $

    (6,852

    )

     

    $

    (10,893

    )

     

    $

    (12,678

    )

    Income taxes

     

     

    (7

    )

     

     

     

     

     

    (45

    )

     

     

     

    Net loss

     

    $

    (6,025

    )

     

    $

    (6,852

    )

     

    $

    (10,938

    )

     

    $

    (12,678

    )

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

     

    $

    (0.19

    )

     

    $

    (3.42

    )

     

    $

    (0.35

    )

     

    $

    (6.67

    )

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

     

     

    31,066,686

     

     

     

    2,005,054

     

     

     

    30,967,453

     

     

     

    1,902,092

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Frequency Therapeutics, Inc.

    Consolidated Balance Sheet Data

    (in thousands)

    (unaudited)

     

     

     

    June 30, 2020

     

    December 31, 2019

    Cash, cash equivalents and short-term investments

     

    $

    195,379

     

     

    $

    217,355

     

    Working capital

     

     

    157,259

     

     

     

    168,575

     

    Total assets

     

     

    204,786

     

     

     

    223,218

     

    Total liabilities

     

     

    43,085

     

     

     

    55,860

     

    Accumulated deficit

     

     

    (79,826

    )

     

     

    (68,888

    )

    Total stockholders' equity

     

     

    161,701

     

     

     

    167,358

     

     

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  23. 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 that it has agreed to sell 2,350,108 shares of its common stock in a private placement to institutional and accredited investors. Institutional investors in the private placement included Wasatch Global, Federated Hermes Kaufmann Funds, RTW Investments, Perceptive Advisors, Driehaus Capital Management, Maven Investment Partners US and Alexandria Venture Investments, in addition to other new and existing investors. The transaction is expected to result in gross proceeds to the Company of approximately $42.3 million, based…

    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 that it has agreed to sell 2,350,108 shares of its common stock in a private placement to institutional and accredited investors. Institutional investors in the private placement included Wasatch Global, Federated Hermes Kaufmann Funds, RTW Investments, Perceptive Advisors, Driehaus Capital Management, Maven Investment Partners US and Alexandria Venture Investments, in addition to other new and existing investors. The transaction is expected to result in gross proceeds to the Company of approximately $42.3 million, based on a price of $18.00 per share, before deducting placement agent fees and other expenses. The closing of the private placement is subject to customary closing conditions and is expected to occur on July 20, 2020.

    The Company plans to use the net proceeds from the private placement to further advance the clinical development of FX-322, its lead product candidate in Phase 2a development for sensorineural hearing loss, by gaining additional insights regarding the patient populations and severity of hearing loss that FX-322 may treat. The Company also plans to increase support for its remyelination program in multiple sclerosis, which it intends to move into the clinic in the second half of 2021, and new areas of research where there is potential to utilize the Company's progenitor cell activation platform.

    Cowen and Company, LLC served as the placement agent for the private placement.

    "We are very pleased with recent clinical advances demonstrating both delivery of FX-322 to the site of action within the cochlea and the durable hearing response seen in patients from our Phase 1/2 study. This additional investment will further support our ongoing FX-322 development efforts to bring a potential disease modifying therapeutic forward to the millions of individuals suffering from hearing loss, and apply our regenerative medicine platform to other serious degenerative diseases including our remyelination work in multiple sclerosis," said David L. Lucchino, Chief Executive Officer of Frequency Therapeutics.

    The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the Securities Act), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.

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

    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 study. 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, Partners Healthcare and the Massachusetts Institute of Technology.

    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 timing and completion of the private placement, the gross proceeds generated from the private placement, the expected use of proceeds from the private placement, the sufficiency of this financing to support ongoing development efforts, the ability of FX-322 to be a disease modifying therapeutic, and the ability of FX-322 to regenerate auditory hair cells and restore hearing function.

    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 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; disruptions to the Company's business and operations due to COVID-19; 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 May 14, 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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  24. Phase 2a Study of FX-322 for Sensorineural Hearing Loss Continues Enrollment at Multiple Sites

    Shares Top-Line Data from Exploratory Clinical Study Confirming Delivery of FX-322 to the Cochlea

    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 first quarter ending March 31, 2020.

    "Our Phase 2a study of FX-322 for sensorineural hearing loss continues to enroll subjects at a number of clinical sites, despite challenges from the COVID-19 pandemic. Overall, we are pleased with our progress and we deeply appreciate the work…

    Phase 2a Study of FX-322 for Sensorineural Hearing Loss Continues Enrollment at Multiple Sites

    Shares Top-Line Data from Exploratory Clinical Study Confirming Delivery of FX-322 to the Cochlea

    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 first quarter ending March 31, 2020.

    "Our Phase 2a study of FX-322 for sensorineural hearing loss continues to enroll subjects at a number of clinical sites, despite challenges from the COVID-19 pandemic. Overall, we are pleased with our progress and we deeply appreciate the work of our investigators, site staff and the engagement of the patients participating in the study during this challenging period," said Frequency Therapeutics Chief Executive Officer David L. Lucchino.

    "Today, we also shared top-line data from a new exploratory clinical study that showed in all study patients that FX-322 was delivered to the intended target within the cochlea at drug levels that could be directly measured. Further, concentrations of FX-322 were predicted to be therapeutically active. With these new data, we have now collectively observed three key elements in FX-322's clinical development trajectory: effective delivery to the target tissue, a favorable safety profile, and clinically meaningful improvements in hearing function.

    "The cochlea is one of the most privileged and difficult-to-reach sites in the body. Quantifying drug concentrations of a potential restorative medicine in the cochlea represents an important advance in inner-ear drug discovery," Mr. Lucchino continued. "This advance furthers Frequency's leadership in hearing regeneration and our enthusiasm for the potential of FX-322 to benefit the millions of individuals suffering from sensorineural hearing loss."

    Recent Program and Business Updates

    FX-322 Phase 2a Study for Sensorineural Hearing Loss: The FX-322 Phase 2a study is a randomized, double-blind, placebo-controlled, single- and repeat-dose study that may enroll up to 96 patients aged 18 to 65 with stable sensorineural hearing loss (SNHL). The objectives of the Phase 2a study are to further establish the hearing benefits observed in the Phase 1/2 study; evaluate the impact of multiple doses; and provide insights on endpoints and the appropriate patient populations for future studies. 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 Company has continued to observe an impact to study operations related to COVID-19. A number of study sites had previously communicated that they temporarily halted enrollment and continue to do so. The Company expects the COVID-19 pandemic may result in other clinical sites being similarly affected for an unknown period of time, slowing or temporarily halting patient enrollment and potentially impacting patient retention. However, principal investigators have reported that patients currently enrolled in the study have remained enrolled and that sites continue to be able to follow the study protocol. Since early March, coincident with the timing of increased COVID-19 related disruptions, patient enrollment has continued and new clinical sites have been activated.

    Frequency continues to evaluate the anticipated timing for reporting top-line data from the Phase 2a study.

    New Exploratory Clinical Study Data: In a separate press release issued today, Frequency announced top-line data from an exploratory clinical study conducted in Germany, designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the approach, study results showed measurable concentrations of FX-322 in every patient and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment, based on computer models.

    The study results were based on analyzing samples of cochlear fluid, known as perilymph, taken intraoperatively from patients undergoing cochlear implant surgery. Each patient received a single intratympanic injection of FX-322, enabling researchers to directly measure the level of FX-322 in perilymph, which is not otherwise feasible in inner-ear studies because accessing the cochlea involves an invasive surgical procedure.

    These data, combined with Phase 1/2 study results of FX-322 where the Company observed statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss, may show the first known evidence of a pharmacokinetic/pharmacodynamic effect of a potential hearing restoration therapeutic.

    Frequency intends to present the results from this study at an upcoming medical conference.

    COVID-19 Impact on Business Operations:

    Frequency's offices are located in states that are currently under mandated lock down orders and/or stay at home advisories, though in Massachusetts, biotechnology firms have been deemed essential and are exempted from such orders. At present, the majority of Frequency employees are working from home, while certain necessary laboratory employees have periodically worked in the lab to ensure that essential experiments continue. The Farmington, CT research site, co-located with the University of Connecticut, has paused activity and this site is expected to re-open when non-essential State offices are permitted to do so. Key experiments have been transitioned to the Company's offices in Woburn, MA and third parties and contract research organizations have been engaged to advance certain projects.

    First Quarter 2020 Financial Results

    Cash Position: Cash, cash equivalents and short-term investments on March 31, 2020 were $206.1 million, as compared to $217.4 million on December 31, 2019. Based on current plans and assumptions, the Company expects its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022. This guidance does not include potential future milestones which could be received from Astellas for continued FX-322 development.

    Revenue: Revenue was $7.3 million for the first quarter of 2020. The Company had no revenue in the comparable period of 2019.

    Research & Development Expenses: Research and development expenses were $6.7 million for the first quarter of 2020, as compared to $3.4 million for the first quarter of 2019. The increase was due to increased costs related to the Company's lead product candidate, FX-322, including external development costs as the Company commenced a Phase 2a clinical trial for FX-322 in October 2019, 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 $6.2 million for the first quarter of 2020, as compared to $2.5 million for the first quarter of 2019. The increase was 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 $4.9 million for the first quarter of 2020, as compared to $5.8 million for the first quarter of 2019. The decrease was primarily due to the impact of recognizing $7.3 million of revenue under the Astellas license and collaboration agreement which was partially offset by increases in research and development and general and administrative expenses.

    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. 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, Partners Healthcare 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 and timing of presentation of results of the exploratory study in Germany, the novelty of the exploratory study in Germany, the implications of the results of the exploratory Germany study in combination with our other trials, the therapeutic levels of FX-322 predicted in the exploratory Germany 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 sufficiency of the Company's cash, cash equivalents and short-term investments, 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 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-K filed with the Securities and Exchange Commission (SEC) on March 26, 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

    March 31,

     

     

    2020

     

     

    2019

     

    Revenue

     

    $

    7,264

     

     

    $

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Research and development

     

     

    6,670

     

     

     

    3,446

     

    General and administrative

     

     

    6,249

     

     

     

    2,470

     

    Total operating expenses

     

     

    12,919

     

     

     

    5,916

     

    Loss from operations

     

     

    (5,655

    )

     

     

    (5,916

    )

    Interest income

     

     

    710

     

     

     

    99

     

    Realized gain on investments

     

     

    69

     

     

     

     

    Foreign exchange gain (loss)

     

     

    1

     

     

     

    (9

    )

    Loss before income taxes

     

    $

    (4,875

    )

     

    $

    (5,826

    )

    Income taxes

     

     

    (38

    )

     

     

     

    Net loss

     

    $

    (4,913

    )

     

    $

    (5,826

    )

    Net loss per share attributable to common stockholders-basic and

    diluted

     

    $

    (0.16

    )

     

    $

    (3.24

    )

    Weighted-average shares of common stock outstanding-basic and

    diluted

     

     

    30,868,220

     

     

     

    1,797,986

     

    Frequency Therapeutics, Inc.

    Consolidated Balance Sheet Data

    (in thousands)

    (unaudited)

     

     

    March 31,

    2020

     

     

    December 31,

    2019

     

    Cash, cash equivalents and short-term investments

     

    $

    206,113

     

     

    $

    217,355

     

    Working capital

     

     

    166,213

     

     

     

    168,575

     

    Total assets

     

     

    215,721

     

     

     

    223,218

     

    Total liabilities

     

     

    50,872

     

     

     

    55,860

     

    Accumulated deficit

     

     

    (73,801

    )

     

     

    (68,888

    )

    Total stockholders' equity

     

     

    164,849

     

     

     

    167,358

     

     

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  25. Top-Line Results Show Consistent Drug Entry in All Patients

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), today announced top-line data from an exploratory clinical study designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the approach, study results showed measurable concentrations of FX-322 in every patient and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment.

    FX-322 is Frequency's lead product candidate, designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients…

    Top-Line Results Show Consistent Drug Entry in All Patients

    Frequency Therapeutics, Inc. (NASDAQ:FREQ), today announced top-line data from an exploratory clinical study designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the approach, study results showed measurable concentrations of FX-322 in every patient and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment.

    FX-322 is Frequency's lead product candidate, designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients with sensorineural hearing loss (SNHL). A Phase 1/2 study of FX-322 previously demonstrated statistically significant and clinically meaningful improvements in key measures of hearing function in patients with SNHL.

    The exploratory study, initiated late in 2019, was conducted at the Hannover Medical Centre in Hannover, Germany. Results were based on an analysis of cochlear fluid, known as perilymph, obtained intraoperatively from patients undergoing cochlear implant surgery. Each patient received a single intratympanic injection of FX-322, enabling researchers to directly measure the level of FX-322 in perilymph, which is not otherwise feasible in inner-ear studies because accessing the cochlea involves an invasive surgical procedure.

    "When we consider these new findings, together with the hearing signal observed in our earlier Phase 1/2 study, we believe we have developed the first known evidence of a pharmacokinetic/pharmacodynamic effect of a potential hearing restoration therapeutic. Through this study we have gained critical insight into the delivery properties of FX-322 and clinical confirmation that it reached the site of action in all study patients," said Carl LeBel, Ph.D., Frequency's Chief Development Officer.

    In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company's Phase 1/2 study and its ongoing Phase 2a study. Levels of both molecules that make up FX-322 were measured in all patients. The presence of round window membrane mucosal folds in certain subjects did not prevent the entry of FX-322 into the cochlea. Both agents that make up FX-322 were also predicted to achieve therapeutically active drug levels in the high frequency range of the cochlea, based on computer models. Study subjects were followed for approximately 30 days after the procedure and no serious treatment related adverse events were observed.

    "Studying perilymph samples from all our cochlear implant patients has helped us to better understand the connection between certain proteins and their association with inner ear disorders. This study has now shown us for the first time that concentrations of a hearing restoration therapeutic candidate can be quantified in perilymph after intratympanic injection, and we believe this novel approach can help accelerate the understanding of therapeutics for the inner ear," said Prof. Thomas Lenarz, Director of the Ear, Nose and Throat Clinic and the German Hearing Center of the Hannover Medical School and the principal investigator for the study.

    Frequency intends to present the results from this study at an upcoming medical conference.

    About Sensorineural Hearing Loss

    Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to the hair cells in the inner ear that convert sound waves from the inner ear to the brain, impacting millions of individuals in the U.S. and worldwide. 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.

    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 study. 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, Partners Healthcare 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 novelty of the exploratory study in Germany, the timing of presentation or publication of results of the exploratory study in Germany, the implications of the results of the exploratory Germany study in combination with our other trials, the therapeutic levels of FX-322 predicted in the exploratory Germany study, the ability of our technology platform to provide patient benefit, estimates of the size of the hearing loss population and population at risk for hearing loss 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 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-K filed with the Securities and Exchange Commission (SEC) on March 26, 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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  26. Phase 2a Study of FX-322 for Sensorineural Hearing Loss Remains Ongoing

    Strong Cash Position at End of 2019 Providing Runway into 2022; Potential for Meaningful FX-322 Development Milestones

    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 fourth quarter and year ended December 31, 2019.

    "2019 was an important year in Frequency's growth and evolution and we believe our business remains well positioned as we work to develop the first restorative, disease-modifying treatment for the millions of patients with sensorineural…

    Phase 2a Study of FX-322 for Sensorineural Hearing Loss Remains Ongoing

    Strong Cash Position at End of 2019 Providing Runway into 2022; Potential for Meaningful FX-322 Development Milestones

    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 fourth quarter and year ended December 31, 2019.

    "2019 was an important year in Frequency's growth and evolution and we believe our business remains well positioned as we work to develop the first restorative, disease-modifying treatment for the millions of patients with sensorineural hearing loss," said Frequency Therapeutics Chief Executive Officer David Lucchino. "We are continuing our Phase 2a exploratory study of FX-322, building upon the statistically significant hearing signal we observed in our Phase 1/2 safety study, and Phase 2a study enrollment has been steady. However, the COVID-19 pandemic has had an impact and we are working closely with our principal investigators, who are based primarily at private clinics across the U.S., to advance the trial. We will provide updated timing on the reporting of top-line data from this study as we learn more. We do believe that, if necessary, we could achieve the key objectives of the study with fewer subjects than originally designed. We deeply appreciate the ongoing engagement and collaboration with the sites and their focus on ensuring patient safety while maintaining study integrity. Our top priority is the well-being of study patients, the site investigators, their staff and our employees."

    Mr. Lucchino added, "We also continue to make progress toward advancing a candidate to the clinic for remyelination in multiple sclerosis, for which we intend to file an investigational new drug application in the second half of 2021, while we further explore a wide range of potential new degenerative disease targets where we can leverage our progenitor cell activation approach."

    Recent Program and Business Updates

    • FX-322 Phase 2a Study for Sensorineural Hearing Loss: The FX-322 Phase 2a study is a randomized, double-blind, placebo-controlled, single- and repeat-dose study in which the Company may enroll up to 96 patients aged 18 to 65 with stable sensorineural hearing loss (SNHL). The objectives of the study are to further establish the hearing signal observed in the Phase 1/2 study; evaluate the impact of multiple doses; and provide insights on endpoints and patient population for future studies. 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, words-in-noise and pure tone audiometry. Tinnitus and quality-of-life measures will also be subjectively evaluated using the Tinnitus Functional Index and the Hearing Handicap Inventory for Adults, respectively. This study builds upon the Phase 1/2 safety study in which the Company observed statistically significant and clinically meaningful improvements in word recognition (clarity of sound) in some subjects with a single dose of FX-322. The Phase 2a study has four dose cohorts and hearing function will be regularly tested over the course of seven months.



      The Company believes the Phase 2a study is the first of its kind in which all enrolled subjects are carefully screened to ensure that their hearing deficit has remained stable. Unlike the Phase 1/2 safety study, where most patients had near-perfect word recognition scores, this stringent enrollment criterion was implemented to help ensure that study subjects have a SNHL deficit that FX-322 may address. As of today, study enrollment is approximately at the halfway point based on its original design.



      Frequency already has observed an impact to study operations from COVID-19 as several study sites have informed Frequency that they have temporarily halted enrollment in the study. The Company expects the pandemic may result in other clinical sites being similarly affected for an unknown period of time, slowing or temporarily halting patient enrollment and potentially impacting patient retention. The Company believes, if necessary, that it would be able to achieve the key objectives of the study with fewer subjects than originally designed. Frequency intends to provide more specific guidance regarding the timing of the reporting of top-line data from the Phase 2a study once the impact of the pandemic is better understood.
    • Strengthened Leadership Team: In February 2020, Frequency announced new appointments to its leadership team with the addition of Wendy Arnold as Chief People Officer and Dr. Lisa Geller as the Company's Head of Intellectual Property. Ms. Arnold has held senior human resources roles at Kaleido BioSciences, Moderna Therapeutics, Celgene, Predictive Biosciences and Inotek Pharmaceuticals. Dr. Geller is an experienced patent attorney with both law firm and in-house experience in the biotechnology and pharmaceutical sectors. Prior to joining Frequency, she held senior roles at Casebia Therapeutics, Seres Therapeutics, Eleven Biotherapeutics and Biogen, and worked at the law firms of Wilmer Cutler Pickering Hale & Dorr and Fish & Richardson P.C.
    • New Corporate Headquarters: In January 2020, Frequency entered into an agreement for the lease of new space in Lexington, Mass., for its headquarters, which it plans to occupy beginning in early 2021. The new site will include laboratory facilities for research and development and will accomodate employees from the Company's current Farmington, CT labs. As of February 29, 2020, Frequency had 64 employees.

    2019 Highlights:

    • Initiation of FX-322 Phase 2a Study for Sensorineural Hearing Loss (October 2019): The Phase 2a clinical trial is a multi-center, randomized, double-blind, placebo-controlled, single- and repeat-dose study of FX-322, which may enroll up to 96 adults aged 18 to 65 with stable sensorineural hearing loss.
    • FX-322 Fast Track Designation (October 2019): The United States Food and Drug Administration (FDA) granted Fast Track designation for FX-322. This designation is intended to facilitate development of new therapies for serious conditions with unmet medical need, expedite review, and enable more frequent engagement between the Company and the FDA regarding study planning and design.
    • Completion of Two Equity Financings Including Initial Public Offering (October and July 2019): Frequency raised $150.6 million in gross proceeds in 2019 through equity financings. Its initial public offering of 6,325,000 shares of common stock, at the offering price of $14.00 per share, yielded total gross proceeds of approximately $88.6 million. Frequency common stock began trading on the Nasdaq Global Select Market on October 3, 2019 under the ticker symbol "FREQ". J.P. Morgan Securities, LLC, Goldman Sachs & Co. LLC and Cowen and Company, LLC were joint book-running managers for the offering. Earlier in the year, the Company closed a $62.0 million Series C financing, led by Perceptive Advisors and a syndicate that included new investors Deerfield Management, RTW Investments and Mizuho Securities Principal Investment, as well as existing investors.
    • Astellas License and Collaboration Agreement for FX-322 (July 2019): Frequency and Astellas Pharma Inc. entered into an exclusive license agreement to develop and commercialize FX-322 for the treatment of SNHL. Under the terms of the agreement, Astellas is responsible for the development and commercialization of FX-322 outside of the U.S. and Frequency is responsible for U.S. development and commercialization. The companies are jointly responsible for conducting global clinical studies and coordinating commercial launch activities. Frequency received an upfront payment of $80 million and may also receive up to an additional $545 million based on development and commercial milestones, as well as royalties on any future product sales in the licensed territory. Specifically, the Company would receive development milestone payments of $65.0 million and $25.0 million upon the first dosing of a patient in a Phase 2b clinical trial for SNHL in Europe and Asia, respectively, and $100.0 million and $40.0 million upon the first dosing of a patient in a Phase 3 clinical trial for SNHL in Europe and Asia, respectively. If the Astellas licensed products are successfully commercialized, Frequency would be eligible for up to $315.0 million in potential commercial milestone payments plus tiered royalties at rates ranging from low- to mid-teen percentages. Frequency continues to maintain all FX-322 product rights for the United States.

    Fourth Quarter and Full Year 2019 Financial Results

    Cash Position: Cash, cash equivalents and short-term investments at December 31, 2019 were $217.4 million, as compared to $42.2 million at December 31, 2018. Cash, cash equivalents and short-term investments at December 31, 2019 reflect the net proceeds of the Company's initial public offering, $79.7 million, which closed in October 2019, the $80.0 million upfront payment received from Astellas in July 2019 under the license and collaboration agreement and the $62.0 million Series C financing closed in July 2019. Based on its current plans and assumptions, the Company expects its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022. This guidance does not include potential future milestones which could be received from Astellas for continued FX-322 development.

    Revenue: Revenue was $4.7 million for the fourth quarter of 2019 and $28.9 million for the year ended December 31, 2019. The Company had no revenue in the comparable periods of 2018. In accordance with the Company's revenue recognition policy, the $80.0 million upfront payment received from Astellas under the license and collaboration agreement in July 2019 is being recognized as revenue over the period from the execution of the agreement until Frequency meets its obligation to complete a Phase 2a clinical trial for FX-322.

    Royalties: Royalty expense was $16.0 million for the year ended December 31, 2019 representing the royalty due to the Massachusetts Institute of Technology on the $80.0 million upfront payment from Astellas. This was paid and expensed in the third quarter of 2019 upon entering into the license and collaboration agreement with Astellas.

    Research & Development Expenses: Research and development expenses were $6.2 million for the fourth quarter of 2019 and $18.8 million for the year ended December 31, 2019, as compared to $2.9 million for the fourth quarter of 2018 and $11.9 million for the year ended December 31, 2018. The increase was primarily due to increased costs related to the Company's lead product candidate, FX-322, including external development costs as the Company commenced a Phase 2a clinical trial for FX-322 in October 2019, 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 $5.0 million for the fourth quarter of 2019 and $14.8 million for the year ended December 31, 2019, as compared to $2.4 million for the fourth quarter of 2018 and $7.1 million for the year ended December 31, 2018. The increase was 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 and consulting and professional fees.

    Net Loss: Net loss was $5.5 million for the fourth quarter of 2019 and $18.7 million for the year ended December 31, 2019, as compared to $5.4 million for the fourth quarter of 2018 and $19.2 million for the year ended December 31, 2018. The decrease was primarily due to the impact of recognizing $28.9 million of revenue under the Astellas license and collaboration agreement which was partially offset by the $16.0 million royalty expense and increases in research and development and general and administrative expenses.

    About Sensorineural Hearing Loss

    Sensorineural hearing loss (SNHL) is the most common form of hearing loss, resulting from damage to the hair cells in the inner ear or problems with the nerve pathways that convert sound waves from the inner ear to the brain. Hair cells are commonly lost due to chronic noise exposure, or as a result of aging, certain viral infections or exposure to ototoxic drugs. The World Health Organization (WHO) estimates that there are currently more than 800 million adults with hearing loss globally and that 1.1 billion children and adults ages 12 to 35 years old are at risk for hearing loss from recreational noise exposure. According to the U.S. National Institutes of Health, more than 90 percent of those with hearing loss are affected by SNHL.

    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. 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, Partners Healthcare 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 novelty of the Phase 2a clinical trial, the timing of top-line data from the Phase 2a clinical trial, the initiation of clinical studies in additional hearing loss patients, the timing of filing an IND for the remyelination program, the ability of our technology platform to provide patient benefit, the data from the Phase 2a trial informing future studies, the impact of COVID-19 on the Company's on-going and planned clinical trials and business, the timing for occupying, and the intended use of, the Company's new corporate headquarters, increases in headcount, the intended purpose of Fast Track designation, 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 sufficiency of the Company's cash, cash equivalents and short-term investments, 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 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 18, 2019 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 Balance Sheet Data

    (in thousands)

     

     

     

    As of December 31,

     

     

     

    2019

     

     

    2018

     

     

     

     

     

     

     

     

     

     

    Cash, cash equivalents and short-term investments

     

    $

    217,355

     

     

    $

    42,189

     

    Working capital

     

     

    168,575

     

     

     

    39,164

     

    Total assets

     

     

    223,218

     

     

     

    44,548

     

    Total liabilities

     

     

    55,860

     

     

     

    4,122

     

    Convertible preferred stock and non-controlling interest

     

     

     

     

     

    88,708

     

    Accumulated deficit

     

     

    (68,888

    )

     

     

    (49,088

    )

    Total stockholders' (deficit) equity

     

     

    167,358

     

     

     

    (48,282

    )

    Frequency Therapeutics, Inc.

    Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

     

    Three Months Ended

     

     

    Year Ended

     

     

     

    December 31,

     

     

    December 31,

     

     

     

    2019

     

     

    2018

     

     

    2019

     

     

    2018

     

    Revenue

     

    $

    4,709

     

     

    $

     

     

    $

    28,947

     

     

    $

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Royalty

     

     

     

     

     

     

     

     

    16,000

     

     

     

     

    Research and development

     

     

    6,196

     

     

     

    2,921

     

     

     

    18,784

     

     

     

    11,880

     

    General and administrative

     

     

    5,001

     

     

     

    2,404

     

     

     

    14,838

     

     

     

    7,064

     

    Total operating expenses

     

     

    11,197

     

     

     

    5,325

     

     

     

    49,622

     

     

     

    18,944

     

    Loss from operations

     

     

    (6,488

    )

     

     

    (5,325

    )

     

     

    (20,675

    )

     

     

    (18,944

    )

    Interest income (expense)

     

     

    942

     

     

     

    (106

    )

     

     

    1,784

     

     

     

    (106

    )

    Loss on extinguishment of debt

     

     

     

     

     

    (174

    )

     

     

     

     

     

    (269

    )

    Realized gain on investments

     

     

    50

     

     

     

     

     

     

    138

     

     

     

     

    Foreign exchange gain (loss)

     

     

    3

     

     

     

    158

     

     

     

    7

     

     

     

    151

     

    Net loss

     

    $

    (5,493

    )

     

    $

    (5,447

    )

     

    $

    (18,746

    )

     

    $

    (19,168

    )

    Cumulative Series C preferred stock dividends

     

     

    (40

    )

     

     

     

     

     

    (1,054

    )

     

     

     

    Net loss attributable to common shareholders

     

    $

    (5,533

    )

     

    $

    (5,447

    )

     

    $

    (19,800

    )

     

    $

    (19,168

    )

    Net loss per share attributable to common stockholders-basic

    and diluted

     

    $

    (0.19

    )

     

    $

    (3.23

    )

     

    $

    (2.29

    )

     

    $

    (12.53

    )

    Weighted-average shares of common stock outstanding-basic

    and diluted

     

     

    28,409,518

     

     

     

    1,689,094

     

     

     

    8,649,245

     

     

     

    1,530,218

     

     

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  27. 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 that Chief Executive Officer David L. Lucchino will present a company overview at the Cowen 40th Annual Healthcare Conference.

    Mr. Lucchino's presentation will take place on Monday, March 2nd at 11:20 a.m. ET in the Dartmouth room on the 3rd floor of the Boston Marriott Copley Place hotel. The presentation will be followed by a question and answer session in the Exeter room at 12:00 p.m. ET. This is the fifth consecutive year that Frequency has presented at the Cowen Healthcare Conference and the first year doing so as…

    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 that Chief Executive Officer David L. Lucchino will present a company overview at the Cowen 40th Annual Healthcare Conference.

    Mr. Lucchino's presentation will take place on Monday, March 2nd at 11:20 a.m. ET in the Dartmouth room on the 3rd floor of the Boston Marriott Copley Place hotel. The presentation will be followed by a question and answer session in the Exeter room at 12:00 p.m. ET. This is the fifth consecutive year that Frequency has presented at the Cowen Healthcare Conference and the first year doing so as a publicly traded company.

    A live webcast of the presentation can be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of the presentation will be posted on the Frequency website following the event.

    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. 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 As