FREQ Frequency Therapeutics Inc.

10.4
+0.16  (+2%)
Previous Close 10.24
Open 10.12
52 Week Low 7.3351
52 Week High 58.37
Market Cap $355,879,212
Shares 34,219,155
Float 24,532,850
Enterprise Value $185,296,319
Volume 321,720
Av. Daily Volume 1,794,142
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Upcoming Catalysts

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

  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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