UNITED STATES
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WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On September 22, 2021, Frequency Therapeutics, Inc. (the “Company”) posted an updated corporate slide presentation in the “Investors & Media” portion of its website at www.frequencytx.com. A copy of the slide presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”).
The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
| Item 8.01. | Other Events. |
On September 22, 2021, the Company announced that four additional sensorineural hearing loss (“SNHL”) subjects from its FX-322-111 open-label study achieved statistically significant hearing improvements when evaluated 8 to 12 months following initial dosing.
Including the five initial responders, there are now a total of nine subjects that participated in the FX-322-111 study (n=32) that have been shown to have statistically significant improvements in word recognition scores, a key measure of speech perception, at time points between 90 days and one year.
These new results suggest that the hearing of individuals administered with a single dose of FX-322 may improve over extended periods. The longer-term measures of their treated ear demonstrated word recognition score improvements when compared to pre-treatment baseline levels and no significant changes were detected in their untreated ears. Of the five subjects that had a statistically significant response at day-90, the four that returned for evaluation had scores that remained above their baseline word recognition measures, though were below the threshold for statistical significance. The Company plans to assess individuals treated in its other studies to evaluate if those subjects may have experienced these longer-term benefits.
FX-322 is the Company’s lead product candidate for the treatment of acquired SNHL, which 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 individuals with SNHL.
The FX-322-111 study is an open-label, multi-center, single-dose trial designed to evaluate the impact of FX-322 injection conditions on tolerability, as well as key measures of hearing benefit. In the study, subjects with mild to severe SNHL (n=33) were injected in one ear with FX-322, with the untreated ear serving as the control. Hearing function was tested in 32 subjects (one subject did not finish the study) over the course of 90 days following dosing. Twenty-five subjects were subsequently evaluated at 8-12 months following FX-322 dosing, with four subjects that had shown improvement trends in word recognition scores at day-90 reaching statistically significant scores when tested at the later time points.
Subjects in the study had an array of hearing loss etiologies, including sudden SNHL, noise-induced SNHL and idiopathic SNHL. Additionally, the subjects ranged in severity from mild to severe. The single dose had a favorable safety profile and both injection conditions were well tolerated. Based on the overall learnings from the multiple FX-322 learning studies, the Company plans to initiate a new FX-322 Phase 2 trial in the fourth quarter of this year to evaluate the impact of single-dose FX-322 administration in a refined population of individuals with SNHL.
Forward-Looking Statements
This Current Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report 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, the interpretation and implications of the results of the FX-322-111 study as well as the results from the follow-up to the FX-322-111 study, the plan to assess individuals in earlier trials for longer-term benefits, and the treatment potential of FX-322.
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 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 Company’s 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 Current Report. Any such forward-looking statements represent management’s estimates as of the date of this Current Report. 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 Current Report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibit relates to Item 7.01, and shall be deemed to be furnished, and not filed:
| Exhibit No. |
Description | |
| 99.1 | Frequency Therapeutics, Inc. Corporate Slide Presentation as of September 22, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| FREQUENCY THERAPEUTICS, INC. | ||||||
| Date: September 22, 2021 | By: | /s/ David L. Lucchino | ||||
| Name: David L. Lucchino | ||||||
| Title: President and Chief Executive Officer | ||||||
Exhibit 99.1 LEADING A NEW CATEGORY IN REGENERATIVE MEDICINE Advancing Novel Approaches to Hearing Restoration Corporate Overview September 2021 Copyright Frequency Therapeutics, Inc. 1Exhibit 99.1 LEADING A NEW CATEGORY IN REGENERATIVE MEDICINE Advancing Novel Approaches to Hearing Restoration Corporate Overview September 2021 Copyright Frequency Therapeutics, Inc. 1
Forward-Looking Statements and Other Disclaimers This presentation contains forward-looking statements within the meaning of the to maintain Fast Track designation for FX-322 and such designation failing to result Private Securities Litigation Reform Act of 1995. All statements contained in this in faster development or regulatory review or approval; costly and damaging presentation that do not relate to matters of historical fact should be considered litigation, including related to product liability, intellectual property or brought by forward-looking statements, including without limitation statements regarding the stockholders; dependence on Astellas Pharma Inc. for the development and interpretation and implications of the results of the Phase 2a study as well as the commercialization of FX-322 outside of the United States; misconduct by FX-322-112 and the FX-322-111 studies, the timing and results of top-line data employees or independent contractors; reliance on third parties, including to from the Phase 1b study in severe SNHL, the initiation, timing and design of the conduct clinical trials and manufacture product candidates; compliance with laws new Phase 2 trial of FX-322, including the ability of study design to address study and regulations, including healthcare and environmental, health, and safety laws bias, the design and timing of future studies of and clinical development path for and regulations; failure to obtain, maintain and enforce protection of patents and FX-322, the results and implications of the Phase 1/2 durability of response data, other intellectual property; security breaches or failure to protect private personal the ability of our technology platform to provide patient benefit, the impact of information; attracting and retaining key personnel; and ability to manage growth. COVID-19 on the Company’s on-going and planned clinical trials and business, future milestone and royalty payments under the license and collaboration These and other important factors discussed under the caption “Risk factors” in the agreement with Astellas Pharma Inc. (“Astellas”), the sufficiency of the Company’s Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on cash, cash equivalents and short-term investments, estimates of the size of the August 12, 2021 and its other reports filed with the SEC could cause actual results hearing loss population and population at risk for hearing loss, estimates of the to differ materially from those indicated by the forward-looking statements made commercial opportunity of FX-322 and the impact on existing treatment in this presentation. Any such forward-looking statements represent management’s paradigms, the timing and progress of the remyelination program, and the estimates as of the date of this presentation. While the Company may elect to potential application of the PCA platform to other diseases. 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 These forward-looking statements are based on management’s current forward-looking statements should not be relied upon as representing the expectations. These statements are neither promises nor guarantees, but involve Company’s views as of any date subsequent to the date of this presentation. 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; Frequency Therapeutics (the “Company”) has incurred and will continue to incur significant losses and is not and may never be profitable; 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 c Frequency Therapeutics, Inc. 2Forward-Looking Statements and Other Disclaimers This presentation contains forward-looking statements within the meaning of the to maintain Fast Track designation for FX-322 and such designation failing to result Private Securities Litigation Reform Act of 1995. All statements contained in this in faster development or regulatory review or approval; costly and damaging presentation that do not relate to matters of historical fact should be considered litigation, including related to product liability, intellectual property or brought by forward-looking statements, including without limitation statements regarding the stockholders; dependence on Astellas Pharma Inc. for the development and interpretation and implications of the results of the Phase 2a study as well as the commercialization of FX-322 outside of the United States; misconduct by FX-322-112 and the FX-322-111 studies, the timing and results of top-line data employees or independent contractors; reliance on third parties, including to from the Phase 1b study in severe SNHL, the initiation, timing and design of the conduct clinical trials and manufacture product candidates; compliance with laws new Phase 2 trial of FX-322, including the ability of study design to address study and regulations, including healthcare and environmental, health, and safety laws bias, the design and timing of future studies of and clinical development path for and regulations; failure to obtain, maintain and enforce protection of patents and FX-322, the results and implications of the Phase 1/2 durability of response data, other intellectual property; security breaches or failure to protect private personal the ability of our technology platform to provide patient benefit, the impact of information; attracting and retaining key personnel; and ability to manage growth. COVID-19 on the Company’s on-going and planned clinical trials and business, future milestone and royalty payments under the license and collaboration These and other important factors discussed under the caption “Risk factors” in the agreement with Astellas Pharma Inc. (“Astellas”), the sufficiency of the Company’s Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on cash, cash equivalents and short-term investments, estimates of the size of the August 12, 2021 and its other reports filed with the SEC could cause actual results hearing loss population and population at risk for hearing loss, estimates of the to differ materially from those indicated by the forward-looking statements made commercial opportunity of FX-322 and the impact on existing treatment in this presentation. Any such forward-looking statements represent management’s paradigms, the timing and progress of the remyelination program, and the estimates as of the date of this presentation. While the Company may elect to potential application of the PCA platform to other diseases. 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 These forward-looking statements are based on management’s current forward-looking statements should not be relied upon as representing the expectations. These statements are neither promises nor guarantees, but involve Company’s views as of any date subsequent to the date of this presentation. 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; Frequency Therapeutics (the “Company”) has incurred and will continue to incur significant losses and is not and may never be profitable; 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 c Frequency Therapeutics, Inc. 2
Frequency Today: Guided by a Clear Signal First ever known clinical studies Leading the field of demonstrating hearing restoration hearing improvements c Frequency Therapeutics, Inc. 3 Copyright Frequency Therapeutics, Inc. 3Frequency Today: Guided by a Clear Signal First ever known clinical studies Leading the field of demonstrating hearing restoration hearing improvements c Frequency Therapeutics, Inc. 3 Copyright Frequency Therapeutics, Inc. 3
Defining the Target, Expanding the Pipeline Learnings from Working to expand our exploratory studies pipeline for hearing support new Phase 2 therapeutics and for trial and help define other degenerative path forward diseases c Frequency Therapeutics, Inc. 4 Copyright Frequency Therapeutics, Inc. 4Defining the Target, Expanding the Pipeline Learnings from Working to expand our exploratory studies pipeline for hearing support new Phase 2 therapeutics and for trial and help define other degenerative path forward diseases c Frequency Therapeutics, Inc. 4 Copyright Frequency Therapeutics, Inc. 4
Today’s Hearing Loss Market Has No Restorative Treatments Only 20% ~$10 Billion ~41 Million $980 Billion Lost annually due market US hearing aid Individuals to untreated penetration for market annual with SNHL in hearing loss hearing aids sales U.S. globally* *Source: World Health Organization c Frequency Therapeutics, Inc. 5Today’s Hearing Loss Market Has No Restorative Treatments Only 20% ~$10 Billion ~41 Million $980 Billion Lost annually due market US hearing aid Individuals to untreated penetration for market annual with SNHL in hearing loss hearing aids sales U.S. globally* *Source: World Health Organization c Frequency Therapeutics, Inc. 5
Intelligibility of Speech and Sound - A Major Unmet Clinical Need People with hearing loss don’t just want their hearing improved, they want hearing restoredIntelligibility of Speech and Sound - A Major Unmet Clinical Need People with hearing loss don’t just want their hearing improved, they want hearing restored
Hearing Loss Can Have a Significant Impact on Overall Health Increased risks with untreated hearing loss “Hearing loss is the largest potentially modifiable risk factor for developing 50% 41% dementia” July, 2020 DEMENTIA DEPRESSION JAMA Nov 8, 2018 Deal J, et al. Incident Hearing Loss and Comorbidity. A Longitudinal © CO OP 2021 Administrative Claims Study.Hearing Loss Can Have a Significant Impact on Overall Health Increased risks with untreated hearing loss “Hearing loss is the largest potentially modifiable risk factor for developing 50% 41% dementia” July, 2020 DEMENTIA DEPRESSION JAMA Nov 8, 2018 Deal J, et al. Incident Hearing Loss and Comorbidity. A Longitudinal © CO OP 2021 Administrative Claims Study.
Frequency Therapeutics: A Vision Built on Regeneration Since 2014, Frequency has focused on developing therapeutics by activating a person’s innate regenerative potential, within the body, to repair tissue and restore human function. c Frequency Therapeutics, Inc. 8Frequency Therapeutics: A Vision Built on Regeneration Since 2014, Frequency has focused on developing therapeutics by activating a person’s innate regenerative potential, within the body, to repair tissue and restore human function. c Frequency Therapeutics, Inc. 8
The Problem: Missing Sensory Hair Cells in the Cochlea Missing Sensory Hair Cells “Analysis of hair cells, auditory nerve fibers and strial tissues … shows that the degree of hearing loss is well predicted from the amount of hair cell loss.” - Journal of Neuroscience Sensory Hair Cells July 2020 Progenitor Cells 9The Problem: Missing Sensory Hair Cells in the Cochlea Missing Sensory Hair Cells “Analysis of hair cells, auditory nerve fibers and strial tissues … shows that the degree of hearing loss is well predicted from the amount of hair cell loss.” - Journal of Neuroscience Sensory Hair Cells July 2020 Progenitor Cells 9
Solution: A Therapy to Address the Underlying Pathology Synergy between pathways aims to activate progenitor cells and regenerate sensory cells in the cochlea 10Solution: A Therapy to Address the Underlying Pathology Synergy between pathways aims to activate progenitor cells and regenerate sensory cells in the cochlea 10
FX-322: Directly Targeting the Regeneration of Sensory Hair Cells in the Cochlea FX-322 is administered via a standard The injection concentrates FX-322 in intratympanic injection, a routine procedure the cochlear region critical for performed by ENTs speech intelligibility c Frequency Therapeutics, Inc. 11FX-322: Directly Targeting the Regeneration of Sensory Hair Cells in the Cochlea FX-322 is administered via a standard The injection concentrates FX-322 in intratympanic injection, a routine procedure the cochlear region critical for performed by ENTs speech intelligibility c Frequency Therapeutics, Inc. 11
Increasing Focus on Hearing Clarity Intelligibility (Clarity) Audibility (Loudness) measured with word recognition and measured with pure tone words-in-noise tests test “When you develop SNHL, the issue is not just that you can't hear soft sounds. That's why if Word Recognition Test you ever talked to anyone who • List of 50 monosyllabic words has a hearing loss, what they'll • Single words played in quiet say is it's not that I can't hear you…it's I can't understand you.” Words-in-Noise Test - Dr. Frank Lin from Externally-Led Patient Focused Drug Development program on • Background noise from SNHL, June 2021 multiple voices • Played at different signal-to-noise ratios c Frequency Therapeutics, Inc. 12Increasing Focus on Hearing Clarity Intelligibility (Clarity) Audibility (Loudness) measured with word recognition and measured with pure tone words-in-noise tests test “When you develop SNHL, the issue is not just that you can't hear soft sounds. That's why if Word Recognition Test you ever talked to anyone who • List of 50 monosyllabic words has a hearing loss, what they'll • Single words played in quiet say is it's not that I can't hear you…it's I can't understand you.” Words-in-Noise Test - Dr. Frank Lin from Externally-Led Patient Focused Drug Development program on • Background noise from SNHL, June 2021 multiple voices • Played at different signal-to-noise ratios c Frequency Therapeutics, Inc. 12
Two Independent Studies (FX-322-201, FX-322-111) Show Hearing Improvements with Single Dose Day 90 Word Recognition Scores Across Studies Phase 1/2 Study FX-322-201 Phase 1b Study FX-322-111 FX-322-201 Phase 1/2 FX-322-111 Phase 1b Overview Overview 40% • Placebo-controlled, multi-center, • Compared different FX-322 % Exceeding Absolute 10% randomized study administration conditions • Mild to moderately severe subjects, age • Open-label, multi-center, 18-65 (n=23) randomized study 30% • NIHL/SSNHL • Mild to severe subjects, age 18- 65 (n=33) 20% Study Results Study Results • 33% of subjects achieved 10% or • 34% of subjects achieved 10% or greater greater absolute improvement in word absolute improvement in word recognition 10% recognition in treated ear (WR) in treated ear • Statistically significant and clinically • Statistically significant and clinically meaningful improvements in WR meaningful improvements in WR • No meaningful changes in • Favorable safety profile 0% placebo group Placebo FX-322 Untreated* FX-322 * *Total of 33 patients enrolled in study, • Favorable safety profile (n=8) (n=15) (n=32) (n=32) 32 subjects completed 90-day clinical assessment period 13Two Independent Studies (FX-322-201, FX-322-111) Show Hearing Improvements with Single Dose Day 90 Word Recognition Scores Across Studies Phase 1/2 Study FX-322-201 Phase 1b Study FX-322-111 FX-322-201 Phase 1/2 FX-322-111 Phase 1b Overview Overview 40% • Placebo-controlled, multi-center, • Compared different FX-322 % Exceeding Absolute 10% randomized study administration conditions • Mild to moderately severe subjects, age • Open-label, multi-center, 18-65 (n=23) randomized study 30% • NIHL/SSNHL • Mild to severe subjects, age 18- 65 (n=33) 20% Study Results Study Results • 33% of subjects achieved 10% or • 34% of subjects achieved 10% or greater greater absolute improvement in word absolute improvement in word recognition 10% recognition in treated ear (WR) in treated ear • Statistically significant and clinically • Statistically significant and clinically meaningful improvements in WR meaningful improvements in WR • No meaningful changes in • Favorable safety profile 0% placebo group Placebo FX-322 Untreated* FX-322 * *Total of 33 patients enrolled in study, • Favorable safety profile (n=8) (n=15) (n=32) (n=32) 32 subjects completed 90-day clinical assessment period 13
FX-322 Phase 1/2 Durability Data: Patients Show Sustained Hearing Improvements 13-21 Months After Initial Dosing 50 50W Month 16** Month 21** Month 21** Month 19** Month 13** 47 Key Findings 50W 50W 40 *25W 39 38 38 50W Preliminary evidence indicating a 50W 35 durable benefit of hearing clarity 34 *25W 50W 30 30 29 50W Baseline - Correct words out of 50 26 50W 50W Day 90 - Correct words out of 50 22 20 20 1-2 Years - Correct words out of 50 50W 50W 16 50W 14 Three patients who had durable improvements 12 10 in intelligibility also had pure tone audiometry 50W improvements of 10 – 15 dB at the highest 7 frequency tested (8k Hz) 0 Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 • *25W = 25 Word test performed outside an official study site at 13-18 months after dosing; results scaled to 50 words • 50W = 50 Word test performed under a formal protocol at original study site at 18-21 months after dosing c Frequency Therapeutics, Inc. 14 • **Since FX-322 dosingFX-322 Phase 1/2 Durability Data: Patients Show Sustained Hearing Improvements 13-21 Months After Initial Dosing 50 50W Month 16** Month 21** Month 21** Month 19** Month 13** 47 Key Findings 50W 50W 40 *25W 39 38 38 50W Preliminary evidence indicating a 50W 35 durable benefit of hearing clarity 34 *25W 50W 30 30 29 50W Baseline - Correct words out of 50 26 50W 50W Day 90 - Correct words out of 50 22 20 20 1-2 Years - Correct words out of 50 50W 50W 16 50W 14 Three patients who had durable improvements 12 10 in intelligibility also had pure tone audiometry 50W improvements of 10 – 15 dB at the highest 7 frequency tested (8k Hz) 0 Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 • *25W = 25 Word test performed outside an official study site at 13-18 months after dosing; results scaled to 50 words • 50W = 50 Word test performed under a formal protocol at original study site at 18-21 months after dosing c Frequency Therapeutics, Inc. 14 • **Since FX-322 dosing
New FX-322-111 Phase 1b Data Show that Additional Study Participants Gain Hearing Improvements at Later Time Points Longer term follow-up of FX-322-111 study subjects following FX-322 dosing • 25 of 33 study subjects were evaluated at 8-12 months following FX-322 dosing Potential for FX-322 to result in accumulating hearing benefits over time • 4 subjects that had shown improvement trends in word recognition scores at day 90, achieved statistically significant scores when tested at the later time points To date, 9 of 32 evaluated study subjects have shown statistically significant improvements in word recognition scores in treated ears between 90 days and 1 year • No change observed in their untreated ears Company will use insights to inform time points for evaluation in future studies and longer- term strategy for retreatmentNew FX-322-111 Phase 1b Data Show that Additional Study Participants Gain Hearing Improvements at Later Time Points Longer term follow-up of FX-322-111 study subjects following FX-322 dosing • 25 of 33 study subjects were evaluated at 8-12 months following FX-322 dosing Potential for FX-322 to result in accumulating hearing benefits over time • 4 subjects that had shown improvement trends in word recognition scores at day 90, achieved statistically significant scores when tested at the later time points To date, 9 of 32 evaluated study subjects have shown statistically significant improvements in word recognition scores in treated ears between 90 days and 1 year • No change observed in their untreated ears Company will use insights to inform time points for evaluation in future studies and longer- term strategy for retreatment
FX-322 Clinical Data Published in Leading Journal FX-322 Phase 1/2 and drug delivery studies • 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. 2021) • Pre-eminent, peer-reviewed journal in the field DOI: 10.1097/MAO.0000000000003120 c Frequency Therapeutics, Inc. 16FX-322 Clinical Data Published in Leading Journal FX-322 Phase 1/2 and drug delivery studies • 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. 2021) • Pre-eminent, peer-reviewed journal in the field DOI: 10.1097/MAO.0000000000003120 c Frequency Therapeutics, Inc. 16
FX-322 Clinical Profile Informed by Broad Range of Learning Studies Enrolled Phase 1/2 Phase 1b Phase 1b Phase 2a Phase 1b (FX-322-201) (FX-322-111) (FX-322-112) (FX-322-202) (FX-322-113) Subjects with mild-to-moderately Subjects with mild-to-severe Subjects with presbycusis (age- Subjects with mild-to-moderately Severe sensorineural hearing loss severe SNHL SNHL related hearing loss) mild-to-mod. severe SNHL severe Subjects with Noise-Induced or Subjects with Noise-Induced or NO SUBJECTS with Noise- Subjects with Noise-Induced or Subjects with severe SNHL Sudden SNHL Sudden SNHL Induced or Sudden SNHL Sudden SNHL Age 18-65; N=31 Age 18-65; N=23 Age 18-65; N=33 Age 66-85; N=30 Age 18-65; N=95 Four administration Single Administration Single administration Single administration Single administration regimen •Single administration •Double-blind, placebo •Open-label, multi-center, •Placebo controlled Double-blind, placebo controlled, controlled, multi-center, randomized study multi-center, randomized study •Placebo controlled •Multi-center, randomized randomized study •FX-322 injected in one ear – •Multi-center, randomized contra lateral ear acted as control •Study enrolled •Clinically meaningful and •Clinically meaningful and •No significant treatment effect •Unexpected increase in word rec statistically significant statistically significant observed with FX-322 compared (WR) scores in placebo group •Data anticipated in Q4 2021 improvements in word improvements in word to placebo suggests bias due to trial design. recognition scores in patients recognition scores In patients •No response in placebo groups or •Lack of reliable baseline scores, with measurable word with measurable word in untreated ears left company unable to evaluate recognition deficits recognition deficits hearing improvements across cohorts Favorable safety and tolerability Favorable safety and tolerability Favorable safety and tolerability Favorable safety and tolerability profile profile profile profile [Detail from subjects across all single-dose studies will provide key insights into potential responders] c Frequency Therapeutics, Inc.FX-322 Clinical Profile Informed by Broad Range of Learning Studies Enrolled Phase 1/2 Phase 1b Phase 1b Phase 2a Phase 1b (FX-322-201) (FX-322-111) (FX-322-112) (FX-322-202) (FX-322-113) Subjects with mild-to-moderately Subjects with mild-to-severe Subjects with presbycusis (age- Subjects with mild-to-moderately Severe sensorineural hearing loss severe SNHL SNHL related hearing loss) mild-to-mod. severe SNHL severe Subjects with Noise-Induced or Subjects with Noise-Induced or NO SUBJECTS with Noise- Subjects with Noise-Induced or Subjects with severe SNHL Sudden SNHL Sudden SNHL Induced or Sudden SNHL Sudden SNHL Age 18-65; N=31 Age 18-65; N=23 Age 18-65; N=33 Age 66-85; N=30 Age 18-65; N=95 Four administration Single Administration Single administration Single administration Single administration regimen •Single administration •Double-blind, placebo •Open-label, multi-center, •Placebo controlled Double-blind, placebo controlled, controlled, multi-center, randomized study multi-center, randomized study •Placebo controlled •Multi-center, randomized randomized study •FX-322 injected in one ear – •Multi-center, randomized contra lateral ear acted as control •Study enrolled •Clinically meaningful and •Clinically meaningful and •No significant treatment effect •Unexpected increase in word rec statistically significant statistically significant observed with FX-322 compared (WR) scores in placebo group •Data anticipated in Q4 2021 improvements in word improvements in word to placebo suggests bias due to trial design. recognition scores in patients recognition scores In patients •No response in placebo groups or •Lack of reliable baseline scores, with measurable word with measurable word in untreated ears left company unable to evaluate recognition deficits recognition deficits hearing improvements across cohorts Favorable safety and tolerability Favorable safety and tolerability Favorable safety and tolerability Favorable safety and tolerability profile profile profile profile [Detail from subjects across all single-dose studies will provide key insights into potential responders] c Frequency Therapeutics, Inc.
Next Steps for Continued FX-322 Clinical Development Plan to commence an additional FX- Clinical data demonstrate potential Important learnings informing 322 Phase 2 placebo-controlled study continued FX-322 development of FX-322 as a restorative treatment in Q4 2021 for SNHL • Continuum of data will further • Two FX-322 single • Understanding specific inform understanding of the populations where FX-322 administration studies have patients and conditions where demonstrates benefit demonstrated treatment FX-322 may have the greatest benefit • Lead-in baseline assessments impact and other controls may mitigate • Favorable safety profile study design bias • Build off totality of study subject dataNext Steps for Continued FX-322 Clinical Development Plan to commence an additional FX- Clinical data demonstrate potential Important learnings informing 322 Phase 2 placebo-controlled study continued FX-322 development of FX-322 as a restorative treatment in Q4 2021 for SNHL • Continuum of data will further • Two FX-322 single • Understanding specific inform understanding of the populations where FX-322 administration studies have patients and conditions where demonstrates benefit demonstrated treatment FX-322 may have the greatest benefit • Lead-in baseline assessments impact and other controls may mitigate • Favorable safety profile study design bias • Build off totality of study subject data
Remyelination Program for Multiple Sclerosis Repair of neurological Using PCA approach to damage is the major unmet address restoration in MS need in MS patients • Currently approved • Pre-clinical data has immunomodulators do not demonstrated potential to restore myelin remyelinate with proprietary small molecule • Remyelination of damaged combinations neurons has potential to reverse neurological • Research efforts underway damage to confirm optimal combination of molecules • Target population for for clinical program remyelination represents 50% of MS patients • Strong IP portfolio c Frequency Therapeutics, Inc. 19Remyelination Program for Multiple Sclerosis Repair of neurological Using PCA approach to damage is the major unmet address restoration in MS need in MS patients • Currently approved • Pre-clinical data has immunomodulators do not demonstrated potential to restore myelin remyelinate with proprietary small molecule • Remyelination of damaged combinations neurons has potential to reverse neurological • Research efforts underway damage to confirm optimal combination of molecules • Target population for for clinical program remyelination represents 50% of MS patients • Strong IP portfolio c Frequency Therapeutics, Inc. 19
Frequency: Developing a Platform Approach that Reduces the Complexity of Regenerative Medicine Harnessing No Change to Ease of Innate Biology Genome Manufacturing Progenitors Activating native Use of small already programs, reducing molecules: no need located within safety concerns to remove or grow target tissue cells ex vivo c Frequency Therapeutics, Inc. 20Frequency: Developing a Platform Approach that Reduces the Complexity of Regenerative Medicine Harnessing No Change to Ease of Innate Biology Genome Manufacturing Progenitors Activating native Use of small already programs, reducing molecules: no need located within safety concerns to remove or grow target tissue cells ex vivo c Frequency Therapeutics, Inc. 20
Summary and Financial Profile Defining FX-322 Development Two Single Dose FX-322 Path and Advancing New Studies Studies Show Hearing Improvements Statistical significance in key Continued clinical validation and measures of hearing clarity development progress $175.5 Million in Cash and Ex-US Partnership with Cash Equivalents* Strong Potential Milestones and Royalties Runway into 2023 21 *As of March. 31, 2021. Excludes restricted cash c Frequency Therapeutics, Inc.Summary and Financial Profile Defining FX-322 Development Two Single Dose FX-322 Path and Advancing New Studies Studies Show Hearing Improvements Statistical significance in key Continued clinical validation and measures of hearing clarity development progress $175.5 Million in Cash and Ex-US Partnership with Cash Equivalents* Strong Potential Milestones and Royalties Runway into 2023 21 *As of March. 31, 2021. Excludes restricted cash c Frequency Therapeutics, Inc.
SAVE THE DATE R&D Event for Investors Frequency Therapeutics (FREQ) Tuesday, November 9th 8:00am – 10:00am ET Details available at investors.frequencytx.com c Frequency Therapeutics, Inc.SAVE THE DATE R&D Event for Investors Frequency Therapeutics (FREQ) Tuesday, November 9th 8:00am – 10:00am ET Details available at investors.frequencytx.com c Frequency Therapeutics, Inc.
LEADING A NEW CATEGORY IN REGENERATIVE MEDICINE Advancing Novel Approaches to Hearing Restoration Corporate Overview September 2021 Copyright Frequency Therapeutics, Inc. 23LEADING A NEW CATEGORY IN REGENERATIVE MEDICINE Advancing Novel Approaches to Hearing Restoration Corporate Overview September 2021 Copyright Frequency Therapeutics, Inc. 23
APPENDIX c Frequency Therapeutics, Inc. 24APPENDIX c Frequency Therapeutics, Inc. 24
Broad Potential of Progenitor Cell Activation Approach c Frequency Therapeutics, Inc. 25Broad Potential of Progenitor Cell Activation Approach c Frequency Therapeutics, Inc. 25
Origin of Frequency Therapeutics Tissue-Specific, Pre-programmed Stem Cells Decoding Intestinal Enabling Cochlear Frequency Therapeutics Regeneration Regeneration Small molecule therapeutics Langer and Karp publish small Same cues reactivate normally molecules activate intestinal inactive progenitors in the show clinical proof of concept progenitors cochlea Clonal Expansion of Lgr5- Niche-independent high-purity Positive Cells from Mammalian cultures of Lgr5+ intestinal Cochlea and High-Purity stem cells and their progeny Generation of Sensory Hair Cells c Frequency Therapeutics, Inc. 26Origin of Frequency Therapeutics Tissue-Specific, Pre-programmed Stem Cells Decoding Intestinal Enabling Cochlear Frequency Therapeutics Regeneration Regeneration Small molecule therapeutics Langer and Karp publish small Same cues reactivate normally molecules activate intestinal inactive progenitors in the show clinical proof of concept progenitors cochlea Clonal Expansion of Lgr5- Niche-independent high-purity Positive Cells from Mammalian cultures of Lgr5+ intestinal Cochlea and High-Purity stem cells and their progeny Generation of Sensory Hair Cells c Frequency Therapeutics, Inc. 26
Frequency Progenitor Cell Activation (PCA) Approach Inactive Progenitor Cell Inactive ACTIVATED Progenitor Progenitor Asymmetric division using native programs + Functional Target Cell Combinations of small molecules designed to activate progenitor cells c Frequency Therapeutics, Inc. 27Frequency Progenitor Cell Activation (PCA) Approach Inactive Progenitor Cell Inactive ACTIVATED Progenitor Progenitor Asymmetric division using native programs + Functional Target Cell Combinations of small molecules designed to activate progenitor cells c Frequency Therapeutics, Inc. 27
Uniqueness of Our PCA approach Previous Approaches Frequency’s PCA Approach Pluripotent Multipotent Yamanaka 4 Factors Partial Reprogramming Bipotent Transdifferentiation Fully Differentiated Hair Progenitor Hair Progenitor Cell Cell Cell Cell c Frequency Therapeutics, Inc. 28Uniqueness of Our PCA approach Previous Approaches Frequency’s PCA Approach Pluripotent Multipotent Yamanaka 4 Factors Partial Reprogramming Bipotent Transdifferentiation Fully Differentiated Hair Progenitor Hair Progenitor Cell Cell Cell Cell c Frequency Therapeutics, Inc. 28
Our Approach: Activation of Progenitors to Replace Hair Cell Loss Audiogram Despite Hair Cell Loss, Progenitor Cells Remain Human Cochlea Cross-section 47 Year Old Male with Occupational Noise Deafness c Frequency Therapeutics, Inc. 29Our Approach: Activation of Progenitors to Replace Hair Cell Loss Audiogram Despite Hair Cell Loss, Progenitor Cells Remain Human Cochlea Cross-section 47 Year Old Male with Occupational Noise Deafness c Frequency Therapeutics, Inc. 29
Profound Synergy Between Pathways to Regenerate Cells Cochlear Progenitor Proliferation (Lgr5-GFP) Culture Media Wnt Activation (glycogen synthase kinase-3 (GSK3) Inhibitor; NCE) HDAC Inhibition (sodium valproate) Wnt Activation + HDAC inhibition HDAC = Histone deacetylase NCE = new chemical entity PROFOUND SYNERGY In vitro mouse model testing c Frequency Therapeutics, Inc. 30Profound Synergy Between Pathways to Regenerate Cells Cochlear Progenitor Proliferation (Lgr5-GFP) Culture Media Wnt Activation (glycogen synthase kinase-3 (GSK3) Inhibitor; NCE) HDAC Inhibition (sodium valproate) Wnt Activation + HDAC inhibition HDAC = Histone deacetylase NCE = new chemical entity PROFOUND SYNERGY In vitro mouse model testing c Frequency Therapeutics, Inc. 30
Strong FX-322 Pre-Clinical Validation Test Outcome In vitro Adult human inner ear tissue Created new hair cells In vivo Restored hair cells and hearing Adult deafened mice across all frequencies Achieved active levels in the Therapeutic drug levels cochlea in multiple species c Frequency Therapeutics, Inc. 31Strong FX-322 Pre-Clinical Validation Test Outcome In vitro Adult human inner ear tissue Created new hair cells In vivo Restored hair cells and hearing Adult deafened mice across all frequencies Achieved active levels in the Therapeutic drug levels cochlea in multiple species c Frequency Therapeutics, Inc. 31
FX-322 Program Advances and Global Opportunity c Frequency Therapeutics, Inc. 32FX-322 Program Advances and Global Opportunity c Frequency Therapeutics, Inc. 32
FX-322: Robust Clinical Phase 1/2 Design Screening NIHL/SSNHL Mild to Moderately Severe Single Study Overview No Injection Injection All 23 • Assess safety in 15 drug, patients patients with 8 placebo sensorineural FX-322 Placebo hearing loss N = 15 N = 8 • Stable patients Day 1 | Dose • Evaluated hearing by word testing and pure tones Follow-up Visits Injection only in one ear creating an Days 15, 30, 60, 90 additional control c Frequency Therapeutics, Inc. 33FX-322: Robust Clinical Phase 1/2 Design Screening NIHL/SSNHL Mild to Moderately Severe Single Study Overview No Injection Injection All 23 • Assess safety in 15 drug, patients patients with 8 placebo sensorineural FX-322 Placebo hearing loss N = 15 N = 8 • Stable patients Day 1 | Dose • Evaluated hearing by word testing and pure tones Follow-up Visits Injection only in one ear creating an Days 15, 30, 60, 90 additional control c Frequency Therapeutics, Inc. 33
Recap: Completed FX-322 Phase 1/2 Safety Study Study Design • FX-322 shown to have a favorable safety Key Findings profile – no serious AEs Absolute Word Recognition Scores 50 Single No Injection 40 Injection • Clinically meaningful improvement in All 23 30 15 drug, patients word recognition scores in patients with 8 placebo 20 measurable word recognition deficits 10 0 % Change from Baseline in Word Recognition Scores • Statistically significant improvement in word recognition scores (words in Injection only in one ear creating an quiet/sound clarity) p = 0.010 additional control • Safety study % Change from Baseline in Words-in-Noise Scores • Improvement trend in words-in-noise • Patients with mild to moderate SNHL; (statistically significant WIN improvement permanent NIHL/SSNHL for at least 6 months shown in SNR) p = 0.211 • Majority of patients did not have measurable impairment in WR FX-322 PlaceboRecap: Completed FX-322 Phase 1/2 Safety Study Study Design • FX-322 shown to have a favorable safety Key Findings profile – no serious AEs Absolute Word Recognition Scores 50 Single No Injection 40 Injection • Clinically meaningful improvement in All 23 30 15 drug, patients word recognition scores in patients with 8 placebo 20 measurable word recognition deficits 10 0 % Change from Baseline in Word Recognition Scores • Statistically significant improvement in word recognition scores (words in Injection only in one ear creating an quiet/sound clarity) p = 0.010 additional control • Safety study % Change from Baseline in Words-in-Noise Scores • Improvement trend in words-in-noise • Patients with mild to moderate SNHL; (statistically significant WIN improvement permanent NIHL/SSNHL for at least 6 months shown in SNR) p = 0.211 • Majority of patients did not have measurable impairment in WR FX-322 Placebo
First Drug Candidate to Show Clinically Meaningful Improvements in Word Recognition Absolute Word Recognition Scores 50 47* Clarity of Sound 40 Used word tests in a quiet background 39* 38 34* Baseline - Correct words out of 50 30 29 Day 90 - Correct words out of 50 26 Test/retest variability is one standard deviation, which for a 50-word list is ~ 3 20 words 20 16* *Statistically significant and clinically 14 12 meaningful improvements in word 10 recognition 8 7 0 Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 c Frequency Therapeutics, Inc. 35First Drug Candidate to Show Clinically Meaningful Improvements in Word Recognition Absolute Word Recognition Scores 50 47* Clarity of Sound 40 Used word tests in a quiet background 39* 38 34* Baseline - Correct words out of 50 30 29 Day 90 - Correct words out of 50 26 Test/retest variability is one standard deviation, which for a 50-word list is ~ 3 20 words 20 16* *Statistically significant and clinically 14 12 meaningful improvements in word 10 recognition 8 7 0 Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 c Frequency Therapeutics, Inc. 35
Phase 1/2 Study Results: Sustained Improvements in Sound Clarity Statistically Significant Improvement Clear Improvement Trend in Sound Clarity (Words-in-Quiet) in Words-in-Noise p = 0.010 p = 0.211 FX-322 Placebo c Frequency Therapeutics, Inc. 36 Improvement % change from baseline % change from baselinePhase 1/2 Study Results: Sustained Improvements in Sound Clarity Statistically Significant Improvement Clear Improvement Trend in Sound Clarity (Words-in-Quiet) in Words-in-Noise p = 0.010 p = 0.211 FX-322 Placebo c Frequency Therapeutics, Inc. 36 Improvement % change from baseline % change from baseline
Clinical Data Confirms FX-322 Delivery to Cochlea Exploratory study to determine direct measurement of cochlear drug levels in patients undergoing cochlear implant surgery following FX-322 injection Key Findings: • Measurement of cochlear fluid confirmed successful drug delivery to cochlea in all samples analyzed • Drug levels predicted to result in therapeutic activity Taken together with the clinical study results, we believe this is the first known clinical evidence of a pharmacokinetic / pharmacodynamic effect of a potential hearing restoration therapeutic c Frequency Therapeutics, Inc. 37Clinical Data Confirms FX-322 Delivery to Cochlea Exploratory study to determine direct measurement of cochlear drug levels in patients undergoing cochlear implant surgery following FX-322 injection Key Findings: • Measurement of cochlear fluid confirmed successful drug delivery to cochlea in all samples analyzed • Drug levels predicted to result in therapeutic activity Taken together with the clinical study results, we believe this is the first known clinical evidence of a pharmacokinetic / pharmacodynamic effect of a potential hearing restoration therapeutic c Frequency Therapeutics, Inc. 37
End of Phase 2a Study Conclusions* There was an unexpected increase in WR scores in the placebo group, which did not occur in previous FX-322 trials and exceeded well-established published standards. Potentially suggesting bias due to trial design As a result of unreliable baseline WR scores in the placebo group due to potential trial design bias, the Company was unable to evaluate hearing improvements in WR scores for FX-322 dosing regimens versus placebo. Four weekly injections of FX-322 did not demonstrate improvements in any other hearing measures versus placebo FX-322 continues to have a favorable safety and tolerability profile. Although there was a higher rate of AEs noted in this 4x dosing trial, there were no treatment-associated serious adverse events observed and no patients withdrew from the study due to treatment-associated AEs. *Additional study detail and data Frequency Therapeutics, Inc. tables provided in SEC Form 8k dated June 30, 2021End of Phase 2a Study Conclusions* There was an unexpected increase in WR scores in the placebo group, which did not occur in previous FX-322 trials and exceeded well-established published standards. Potentially suggesting bias due to trial design As a result of unreliable baseline WR scores in the placebo group due to potential trial design bias, the Company was unable to evaluate hearing improvements in WR scores for FX-322 dosing regimens versus placebo. Four weekly injections of FX-322 did not demonstrate improvements in any other hearing measures versus placebo FX-322 continues to have a favorable safety and tolerability profile. Although there was a higher rate of AEs noted in this 4x dosing trial, there were no treatment-associated serious adverse events observed and no patients withdrew from the study due to treatment-associated AEs. *Additional study detail and data Frequency Therapeutics, Inc. tables provided in SEC Form 8k dated June 30, 2021
Pipeline Sensorineural Hearing DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Loss (SNHL) FX-322 Phase 2a – 202 Study Study enrolled with 95 subjects, Study of noise induced and sudden SNHL patients with completed June 2021 mild to moderately severe acquired SNHL, ages 18 – 65 FX-322 Phase 1b – 111 Study Study enrolled with 33 subjects, completed Open-label safety study focused on administration March 2021 conditions for FX-322. Subjects had mild to severe SNHL, ages 18 – 65 Study enrolled with 30 subjects, FX-322 Phase 1b – 112 Study Study of (presbycusis (age-related hearing loss completed May 2021 patients) ages 66 - 85 FX-322 Phase 1b – 113 Study Study enrolled with 31 subjects, read out Study of patients with severe SNHL, planned for Q4 2021 ages 18 – 65 DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Remyelination in Multiple Sclerosis* *We established an internal research program using PCA to drive remyelination as a potential therapy for MS and have identified compounds that display promising preliminary preclinical results in an in vivo model of remyelination. 39Pipeline Sensorineural Hearing DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Loss (SNHL) FX-322 Phase 2a – 202 Study Study enrolled with 95 subjects, Study of noise induced and sudden SNHL patients with completed June 2021 mild to moderately severe acquired SNHL, ages 18 – 65 FX-322 Phase 1b – 111 Study Study enrolled with 33 subjects, completed Open-label safety study focused on administration March 2021 conditions for FX-322. Subjects had mild to severe SNHL, ages 18 – 65 Study enrolled with 30 subjects, FX-322 Phase 1b – 112 Study Study of (presbycusis (age-related hearing loss completed May 2021 patients) ages 66 - 85 FX-322 Phase 1b – 113 Study Study enrolled with 31 subjects, read out Study of patients with severe SNHL, planned for Q4 2021 ages 18 – 65 DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Remyelination in Multiple Sclerosis* *We established an internal research program using PCA to drive remyelination as a potential therapy for MS and have identified compounds that display promising preliminary preclinical results in an in vivo model of remyelination. 39
Astellas Collaboration: Ex-US Development and Commercialization of FX-322 • Development and commercialization collaboration for FX-322, including lifecycle improvements • Astellas has ex-US rights; Frequency retains US rights to FX-322 • Payments of up to $625mm which included $80mm upfront - Development milestone payments to Frequency of $65.0 million and $25.0 million upon the first dosing of a patient in a Phase 2b clinical trial for • Strategic commitment to SNHL in Europe and Asia, respectively invest in ENT as a therapeutic area - $100.0 million and $40.0 million upon the first dosing of a patient in a Phase 3 clinical trial for • Research focus in SNHL in Europe and Asia, respectively regenerative medicine • Development & commercialization: • Global footprint in major Astellas responsible for execution and costs of ex- markets and US clinical development and commercialization distributorship model in Africa/ME and LATAM c Frequency Therapeutics, Inc. 40Astellas Collaboration: Ex-US Development and Commercialization of FX-322 • Development and commercialization collaboration for FX-322, including lifecycle improvements • Astellas has ex-US rights; Frequency retains US rights to FX-322 • Payments of up to $625mm which included $80mm upfront - Development milestone payments to Frequency of $65.0 million and $25.0 million upon the first dosing of a patient in a Phase 2b clinical trial for • Strategic commitment to SNHL in Europe and Asia, respectively invest in ENT as a therapeutic area - $100.0 million and $40.0 million upon the first dosing of a patient in a Phase 3 clinical trial for • Research focus in SNHL in Europe and Asia, respectively regenerative medicine • Development & commercialization: • Global footprint in major Astellas responsible for execution and costs of ex- markets and US clinical development and commercialization distributorship model in Africa/ME and LATAM c Frequency Therapeutics, Inc. 40
LEADERSHIP c Frequency Therapeutics, Inc. 41LEADERSHIP c Frequency Therapeutics, Inc. 41
Proven Leadership Team Peter Pfreundschuh David Lucchino Chris Loose, Ph.D. Chief Financial Officer President, CEO & Co-Founder Chief Scientific Officer & Co-Founder CFO of numerous public life sciences companies Former CEO of Entrega Bio (PureTech). Co-founder/CTO of Semprus BioSciences through including UroGen and Sucampo, as well as business Co-founder/CEO of Semprus BioSciences FDA/CE clearance and acquisition. Princeton, MIT, development and finance leadership positions at Astra (acquired), Polaris Partners. MIT Sloan Fellow. Hertz Fellow and Yale Faculty. Zeneca and J&J. Sue Stewart, J.D., LLM Dana Hilt, M.D. Carl Lebel, Ph.D. Chief Regulatory Consultant Chief Medical Officer Chief Development Officer CRO at numerous biopharma companies including Neurologist and neuroscientist with two decades in Chief Scientific Officer of Otonomy (2009 to 2016). Kaleido Biosciences, Candel Therapeutics, and biopharma and CNS drug development. Amgen, Executive Director, Amgen. Scientific fellow of the regulatory leadership roles at Tokai Pharma, Lysosomal, Forum Pharma. American Academy of Otolaryngology. Transmolar and Genzyme Corp. Quentin McCubbin, Ph.D. Wendy Arnold Chief Manufacturing Officer Chief People Officer Led pharmaceutical sciences and process chemistry at HR leader with extensive life science experience Takeda/Millennium and headed technical operations including senior leadership roles at Kaleido Cerevel Therapeutics. Biosciences, Moderna, Celgene Avilomics Research, and Inotek Pharmaceuticals c Frequency Therapeutics, Inc. 42Proven Leadership Team Peter Pfreundschuh David Lucchino Chris Loose, Ph.D. Chief Financial Officer President, CEO & Co-Founder Chief Scientific Officer & Co-Founder CFO of numerous public life sciences companies Former CEO of Entrega Bio (PureTech). Co-founder/CTO of Semprus BioSciences through including UroGen and Sucampo, as well as business Co-founder/CEO of Semprus BioSciences FDA/CE clearance and acquisition. Princeton, MIT, development and finance leadership positions at Astra (acquired), Polaris Partners. MIT Sloan Fellow. Hertz Fellow and Yale Faculty. Zeneca and J&J. Sue Stewart, J.D., LLM Dana Hilt, M.D. Carl Lebel, Ph.D. Chief Regulatory Consultant Chief Medical Officer Chief Development Officer CRO at numerous biopharma companies including Neurologist and neuroscientist with two decades in Chief Scientific Officer of Otonomy (2009 to 2016). Kaleido Biosciences, Candel Therapeutics, and biopharma and CNS drug development. Amgen, Executive Director, Amgen. Scientific fellow of the regulatory leadership roles at Tokai Pharma, Lysosomal, Forum Pharma. American Academy of Otolaryngology. Transmolar and Genzyme Corp. Quentin McCubbin, Ph.D. Wendy Arnold Chief Manufacturing Officer Chief People Officer Led pharmaceutical sciences and process chemistry at HR leader with extensive life science experience Takeda/Millennium and headed technical operations including senior leadership roles at Kaleido Cerevel Therapeutics. Biosciences, Moderna, Celgene Avilomics Research, and Inotek Pharmaceuticals c Frequency Therapeutics, Inc. 42
Scientific Advisory Board Clinical Advisory Board Jeff Karp, Ph.D. Robin Franklin, Robert Langer, Sheng Ding, Rene Gifford, Steve Rauch, Ruth Litovsky, Dan Lee, Associate Professor at Ph.D. SC.D. Ph.D. Ph.D. M.D. Ph.D. M.D. Brigham and Women’s Professor of Stem Cell David H. Koch Institute Senior Investigator, Associate Director of Director, Vestibular Professor, Communications Director, Pediatric Hospital, Harvard Medical Medicine, Professor at the Gladstone Pediatric Audiology, Division, Medical Sciences and Disorders and Otology and School Wellcome Trust-MRC Massachusetts Institute Institute of Director of Cochlear Director, Mass. Eye Surgery Division of Neurotology, Mass Cambridge of Technology Cardiovascular Disease Implant Program, and Ear Balance and Otolaryngology, University Eye and Ear Stem Cell Institute Vanderbilt University Vestibular Center of Wisconsin Sean J. Siddhartha Amy Wagers, Julie Arenberg, Chris Runge, Joni Doherty, David Friedland, Morrison, Ph.D. Mukherjee, Ph.D. MS, Ph.D. Ph.D. MD, Ph.D. M.D., Ph.D. Director of the M.D., D.Phil. Forst Family Professor Associate Director of Chief of the Division of Assistant Professor of Vice-Chair of the Department Children's Medical of Clinical Audiology for Communication Clinical Assistant Professor of of Otolaryngology and Center Research Stem Cell and Research and Medicine, Sciences, Medical Otolaryngology-Head Communications Sciences, Institute, Regenerative Biology, Education, Mass Eye College of Wisconsin and Neck Surgery, Columbia University Medical College of Wisconsin UT Southwestern Harvard University and Ear Medical Center Keck School of Medicine of USC. c Frequency Therapeutics, Inc. 43Scientific Advisory Board Clinical Advisory Board Jeff Karp, Ph.D. Robin Franklin, Robert Langer, Sheng Ding, Rene Gifford, Steve Rauch, Ruth Litovsky, Dan Lee, Associate Professor at Ph.D. SC.D. Ph.D. Ph.D. M.D. Ph.D. M.D. Brigham and Women’s Professor of Stem Cell David H. Koch Institute Senior Investigator, Associate Director of Director, Vestibular Professor, Communications Director, Pediatric Hospital, Harvard Medical Medicine, Professor at the Gladstone Pediatric Audiology, Division, Medical Sciences and Disorders and Otology and School Wellcome Trust-MRC Massachusetts Institute Institute of Director of Cochlear Director, Mass. Eye Surgery Division of Neurotology, Mass Cambridge of Technology Cardiovascular Disease Implant Program, and Ear Balance and Otolaryngology, University Eye and Ear Stem Cell Institute Vanderbilt University Vestibular Center of Wisconsin Sean J. Siddhartha Amy Wagers, Julie Arenberg, Chris Runge, Joni Doherty, David Friedland, Morrison, Ph.D. Mukherjee, Ph.D. MS, Ph.D. Ph.D. MD, Ph.D. M.D., Ph.D. Director of the M.D., D.Phil. Forst Family Professor Associate Director of Chief of the Division of Assistant Professor of Vice-Chair of the Department Children's Medical of Clinical Audiology for Communication Clinical Assistant Professor of of Otolaryngology and Center Research Stem Cell and Research and Medicine, Sciences, Medical Otolaryngology-Head Communications Sciences, Institute, Regenerative Biology, Education, Mass Eye College of Wisconsin and Neck Surgery, Columbia University Medical College of Wisconsin UT Southwestern Harvard University and Ear Medical Center Keck School of Medicine of USC. c Frequency Therapeutics, Inc. 43
LEADING A NEW CATEGORY IN REGENERATIVE MEDICINE Advancing Novel Approaches to Hearing Restoration Corporate Overview September 2021 Copyright Frequency Therapeutics, Inc. 44LEADING A NEW CATEGORY IN REGENERATIVE MEDICINE Advancing Novel Approaches to Hearing Restoration Corporate Overview September 2021 Copyright Frequency Therapeutics, Inc. 44