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Frequency Therapeutics Corporate Presentation April 2022
Forward-Looking Statements and Other Disclaimers This presentation
contains forward-looking statements within the meaning of the process of clinical drug development and regulatory approval; limited experience Private Securities Litigation Reform Act of 1995. All statements contained in this successfully obtaining
marketing approval for and commercializing product presentation that do not relate to matters of historical fact should be considered candidates; the results of earlier clinical trials not being indicative of the results forward-looking statements,
including without limitation statements regarding the from later clinical trials; differences between preliminary or interim data and final timing and design of Frequency Therapeutics' (the "Company") new Phase 2b data; adverse
events or undesirable side effects; disruptions at the FDA and other trial of FX-322, including the type of SNHL that the enrolled patients will have and regulatory agencies; failure to identify additional product candidates; new or the ability of
design features to reduce bias, the interpretation and implications of changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or the results and
learnings of other FX-322 clinical studies, the acceptance by the FDA of particular endpoints in the Company's trials, the treatment potential of FX- approval; costly and damaging litigation, including related to product liability, 322,
FX-345, and the novel approach for remyelination in multiple sclerosis, the intellectual property or brought by stockholders; dependence on Astellas Pharma timing and progress of the FX-345 and remyelination programs, the sufficiency of Inc. for the
development and commercialization of FX-322 outside of the United the Company's cash, cash equivalents and short-term investments, estimates of States; misconduct by employees or independent contractors; reliance on third the size of the
hearing loss population and population at risk for hearing loss, parties, including to conduct clinical trials and manufacture product candidates; estimates of the size of the population with multiple sclerosis, estimates of the compliance with laws
and regulations, including healthcare and environmental, commercial opportunity of FX-322 and the impact on existing treatment health, and safety laws and regulations; failure to obtain, maintain and enforce paradigms, the ability of our technology
platform to provide patient benefit, and protection of patents and other intellectual property; security breaches or failure the potential application of the PCA platform to other diseases. to protect private personal information; attracting and
retaining key personnel; and ability to manage growth. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve These and other important factors
discussed under the caption "Risk factors" in known and unknown risks, uncertainties and other important factors that may the Company's Form 10-K filed with the Securities and Exchange Commission cause actual results, performance
or achievements to be materially different from (SEC) March 15, 2022 and its other reports filed with the SEC could cause actual any future results, performance or achievements expressed or implied by the results to differ materially from those
indicated by the forward-looking statements forward-looking statements, including, but not limited to, the following: the impact made in this presentation. Any such forward-looking statements represent management's estimates as of the date of
this presentation. While the Company of COVID-19 on the Company's ongoing and planned clinical trials, research and development and manufacturing activities, the Company's business and financial may elect to update such forward-looking
statements at some point in the future, markets; the Company has incurred and will continue to incur significant losses it disclaims any obligation to do so, even if subsequent events cause its views to and is not and may never be profitable; need
for additional funding to complete change. These forward-looking statements should not be relied upon as development and commercialization of any product candidate; the Company's representing the Company's views as of any date subsequent
to the date of this dependence on the development of FX-322; the unproven approach of the PCA presentation. platform; the lengthy, expensive and uncertain Frequency Therapeutics, Inc. | 2
2022/2023 Milestones and Catalysts FX-345 Remyelination in FX-322-208
(Hearing Restoration) Multiple Sclerosis (Hearing Restoration) Projected Enrollment Candidate Phase 1b Start Completion Selection H2:22 Q3:22 2022 Phase 1b MS Clinical Projected Readout Readout Trial Start Q4:22 or Q1:23 H1:23 2023 F
Fr req equ uen enc cy y T Th her era ap peu eut tiic cs s, I , In nc c. . | | 3 3
A Vision Built on Regeneration Since 2014, Frequency has been developing
small molecule therapeutics to activate a person's innate regenerative potential, within the body, to repair tissue and restore human function. Frequency Therapeutics, Inc. | 4
Power of the Progenitor Cell Activation (PCA) Approach Ease of No Change
to Harnessing Manufacturing Genome Innate Biology Use of small Activating native Progenitors molecules: no need programs, already located to remove or grow reducing safety within the cells ex vivo concerns target tissue Frequency
Therapeutics, Inc. | 5 Frequency Therapeutics, Inc. | 5
A Series of Firsts in Hearing Restoration First PK/PD First clinical
First speech First to show shown for a studies to show perception sustained hearing therapeutic hearing improvements improvements candidate improvements measured and continued improvements over time F Fr req equ uen enc cy y T Th her
era ap peu eut tiic cs s, I , In nc c. . | | 6 6
FX-322: A Small Molecule Candidate to Address the Underlying Pathology
Synergy between pathways aims to activate progenitor cells and regenerate sensory cells in the cochlea Frequency Therapeutics, Inc. | 7
FX-322: Directly Targeting the Regeneration of Sensory Hair Cells in the
Cochlea The injection concentrates FX-322 FX-322 is administered via a standard in the cochlear region critical for intratympanic injection, a routine speech intelligibility procedure performed by ENTs Frequency Therapeutics, Inc. |
Five FX-322 Completed Studies: 193 Treated Subjects Favorable Safety
Profile with No Treatment-Related SAEs 2018 2019 2020 2021 2022 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 SINGLE-DOSE STUDIES SSNHL and NIHL Study (201) Phase 1/2 Durability Mild-Moderately Severe [18-65 y/o] Study (201-2) 1 201 Study of
Administration Conditions (111) All Etiologies, Mild-Severe [18-65 y/o] 2 111 Age-Related Hearing Loss Study (112) Mild-Moderately Severe [66-85 y/o] 3 112 Severe Hearing Loss Study (113) All Etiologies [18-65 y/o] 4 113 MULTIPLE-INJECTION STUDY
SSNHL and NIHL Study (202) [Mild-Moderately Severe [18-65 y/o] 5 202 = Data Readout Frequency Therapeutics, Inc. | 9
FX-322-201, FX-322-111, FX-322-113 Single-Dose Safety Studies with
Hearing Improvement Signal 2018 2019 2020 2021 2022 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 SINGLE-DOSE STUDIES SSNHL and NIHL Study (201) Phase 1/2 Durability Mild-Moderately Severe [18-65 y/o] Study (201-2) 1 201 Study of
Administration Conditions (111) All Etiologies, Mild-Severe [18-65 y/o] 2 111 Age-Related Hearing Loss Study (112) Mild-Moderately Severe [66-85 y/o] 3 112 Severe Hearing Loss Study (113) All Etiologies [18-65 y/o] 4 113 MULTIPLE-INJECTION STUDY
SSNHL and NIHL Study (202) [Mild-Moderately Severe [18-65 y/o] 5 202 = Data Readout Frequency Therapeutics, Inc. | 10
Data from Controlled Studies (FX-322-201, FX-322-111) Improvement Shown
in Speech Perception in Quiet with Single Dose Day-90 Word Recognition Scores Across Studies Phase 1/2 Study Phase 1b Study FX-322-111 FX-322-201 Overview Overview FX-322-201 Phase 1/2 FX-322-111 Phase 1b Placebo-controlled, multi-center,
Compared different FX-322 40% randomized study administration conditions Mild to moderately severe subjects, Open-label, multi-center, age 18-65 (n=23) randomized study NIHL/SSNHL Mild to severe subjects, age
30% 18-65 (n=33) Study Results Study Results 20% 33% of subjects achieved 10% or 34% of subjects achieved 10% or greater absolute improvement in greater absolute improvement in word word recognition in treated ear recognition (WR) in
treated ear 10% Statistically significant and clinically Statistically significant and clinically meaningful improvements in WR meaningful improvements in WR No meaningful changes in Favorable safety profile placebo
group 0% Favorable safety profile Placebo FX-322 Untreated FX-322 *Total of 33 patients enrolled in study, 32 subjects * * completed 90-day clinical assessment period (n=8) (n=15) (n=32) (n=32) Frequency Therapeutics, Inc. | 11 %
Exceeding Absolute 10%
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 19** Month 13** Month 21** 47 Key Findings 50W 40 Preliminary evidence *25W 50W 39 indicating a durable benefit 38 38 50W 50W of hearing clarity 35 34 *25W 50W 30 30
29 50W Baseline - Correct words out of 50 26 50W Day 90 - Correct words out of 50 50W 22 20 20 1-2 Years - Correct words out of 50 50W 50W 16 50W 14 Three patients who had durable 12 10 improvements in intelligibility also had 50W pure tone
audiometry improvements 7 of 10 - 15 dB at the highest 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 **Since FX-322 dosing Frequency Therapeutics, Inc. | 12
Subjects in FX-322-111 Study Show Additional Hearing Improvements at
Later Time Points Conducted longer-term, follow-up of FX-322-111 study subjects 25 of 33 study subjects evaluated at 8-12 months following FX-322 dosing Results show some FX-322 dosed subjects accumulated hearing benefits over time 3
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, 8 of 32 evaluated study subjects have shown statistically significant
improvements in speech perception scores in treated ears between 90 days and 1 year No change observed in untreated ears Frequency Therapeutics, Inc. | 13
Pooled FX-322 Data Shows Patterns of Response Single-dose Studies (201,
111, 112) Exceed 95% Confidence Interval % Exceeding Single-dose Studies Single-dose Studies 95% Confidence Interval (201, 111, 112) (201, 111 & 112) 25% 20 Exceeds 95% Confidence Interval 20% 10 14.1% 15% +10% 10% (5 words) 0 -10% (5 words) 5%
2.5% 2.1% 0% -10 Untreated Literature* Treated Treated Untreated Placebo and Placebo n = 71 n = 84 n = 13 n = 71 n = 97 95% confidence intervals established by Thornton & Raffin (1978) and modified by Carney & Schlauch (2007)
Frequency Therapeutics, Inc. | 14 Change in Words
FX-322-113: Hearing Signal and Speech Perception Improvements Observed
in Subjects with Severe SNHL Double-blind, placebo-controlled study of 31 individuals randomized 4:1 Pure tone average deficit between 71-90 decibel hearing level (dBHL) Potential cochlear implant candidates Improvements in
Bamford-Kowal-Bench Sentence-in-Noise exam (BKB- SIN) observed in treated ears BKB-SIN measures signal-to-noise ratios required for subjects to correctly repeat words in sentences Four FX-322 treated subjects show improvement, two
with a 6 dB response A single placebo subject showed a 3.6 dB change No improvements observed in words-in-quiet Favorable safety profile No treatment-related SAEs Frequency Therapeutics, Inc. | 15 Frequency
Therapeutics, Inc. | 15
FX-322-202: Multiple Injection Study Impacted by Inconsistent Baseline
Measures 2018 2019 2020 2021 2022 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 SINGLE-DOSE STUDIES SSNHL and NIHL Study (201) Phase 1/2 Durability Mild-Moderately Severe [18-65 y/o] Study (201-2) 1 201 Study of Administration Conditions
(111) All Etiologies, Mild-Severe [18-65 y/o] 2 111 Age-Related Hearing Loss Study (112) Mild-Moderately Severe [66-85 y/o] 3 112 Severe Hearing Loss Study (113) All Etiologies [18-65 y/o] 4 113 MULTIPLE-INJECTION STUDY SSNHL and NIHL Study (202)
[Mild-Moderately Severe [18-65 y/o] 5 202 = Data Readout Frequency Therapeutics, Inc. | 16
Comparing Pooled Data to Multiple-Injection Study FX-322-202
Placebo-Treated and Untreated Ears are Outside 95% Confidence Interval % Exceeding % Exceeding Single-dose Studies Multiple Injection Study 95% Confidence 95% Confidence Interval Interval (201, 111, 112) (202) 25% 25% 21.2% 20% 20% 15.4% 14.1% 15%
15% 10% 10% 5% 5% 2.5% 2.5% 2.1% 0% 0% Untreated Untreated Literature* Treated Literature Treated and Placebo and Placebo n = 71 n = 66 n = 104 n = 97 95% confidence intervals established by Thornton & Raffin (1978) and modified by Carney &
Schlauch (2007) Frequency Therapeutics, Inc. | 17
Clinical Study Data Informs New FX-322 Phase 2b Study Frequency
Therapeutics, Inc. | 18
New Clinical Study FX-322-208 Designed to Advance Drug Candidate to
Pivotal Trials Built upon insights Sufficient sample Reduce from trials with hearing size to demonstrate potential restoration signal efficacy for bias Etiology, severity, Multiple baseline Approach based baseline speech measures on pooled data
perception Primary endpoint of Multiple speech speech perception perception tests F Fr req equ uen enc cy y T Th her era ap peu eut tiic cs s, I , In nc c. . | | 19 19
Pooled Single-Dose Studies (201, 111, 112) Data Suggest Patterns
Between Etiology/Severity and Response Moderately- Moderate Mild Severe Severe 71 Treated with single-dose of FX-322 Noise The size of each circle represents the 0% 0% 33% (18-65 years) number of people tested per group The color of the circle
represents the percentage of responders Sudden 208 Trial: Target Population 0% 27% 40% (18-65 years) 7-10 Million U.S. patients 208 Trial FX-322: Extended Population Age-related 0% 7% 0% (65+ years) 15+ Million U.S. patients Frequency
Therapeutics, Inc. | 20
Multiple Design Features Have Been Added to Mitigate Bias And
Demonstrate Greater Separation Between Signal and Placebo Lead-in phase with multiple Start of 1-Month Lead-in baseline measures Day -30 Lead-in Sites and patients masked to Day -15 qualifying test results Baseline Day 1 All sessions recorded and
monitored Ability to disqualify subjects based on symptom stability Frequency Therapeutics, Inc. | 21
New FX-322 Placebo-Controlled Phase 2b Study Commenced First patient
dosed in FX-322-208 Study in October 2021 Subjects Screened to Enter Lead-in Pure tone average 35-85dB 124 Subjects Start of 1-Month Lead-in Day -30 Subjects will have diagnosed Lead-in period with noise induced or sudden 3 visits determines Lead-in
sensorineural hearing loss trial candidacy based Day -15 on consistency of audiologic testing Ages 18 - 65 Baseline Day 1 Randomize 124 subjects assumes 10% attrition Study powered at 80% FX-322 Placebo Effect size 20% over placebo Placebo 1X
1X Significance level is 0.05 1X N = 62 N = 62 N = 62 Follow-up Visits: Days 30, 60, 90 Frequency Therapeutics, Inc. | 22
FDA Type C Meeting Held to Gain Alignment ALIGNMENT Primary Endpoint
Gained alignment with FDA on speech perception as the primary endpoint 208 Study Design FDA reviewed and commented on 208 study, comments were incorporated into study protocol Patient Reported Outcomes (PRO) FDA feedback provided on novel PRO
development called RADIAL; special meeting granted for further discussion Frequency Therapeutics, Inc. | 23
Today's Hearing Loss Market Has No Restorative Treatments Only
~$10 ~41 $980 20% Billion Million Billion Market US hearing aid Individuals Lost annually due penetration for market annual with SNHL to untreated hearing hearing aids sales in U.S. loss globally* *Source: World Health Organization Frequency
Therapeutics, Inc. | 24
Hearing Loss Can Have a Significant Impact on Overall Health July, 2020