8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 11, 2021

 

 

FREQUENCY THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-39062   47-2324450

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

19 Presidential Way, 2nd Floor

Woburn, MA 01801

(Address of principal executive offices) (Zip Code)

(866) 389-1970

(Registrant’s telephone number, include area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2 below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common stock, par value $0.001 per share   FREQ   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 7.01. Regulation FD Disclosure.

On January 11, 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 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 January 11, 2021


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: January 11, 2021     By:  

/s/ Michael D. Bookman

      Name: Michael D. Bookman
      Title: Deputy General Counsel and Secretary
EX-99.1

Exhibit 99.1

 

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REIMAGINING THE TREATMENT OF HEARING LOSS Corporate Overview January 2021


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Forward-Looking Statements and Other Disclaimers This presentation contains forward-looking statements within the approval for and commercializing product candidates; the results of meaning of the Private Securities Litigation Reform Act of 1995. All earlier clinical trials not being indicative of the results from later statements contained in this presentation that do not relate to clinical trials; differences between preliminary or interim data and matters of historical fact should be considered forward-looking final data; adverse events or undesirable side effects; disruptions at statements, including without limitation statements regarding the the FDA and other regulatory agencies; the impact of the COVID-19 treatment potential of FX-322, the Phase 2a clinical trial of FX-322 impact; failure to identify additional product candidates; new or and the Phase 1b studies in age-related hearing loss and severe changed legislation; failure to maintain Fast Track designation for SNHL patients, design, pace and timing of enrollment for the Phase FX-322 and such designation failing to result in faster development 1b studies in age-related hearing loss and severe SNHL, the timing or regulatory review or approval; costly and damaging litigation, and completeness of data from the Phase 2a clinical trial and Phase including related to product liability, intellectual property or 1b studies in age-related hearing loss and severe SNHL, the results brought by stockholders; dependence on Astellas for the and implications of the Phase 1/2 durability of response data, the development and commercialization of FX-322 outside of the timing of end of phase 2 meetings with the FDA and future pivotal United States; misconduct by employees or independent studies, the ability of our technology platform to provide patient contractors; reliance on third parties, including to conduct clinical benefit, the impact of COVID-19 on the Company’s on-going and trials and manufacture product candidates; compliance with laws planned clinical trials and business, future milestone and royalty and regulations, including healthcare and environmental, health, payments under the license and collaboration agreement with and safety laws and regulations; failure to obtain, maintain and Astellas Pharma Inc. (“Astellas”), the sufficiency of the Company’s enforce protection of patents and other intellectual property; cash, cash equivalents and short-term investments, estimates of the security breaches or failure to protect private personal information; size of the hearing loss population and population at risk for hearing attracting and retaining key personnel; and ability to manage loss, estimates of the commercial opportunity of FX-322 and the growth. impact on existing treatment paradigms, the timing of the remyelination program, and the potential application of the PCA These and other important factors discussed under the caption platform to other diseases. “Risk factors” in the Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 16, 2020 and its These forward-looking statements are based on management’s other reports filed with the SEC could cause actual results to differ current expectations. These statements are neither promises nor materially from those indicated by the forward-looking statements guarantees, but involve known and unknown risks, uncertainties made in this presentation. Any such forward-looking statements and other important factors that may cause actual results, represent management’s estimates as of the date of this performance or achievements to be materially different from any presentation. While the Company may elect to update such future results, performance or achievements expressed or implied forward-looking statements at some point in the future, it disclaims by the forward-looking statements, including, but not limited to, any obligation to do so, even if subsequent events cause its views to the following: Frequency Therapeutics (the “Company”) has change. These forward-looking statements should not be relied incurred and will continue to incur significant losses and is not and upon as representing the Company’s views as of any date may never be profitable; need for additional funding to complete subsequent to the date of this presentation. 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 c Frequency Therapeutics, Inc. 2


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2021 – A Year of Data and Growth LEADERSHIP MOMENTUM CLARITY Bringing focus to Speech Late Q1 2021: day-90 read Understanding the broadest Intelligibility as the major out of FX-322 Phase 2a study patient population that can unmet clinical need for Late Q2 2021: end-of-study be helped by FX-322. New hearing loss patients Phase 1b studies in age readout of FX-322 Phase 2a related and severe hearing Acceptance of clinical data study loss in Otology & Neurotology Continued partnership with Developing extensive HCP, Setting the standard—Astellas patient and payor insights to Creating the regulatory and guide strategy clinical path forward c Frequency Therapeutics, Inc. 3


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Frequency Therapeutics: Pioneering a New Mode of Medicine Lead program, FX-322, showed first evidence of a hearing signal and hearing restoration in a clinical study; potential to treat tens of millions of patients Clinical-stage company that uses small molecules to activate progenitor cells within the body to restore damaged cells and tissue Transformative approach to regenerative medicine potentially for a broad range of degenerative diseases, including a 2nd program in multiple sclerosis c Frequency Therapeutics, Inc.


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Frequency Therapeutics: A Vision Built on Regeneration Since 2014 Frequency Hearing loss: has been developing a powerful new the 4th therapeutic approach largest cause to address a condition for which there has of disability been limited innovation in decades. globally Source: Wilson, et al. Lancet. (2017) c Frequency Therapeutics, Inc.


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Large Hearing Loss Market: No Restorative Treatments Only 20% market ~$10 Billion ~41 Million $750 Billion penetration for Hearing Aids US hearing aid SNHL patients Lost annually due to market annual sales in US untreated hearing loss globally c Frequency Therapeutics, Inc. 6


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Intelligibility—The Major Unmet Clinical Need I’M NOTICING AND UNDERSTANDING WHAT YOU’RE SAYING.


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High Frequencies are Critical for Intelligibility For someone with high-frequency hearing loss, words may be indistinguishable –impacting their ability to understand and communicate.


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40% of the words in English rely on the use of High Frequency Consonants 42% Of the words in Mandarin 55% Of the words in Spanish c Frequency Therapeutics, Inc.


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Hearing Loss May Have a Significant Impact on Overall Health Increased risks with untreated “Hearing loss is the hearing loss largest potentially modifiable risk factor for 50% 41% developing dementia” July, 2020 DEMENTIA DEPRESSION JAMA Nov 8, 2018 Deal J, et al. Incident Hearing Loss and Comorbidity. A Longitudinal Administrative Claims Study.


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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.” Sensory Hair Cells - Journal of Neuroscience, July 2020 Progenitor Cells


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Solution: A Therapy to Address the Underlying Pathology Activating progenitor cells to regenerate sensory hair cells in the cochlea


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Solution: Directly Targeting Regenerating Sensory Hairs in the Cochlea FX-322 is administered via a standard The injection concentrates FX-322 in the cochlear intratympanic injection, a common region that detects extended high-frequency procedure ENTs perform routinely sounds, critical for speech intelligibility c Frequency Therapeutics, Inc. 14


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Increasing Focus on Higher-Level Hearing Benefit Audibility (Loudness) Intelligibility (Clarity) measured with pure tone test measured with word recognition and words-in-noise tests (Standard, Validated Tests) Word Recognition Test • List of 50 monosyllabic words • Single words played in quiet Words-in-Noise Test • Background noise from multiple voices • Played at different signal-to-noise ratios c Frequency Therapeutics, Inc. 15


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Recap: Completed FX-322 Phase 1/2 Safety Study Study Design Key Findings • FX-322 shown to have a favorable safety profile – no serious AEs Absolute Word Recognition Scores Single No 50 Injection Injection 40 • Clinically meaningful improvement in 15 drug, All 23 30 word recognition scores in patients 8 placebo patients 20 with measurable word recognition 10 deficits 0 % Change from Baseline in Word Recognition Scores • Statistically significant improvement in word recognition scores (words in Injection only in one ear creating quiet/sound clarity) an additional control p = 0.010 • Safety study % Change from Baseline in Words-in-Noise Scores • Patients with mild to moderate SNHL; permanent NIHL/SSNHL for at least 6 • Improvement trend in words-in-noise months • Majority of patients did not have p = 0.211 measurable impairment in WR FX-322 Placebo


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FX-322 Patients Show Sustained Hearing Improvements 13-21 Months After Initial Dosing 50 50W 47 Key Findings 40 50W 50W *25W • Preliminary evidence 39 38 38 50W 50W indicating a durable 34 35 *25W benefit of hearing clarity 30 50W 30 50W 29 26 Baseline—Correct words out of 50 50W 50W Day 90—Correct words out of 50 20 22 20 1-2 Years—Correct words out of 50 50W 50W 16 50W 14 10 12 Three patients who had durable 50W improvements in intelligibility 7 also had pure tone audiometry improvements of 10 – 15 dB at the 0 Month 16** Month 21** Month 19** Month 13** Month 21** highest frequency tested (8k Hz) 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 Frequency Therapeutics, c Inc. • **Since FX-322 dosing 17


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Forthcoming Data Publication FX-322 Phase 1/2 and drug delivery studies • Peer-reviewed journal • The pre-eminent journal in the field • Focused on research and clinical advances • Editor: Dr. Larry Lustig, Columbia University c Frequency Therapeutics, Inc. 18


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FX-322 Study—Phase 2a Design, Single and Multiple Doses Screening NIHL/SSNHL Mild to Moderately Severe • Double-blind, placebo-controlled, multi-center, adults Randomize 1:1:1:1 ages 18-65 • All subjects have meaningful word recognition deficits • Efficacy and exploratory FX-322 FX-322 FX-322 Placebo endpoints 1X 2X 4X 4X • Word recognition N = 24 N = 24 N = 24 N = 24 • Words-in-noise • Pure tone audiometry (0.25-16kHz) Weekly Dosing • Tinnitus questionnaire • QoL questionnaires Follow-up Visits Days 15, 30, 60, 90, 120, 150, 180, 210 Study Enrollment Completed Sept. 2020 c Frequency Therapeutics, Inc. 19


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Phase 2a Study objectives Further establish Evaluate Clarify endpoints hearing signal repeat dosing and patient population for registration Improvements in FX-322 impact on key intelligibility secondary measures measures such as word including ultra-high recognition and words frequency pure tones, in noise tinnitus and QOL measures c Frequency Therapeutics, Inc. 20


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Collecting Key Data to Inform Clinical Program Phase 1/2 Study Phase 2a Study Overview N= 23 N= 95 Hearing restoration signal observed Further establish signal & validate potential endpoints Word recognition/Words-in-noise Word recognition/Words-in-noise Pure tone audiometry at 8kHz (0.25-8kHz) Pure tone audiometry /extended frequencies (0.25-16kHz) Tinnitus questionnaire QoL questionnaires Entrance criteria limited participation of subjects Entrance criteria required all subjects have meaningful with meaningful word recognition/words-in-noise word recognition deficits deficits Single dose Single and multiple doses Studies are double-blind, placebo-controlled, multi-center, in adults ages 18-65


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Phase 2a Readouts: Data to be Provided Day-90 FX-322 day-90 group-level data review (late Q1 2021): • Speech intelligibility as measured by WR and WIN testing • Pure Tone Audiometry measures at frequencies from 0.25Hz to 16k Hz • Partial data on measures of FX-322 on tinnitus, impact on QoL • Safety profile


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Phase 2a Readouts: Data to be Provided End of Study FX-322 end-of-study group- and individual- level data readout (late Q2 2021): • Full (7 month) intelligibility and audibility data. • Seven-month durability data (all patients) • Full study data on measures of FX-322 on tinnitus, impact on QoL • Safety profile


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Building on Existing Treatment Paradigms ENT treatment role in ENT diagnosis, cochlear Without implant or bone-Therapeutics anchored hearing aid (Current State) Audiologist Empowers ENT’s with a therapeutic Patient intervention Diagnosis Treatment Monitoring Journey Anticipate Audiologists will Audiologist see increased patient flow With Increased patient flow Hearing aid still Need for on-going Therapeutics to AUD for diagnosis dispensed by AUD monitoring by AUD (Future State) ENT Diagnosis, therapeutic administered by ENT c Frequency Therapeutics, Inc. 24


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Understanding the Broader of FX Phase 1b Study 5M severe evaluating ages 18- 65 with Each SNHL Type Being Studied in severe hearing loss FX-322 clinical program represents a significant patient population Phase 1b Study evaluating ages 66-85 with 16M mild to moderate, age 65+ mild to moderately severe age- related hearing loss Phase 2a Study evaluating ages 18 – 65 with 20M mild to moderate, age 18-65 noise induced and sudden mild to moderately severe SNHL Source: NCHS Survey Data 2016-18; NCHS 2017; NCHS 2016; c Frequency Therapeutics, Inc. 25


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Program Momentum and Expansion Sensorineural Hearing Loss DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 (SNHL) FX-322 Phase 2a – 202 Study Study of noise induced and sudden SNHL Fully enrolled; Day-90 data analysis planned for late Q1 2021 patients with mild to moderately severe with end of study read out in late Q2 2021 acquired SNHL, ages 18 – 65 FX-322 Phase 1b – 112 Study First patient dosed October 2020, Study of mild to moderately severe age- read out planned for Q2 2021 related hearing loss patients, ages 66—85 FX-322 Phase 1b – 113 Study Study commenced in Q4 2020, read out Study of patients with severe SNHL, planned for Q3 2021 ages 18 – 65 DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Remyelination in Regulatory submission Multiple Sclerosis planned for H2 2021 c Frequency Therapeutics, Inc. 26


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Regenerative Approach with Broad PotentialBrainEar EyeLung SkinProgenitor cells are stem cells that are pre-programmed to Intestine Bone perform a specific activityMuscle CartilagePotential to address a range of degenerative diseasesc Frequency Therapeutics, Inc. 27


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Remyelination Program for Multiple SclerosisRemyelination is the Target Regulatory major unmet need in MS submission—2H21• Little room to improve • Single agents have current demonstrated signal in immunomodulators early Phase 2 MS studies• Patients still decline due • Frequency has secured to lack of myelination rights across multiple • Target population for key classes of molecules remyelination • Building on Frequency represents 50% of MS expertise in synergistic patients combinations of small moleculesc Frequency Therapeutics, Inc. 28


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Summary and Financial ProfileAddressing Broadest FX-322 Near-Term Ex-US Partnership with Potential SNHL Market Data Readouts Strong Potential Milestones and RoyaltiesStudies across all major Continued clinical validation SNHL types and development progressAddressable market of >40 towards pivotal studies million people in the USPlatform $224.2 Million in Cash and Well capitalized for Potential Cash Equivalents advancement of pivotal trials. PCA platform with potential to treat patients across Runway into 2023numerous degenerative *As of Sept. 30, 2020. Excludes diseases restricted cash29c Frequency Therapeutics, Inc.


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REIMAGINING THE TREATMENT OF HEARING LOSS


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APPENDIX


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Broad Potential of Progenitor Cell Activation Approach. 32Broad Potential of Progenitor Cell Activation Approach. 32Broad Potential of Progenitor Cell Activation Approach32Broad Potential of Progenitor Cell Activation Approach32Broad Potential of Progenitor Cell Activation Approach32APPENDIXCorporate Overview January 2021


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Origin of Frequency TherapeuticsTissue-Specific, Pre-programmed Stem CellsDecoding Intestinal Enabling Cochlear Frequency Regeneration Regeneration TherapeuticsLanger and Karp publish Same cues reactivate Small molecule small molecules activate normally inactive therapeutics show clinical intestinal progenitors progenitors in the cochlea proof of conceptNiche-independent high- Clonal Expansion of Lgr5-purity cultures of Lgr5+ Positive Cells from intestinal stem cells and Mammalian Cochlea and their progeny High-Purity Generation of Sensory Hair Cells


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Frequency Progenitor Cell Activation (PCA) ApproachInactive Progenitor CellInactive ACTIVATEDProgenitor ProgenitorAsymmetric division using native programs + Functional Target CellCombinations of small molecules designed to activate progenitor


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Uniqueness of Our PCA approachPrevious Approaches Frequency’s PCA ApproachPluripotentMultipotentYamanaka 4 Factors Partial ReprogrammingBipotentTransdifferentiationFully DifferentiatedHair Progenitor Hair Progenitor Cell Cell Cell Cell


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Frequency: Developing a Platform Approach that Reduces the Complexity of Regenerative MedicineHarnessing No Change to Ease of Innate Biology Genome ManufacturingProgenitors Activating Use of small already native molecules: no located within programs, need to remove target tissue reducing safety or grow cells ex concerns vivoc Frequency Therapeutics, Inc. 36


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Progenitors in Place to Replace Hair Cell Loss Human Cochlea Cross-section AudiogramDespite Hair Cell Loss, Progenitor Cells Remain47 Year Old Male with Occupational Noise Deafnessc Frequency Therapeutics, Inc. 37


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Profound Synergy Between Pathways to Regenerate CellsCochlear Progenitor Proliferation (Lgr5-GFP)Culture MediaWnt Activation (glycogen synthase kinase-3 (GSK3) Inhibitor; NCE)HDAC Inhibition (sodium valproate)Wnt Activation + HDAC inhibitionHDAC = Histone deacetylaseNCE = new chemical entity PROFOUND SYNERGY In vitro mouse model testingc Frequency Therapeutics, Inc. 38


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Strong FX-322 Pre-Clinical ValidationTest OutcomeIn vitroAdult human inner ear tissue Created new hair cellsIn vivoRestored hair cells and Adult deafened mice hearing across all frequenciesAchieved active levels in the Therapeutic drug levels cochlea in multiple speciesc Frequency Therapeutics, Inc. 39


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FX-322 Program Advances and Global Opportunity


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FX-322: Robust Clinical Phase 1/2 DesignScreening NIHL/SSNHL Mild to Moderately SevereSingle No Study Overview Injection Injection• Assess safety in 15 drug, All 23 patients with 8 placebo patients sensorineural FX-322 Placebo hearing loss N = 15 N = 8• Stable patientsDay 1 | Dose• Evaluated hearing by word testing and pure tonesFollow-up VisitsInjection only in one ear Days 15, 30, 60, 90 creating an additional controlc Frequency Therapeutics, Inc. 41


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FX-322: Successful Phase 1/2 Study CompletedExploratory Endpoints—Screening NIHL/SSNHL Key Findings Evaluating Hearing Signal Mild to Moderately Severe• Favorable safety profile Mild SNHL patients (9 treated w/FX-322; 5 • No change in placebo patients placebo)• Baseline WR typically ears FX-322 Placebo • No change in untreated45+ word out of 50 N = 15 N = 8 (ceiling effect)Moderate SNHL patients Day 1 | Dose(6 treated w/FX-322; 3 Placebo) • Could be assessed for Follow-up Visits hearing improvement Days 15, 30, 60, 9042 c Frequency Therapeutics, Inc.


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First Drug Candidate to Show Clinically Meaningful Improvements in Word RecognitionAbsolute Word Recognition Scores5047*Clarity of Sound40 Used word tests in a quiet 39* background3834*30 Baseline—Correct words out of 5029 Day 90—Correct words out of 5026 Test/retest variability is one standard deviation, which for a 50-word list is 2020 ~ 3 words16*14 *Statistically significant and 10 12 clinically meaningful improvements in word recognition8 70Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6c Frequency Therapeutics, Inc. 43


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Sustained Improvements in Sound ClarityStatistically Significant Clear Improvement Trend Improvement in Words-in-Noise in Sound Clarity (words in quiet)line base baseline from from Improvementchange change % % p = 0.010 p = 0.211FX-322 Placeboc Frequency Therapeutics, Inc. 44


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Clinical Data Confirms FX-322 Delivery to CochleaExploratory study to see if cochlear drug levels can be directly measured in patients undergoing cochlear implant surgery following FX-322 injectionKey Findings:• Measurement of cochlear fluid confirmed successful drug delivery to cochlea in all samples analyzed• Drug levels predicted to result in therapeutic activityTaken together with the Phase 1/2 study, we believe this is the first known clinical evidence of a pharmacokinetic / pharmacodynamic effect of a potential hearing restoration therapeuticc Frequency Therapeutics, Inc. 45


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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 • Strategic commitment 2b clinical trial for SNHL in Europe and Asia, to invest in ENT as a respectively therapeutic area- $100.0 million and $40.0 million upon the first dosing of a patient in a Phase 3 clinical • Research focus in trial for SNHL in Europe and Asia, regenerative medicine respectively • Global footprint in • Development & commercialization: major markets and Astellas responsible for execution and costs of distributorship model ex-US clinical development and in Africa/ME and commercialization LATAMc Frequency Therapeutics, Inc. 46


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REIMAGINING THE TREATMENT OF HEARING LOSSCorporate OverviewJanuary 2021LEADERSHIP c Frequency Therapeutics, Inc. 47


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Proven Leadership TeamDavid Lucchino Chris Loose, Ph.D. Carl Lebel, Ph.D.President, CEO & Co-Founder Chief Scientific Officer & Co-Founder Chief Development OfficerFormer CEO of Entrega Bio (PureTech). Co-founder/CTO of Semprus BioSciences Chief Scientific Officer of Otonomy (2009 to Co-founder/CEO of Semprus BioSciences through FDA/CE clearance and acquisition. 2016). Executive Director, Amgen. Scientific (acquired), Polaris Partners. MIT Sloan Fellow. Princeton, MIT, Hertz Fellow and Yale Faculty. fellow of the American Academy of Otolaryngology.Dana Hilt, M.D. William Chin, M.D. Will McLean, Ph.D. Chief Medical Officer EVP, Clinical & Translational Science VP, Biology & Regen. Med, Co-FounderNeurologist and neuroscientist with two SVP, Discovery Research and Clinical 15 years experience in inner ear biology. decades in biopharma and CNS drug Investigation at Eli Lilly, EVP at PhRMA, Discovered specific stem cells that make hair development. Amgen, Lysosomal, Forum Executive Dean for Research at Harvard cells and neurons. Harvard-MIT Health Sciences Pharma. Medical School. and Technology Program.Wendy Arnold Peter PfreundschuhChief People Officer Chief Financial OfficerHR leader with extensive life science experience CFO of numerous public life sciences including senior leadership roles at Kaleido companies including UroGen and Sucampo, as Biosciences, Moderna, Celgene Avilomics well as business development and finance Research, and Inotek Pharmaceuticals leadership positions at Astra Zeneca and J&J.c 48


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Hearing Clinical Advisory BoardDan Lee, M.D. Rene Gifford, Ph.D. Steve Rauch, M.D. Ruth Litovsky, Ph.D. Director, Pediatric Associate Director of Director, Vestibular Professor, Communications Otology and Neurotology, Pediatric Audiology, Director Division, Medical Director, Sciences and Disorders and Mass Eye and Ear of Cochlear Implant Program, Mass. Eye and Ear Balance Surgery Division of Otolaryngology, Vanderbilt University and Vestibular Center University of WisconsinChris Runge, David Friedland, M.D., Julie Arenberg, MS, Joni Doherty, MD, Ph.D. Ph.D. Ph.D. Ph.D. Chief of the Division of Vice-Chair of the Department of Associate Director of Clinical Assistant Professor of Clinical Communication Otolaryngology and Communications Audiology for Research and Otolaryngology-Head and Neck Sciences, Medical College Sciences, Medical College of Wisconsin Education, Mass Eye and Ear Surgery, Keck School of Medicine of Wisconsin of USC.c Frequency Therapeutics, Inc. 49


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Scientific Advisory BoardJeff Karp, Ph.D. Robert Langer, SC.D. Robin Franklin, Ph.D. Sheng Ding, Ph.D. Associate Professor at David H. Koch Institute Professor of Stem Cell Medicine, Senior Investigator, Gladstone Brigham and Women’s Hospital, Professor at the Massachusetts Wellcome Trust-MRC Cambridge Institute of Cardiovascular Disease Harvard Medical School Institute of Technology Stem Cell InstituteSean J. Morrison, Ph.D. Siddhartha Mukherjee, Amy Wagers, Ph.D. Director of the Children’s Medical M.D., D.Phil. Forst Family Professor of Center Research Institute, Stem Cell and Regenerative Assistant Professor of Medicine, UT Southwestern Biology, Harvard University Columbia University Medical Centerc Frequency Therapeutics, Inc. 50


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REIMAGINING THE TREATMENT OF HEARING LOSSCorporate OverviewJanuary 2021