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): October 29, 2020

 

 

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 October 29, 2020, 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 October 29, 2020, the Company announced plans for a day-90 readout of its Phase 2a study of FX-322 in patients with sensorineural hearing loss (“SNHL”), which is anticipated late in the first quarter of 2021. FX-322 is the Company’s lead product candidate for the treatment of acquired SNHL. SNHL is the primary cause of more than 90 percent of all hearing loss.

The Phase 2a day-90 readout will assess all safety and efficacy endpoints following single or multiple doses of FX-322, or placebo. This time period is consistent with the evaluation period from the prior Phase 1/2 study of FX-322, in which the Company observed a hearing signal and improvement in word recognition scores in patients with moderate to moderately severe acquired SNHL.

The end of Phase 2a data readout at seven months will evaluate all data using the same metrics as at day-90, as well as the durability of the effect of FX-322 over seven months.

The Phase 2a study is a double-blind, placebo-controlled, single and repeat dose study of FX-322 in patients aged 18 to 65 with mild to moderately severe acquired SNHL. The FX-322 Phase 2a study has four dose cohorts and hearing function is regularly tested in all patients over the course of seven months. The study is being conducted at private ear, nose and throat clinics across the US.

Efficacy measures of the Phase 2a study include speech intelligibility (clarity), as measured by standard, validated word recognition (“WR”) or words-in-noise (“WIN”) testing. Exploratory efficacy measures include pure tone audiometry at extended high frequencies (up to 16kHz) that are known to contribute to speech intelligibility, as well as assessments of tinnitus and quality of life measures.

In addition, the Company announced that the first patient has been dosed in a Phase 1b safety study of FX-322 for age-related hearing loss. This study is a double-blind, placebo-controlled, randomized multicenter safety study of up to 30 individuals aged 66-85 with mild to moderately severe age-related hearing loss. In the Phase 1/2 study of FX-322, which enrolled patients with sudden SNHL and noise-induced hearing loss, the mean age of study participants was in the mid 50’s.

The primary objectives of the Phase 1b study are to assess the local and systemic safety of a single dose of FX-322 and evaluate hearing responses in an older adult cohort. Study participants will be randomized 4:1 to receive either FX-322 or placebo in one ear. Validated measures of hearing including WR, WIN and pure tone audiometry will be used. Safety, otologic and audiologic assessments will be conducted at day 30 and 90 following administration of FX-322 or placebo. The Company expects to share results from this study in the second quarter of 2021.

In addition, the Company announced plans to start a Phase 1b study of FX-322 in patients aged 18-65 with severe SNHL during the fourth quarter of 2020. Severe SNHL is defined as a pure tone average deficit between 71-90 dB, patients that typically would be candidates for cochlear implants. This study is expected to employ a similar design to the age-related Phase 1b study that is currently underway. The Company anticipates sharing results from this study in the third quarter of 2021.

On October 29, 2020, the Company issued a press release in connection with the foregoing, which is furnished as Exhibit 99.2 to this Current Report. Exhibit 99.2 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of 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 or the Exchange Act, except as expressly set forth by specific reference in such filing.

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 Phase 2a clinical trial, the Phase 1b study of age-related hearing loss, the Phase 1b study of severe SNHL, design, pace and timing of enrollment for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completeness of data readouts from the Phase 2a clinical trial and the Phase 1b studies in age-related hearing loss and severe SNHL, the therapeutic levels of FX-322 predicted in the exploratory pharmacokinetic study, the ability of the


Company’s technology platform to provide patient benefit, the impact of COVID-19 on the Company’s on-going and planned clinical trials and business, increases in headcount, future milestone and royalty payments under the license and collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company’s ability to advance its hearing program and further diversify its portfolio and the potential application of the PCA platform to other diseases.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company’s ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company’s offices and laboratory facilities, the Company’s business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company’s need for additional funding to complete development and commercialization of any product candidate; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on August 12, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this 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) Exhibit

The following exhibits relate to Items 7.01 and 8.01, and shall be deemed to be furnished, and not filed:

 

Exhibit

No.

  

Description

99.1    Frequency Therapeutics, Inc. Corporate Slide Presentation as of October 29, 2020
99.2    Press Release issued by Frequency Therapeutics, Inc. on October 29, 2020


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: October 29, 2020     By:  

/s/ Michael D. Bookman

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

Slide 1

Frequency Therapeutics Corporate Overview October 2020 Exhibit 99.1


Slide 2

FORWARD-LOOKING STATEMENTS AND OTHER DISCLAIMERS   This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the treatment potential of FX-322, the Phase 2a clinical trial of FX-322 and the Phase 1b studies in age-related hearing loss and severe SNHL patients, design, pace and timing of enrollment for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completeness of data from the Phase 2a clinical trial and Phase 1b studies in age-related hearing loss and severe SNHL, the therapeutic levels of FX-322 predicted in the exploratory Germany study, the results and implications of the Phase 1/2 durability of response data, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Company’s on-going and planned clinical trials and business, future milestone and royalty payments under the license and collaboration agreement with Astellas Pharma Inc. (“Astellas”), the sufficiency of the Company’s cash, cash equivalents and short-term investments, estimates of the size of the hearing loss population and population at risk for hearing loss, the timing of the remyelination program, and the potential application of the PCA platform to other diseases. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: 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; the impact of the COVID-19 impact; 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, intellectual property or brought by stockholders; dependence on Astellas for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth. These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation. Any such forward-looking statements represent management’s estimates as of the date of this presentation. 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 presentation.


Slide 3

Pioneering a New Mode of Medicine Clinical-stage company that uses small molecules to activate progenitor cells within the body Lead program, FX-322, showed first evidence of a hearing signal in Phase 1/2 study; potential to treat tens of millions of patients Platform to reduce complexity of regenerative medicine and treat a broad range of degenerative diseases without changes to genome


Slide 4

Clinical Development Update: FX-322 STRATEGIC FOCUS on evaluating the broadest potential for FX-322 to treat the most common form of hearing loss MOMENTUM with planned Phase 2a day-90 results in late Q1 2021; End of study readout Q2 2021 EXPANSION with start of Phase 1b study in age-related hearing loss and planned study in severe hearing loss patients


Slide 5

“I can hear you… I just can’t understand you.” Focus on Intelligibility (Clarity of Sound): The Major Unmet Clinical Need The current standard of care does not address the underlying cause of hearing loss or its most important unmet need: an inability to understand speech.


Slide 6

Focus on the importance of Hearing Health: Impacts Brain Health “Hearing loss is the largest potentially modifiable risk factor for developing dementia” July, 2020 Increased Risks with Untreated Hearing Loss DEMENTIA 50% 41% DEPRESSION JAMA Nov 8, 2018 Deal J, et al. Incident Hearing Loss and Comorbidity. A Longitudinal Administrative Claims Study.


Slide 7

Hearing Aid Market Large market despite limited adoption and lack of disease modification. Focus on Substantial Market Opportunity with No Existing Medicines FREQ: Disease Modifying Therapy FX-322 has potential to be used with or without hearing aids across a broad range of patients. Retreatment over time likely for some patients. Rapid Market Adoption Illustration of potential uptake speed for a new procedure to address sensory impairment. 26MM Mild Hearing Loss Patients (US) 15MM Moderate-to-Severe Hearing Loss Patients (US) >60% Patients with Bilateral Hearing Loss (injection in both ears) $10B Hearing Aid Market US (Device + Associated revenue) 20% Market Penetration >4MM Hearing Aid Units Sold per year (replace every 5-8 year) Number of LASIK Surgeries (US) *Lasik typically is not reimbursed, uptick based on elective rather than prescribed procedure.


Slide 8

The Problem: Missing Sensory Hair Cells in the Cochlea Healthy Cochlea Inner Hair Cells (IHCs) Outer Hair Cells (OHCs) “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, July 2020 DOI: https://doi.org/10.1523/JNEUROSCI.0937-20.2020 Sensorineural Hearing Loss Copyright Frequency Therapeutics, Inc.


Slide 9

FX-322 Program: Developing a Therapeutic to Repair the Underlying Pathology Progenitors in place despite loss of hair cells FX-322 molecules aim to activate genetic pathways to regenerate missing hair cells Progenitor cell Sensory hair cell Damaged sensory hair cells


Slide 10

FX-322: Simple and Well-Established Delivery Middle ear Cochlea Inner ear Outer ear Ear drum Round window Needle Eustachian tube US Phase 1/2 Study FX-322-201 Standard intratympanic injection Analysis in partnership with Mass Eye and Ear Institute Temporal Bone Bank 2,000 Hz 16,000 Hz 14,000 Hz 12,000 Hz 8,000 Hz 6,000 Hz 250 Hz 20,000 Hz 1,000 Hz 10,000 Hz 3,000 Hz 4,000 Hz 500 Hz FX-322 concentrates in the highest frequency region, critical for sound clarity


Slide 11

Source: Monson et al (2014) The perceptual significance of high-frequency energy in the human voice. Frontiers in Psychology, 5, 587 20 16 12 8 4 Frequency (kHz) “Oh say can you see … by the dawn’s early light” Spectrogram of Sound High Frequencies are Critical for Intelligibility 0.5 1 1.5 2 2.5 3 Time (Secs)


Slide 12

Successful Phase 1/2 Study Completed Single Injection 15 drug, 8 placebo No Injection All 23 patients Study Overview Safety in patients with sensorineural hearing loss Stable patients Assessed hearing by word testing and pure tones Follow-up Visits Days 15, 30, 60, 90 Day 1 | Dose Screening NIHL/SSNHL Mild to Moderately Severe Placebo N = 8 FX-322 N = 15


Slide 13

Clinically Meaningful Improvement in Word Recognition Mild Hearing Loss 14 patients (5 placebo) Typically very high word recognition scores (45+ words) Ceiling effect: Limited room for improvement Moderate to Moderately Severe Hearing Loss 9 patients (3 placebo) All treated subjects showed increases in word recognition 4 of 6 showed statistically significant and clinically meaningful improvement No change in placebo No change in untreated ear


Slide 14

Baseline – Correct words out of 50 Day 90 – Correct words out of 50 Clinically Meaningful Improvements in Word Recognition Clarity of Sound Used word tests in a quiet background Absolute Word Recognition Scores *Statistically significant and clinically meaningful improvements in word recognition * * * * Test/retest variability is one standard deviation, which for a 50-word list is ~ 3 words


Slide 15

First Drug Candidate to Show Improvements in Sound Clarity Day 15 Day 30 Day 60 Day 90 p=0.010 % Change from Baseline Improvement FX-322 Placebo US Phase 1/2 Study FX-322-201 Day 15 Day 30 Day 60 Day 90 p=0.211 Clear Improvement Trend in Words-in-Noise Statistically Significant Improvement in Sound Clarity (words in quiet)


Slide 16

FX-322 Patients Show Sustained Hearing Improvements 13 – 21 Months After Initial Dosing Absolute Word Recognition Scores *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 Baseline – Correct words out of 50 Day 90 – Correct words out of 50 Clarity of Sound Used word tests in a quiet background 1-2 years – Correct words out of 50 50W 50W 50W 50W 50W 25W* 25W* 50W 50W 50W Month 16** Month 21** Month 19** Month 13** Month 21** 50W 50W 50W 50W 50W Three patients who had durable improvements in intelligibility also had pure tone audiometry improvements of 10 – 15 dB at the highest frequency tested (8 kHz)


Slide 17

Phase 2a Study Objectives Clear improvements in key intelligibility measures such as word recognition and words in noise Evaluate potential impact on high frequency pure tones, tinnitus and quality of life measures Evaluate repeat dosing Clarify endpoints and patient population for registration Further establish hearing signal


Slide 18

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


Slide 19

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


Slide 20

Regenerative Approach with Broad Potential Potential to address a range of degenerative diseases Brain Ear Lung Intestine Cartilage Skin Bone Muscle Eye Progenitor cells are stem cells that are pre-programmed to perform a specific activity


Slide 21

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


Slide 22

Summary + FX-322 Program Expansion and Near-Term Catalysts Continued clinical validation and development progress + Focus: Large Market Addressable market of >40 million people in the U.S. + Ex-US Partnership Global development and commercial partner; substantial royalties and milestones, U.S. rights retained + Platform Potential PCA platform with potential to treat patients with numerous degenerative diseases


Slide 23

Frequency Therapeutics Corporate Overview October 2020


Slide 24

Appendix


Slide 25

Broad Potential of Progenitor Cell Activation Approach


Slide 26

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


Slide 27

Frequency Progenitor Cell Activation (PCA) Approach Inactive Progenitor ACTIVATED Progenitor Asymmetric division using native programs Combinations of small molecules designed to activate progenitor cells Inactive Progenitor Cell Functional Target Cell


Slide 28

Uniqueness of Our PCA Approach Pluripotent Multipotent Bipotent Fully differentiated Hair cell Progenitor cell Transdifferentiation Yamanaka 4 factors Stem cell Partial reprogramming Hair cell Progenitor cell Based on Conrad Waddington’s Epigenetic Landscape Previous approaches Frequency’s PCA approach


Slide 29

Frequency: Developing a Platform Approach that Reduces the Complexity of Regenerative Medicine Harnessing Innate Biology Progenitors already located within target tissue No Change To Genome Activating native programs, reducing safety concerns Ease of Manufacturing Use of small molecules: no need to remove or grow cells ex vivo


Slide 30

Progenitors in Place to Replace Hair Cell Loss Hearing loss correlates with hair cell loss Normal Ion Transport Normal Nerve Function Despite Hair Cell Loss, Progenitor Cells Remain 47 Year Old Male with Occupational Noise Deafness Analysis in Partnership with Mass Eye and Ear Institute Temporal Bone Bank Human Cochlear Cross-section Audiogram


Slide 31

Cochlear Progenitor Proliferation (Lgr5-GFP) Cell Rep. 2017 Feb 21;18(8):1917-1929. doi: 10.1016/j.celrep.2017.01.066 HDAC = Histone deacetylase NCE = new chemical entity In vitro mouse model testing Profound Synergy Between Pathways to Regenerate Cells Culture Media Wnt Activation (glycogen synthase kinase-3 (GSK3) Inhibitor; NCE) HDAC Inhibition (sodium valproate) Wnt Activation + HDAC inhibition PROFOUND SYNERGY


Slide 32

Strong FX-322 Pre-Clinical Validation Test Outcome In vitro Adult human inner ear tissue Created new hair cells In vivo Adult deafened mice Restored hair cells and hearing across all frequencies Therapeutic drug levels Achieved active levels in the cochlea in multiple species


Slide 33

FX-322 Program Advances and Global Opportunity


Slide 34

Expanded FX-322 Clinical Program to Evaluate Broadest Potential SNHL Patient Population Study Population Status & Anticipated Data Phase 2a Mild to moderately severe acquired SNHL Ages 18-65 n=95 Fully enrolled: Sept. 2020 Day-90 data release: Late Q1 2021 End of study month-7 data: Late Q2 2021 Phase 1b Mild to moderate age-related hearing loss SNHL Ages 66-85 n= ~30 First patient dosed: Oct. 2020 Data anticipated: Q2 2021 Phase 1b Severe SNHL Ages 18-65 n= ~30 Anticipated study start: Q4 2020 Data anticipated: Q3 2021


Slide 35

Pure Tone (Measures of Loudness) Improvements Also Shown at Highest Tested Frequency in Phase 1/2 Study US Phase 1/2 Study FX-322-201 Loudness of Sound measured pure tones Standard frequency range was measured (500 – 8000 Hz) Consistent pure tone improvements observed at 8000 Hz in only FX-322 subjects Analysis includeds subjects with a measurable baseline hearing deficit at 8000 Hz 4 / 13 subjects 0 / 7 subjects


Slide 36

Clinical Data Confirms FX-322 Delivery to Cochlea Exploratory study to see if cochlear drug levels can be directly measured 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 Phase 1/2 study, this is the first clinical evidence of a pharmacokinetic / pharmacodynamic effect of a potential hearing restoration therapeutic


Slide 37

Effective delivery to the target tissue Favorable safety profile Clinically meaningful improvements in hearing function Preliminary evidence of longer-term durability Leadership In Hearing Drug Development


Slide 38

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


Slide 39

Leadership


Slide 40

Proven Leadership Team David Lucchino President, CEO & Co-Founder Chris Loose, Ph.D. Chief Scientific Officer & Co-Founder Carl Lebel, Ph.D. Chief Development Officer Former CEO of Entrega Bio (PureTech). Co-founder/CEO of Semprus BioSciences (acquired), Polaris Partners. MIT Sloan Fellow. Co-founder/CTO of Semprus BioSciences through FDA/CE clearance and acquisition. Princeton, MIT, Hertz Fellow and Yale Faculty. Chief Scientific Officer of Otonomy (2009 to 2016). Executive Director, Amgen. Scientific fellow of the American Academy of Otolaryngology. Dana Hilt, M.D. Chief Medical Officer William Chin, M.D. EVP, Clinical & Translational Science Will McLean, Ph.D. VP, Biology & Regen. Med, Co-Founder Neurologist and neuroscientist with two decades in biopharma and CNS drug development. Amgen, Lysosomal, Forum Pharma. SVP, Discovery Research and Clinical Investigation at Eli Lilly, EVP at PhRMA, Executive Dean for Research at Harvard Medical School. 15 years experience in inner ear biology. Discovered specific stem cells that make hair cells and neurons. Harvard-MIT Health Sciences and Technology Program.


Slide 41

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


Slide 42

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


Slide 43

Frequency Therapeutics Corporate Overview October 2020

EX-99.2

Exhibit 99.2

 

LOGO

FREQUENCY THERAPEUTICS ANNOUNCES EXPANDED FX-322 CLINICAL

DEVELOPMENT PROGRAM AND UPCOMING DAY-90 PHASE 2a ANALYSIS

Company Will Report Data from Phase 2a Sensorineural Hearing Loss (SNHL) Study in Late Q1

2021

First Patient Dosed in Phase 1b Study of Age-Related Hearing Loss; Additional Phase 1b Study

for Severe SNHL Patients to Start This Quarter

WOBURN, Mass., October 29, 2020 – Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today provided an update to its strategy and clinical development program for FX-322, its lead product candidate for the treatment of acquired sensorineural hearing loss (SNHL). SNHL is the primary cause of more than 90 percent of all hearing loss.

The Company announced today plans to report an analysis of day-90 data from its Phase 2a study of FX-322 in late Q1 2021. In its previously disclosed Phase 1/2 study, Frequency observed improvements in key measures of hearing function, following a single dose of FX-322, in patients with moderate to moderately severe acquired SNHL. The evaluation period for the Phase 1/2 study was 90 days.

The primary objectives of the FX-322 Phase 2a study are to: 1) further establish the hearing signal observed in the Phase 1/2 study; 2) evaluate the impact of multiple doses; and 3) characterize exploratory endpoints to inform future studies.

Frequency also is expanding its clinical development program to evaluate FX-322’s clinical profile in other SNHL patient groups, including age-related and severe SNHL patients, in order to identify the broadest population that may benefit from its potentially restorative therapeutic approach.

Summary of FX-322 clinical studies and anticipated milestones:

 

   

FX-322 Phase 2a study of patients with mild to moderately severe acquired SNHL (ages 18-65): The Phase 2a study completed enrollment with 95 patients in September 2020. The Company today announced plans to provide a complete analysis of day-90 Phase 2a study data, which is anticipated late in Q1 2021. The Phase 2a end-of-study (seven month) readout is anticipated late in Q2 2021.


   

FX-322 Phase 1b study of patients with age-related hearing loss (ages 66 – 85): The first patient in this study was dosed in October 2020 and the complete data readout is anticipated in Q2 2021.

 

   

FX-322 Phase 1b study in patients with severe SNHL (ages 18-65): This study is expected to start this quarter and the complete data readout is anticipated in Q3 2021.

“The first half of 2021 will be an important period for Frequency in which we will obtain multiple clinical datasets that will guide and potentially accelerate our future regulatory and later stage development activities,” said David L. Lucchino, Frequency’s chief executive officer. “Improved clarity of sound and speech remains the critical unmet need for the tens of millions of individuals in the US with hearing loss, and we look forward to sharing key insights from our Phase 2a study early next year.”

FX-322 Phase 2a Study

The Phase 2a day-90 readout will assess all efficacy and safety endpoints following single or multiple doses of FX-322, or placebo. This evaluation period is consistent with the prior Phase 1/2 study of FX-322, in which the Company observed improvements in word recognition scores following a single intratympanic dose of FX-322 in patients with moderate to moderately severe acquired SNHL.

The end of Phase 2a data readout will evaluate the same metrics as at day-90, as well as the durability of the effect of FX-322 over seven months.

The Phase 2a study is a double-blind, placebo-controlled, single and repeat dose study of FX-322 in patients aged 18 to 65 with mild to moderately severe acquired SNHL. The FX-322 Phase 2a study has four dose cohorts and hearing function is regularly tested in all patients over the course of seven months. The study is being conducted at private ear, nose and throat clinics across the US.

Efficacy measures include speech intelligibility (clarity), as measured by standard, validated word recognition (WR) and words-in-noise (WIN) testing. Exploratory efficacy measures include pure tone audiometry at extended high frequencies (up to 16kHz) that are known to contribute to speech intelligibility, as well as assessments of tinnitus and quality of life measures.

At the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) annual meeting in September 2020, Frequency presented clinical results from a follow-up durability study of patients who had shown statistically significant improvements in word recognition scores in the Phase 1/2 study. These data showed that three of four patients maintained statistically significant improvements in word recognition between 13 - 21 months following initial dosing, while a fourth patient maintained some improvement. A fifth patient that had shown non-statistically significant improvements had returned to baseline.


The results of the Phase 2a end of study analysis, as well as those reported from the age-related hearing loss and severe SNHL studies, are expected to provide the basis for an end of Phase 2 meeting with the US Food and Drug Administration regarding potential registrational studies of FX-322.

New FX-322 Clinical Studies:

 

   

FX-322 Phase 1b Study for Age-Related Hearing Loss: Frequency announced today that the first patient has been dosed in a Phase 1b safety study of FX-322 for age-related hearing loss. The study is a double-blind, placebo-controlled, randomized multicenter safety study of up to 30 individuals aged 66-85 with mild to moderately severe age-related hearing loss. In the Phase 1/2 study of FX-322, which enrolled patients with sudden SNHL and noise-induced hearing loss, the mean age of study participants was in the mid 50’s.

The primary objectives of the Phase 1b study are to assess the local and systemic safety of a single dose of FX-322 and evaluate hearing responses in an older adult cohort. Study participants will be randomized 4:1 to receive either FX-322 or placebo in one ear. Validated measures of hearing including WR, WIN and pure tone audiometry will be used. Safety, otologic and audiologic assessments will be conducted at day 30 and 90 following administration of FX-322 or placebo. Frequency expects to share results from this study in Q2 2021.

 

   

FX-322 Phase 1b Study of Severe SNHL: Frequency plans to start a Phase 1b study in patients aged 18-65 with severe SNHL this quarter. Severe SNHL is defined as a pure tone average deficit between 71-90 dB. Many patients with this clinical profile typically would be candidates for cochlear implants. This study is expected to employ a similar design to the age-related Phase 1b study that is currently underway. Frequency expects to share results from this study in Q3 2021.

“Over this past year we shared results from clinical research that built on our original Phase 1/2 data. These recent findings have given us additional confidence that FX-322 reaches the site of action in the cochlea at therapeutic levels, that the treatment may be durable and disease modifying and that it continues to show a favorable safety profile,” added Carl LeBel, Ph.D., Frequency’s chief development officer. “We look forward to the Phase 2a day-90 analysis of FX-322, and we expect that these data will enable us to refine the design and endpoints of future studies and provide a fuller understanding of the effects of FX-322 on hearing clarity.”


About Sensorineural Hearing Loss

Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to auditory sensory hair cells in the inner ear. These cells convert sound waves to a signal sent to the brain. Sensory hair cells may be lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. This type of damage impacts hundreds of millions of individuals in the U.S. and worldwide.

About Frequency Therapeutics

Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company’s lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a pre-clinical program in multiple sclerosis.

Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Cambridge Enterprises Limited, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Phase 2a clinical trial, the Phase 1b study of age-related hearing loss, the Phase 1b study of severe SNHL, design, pace and timing of enrollment for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completeness of data readouts from the Phase 2a clinical trial and the Phase 1b studies in age-related hearing loss and severe SNHL, the therapeutic levels of FX-322 predicted in the exploratory pharmacokinetic study, the ability of our technology platform to provide patient benefit, the impact of COVID-19 on the Company’s on-going and planned clinical trials and business, increases in headcount, future milestone and royalty payments under the license and


collaboration agreement with Astellas, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company’s ability to advance its hearing program and further diversify its portfolio and the potential application of the PCA platform to other diseases.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company’s ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company’s offices and laboratory facilities, the Company’s business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company’s need for additional funding to complete development and commercialization of any product candidate; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the


future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

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Contacts:

Investor Contact:

Carlo Tanzi, Ph.D.

Kendall Investor Relations

ctanzi@kendallir.com

617-914-0008

Media Contact:

Suzanne Day

Frequency Therapeutics

sday@frequencytx.com

781-496-2211