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): May 14, 2020

 

FREQUENCY THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

19 Presidential Way, 2^nd 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):

 

 

 

 

 

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

 

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.  ☐

 

 

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Item 2.02. Results of Operations and Financial Condition.

On May 14, 2020, Frequency Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2020 and provided operational updates. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 of this Form 8-K (including Exhibit 99.1) 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, or the Exchange Act, except as expressly provided by specific reference in such a filing.

Item 7.01. Regulation FD Disclosure.

On May 14, 2020, in connection with the distribution of the Company’s financial results for the quarter ended March 31, 2020, the Company posted a press release sharing top-line data from its exploratory clinical study in Germany and a corporate slide presentation in the Investors & Media portion of its website https://investors.frequencytx.com/. A copy of the press release and slide presentation are attached as Exhibit 99.2 and Exhibit 99.3 to this Current Report on Form 8-K, respectively.

The information in this Item 7.01 of this Form 8-K (including Exhibit 99.2 and Exhibit 99.3) 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 of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following exhibits relate to Item 2.02 and Item 7.01, which shall be deemed to be furnished, and not filed:

 

 

 

 

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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.

 

 

 

 

Exhibit 99.1

FREQUENCY THERAPEUTICS PROVIDES BUSINESS UPDATES AND REPORTS

FIRST QUARTER 2020 FINANCIAL RESULTS

Phase 2a Study of FX-322 for Sensorineural Hearing Loss Continues Enrollment at Multiple Sites

Shares Top-Line Data from Exploratory Clinical Study Confirming Delivery of FX-322 to the Cochlea

WOBURN, Mass., May 14, 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 announced business updates and financial results for the first quarter ending March 31, 2020.

“Our Phase 2a study of FX-322 for sensorineural hearing loss continues to enroll subjects at a number of clinical sites, despite challenges from the COVID-19 pandemic. Overall, we are pleased with our progress and we deeply appreciate the work of our investigators, site staff and the engagement of the patients participating in the study during this challenging period,” said Frequency Therapeutics Chief Executive Officer David L. Lucchino.

“Today, we also shared top-line data from a new exploratory clinical study that showed in all study patients that FX-322 was delivered to the intended target within the cochlea at drug levels that could be directly measured. Further, concentrations of FX-322 were predicted to be therapeutically active. With these new data, we have now collectively observed three key elements in FX-322’s clinical development trajectory: effective delivery to the target tissue, a favorable safety profile, and clinically meaningful improvements in hearing function.

“The cochlea is one of the most privileged and difficult-to-reach sites in the body. Quantifying drug concentrations of a potential restorative medicine in the cochlea represents an important advance in inner-ear drug discovery,” Mr. Lucchino continued. “This advance furthers Frequency’s leadership in hearing regeneration and our enthusiasm for the potential of FX-322 to benefit the millions of individuals suffering from sensorineural hearing loss.”

Recent Program and Business Updates

FX-322 Phase 2a Study for Sensorineural Hearing Loss: The FX-322 Phase 2a study is a randomized, double-blind, placebo-controlled, single- and repeat-dose study that may enroll up to 96 patients aged 18 to 65 with stable sensorineural hearing loss (SNHL). The objectives of the Phase 2a study are to further establish the hearing benefits observed in the Phase 1/2 study; evaluate the impact of multiple doses; and provide insights on endpoints and the appropriate patient populations for future studies. Phase 2a study subjects are randomized to receive either FX-322 or placebo in one ear, with the untreated ear acting as an additional measure of control.

The Company has continued to observe an impact to study operations related to COVID-19. A number of study sites had previously communicated that they temporarily halted enrollment and continue to do

 

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so. The Company expects the COVID-19 pandemic may result in other clinical sites being similarly affected for an unknown period of time, slowing or temporarily halting patient enrollment and potentially impacting patient retention. However, principal investigators have reported that patients currently enrolled in the study have remained enrolled and that sites continue to be able to follow the study protocol. Since early March, coincident with the timing of increased COVID-19 related disruptions, patient enrollment has continued and new clinical sites have been activated.

Frequency continues to evaluate the anticipated timing for reporting top-line data from the Phase 2a study.

New Exploratory Clinical Study Data: In a separate press release issued today, Frequency announced top-line data from an exploratory clinical study conducted in Germany, designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the approach, study results showed measurable concentrations of FX-322 in every patient and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment, based on computer models.

The study results were based on analyzing samples of cochlear fluid, known as perilymph, taken intraoperatively from patients undergoing cochlear implant surgery. Each patient received a single intratympanic injection of FX-322, enabling researchers to directly measure the level of FX-322 in perilymph, which is not otherwise feasible in inner-ear studies because accessing the cochlea involves an invasive surgical procedure.

These data, combined with Phase 1/2 study results of FX-322 where the Company observed statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss, may show the first known evidence of a pharmacokinetic/pharmacodynamic effect of a potential hearing restoration therapeutic.

Frequency intends to present the results from this study at an upcoming medical conference.

COVID-19 Impact on Business Operations:

Frequency’s offices are located in states that are currently under mandated lock down orders and/or stay at home advisories, though in Massachusetts, biotechnology firms have been deemed essential and are exempted from such orders. At present, the majority of Frequency employees are working from home, while certain necessary laboratory employees have periodically worked in the lab to ensure that essential experiments continue. The Farmington, CT research site, co-located with the University of Connecticut, has paused activity and this site is expected to re-open when non-essential State offices are permitted to do so. Key experiments have been transitioned to the Company’s offices in Woburn, MA and third parties and contract research organizations have been engaged to advance certain projects.  

First Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and short-term investments on March 31, 2020 were $206.1 million, as compared to $217.4 million on December 31, 2019. Based on current plans and assumptions, the Company expects its existing cash, cash equivalents and short-term investments will be sufficient to

 

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fund its operations into 2022. This guidance does not include potential future milestones which could be received from Astellas for continued FX-322 development.

Revenue: Revenue was $7.3 million for the first quarter of 2020. The Company had no revenue in the comparable period of 2019.

Research & Development Expenses: Research and development expenses were $6.7 million for the first quarter of 2020, as compared to $3.4 million for the first quarter of 2019. The increase was due to increased costs related to the Company’s lead product candidate, FX-322, including external development costs as the Company commenced a Phase 2a clinical trial for FX-322 in October 2019, as well as increased personnel-related costs due to additional headcount to support the growth of Frequency’s research and development organization.

General and Administrative Expenses: General and administrative expenses were $6.2 million for the first quarter of 2020, as compared to $2.5 million for the first quarter of 2019. The increase was primarily due to an increase in personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company as well as costs associated with being a public company, primarily comprised of insurance, consulting and professional fees.

Net Loss: Net loss was $4.9 million for the first quarter of 2020, as compared to $5.8 million for the first quarter of 2019. The decrease was primarily due to the impact of recognizing $7.3 million of revenue under the Astellas license and collaboration agreement which was partially offset by increases in research and development and general and administrative expenses.

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. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a discovery 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, Cambridge Enterprises Limited, Massachusetts Eye and Ear, Partners Healthcare 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

 

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statements regarding the Phase 2a clinical trial, the timing of top-line data from the Phase 2a clinical trial and timing of presentation of results of the exploratory study in Germany, the novelty of the exploratory study in Germany, the implications of the results of the exploratory Germany study in combination with our other trials, the therapeutic levels of FX-322 predicted in the exploratory Germany 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 sufficiency of the Company’s cash, cash equivalents and short-term investments, 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 Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company’s need for additional funding to complete development and commercialization of any product candidate; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-K filed with the Securities and Exchange Commission (SEC) on March 26, 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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Frequency Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

 

 

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Frequency Therapeutics, Inc.

Consolidated Balance Sheet Data

(in thousands)

(unaudited)

 

 

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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

Tel: 781-496-2211

Email: sday@frequencytx.com

 

Exhibit 99.2

 

 

 

FREQUENCY THERAPEUTICS SHARES CLINICAL DATA FROM EXPLORATORY STUDY CONFIRMING DELIVERY OF FX-322 TO THE COCHLEA

Top-Line Results Show Consistent Drug Entry in All Patients

 

WOBURN, Mass., May 14, 2020 – Frequency Therapeutics, Inc. (Nasdaq: FREQ), today announced top-line data from an exploratory clinical study designed to show whether drug levels of FX-322 in the cochlea can be directly measured. In addition to confirming the viability of the approach, study results showed measurable concentrations of FX-322 in every patient and that anatomical factors did not prevent the active agents of FX-322 from reaching the cochlea. Further, the levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment.

FX-322 is Frequency’s lead product candidate, designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients with sensorineural hearing loss (SNHL). A Phase 1/2 study of FX-322 previously demonstrated statistically significant and clinically meaningful improvements in key measures of hearing function in patients with SNHL.

The exploratory study, initiated late in 2019, was conducted at the Hannover Medical Centre in Hannover, Germany. Results were based on an analysis of cochlear fluid, known as perilymph, obtained intraoperatively from patients undergoing cochlear implant surgery. Each patient received a single intratympanic injection of FX-322, enabling researchers to directly measure the level of FX-322 in perilymph, which is not otherwise feasible in inner-ear studies because accessing the cochlea involves an invasive surgical procedure.

“When we consider these new findings, together with the hearing signal observed in our earlier Phase 1/2 study, we believe we have developed the first known evidence of a pharmacokinetic/pharmacodynamic effect of a potential hearing restoration therapeutic. Through this study we have gained critical insight into the delivery properties of FX-322 and clinical confirmation that it reached the site of action in all study patients,” said Carl LeBel, Ph.D., Frequency’s Chief Development Officer.

In the study, seven subjects received a single dose of FX-322 at the same dose level given in the Company’s Phase 1/2 study and its ongoing Phase 2a study. Levels of both molecules that make up FX-322 were measured in all patients. The presence of round window membrane mucosal folds in certain subjects did not prevent the entry of FX-322 into the cochlea. Both agents that make up FX-322 were also predicted to achieve therapeutically active drug levels in the high frequency range of the cochlea, based on computer models. Study subjects were followed for

 

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approximately 30 days after the procedure and no serious treatment related adverse events were observed.

“Studying perilymph samples from all our cochlear implant patients has helped us to better understand the connection between certain proteins and their association with inner ear disorders. This study has now shown us for the first time that concentrations of a hearing restoration therapeutic candidate can be quantified in perilymph after intratympanic injection, and we believe this novel approach can help accelerate the understanding of therapeutics for the inner ear,” said Prof. Thomas Lenarz, Director of the Ear, Nose and Throat Clinic and the German Hearing Center of the Hannover Medical School and the principal investigator for the study.  

Frequency intends to present the results from this study at an upcoming medical conference.

About Sensorineural Hearing Loss

Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to the hair cells in the inner ear that convert sound waves from the inner ear to the brain, impacting millions of individuals in the U.S. and worldwide. These auditory 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.

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 an ongoing Phase 2a study. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including a discovery 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, Cambridge Enterprises Limited, Massachusetts Eye and Ear, Partners Healthcare and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

 

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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 novelty of the exploratory study in Germany, the timing of presentation or publication of results of the exploratory study in Germany, the implications of the results of the exploratory Germany study in combination with our other trials, the therapeutic levels of FX-322 predicted in the exploratory Germany study, the ability of our technology platform to provide patient benefit, estimates of the size of the hearing loss population and population at risk for hearing loss 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 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.

 

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These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-K filed with the Securities and Exchange Commission (SEC) on March 26, 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

Tel: 781-496-2211

Email: sday@frequencytx.com  

 

 

Frequency Therapeutics Corporate Overview May, 2020 Exhibit 99.3

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 design and enrollment of the Phase 2a clinical trial of FX-322, the timing of top-line data from the Phase 2a clinical trial and timing of presentation of results of the exploratory study in Germany, the novelty of the exploratory study in Germany, the implications of the results of the exploratory Germany study in combination with our other trials, the therapeutic levels of FX-322 predicted in the exploratory Germany 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, 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 May 14, 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.

Frequency Today FX-322 program for sensorineural hearing loss in Phase 2a clinical development Phase 1/2 results provided evidence of hearing restoration; favorable safety profile Phase 2a study ongoing; continue to enroll at a number of sites; some sites have temporarily stopped new enrollment due to COVID-19 Recent clinical study data confirms FX-322 delivery to the cochlea FDA Fast Track designation Additional opportunities across multiple degenerative diseases Multiple sclerosis program advancing toward IND; target submission H2 2021 Broad IP portfolio in hearing and additional applications Operating runway into 2022 $206.1 million in cash, cash equivalents and short-term investments (as of March 31, 2020) Potential development milestones related to Astellas ex-US FX-322 collaboration including $90M at first 2b dosing in Europe & Asia and $140M for the first Phase 3 dosing in Europe & Asia

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

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

Reducing 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

Our Pipeline Sensorineural hearing loss (FX-322) DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Exploring additional opportunities in: muscle, skin, gastrointestinal tract and bone Multiple Sclerosis

Hearing Restoration Program: Preclinical Validation

Cochlear Function: Hearing Different Frequencies Healthy Cochlea » Oval window base Round window 20,000 Hz (high frequency) 1,500 Hz (medium frequency) 20 Hz (low frequency) Schematic of expanded cochlea Apex

Impact of Damage on Cochlear Hair Cells Healthy Cochlea Inner Hair Cells (IHCs) Outer Hair Cells (OHCs) Hair cells spontaneously regenerate in other species, but not in humans Noise Damage Copyright Frequency Therapeutics, Inc.

Cochlear Progenitor Proliferation (Lgr5-GFP) Culture Media Wnt Activation (glycogen synthase kinase-3 (GSK3) Inhibitor; NCE) HDAC Inhibition (sodium valproate) Wnt Activation and HDAC inhibition HIGH SYNERGY Cell Rep. 2017 Feb 21;18(8):1917-1929. doi: 10.1016/j.celrep.2017.01.066 Strong synergy seen between pathways activated by small molecules HDAC = Histone deacetylase In vitro mouse model testing NCE = new chemical entity Profound, Unexpected Synergy

FX-322 Program: Aiming to Repair Underlying Pathology Progenitors in place despite loss of hair cells FX-322 molecules aim to activate genetic pathways to regenerate missing hair cells

Strong 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

Clinical Program

FX-322 Administration and Concentration Middle ear Cochlea Inner ear Outer ear Ear drum Round window Needle Eustachian tube US Phase 1/2 Study FX-322-201 Quick intratympanic injection into the middle ear 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

Hearing is Measured Using Validated Tests Intelligibility (Clarity) measured with word recognition and words-in-noise tests Audibility (Loudness) measured with pure tones Word Recognition Test: List of 50 monosyllabic words Single words played in quiet Words-in-Noise Test: Standard, clinically accepted measure Background noise from multiple voices Played at different signal-to-noise ratios

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 Critical Information Lost at High Frequencies 0.5 1 1.5 2 2.5 3 Time (Secs)

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

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

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 Patient 1 14 34 patient 2 7 16 patient 3 20 39 patient 4 26 47 patient 29 38 patient 8 12

Statistically Significant Improvement in Sound Clarity Placebo FX-322 Clarity of Sound Used word tests in a quiet background [all patients] Word Recognition Day 15 Day 30 Day 60 Day 90 p=0.010 % Change from Baseline Improvement US Phase 1/2 Study FX-322-201

Clear Improvement Trend in Words-in-Noise Placebo FX-322 Clarity of Sound Used word tests in a noisy background [all patients] Words-in-Noise Day 15 Day 30 Day 60 Day 90 p=0.211 % Change from Baseline Improvement US Phase 1/2 Study FX-322-201

Pure Tone Improvements at Highest Tested Frequency 0/8 4/15 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

Data Presented at AAO-HNS, September 2019 Phase 1/2 results delivered by principal investigator First ever clinical data to show hearing improvement Significant enthusiasm amongst community Results since shared broadly with ENT and auditory science KOLs

Clinical Data Confirms FX-322 Delivery to Cochlea Exploratory study in Germany to see if cochlear drug levels can be directly measured Patients undergoing cochlear implant surgery receive standard FX-322 injection Cochlear fluid (perilymph) obtained Key findings: Measurement of cochlear fluid confirmed successful drug delivery to cochlea Drug levels predicted to result in therapeutic activity Taken together with Phase 1/2 study, we believe this is the first known evidence of a pharmacokinetic / pharmacodynamic effect of a potential hearing restoration therapeutic

Leadership in Hearing Drug Development Key elements in FX-322 development: Effective delivery to the target tissue Favorable safety profile Clinically meaningful improvements in hearing function

Phase 2a Study – Objectives Evaluate repeat dosing Clarify endpoints and patient population Further establish hearing signal

FX-322 Study - Phase 2a Design 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 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

Stringent Enrollment Criteria Only double-blind, placebo-controlled hearing restoration studies for SNHL – greater rigor over past approaches Stable Sensorineural Hearing Loss: Careful screening of all study subjects Working to ensure study subjects have disease etiology that FX-322 may help treat Aiming to reduce endpoint variability

Hearing Loss Overview

Opportunity to Treat Substantial Patient Population (US) Notes: Prevalence based on self-reported hearing loss; sensorineural accounts for >90% of hearing loss Source: National Health Interview Survey (sample size of 35,000 households); Census Bureau; NIH; NCBI Moderate / Severe Hearing Loss Mild Hearing Loss 2018 Hearing Loss Prevalence – US Adults Patients (millions) = not treated = treated with hearing aids 15 26 ~40m SNHL patients – expected to grow by 20% by 2030 Opportunity to treat patients both with and without hearing aids Significant opportunity to expand treatment rate among mild patients No restorative therapies exist to treat underlying cause of SNHL

“I can hear you… I just can’t understand you.” Improvement in Hearing Clarity is the Major Unmet Need Among Hearing Loss Patients

Hearing Health Impacts Brain Health “Hearing loss is the largest modifiable risk factor for developing dementia” DEC 30, 2019 Risks Associated 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.

Broad Potential of Progenitor Cell Activation Approach

Building on strong progenitor biology foundation Scripps Institute applied PCA approach to brain progenitors Validated in multiple animal models Clinically validated using a single agent (Lancet Dec ’17) Target IND submission in 2H21 Building on expertise in discovering and developing synergistic combinations of small molecules Worldwide license and ongoing research partnership with Scripps Remyelination Program for Multiple Sclerosis

Moving Forward

Summary + Hearing Signal Established Potential first-in-class regenerative treatment to restore hearing + Large Market Immediate addressable market of >30 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

Appendix

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

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

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

Astellas Collaboration 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

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.

Hearing Clinical Advisory Board Dan Lee, M.D. | Mass Eye & Ear As the Director of the Pediatric Ear, Hearing and Balance Center, Dan Lee enjoys the challenges that come with diagnosing and treating children with complex ear conditions. David Friedland, M.D., Ph.D. | Wisconsin Board-certified otolaryngologist head and neck surgeon with specialized training in surgery for hearing restoration. He is Vice-Chair of the Department of Otolaryngology and Communications Sciences. Rene Gifford, Ph.D. | Vanderbilt As Director of the cochlear implant program, Rene Gifford’s research interests include combined electric and acoustic stimulation, hearing preservation, preoperative prediction of outcomes, speech perception and spatial hearing abilities with cochlear implants. Steve Rauch, M.D. | Mass Eye & Ear As an Otologist and Director of the Vestibular Division, Steve Rauch divides his time between clinical care and studying disorders that affect hearing and balance, such as Meniere's disease. Chris Runge, Ph.D. | Wisconsin As Chief of the Division of Communication Sciences, Chris Runge’s research interests include pediatric hearing disorders, genetics of hearing loss, speech and music understanding and the effects of aging on cochlear implant performance. Joni Doherty, MD, Ph.D. | USC Board Certified in both Otolaryngology-Head and Neck Surgery and Neurotology, with exceptional clinical skills in both general otology and skull base surgery. She is Assistant Professor of Clinical Otolaryngology-Head and Neck Surgery at the Keck School of Medicine of USC.

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 Lee Rubin, Ph.D. Professor and lead Investigator for the Rubin Laboratory, Harvard Stem Cell Institute 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

Frequency Therapeutics Corporate Overview May, 2020