Product Development and Clinical Trials - FX-322, the lead product candidate, is still under clinical development and its success is critical for the company's business[13] - The Phase 1/2 clinical trial for FX-322 showed that 33% of subjects achieved a 10% or greater absolute improvement in word recognition scores[17] - Interim results from the Phase 2a trial indicated that four weekly injections did not demonstrate improvements in hearing measures compared to placebo[18] - The FDA granted FX-322 Fast Track designation, which may expedite its development process[18] - The Phase 1b clinical trial for FX-322 showed that 34% of subjects achieved a 10% or greater absolute improvement in word recognition scores after a single injection[22] - The Phase 2a clinical trial of FX-322 showed no improvements in hearing measures versus placebo, with 95 subjects evaluated across four arms[47] - The exploratory clinical study in Germany demonstrated measurable concentrations of FX-322 in cochlear fluid samples, confirming effective delivery to the cochlea[48] - The company plans to advance FX-322 as a single-dose regimen for SNHL, following interim results indicating dampened hearing benefits from repeated weekly injections[35] - FX-322 demonstrated a 34% improvement in word recognition (WR) scores of 10% or greater in treated subjects at day 90, statistically significant compared to the control group (p < 0.05) [51] - The clinical trial assessed hearing function using word recognition and words-in-noise tests, with follow-up visits at 15, 30, 60, and 90 days post-injection[82] - FX-322 treatment resulted in a mean percentage of words correct (WR) of 38.4% at baseline, improving to 69.6% at day 90, and 54.8% at follow-up[86] - A statistically significant improvement in WR was observed in FX-322-treated patients compared to placebo (p=0.010)[88] - The Phase 2a trial enrolled 95 patients across 16 sites, focusing on stable noise-induced hearing loss (NIHL) or stable sudden sensorineural hearing loss (SSNHL)[95] - The company plans to report an analysis of the end of Phase 2a data (210 days) in late Q2 2021[98] Financial Agreements and Collaborations - The company has received an upfront payment of $80 million from Astellas Pharma Inc. under the collaboration agreement for FX-322, with potential milestone payments of up to $230 million[26] - The company has an agreement with Astellas, which includes an upfront payment of $80 million and potential development milestone payments up to $230 million[130] - If the Astellas licensed products are successfully commercialized, the company could be eligible for up to $315 million in potential commercial milestone payments and tiered royalties ranging from low- to mid-teen percentages[130] - The company is engaged in collaborations with The Scripps Research Institute and Cambridge Enterprise to advance its MS program[27] Market and Competitive Landscape - The company faces significant competition in the biotechnology and pharmaceutical sectors, which could impact its operating results[14] - The company is aware of multiple companies developing therapeutics for hearing loss, including Novartis and Audion Therapeutics, which are conducting clinical trials[157] - The company recognizes that there are no approved therapies promoting remyelination for multiple sclerosis, highlighting a significant market opportunity[158] - The company faces competition from various companies in the pharmaceutical and biotechnology sectors, which may have greater financial resources and established market presence[154][155] Regulatory Environment - The FDA imposes substantial requirements on the company for drug development, which necessitates significant time and financial resources[161][162] - The FDA has a goal of ten months from the date of filing of a standard NDA for a new molecular entity to review and act on the submission[170] - The FDA conducts a preliminary review of all NDAs within the first 60 days after submission[172] - The FDA may require submission of a REMS plan for certain medications with serious safety concerns[173] - The FDA may issue a Complete Response Letter (CRL) if specific conditions must be met for final approval of the NDA[176] - The Pediatric Research Equity Act (PREA) requires a pediatric assessment for most drugs unless a deferral or waiver is granted[178] - The FDA has various expedited programs, including fast track designation and priority review, to expedite the development and review of drugs[179] - A priority review means that the goal for the FDA to review an application is six months, compared to the standard review of ten months[182] - Drugs may be eligible for accelerated approval based on adequate and well-controlled clinical trials establishing effects on surrogate endpoints[183] - The FDA may impose post-approval requirements, including Phase 4 clinical trials, to further assess a product's safety and effectiveness[188] - Manufacturers must continue to comply with cGMP requirements and may face inspections by government agencies[189] - The FDA provides a five-year period of non-patent marketing exclusivity for the first applicant to obtain approval of a New Drug Application (NDA) for a new chemical entity[193] Intellectual Property and Licensing - As of March 19, 2021, the company owned, licensed, or had an option to license 38 patent families, including 22 U.S. patents and 35 ex-U.S. patents[118] - The patent portfolio for the Hearing Loss program includes 31 patent families, with 17 U.S. patents and 32 ex-U.S. patents as of March 19, 2021[120] - The company has obtained worldwide licenses for intellectual property from Scripps and Cambridge to promote remyelination of nerve fibers[35] - The company relies on trade secrets and confidential know-how, but acknowledges the difficulty in protecting such information[125] - The company entered into a Non-Exclusive Patent License Agreement with Massachusetts Eye and Ear, making a $20 thousand license fee payment and committing to milestone payments up to $350 thousand for each product incorporating the licensed patent rights[138][139] - The company is obligated to pay annual license maintenance fees between $5 thousand and $7.5 thousand per MEE patent family case number prior to the first commercial sale of an MEE licensed product, and a minimum annual royalty payment of $15 thousand thereafter[139] - The company made a $1.0 million license fee payment upon entering the CALIBR License and is required to make milestone payments up to $26 million for each category of CALIBR licensed products[145] - The company is obligated to pay a mid-single-digit royalty on CALIBR licensed products and a royalty on sub-license revenues ranging from a low-teen percentage to 50%[145] - The Cambridge License requires the company to make a $50 thousand license fee payment and annual license fees of $50 thousand, along with milestone payments up to $10.5 million for each Cambridge licensed product[151] Impact of External Factors - The COVID-19 pandemic has had an adverse impact on the company's operations, potentially affecting clinical trials and capital raising efforts[30] - Third-party payors are increasingly reducing reimbursements for pharmaceutical products and services, impacting sales and physician utilization[200] - Significant uncertainty exists regarding the coverage and reimbursement status of newly approved products, requiring manufacturers to provide scientific support to each payor separately[199] - Legislative changes have resulted in aggregate reductions of Medicare payments to providers of 2% per fiscal year, impacting the pharmaceutical industry[205] - The Affordable Care Act (ACA) increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1%[203] - The ACA imposes a nondeductible annual fee on pharmaceutical manufacturers or importers who sell branded prescription drugs to specified federal government programs[203] - The distribution of prescription pharmaceutical products is regulated by the Prescription Drug Marketing Act, which sets minimum standards for drug distributors[192] - In the European Economic Area, medicinal products can only be commercialized after obtaining a Marketing Authorization, which varies in approval process and requirements[207] Research and Development Focus - The company is developing a product candidate for multiple sclerosis (MS) using its Progenitor Cell Activation (PCA) platform, with promising preliminary preclinical results[27] - The PCA platform has potential applications beyond hearing, including diseases of muscle, gastrointestinal tract, skin, and bone, with ongoing research for MS[35] - The company has initiated a discovery and preclinical program in multiple sclerosis (MS) targeting remyelination through small molecules[103] - The company is focused on building strategic collaborative relationships to facilitate the development of its PCA platform and product pipeline[35] Leadership and Strategic Vision - The leadership team includes experienced biotech executives and a Clinical Advisory Board focused on hearing science and technology[34] - The company aims to establish itself as a global leader in hearing function and expand its presence in hearing restoration[35] - Current treatment options for hearing loss are limited to hearing aids and cochlear implants, with no FDA-approved drug therapies for SNHL[66] - FX-322 is designed to regenerate hair cells in the cochlea, potentially improving overall hearing function and quality of life for patients with hearing loss[70] - The administration of FX-322 is performed intratympanically, taking approximately 10 to 15 minutes and is generally well-tolerated[72] - In preclinical studies, FX-322 showed the ability to regenerate hair cells in cochlea exposed to aminoglycoside antibiotics, restoring hair cells to near native levels[76] - The company plans to directly market and commercialize its lead product candidate, FX-322, for the treatment of SNHL in the United States, developing its own sales and marketing force targeting ENTs and audiologists[114]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of inc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpor ...

Revenue and Financial Performance - Revenue for the three months ended March 31, 2020, was $7,264,000, compared to $0 for the same period in 2019[19]. - The total comprehensive loss for Q1 2020 was $4,982,000, compared to $5,756,000 in Q1 2019, showing a 13% improvement[22]. - The company reported a net loss of $4.913 million for the three months ended March 31, 2020, compared to a net loss of $5.826 million for the same period in 2019, representing a decrease of approximately 15.7%[91]. - Basic and diluted net loss per share was $(0.16) for the three months ended March 31, 2020, compared to $(3.24) for the same period in 2019, indicating a significant improvement in loss per share[91]. - The net loss for the three months ended March 31, 2020, was $4.9 million, an improvement of $0.9 million compared to a net loss of $5.8 million in 2019[209]. - Interest income increased to $0.7 million for the three months ended March 31, 2020, compared to $0.1 million in 2019, reflecting an increase of $0.6 million[209]. Operating Expenses - Total operating expenses for Q1 2020 were $12,919,000, a 118% increase from $5,916,000 in Q1 2019[19]. - Research and development expenses for the three months ended March 31, 2020 totaled $6.67 million, a significant increase from $3.45 million in the same period in 2019[197]. - General and administrative expenses were $6.2 million for the three months ended March 31, 2020, compared to $2.5 million in 2019, an increase of $3.7 million[214]. - The company reported a stock-based compensation expense of $2,164,000 for Q1 2020, significantly higher than $49,000 in Q1 2019[27]. - FX-322 external development costs were $1.0 million for the three months ended March 31, 2020, compared to $0.8 million in 2019, an increase of $0.2 million[212]. - Platform development, early-stage research, and unallocated expenses rose to $5.6 million in Q1 2020, up from $2.6 million in Q1 2019, marking a $3.0 million increase[213]. Cash and Liquidity - Cash and cash equivalents increased to $203,090,000 as of March 31, 2020, from $200,158,000 at the end of 2019[16]. - Cash used in operating activities for Q1 2020 was $9,363,000, compared to $6,150,000 in Q1 2019, indicating a 52% increase in cash outflow[27]. - Total current liabilities decreased to $43,728,000 as of March 31, 2020, down from $52,780,000 at the end of 2019, a reduction of 17%[16]. - The company’s cash and cash equivalents at March 31, 2020, consist entirely of cash held in banks and money market funds[47]. Stock and Equity - Stockholders' equity as of March 31, 2020, was $164,849,000, compared to $167,358,000 at the end of 2019, reflecting a decrease of 1.5%[16]. - The weighted-average shares of common stock outstanding for Q1 2020 were 30,868,220, compared to 1,797,986 in Q1 2019, reflecting a significant increase in shares[19]. - As of March 31, 2020, the Company had 6,908,115 stock options outstanding, an increase from 5,968,672 as of December 31, 2019, indicating potential future dilution[110]. - The Company has authorized 200,000,000 shares of common stock, with 31,009,250 shares issued and outstanding as of March 31, 2020, reflecting ongoing equity management[107]. Research and Development - The company is focused on developing FX-322 for sensorineural hearing loss (SNHL), with a Phase 1/2 clinical trial showing statistically significant improvements in hearing measures among 23 patients[169]. - FX-322 demonstrated measurable concentrations in cochlear fluid in an exploratory study in Germany, with no serious treatment-related adverse events observed in seven patients[170]. - The company expects research and development expenses to continue to increase substantially as it completes the Phase 2a clinical trial for FX-322 and initiates additional clinical trials[197]. - The company has incurred recurring losses since its inception and has funded operations primarily through capital stock sales and collaboration agreements[36]. Collaboration and Agreements - The company completed its IPO on October 31, 2019, raising approximately $79.7 million in net proceeds from the sale of 6,325,000 shares at $14.00 per share[31]. - Astellas paid the Company an upfront payment of $80.0 million in July 2019, with potential development milestone payments up to $230.0 million and commercialization milestones of up to $315.0 million[141]. - The Company recognized revenue when customers obtain control of promised goods or services, following a five-step model under ASC Topic 606[73]. - The Astellas Agreement remains in effect until the expiration of all royalty obligations, which are paid on a licensed product-by-licensed product and country-by-country basis[142]. Risks and Uncertainties - The company expects to continue generating operating losses for the foreseeable future, with future viability dependent on raising additional capital[36]. - The company relies on a single manufacturer for its product candidates, which poses a risk of supply interruption[53]. - The COVID-19 pandemic has impacted clinical trial enrollment and operations, with some sites temporarily halting enrollment[169][174]. - The company has realized gains on investments and foreign exchange gains, but has not recorded any net tax benefit from cumulative net operating loss carryforwards due to uncertainty around utilizing these tax attributes[205][207].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 47-2324450 (State or other jurisdi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39062 FREQUENCY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-2324450 (State or other ...