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 March 31, 2023 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 jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Delaware 47-2324450 (State or Other Jurisdiction of Incorporation or Organization) (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, 2022 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 ...

Financial Performance - The company reported no revenue for the three months ended September 30, 2022, compared to $14,068,000 for the same period in 2021[20]. - For the nine months ended September 30, 2022, the net loss was $64,218,000, compared to a net loss of $63,186,000 for the same period in 2021, indicating a slight increase in losses year-over-year[29]. - The company reported a net loss per share of $1.83 for the nine months ended September 30, 2022, compared to $1.84 for the same period in 2021, indicating a stable loss per share[51]. - The company reported a comprehensive loss of $19,531,000 for the three months ended September 30, 2022, compared to a comprehensive loss of $25,159,000 for the same period in 2021, indicating an improvement of approximately 22%[23]. - The company reported net losses of $64.2 million and $84.7 million for the nine months ended September 30, 2022, and the year ended December 31, 2021, respectively[145]. Assets and Liabilities - Total current assets decreased from $134,748,000 on December 31, 2021, to $100,990,000 on September 30, 2022, a decline of approximately 25%[17]. - Cash and cash equivalents decreased from $79,635,000 on December 31, 2021, to $43,846,000 on September 30, 2022, a reduction of approximately 45%[17]. - The accumulated deficit increased from $180,085,000 on December 31, 2021, to $244,303,000 on September 30, 2022, reflecting a rise of about 36%[17]. - The company had total liabilities of $54,040,000 as of September 30, 2022, compared to $54,534,000 on December 31, 2021, showing a slight decrease of about 1%[17]. - Cash, cash equivalents, and restricted cash at the end of the period were $45,545,000, down from $113,760,000 at the end of the same period in 2021, indicating a significant decrease in liquidity[29]. Operating Expenses - Total operating expenses for the three months ended September 30, 2022, were $20,275,000, down from $24,990,000 in the same period of 2021, representing a decrease of about 19%[20]. - Research and development expenses for the nine months ended September 30, 2022, were $38,769,000, down from $48,169,000 for the same period in 2021, a decrease of about 19%[20]. - General and administrative expenses for the three months ended September 30, 2022, were $8.6 million, down $0.8 million from $9.3 million in 2021[187]. - Total operating expenses for the nine months ended September 30, 2022, were $64.8 million, down $11.9 million from $76.7 million in 2021[195]. - General and administrative expenses were $26.0 million for the nine months ended September 30, 2022, a decrease of $2.5 million from $28.6 million in 2021[201][202]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2022, was $42,618,000, a decrease from $58,171,000 in the prior year, reflecting improved cash flow management[29]. - The company had net cash provided by investing activities of $6,573,000 for the nine months ended September 30, 2022, a significant improvement from a net cash used of $51,479,000 in the prior year[29]. - Cash, cash equivalents, and marketable securities totaled $99.3 million as of September 30, 2022, expected to fund operations into 2024[210]. Stock and Equity - The weighted-average shares of common stock outstanding increased from 34,448,746 for the three months ended September 30, 2021, to 35,247,680 for the same period in 2022, an increase of approximately 2%[20]. - The company had 35,262,233 shares of common stock issued and outstanding as of September 30, 2022, an increase from 34,611,213 shares as of December 31, 2021[53]. - The company sold 12,767 shares of common stock under the ATM program for net proceeds of approximately $50,000 during the nine months ended September 30, 2022[58]. - The company recognized stock-based compensation of $5,994,000 for the nine months ended September 30, 2022, compared to $7,393,000 for the same period in 2021[70]. - The total unrecognized stock-based compensation expense relating to unvested stock options and restricted stock units was $23,888,000, expected to be recognized over a weighted-average period of 1.72 years[70]. Research and Development - Research and development expenses for the three months ended September 30, 2022, were $11.7 million, a decrease of $3.9 million from $15.7 million in 2021[180]. - The company incurred $2.9 million in costs related to FX-322 for the three months ended September 30, 2022, primarily for clinical costs associated with ongoing trials[183]. - FX-322, the Company's lead product candidate, showed a statistically significant improvement in word recognition scores in a Phase 1/2 clinical trial with 23 subjects[133]. - In the Phase 2a clinical trial, four weekly injections of FX-322 did not demonstrate improvements in hearing measures versus placebo, attributed to uncontrolled bias[134]. - The safety profile of FX-322 has been favorable across multiple clinical trials, with no treatment-related serious adverse events reported[136]. Future Outlook - The company expects to continue generating operating losses for the foreseeable future, emphasizing the need for additional capital to finance operations[33]. - The company plans to reduce its workforce by approximately 30% to align with business needs and focus on R&D programs[142]. - The prolonged COVID-19 pandemic may adversely impact the company's ability to raise additional capital and conduct clinical trials[149]. - The company is unable to estimate potential losses related to ongoing legal proceedings, including class action lawsuits filed against it[123].

Financial Performance - Revenue for the three months ended June 30, 2022, was $0, compared to $9,417,000 for the same period in 2021, indicating a 100% decrease[19]. - The company had no revenue for the six months ended June 30, 2022, compared to $14,068,000 for the same period in 2021, indicating a 100% decrease[19]. - Net loss for the six months ended June 30, 2022, was $44,671,000, compared to a net loss of $38,031,000 for the same period in 2021, reflecting an increase in loss of approximately 17.5%[23]. - The net loss for the three months ended June 30, 2022, was $21,285, compared to a net loss of $17,656 for the same period in 2021, reflecting a year-over-year increase of approximately 9.2%[50]. - For the six months ended June 30, 2022, the net loss was $44,671, up from $38,031 in the same period of 2021, representing an increase of about 17.4%[50]. Assets and Cash Flow - Total assets decreased from $185,358,000 on December 31, 2021, to $149,658,000 on June 30, 2022, representing a decline of approximately 19.2%[17]. - Cash and cash equivalents decreased from $79,635,000 on December 31, 2021, to $42,373,000 on June 30, 2022, a reduction of about 46.8%[17]. - The company reported a net cash used in operating activities of $30,821,000 for the six months ended June 30, 2022, compared to $43,148,000 for the same period in 2021, a reduction of about 28.5%[29]. - Cash, cash equivalents, and marketable securities totaled $111.0 million as of June 30, 2022, expected to fund operations into 2024[209]. Operating Expenses - Total operating expenses for the three months ended June 30, 2022, were $21,273,000, down from $26,900,000 in the same period of 2021, a decrease of approximately 21.1%[19]. - Total operating expenses decreased to $44.5 million for the six months ended June 30, 2022, down from $51.8 million in 2021, representing a reduction of $7.2 million[193]. - Research and development expenses totaled $27.1 million for the six months ended June 30, 2022, a decrease of $5.5 million from $32.5 million in 2021[196]. - General and administrative expenses were $17.5 million for the six months ended June 30, 2022, down $1.8 million from $19.3 million in 2021[200]. Stockholder Equity and Shares - Stockholders' equity decreased from $130,824,000 on December 31, 2021, to $95,853,000 on June 30, 2022, a decline of approximately 26.7%[17]. - The weighted-average shares of common stock outstanding increased from 34,238,394 for the three months ended June 30, 2021, to 34,976,409 for the same period in 2022, an increase of approximately 2.2%[19]. - The company has authorized 200,000,000 shares of common stock, with 34,976,409 shares issued and outstanding as of June 30, 2022[54]. Research and Development - The company is focused on developing FX-322 to treat sensorineural hearing loss (SNHL), with a goal to help millions of people[127]. - In the Phase 1/2 clinical trial (FX-322-201), 23 subjects showed a statistically significant improvement in word recognition scores, with 34% achieving a 10% or greater absolute improvement[128][130]. - The Phase 2a clinical trial (FX-322-202) did not demonstrate improvements in hearing measures compared to placebo, raising concerns about the reliability of baseline scores[129]. - The company expects research and development expenses to continue to increase substantially as it conducts ongoing clinical trials and develops additional product candidates[162]. Financing and Capital Needs - The company expects to continue generating operating losses for the foreseeable future, emphasizing the need for additional capital to finance operations[32]. - Additional financing will be necessary to support ongoing operations, as the company does not expect to generate significant revenue from product sales in the foreseeable future[141]. - The company has raised approximately $378.3 million to date, including from grants and option exercises[209]. Legal and Compliance - The company intends to vigorously defend against ongoing class action lawsuits alleging violations of securities laws, with no accruals recorded as of June 30, 2022[119][123]. - The company has recorded a valuation allowance against its deferred tax assets due to uncertainty around utilizing these tax attributes[175]. Workforce and Operational Changes - The company announced a reduction in force of approximately 30% of its workforce to align with near-term business needs and focus on research and development for its lead candidates FX-322 and FX-345[137]. - The company announced a reduction in force of approximately 30% of its workforce to better align resources with business needs, with estimated costs of $1.2 million related to severance[212].

Financial Performance - The company had a net loss of $23,386,000 for the three months ended March 31, 2022, compared to a net loss of $20,375,000 for the same period in 2021, representing an increase in loss of approximately 15%[20]. - The Company reported a net loss of $23,386,000 for the three months ended March 31, 2022, compared to a net loss of $20,375,000 for the same period in 2021, representing an increase in loss of approximately 14.8%[53]. - Revenue for the three months ended March 31, 2022 was $0, a decrease of $4.7 million compared to $4.7 million for the same period in 2021, attributed to the conclusion of revenue recognition from the Astellas Agreement[181]. - Total operating expenses for the three months ended March 31, 2022 were $23.3 million, a decrease of $1.6 million from $24.9 million in the same period in 2021[180]. - Net loss for the three months ended March 31, 2022 was $23.4 million, compared to a net loss of $20.4 million for the same period in 2021, reflecting an increase in losses of $3 million[180]. - Research and development expenses totaled $13.8 million for the three months ended March 31, 2022, down from $15.1 million in the same period in 2021, a decrease of $1.3 million[183]. Assets and Liabilities - As of March 31, 2022, Frequency Therapeutics reported total assets of $164,939,000, a decrease of 11% from $185,358,000 as of December 31, 2021[18]. - Cash and cash equivalents decreased to $49,830,000 as of March 31, 2022, down 37% from $79,635,000 at the end of 2021[18]. - The accumulated deficit increased to $203,471,000 as of March 31, 2022, compared to $180,085,000 at the end of 2021[18]. - The company had total liabilities of $52,269,000 as of March 31, 2022, a slight decrease from $54,534,000 at the end of 2021[18]. - Cash, cash equivalents, and marketable securities totaled $124.8 million as of March 31, 2022, expected to fund operations into 2024[196]. Stock and Shares - The weighted-average shares of common stock outstanding increased to 34,810,676 in Q1 2022 from 34,115,682 in Q1 2021, reflecting an increase of approximately 2%[20]. - The weighted-average shares of common stock outstanding increased to 34,810,676 as of March 31, 2022, from 34,115,682 in the prior year, reflecting a growth of about 2.0%[53]. - The Company has authorized 200,000,000 shares of common stock, with 34,976,409 shares issued and outstanding as of March 31, 2022, up from 34,611,213 shares as of December 31, 2021[57]. - The Company sold 12,767 shares of common stock under its ATM program for net proceeds of approximately $50,000 during the three months ended March 31, 2022[59]. - The total grant date fair value of options vested during the three months ended March 31, 2022, was $5,097,000, compared to $4,284,000 for the same period in 2021, an increase of approximately 18.9%[64]. Operating Activities - The company had a net cash used in operating activities of $17,343,000 for Q1 2022, a decrease from $25,474,000 in Q1 2021[29]. - Net cash used in operating activities for the three months ended March 31, 2022 was $17.3 million, a decrease from $25.5 million in the same period in 2021[201]. - The company incurred $12.7 million in net cash used in investing activities for the three months ended March 31, 2022, primarily due to $20.8 million in purchases of marketable securities[203]. - Net cash used in investing activities for Q1 2021 was $26.2 million, primarily from the purchase of marketable securities totaling $25.7 million[207]. - Net cash provided by financing activities for Q1 2021 was $0.6 million from the exercise of stock options[208]. Future Outlook and Funding - The company expects to continue generating operating losses for the foreseeable future, with future viability dependent on raising additional capital[33]. - Anticipated operating expenses are expected to increase substantially due to the expansion of product development programs, necessitating additional financing[143][144]. - Future funding requirements will depend on the progress and costs associated with clinical development of FX-322 and other product candidates, as well as regulatory requirements[211]. - The company may finance cash needs through public or private equity or debt financings, which could dilute ownership interests[212]. - Existing cash, cash equivalents, and marketable securities are projected to fund operating expenses and capital requirements into 2024, although this estimate is subject to change[210]. Clinical Trials and Product Development - FX-322, the lead product candidate, showed a statistically significant improvement in word recognition scores in a Phase 1b trial, with 34% of subjects achieving a 10% or greater absolute improvement[133]. - The Phase 2a trial of FX-322 did not demonstrate improvements in hearing measures compared to placebo, attributed to uncontrolled bias and limitations in baseline measures[132]. - The company plans to file an investigational new drug application for FX-345 in the second half of 2022, aiming to expand treatment opportunities for different types of sensorineural hearing loss[137]. - The company is focused on advancing its progenitor cell activation approach to potentially treat multiple sclerosis, with a preclinical compound FREQ-162 showing promising results in remyelination[138]. - The company is actively engaged in clinical trials, including a Phase 2b study of FX-322, with the primary endpoint being speech perception in subjects with noise-induced or sudden sensorineural hearing loss[136]. Collaborations and Agreements - Astellas paid the company an upfront payment of $80,000, with potential development milestone payments up to $230,000 and commercialization milestones of up to $315,000 under the collaboration agreement[81]. - The collaboration with Astellas is governed by a joint steering committee, with both parties responsible for development and commercialization activities in their respective territories[80]. - The company has a license agreement with MIT, which includes potential milestone payments up to $2,900 for each Licensed Product or Licensed Process[94]. - The Company is required to make milestone payments up to $26,000 for each Category of CALIBR Licensed Products, with a $1,000 initial license fee payment[101]. - The Company has entered into a license agreement with CALIBR for exclusive rights to certain patent rights for the treatment of multiple sclerosis[99]. Workforce and Operational Changes - Approximately 30% of the workforce was reduced to better align with business needs and focus capital resources on research and development programs, with estimated future cash outlays of $1.2 million related to severance costs[127][139]. - The company announced a reduction in force of approximately 30% of its workforce, with estimated future cash outlays of $1.2 million related to severance costs[200]. Accounting and Compliance - The company is classified as an emerging growth company, allowing it to take advantage of an extended transition period for compliance with new accounting standards[216]. - There were no material changes to critical accounting policies during the three months ended March 31, 2022, compared to the previous annual report[214].

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, 2021 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, 2021 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 (Address of principal executive offices) (Zip Code) (781) 315-4600 (Registrant's telephone number, including area code) ...

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, 2021 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 ...

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 March 31, 2021 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 incorpo ...

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]