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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Frequency Therapeutics Inc | NASDAQ:FREQ | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 14.98 | 0.3026 | 0.34 | 0 | 01:00:00 |
Recent FX-322 Study Readouts Support Single-Dose Administration as Part of Future Trial Designs; Company Planning Additional Single Injection Studies
Results from Exploratory FX-322 Phase 1b Studies in Patients with Age-Related and Severe Hearing Loss Anticipated in Q2 and Q3 Respectively
Company Ends Year with $220 Million in Unrestricted Cash Providing Runway Into 2023
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 fourth quarter and year ended December 31, 2020.
“We recently obtained valuable data from two clinical studies in patients with sensorineural hearing loss that have provided us with important learnings that already are informing our future development plans for FX-322, specifically around trial design and using a single administration approach in our studies,” said David L. Lucchino, Frequency’s President and CEO. “Combined with data from our published Phase 1/2 results, we have now shown statistically significant and clinically meaningful improvements in speech intelligibility from two independent, single injection studies that we believe provide encouraging support for FX-322 as a potential novel treatment option as we drive forward in this new area of regenerative medicine.”
Mr. Lucchino continued: “Upcoming readouts from our ongoing studies will be further clarifying, and we will use these insights as we plan for future placebo-controlled FX-322 clinical studies using a single administration regimen. We have utilized a multi-study development approach that enables us to continually learn more about the clinical profile of FX-322, its potential application in different potential populations, as well as how to carry out trials most effectively in this emerging therapeutic area. In Q2, we anticipate results of a FX-322 Phase 1b study in patients with age-related hearing loss and in Q3 results of a FX-322 Phase 1b study of patients with severe sensorineural hearing loss, which will further inform our path forward. There is a tremendous need to advance the standard of care for people with sensorineural hearing loss, and we are grateful to the patient community and all of those that have participated in our clinical studies for their continued support as we work to advance a medicine for hearing restoration.”
FX-322 Day-90 Study Detail and Ongoing Program
Other FX-322 Program Highlights
2020 and Recent Business Activity:
Fourth Quarter 2020 Financial Results
Cash Position: Cash, cash equivalents and short-term investments on Dec. 31, 2020 were $220.3 million. Based on current plans and assumptions, the Company expects its existing cash and cash equivalents, and short-term investments will be sufficient to fund its operations into 2023. This guidance does not include potential future milestones which could be received from Astellas Pharma for continued FX-322 development.
Revenue: Revenue was $10.0 million and $37.0 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively. The Company had revenue of $4.7 million and $28.9 million in each of the comparable periods of 2019.
Research & Development Expenses: Research and development expenses were $11.8 million and $37.4 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively, as compared to $6.2 million and $18.8 million for the comparable periods of 2019. The increases are due to increased costs related to the Company’s lead product candidate, FX-322, including external development costs related to the Company’s ongoing Phase 2a clinical trial, 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 $8.4 million and $27.1 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively, as compared to $5.0 million and $14.8 million for the comparable periods of 2019. The increases are 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 $10.2 million and $26.5 million for the three- and twelve-month periods ended Dec. 31, 2020, respectively, as compared to $5.5 million and $18.7 million for the comparable periods of 2019. The increase in net loss in 2020 reflects the increase in research and development costs associated with the growth of Frequency’s research and development organization and the increase in general and administrative expenses required to support the growth of the Company and the cost associated with operating as a public company.
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. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.
Headquartered in Woburn, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the interpretation and implications of the results of the interim day-90 Phase 2a data and the FX-322-111 data, including advancing FX-322 as a single-dose regimen and re-treatment at longer intervals, the impact of the trial design of the Phase 2a study on clinical data, the timing of results of the Company’s clinical studies, the treatment potential of FX-322, 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, the Company’s ability to advance its hearing program and further diversify its portfolio, the timing of the Company’s remyelination program, the sufficiency of the Company’s capital resources, the license and collaboration with Astellas Pharma Inc., and the potential application of the PCA platform to other diseases.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company’s ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company’s offices and laboratory facilities, the Company’s business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company’s need for additional funding to complete development and commercialization of any product candidate; the Company’s dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.
These and other important factors discussed under the caption “Risk factors” in the Company’s Form 10-K filed with the Securities and Exchange Commission (SEC) on March 29, 2021 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.
Frequency Therapeutics, Inc. Consolidated Statements of Operations (in thousands, except share and per share amounts)
Three Months Ended December 31,
Year Ended December 31,
2020
2019
2020
2019
Revenue
$
9,950
$
4,709
$
36,984
$
28,947
Operating expenses:
Royalty
—
—
—
16,000
Research and development
11,828
6,196
37,415
18,784
General and administrative
8,399
5,001
27,119
14,838
Total operating expenses
20,227
11,197
64,534
49,622
Loss from operations
(10,277
)
(6,488
)
(27,550
)
(20,675
)
Interest income
32
942
994
1,784
Realized gain on investments
19
50
84
138
Foreign exchange gain (loss)
(31
)
3
(4
)
7
Loss before income taxes
(10,257
)
(5,493
)
(26,476
)
(18,746
)
Income taxes
25
-
(35
)
-
Net loss
(10,232
)
(5,493
)
(26,511
)
(18,746
)
Cumulative Series C convertible preferred stock
dividends
-
(40
)
-
(1,054
)
Net loss attributable to common stockholders
$
(10,232
)
$
(5,533
)
$
(26,511
)
$
(19,800
)
Net loss per share attributable to common stockholders - basic and diluted
$
(0.30
)
$
(0.19
)
$
(0.82
)
$
(2.29
)
Weighted-average shares of common stock outstanding - basic and diluted
33,807,943
28,409,518
32,253,227
8,649,245
Frequency Therapeutics, Inc. Consolidated Balance Sheet Data (in thousands)
December 31, 2020
December 31, 2019
Cash, cash equivalents and short-term investments
$
220,341
$
217,355
Working capital
198,430
168,575
Total assets
264,722
223,218
Total liabilities
72,231
55,860
Accumulated deficit
(95,399
)
(68,888
)
Total stockholders’ equity
192,491
167,358
View source version on businesswire.com: https://www.businesswire.com/news/home/20210329005687/en/
Investor: Carlo Tanzi, Ph.D. Kendall Investor Relations ctanzi@kendallir.com 617-914-0008 Media: Suzanne Day Frequency Therapeutics sday@frequencytx.com 781-496-2211
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