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Frequency Therapeutics Making The Right Noises, IPO Lockup Expires On Mar.31

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Shares of Frequency Therapeutics Inc. (FREQ) which closed at a new high of $26, have gained 50 percent over the last 1 month.

Frequency Therapeutics is a clinical-stage biotechnology company developing a disease-modifying therapy for the treatment of sensorineural hearing loss (SNHL), the most common type of hearing loss.

About 48 million people in the U.S. and about 466 million people worldwide are affected by hearing loss. Sensorineural hearing loss accounts for about 90% of the hearing loss cases. There are no FDA-approved medicines for SNHL yet.

The Company's lead product candidate is FX-322, designed to regenerate auditory hair cells to restore hearing function. This compound is currently under a phase IIa trial, which is designed to enroll approximately 96 adults aged 18 to 65 with stable SNHL at 12 sites in the U.S. The key efficacy endpoints of this trial are word recognition (WR), words-in-noise (WIN), and standard pure tone audiometry.

In a phase I/II study, FX-322 demonstrated a statistically significant and clinically meaningful improvement in key measures of hearing loss, including clarity of sound and word recognition, with no serious adverse events observed, according to the Company.

Initiated in October 2019, the trial is recruiting participants, and top-line data are expected in the second half of 2020.

Frequency Therapeutics has an exclusive license agreement with Astellas Pharma Inc. , under which Astellas is responsible for the development and commercialization of FX-322 outside of the U.S. The deal, signed last July, is worth $625 million, including the $80 million upfront payment received by Frequency Therapeutics.

The Company is also advancing its multiple sclerosis discovery program, with the Investigational New Drug Application expected to be submitted in the second half of 2021.

Frequency Therapeutics went public on the Nasdaq Global Select Market on October 3, 2019, offering its shares at a price of $14 each. The IPO lock-up period expires on March 31, 2020.

The Company had cash, cash equivalents and short-term marketable securities of $165.3 million on September 30, 2019.

FREQ has thus far hit a low of $11.17 and a high of $26.66. The stock closed Tuesday's (Jan21, 2020) trading at $26.00, up 5.01%.

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