SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 30, 2020
FREQUENCY THERAPEUTICS, INC.
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction
|(Commission File Number)||
19 Presidential Way, 2 nd Floor
Woburn, MA 01801
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, include area code)
(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):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
|Common stock, par value $0.001 per share||FREQ||The Nasdaq Global Select Market|
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. ☐
Item 7.01. Regulation FD Disclosure.
On April 30, 2020, in connection with the distribution of proxy materials for the Frequency Therapeutics, Inc. (the “Company”) annual meeting of stockholders, the Company included in its 2019 Annual Report a letter to stockholders from its President and Chief Executive Officer. A copy of the letter to stockholders is furnished as Exhibit 99.1 to this Current Report on Form 8-K and the 2019 Annual Report is available on the Investors & Media section of the Company’s website at https://investors.frequencytx.com/.
The information contained in Item 7.01 of this Current Report on 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 filing.
Item 9.01. Financial Statements and Exhibits
|99.1||Letter to Stockholders dated April 30, 2020|
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.
|FREQUENCY THERAPEUTICS, INC.|
|Date: April 30, 2020||By:||/s/ Michael D. Bookman|
Name: Michael D. Bookman
Title: Deputy General Counsel and Secretary
A letter from David L. Lucchino
Chief Executive Officer
Dear fellow shareholders,
This past year was one of tremendous progress for Frequency Therapeutics, and I could not be more proud to lead an organization that may redefine the landscape for regenerative therapeutics and transform the treatment paradigm for those suffering from the most common form of hearing loss.
We achieved several major milestones in 2019, advancing our hearing program, executing a global licensing and collaboration agreement, expanding our organization for the demands of future growth and taking the company public. We reported data from our Phase 1/2 study of FX-322, our lead product candidate for the treatment of sensorineural hearing loss (SNHL), in which we observed a hearing signal and the potential return of function in patients with hearing loss. We believe these results have never before been seen in hearing research and have positioned Frequency to advance what may be the first restorative, disease-modifying treatment for the millions of patients with SNHL. Our approach may potentially transform how this debilitating condition is treated beyond the device-based standard of care.
We entered into a global licensing and collaboration agreement for FX-322 with Astellas Pharma Inc. in a deal worth more than $600 million, including an $80 million up-front payment. Astellas has the rights to develop and commercialize FX-322 outside of the U.S., while Frequency maintains rights in the U.S. market.
Our Phase 2a trial of FX-322 commenced dosing in October 2019 and was followed by the U.S. Food and Drug Administration (FDA) granting FX-322 Fast Track designation, increasing our ability to engage with the agency regarding our ongoing development efforts.