freq-10q_20200630.htm

 

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)

 

 

Delaware

47-2324450

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

19 Presidential Way, 2nd Floor

Woburn, MA

01801

(Address of principal executive offices)

(Zip Code)

 

(866) 389-1970

(Registrant’s telephone number, including area code 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.001 par value per share

 

FREQ

 

The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes      No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).     Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

  

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

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. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).     Yes      No  

As of July 31, 2020, the registrant had 33,645,901 shares of common stock, $0.001 par value per share, outstanding.

 

 

 

 


Table of Contents

 

 

 

Page

 

 

 

PART I.

FINANCIAL INFORMATION

4

Item 1.

Consolidated Financial Statements (Unaudited)

4

 

Consolidated Balance Sheets

4

 

Consolidated Statements of Operations

5

 

Consolidated Statements of Comprehensive Loss

6

 

Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

7

 

Consolidated Statements of Cash Flows

8

 

Notes to Unaudited Consolidated Financial Statements

9

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

31

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

45

Item 4.

Controls and Procedures

45

PART II.

OTHER INFORMATION

46

Item 1.

Legal Proceedings

46

Item 1A.

Risk Factors

46

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

92

Item 3.

Defaults Upon Senior Securities

92

Item 4.

Mine Safety Disclosures

92

Item 5.

Other Information

92

Item 6.

Exhibits

93

Signatures

94

 

 

 

 


FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, product candidates, clinical development plans and expectations, patient enrollment expectations, prospective products, product approvals, research and development costs, timing and likelihood of success, and plans and objectives of management for future operations and results, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the risks, uncertainties and assumptions described under the sections in this Quarterly Report titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These forward-looking statements are subject to numerous risks, including, without limitation, the following:

 

the impact of the novel coronavirus, COVID-19, on our ongoing and planned clinical trials, our research development and manufacturing activities, the relocation of our offices and laboratory facilities and our business and financial markets;

 

the initiation, timing, progress and results of our preclinical and clinical trials and research and development of programs, including our ongoing Phase 2a clinical trial and any planned additional clinical trials for FX-322 and our program to develop a product candidate for the treatment of multiple sclerosis, or MS;

 

our ability to continue to develop our progenitor cell activation, or PCA, platform and identify additional product candidates;

 

our ability to successfully complete clinical trials of any product candidate and obtain regulatory approval for it;

 

the timing or likelihood of regulatory filings and approvals, including our planned filing of an investigational new drug application for our MS product candidate;

 

the commercialization, marketing and manufacture of any product candidate, if approved;

 

the pricing and reimbursement of any product candidate, if approved;

 

the rate and degree of market acceptance and clinical utility of any products for which we receive regulatory approval;

 

the implementation of our strategic plans for our business, product candidates, and technology;

 

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates, PCA platform, and technology;

 

estimates of our expenses, future revenues, capital requirements, and our needs for additional financing;

 

our ability to maintain and establish collaborations, including our License and Collaboration Agreement with Astellas Pharma Inc.;

 

our financial performance and the sufficiency of our financial resources; and

 

developments relating to our competitors and our industry, including the impact of government regulation.

2


Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.

You should read this Quarterly Report and the documents that we reference in this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

3


PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

Frequency Therapeutics, Inc.

 

Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

195,379

 

 

$

200,158

 

Short-term marketable securities

 

 

 

 

 

17,197

 

Prepaid expenses and other current assets

 

 

3,045

 

 

 

4,000

 

Total current assets

 

 

198,424

 

 

 

221,355

 

Property and equipment, net

 

 

2,555

 

 

 

1,762

 

Operating lease - right-of-use

 

 

1,998

 

 

 

 

Restricted cash

 

 

1,809

 

 

 

101

 

Total assets

 

$

204,786

 

 

$

223,218

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,190

 

 

$

1,219

 

Accrued expenses

 

 

3,289

 

 

 

3,239

 

Deferred revenue

 

 

35,265

 

 

 

48,152

 

Operating lease liability - right-of-use

 

 

421

 

 

 

 

Other current liabilities

 

 

 

 

 

170

 

Total current liabilities

 

 

41,165

 

 

 

52,780

 

Deferred revenue, net of current portion

 

 

 

 

 

2,900

 

Operating lease liability - right of use, net of current portion

 

 

1,920

 

 

 

 

Long-term liabilities

 

 

 

 

 

180

 

Total liabilities

 

 

43,085

 

 

 

55,860

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or

   outstanding at June 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

 

Common stock, $0.001 par value; 200,000,000 and 165,000,000 shares authorized,

   31,249,499 and 30,844,507 shares issued and outstanding at June 30, 2020 and

   December 31, 2019, respectively

 

 

31

 

 

 

31

 

Additional paid-in capital

 

 

241,436

 

 

 

236,161

 

Accumulated other comprehensive income

 

 

60

 

 

 

54

 

Accumulated deficit

 

 

(79,826

)

 

 

(68,888

)

Total stockholders’ equity

 

 

161,701

 

 

 

167,358

 

Total liabilities and stockholders’ equity

 

$

204,786

 

 

$

223,218

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes.

 

4


Frequency Therapeutics, Inc.

 

Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue

 

$

8,523

 

 

$

 

 

$

15,787

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

8,764

 

 

 

3,921

 

 

 

15,434

 

 

 

7,367

 

General and administrative

 

 

5,959

 

 

 

3,098

 

 

 

12,208

 

 

 

5,568

 

Total operating expenses

 

 

14,723

 

 

 

7,019

 

 

 

27,642

 

 

 

12,935

 

Loss from operations

 

 

(6,200

)

 

 

(7,019

)

 

 

(11,855

)

 

 

(12,935

)

Interest income

 

 

178

 

 

 

119

 

 

 

888

 

 

 

218

 

Realized (loss) gain on investments

 

 

(4

)

 

 

26

 

 

 

65

 

 

 

26

 

Foreign exchange gain

 

 

8

 

 

 

22

 

 

 

9

 

 

 

13

 

Loss before income taxes

 

 

(6,018

)

 

 

(6,852

)

 

 

(10,893

)

 

 

(12,678

)

Income taxes

 

 

(7

)

 

 

 

 

 

(45

)

 

 

 

Net loss

 

$

(6,025

)

 

$

(6,852

)

 

$

(10,938

)

 

$

(12,678

)

Net loss per share attributable to common stockholders-basic

   and diluted

 

$

(0.19

)

 

$

(3.42

)

 

$

(0.35

)

 

$

(6.67

)

Weighted-average shares of common stock outstanding-basic

   and diluted

 

 

31,066,686

 

 

 

2,005,054

 

 

 

30,967,453

 

 

 

1,902,092

 

 

See accompanying notes.

5


Frequency Therapeutics, Inc.

 

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss

 

$

(6,025

)

 

$

(6,852

)

 

$

(10,938

)

 

$

(12,678

)

Other comprehensive gain:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on marketable securities

 

 

75

 

 

 

80

 

 

 

6

 

 

 

150

 

Total comprehensive gain

 

 

75

 

 

 

80

 

 

 

6

 

 

 

150

 

Comprehensive loss

 

$

(5,950

)

 

$

(6,772

)

 

$

(10,932

)

 

$

(12,528

)

 

See accompanying notes.

 

 

6


Frequency Therapeutics, Inc.

 

Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share and per share amounts)

 

 

 

Series B

convertible

preferred

shares

issued

 

 

Series B

convertible

preferred

value

 

 

Series B-1

convertible

preferred

shares

issued

 

 

Series B-1

convertible

preferred

value

 

 

Series A

convertible

preferred

shares

issued

 

 

Series A

convertible

preferred

value

 

 

Series A-1

convertible

preferred

shares

issued

 

 

Series A-1

convertible

preferred

value

 

 

Non-

controlling

interest

 

 

 

Common

shares

issued

 

 

Common

par

value

 

 

Additi-

onal

paid-in

capital

 

 

Accumulated

other

comprehensive income

 

 

Accumu-

lated

deficit

 

 

Total

stock-

holders’

equity (deficit)

 

Balance, December 31, 2019

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

$

 

 

 

 

30,844,507

 

 

$

31

 

 

$

236,161

 

 

$

54

 

 

$

(68,888

)

 

$

167,358

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,575

 

 

 

 

 

 

 

 

 

4,575

 

Issuance of common stock upon

   exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

404,992

 

 

 

 

 

 

700

 

 

 

 

 

 

 

 

 

700

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

 

 

 

6

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,938

)

 

 

(10,938

)

Balance, June 30, 2020

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

$

 

 

 

 

31,249,499

 

 

$

31

 

 

$

241,436

 

 

$

60

 

 

$

(79,826

)

 

$

161,701

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2018

 

 

41,857,005

 

 

$

38,224

 

 

 

10,000

 

 

$

9

 

 

 

62,528,507

 

 

$

46,694

 

 

 

10,000

 

 

$

8

 

 

$

3,773

 

 

 

 

2,084,710

 

 

$

2

 

 

$

804

 

 

$

 

 

$

(49,088

)

 

$

(48,282

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,531

 

 

 

 

 

 

 

 

 

1,531

 

Issuance of Series B convertible

   preferred stock

 

 

288,991

 

 

 

266

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon

   exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

219,558

 

 

 

 

 

 

164

 

 

 

 

 

 

 

 

 

164

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

150

 

 

 

 

 

 

150

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,678

)

 

 

(12,678

)

Balance, June 30, 2019

 

 

42,145,996

 

 

$

38,490

 

 

 

10,000

 

 

$

9

 

 

 

62,528,507

 

 

$

46,694

 

 

 

10,000

 

 

$

8

 

 

$

3,773

 

 

 

 

2,304,268

 

 

$

2

 

 

$

2,499

 

 

$

150

 

 

$

(61,766

)

 

$

(59,115

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series B

convertible

preferred

shares

issued

 

 

Series B

convertible

preferred

value

 

 

Series B-1

convertible

preferred

shares

issued

 

 

Series B-1

convertible

preferred

value

 

 

Series A

convertible

preferred

shares

issued

 

 

Series A

convertible

preferred

value

 

 

Series A-1

convertible

preferred

shares

issued

 

 

Series A-1

convertible

preferred

value

 

 

Non-

controlling

interest

 

 

 

Common

shares

issued

 

 

Common

par

value

 

 

Additi-

onal

paid-in

capital

 

 

Accumulated

other

comprehensive income

 

 

Accumu-

lated

deficit

 

 

Total

stock-

holders’

equity (deficit)

 

Balance, March 31, 2020

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

$

 

 

 

 

31,009,250

 

 

$

31

 

 

$

238,634

 

 

$

(15

)

 

$

(73,801

)

 

$

164,849

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,411

 

 

 

 

 

 

 

 

 

2,411

 

Issuance of common stock upon

   exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

240,249

 

 

 

 

 

 

391

 

 

 

 

 

 

 

 

 

391

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

75

 

 

 

 

 

 

75

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,025

)

 

 

(6,025

)

Balance, June 30, 2020

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

$

 

 

 

 

31,249,499

 

 

$

31

 

 

$

241,436

 

 

$

60

 

 

$

(79,826

)

 

$

161,701

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

</