SEC Filing - Frequency Therapeutics

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freq-10q_20200930.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 September 30, 2020

☐	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.

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 October 31, 2020, the registrant had 33,734,692 shares of common stock, $0.001 par value per share, outstanding.

Table of Contents

		Page

	Forward-Looking Statements	2
	Risk Factors Summary	4
PART I.	FINANCIAL INFORMATION	5
Item 1.	Consolidated Financial Statements (Unaudited)	5
	Consolidated Balance Sheets	5
	Consolidated Statements of Operations	6
	Consolidated Statements of Comprehensive Loss	7
	Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)	8
	Consolidated Statements of Cash Flows	10
	Notes to Unaudited Consolidated Financial Statements	11
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	34
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	50
Item 4.	Controls and Procedures	50
PART II.	OTHER INFORMATION	51
Item 1.	Legal Proceedings	51
Item 1A.	Risk Factors	51
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	97
Item 3.	Defaults Upon Senior Securities	97
Item 4.	Mine Safety Disclosures	97
Item 5.	Other Information	97
Item 6.	Exhibits	98
Signatures		99

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, including, without limitation, planned commencements of clinical studies, patient enrollment expectations, expected release of clinical trial results and data, and expected completion dates, potential regulatory submissions, 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, Phase 1b clinical trial in age-related hearing loss and any planned additional clinical trials for FX-322, including the Phase 1b clinical trial in sever sensorineural hearing loss, 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 or comparable foreign equivalent 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.

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.

RISK FACTORS SUMMARY

Our business is subject to numerous risks and uncertainties, including those described in Part II Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. You should carefully consider these risks and uncertainties when investing in our common stock. The principal risks and uncertainties affecting our business include the following:

•

We are heavily dependent on the success of FX-322, our lead product candidate, which is still under clinical development. If FX-322 does not receive regulatory approval or is not successfully commercialized, our business will be materially adversely harmed;

•

We utilize our PCA platform to develop product candidates that are designed to activate progenitor cells, which is a new approach to therapeutic intervention and, as a result, successful development, approval, and commercialization of our product candidates, including FX-322, is uncertain;

•

Clinical trials are expensive, time consuming, and difficult to design and implement, and involve an uncertain outcome. The results of preclinical studies and early clinical trials are not always predictive of future results. Any drug candidate that we advance into clinical trials may not achieve favorable results in later clinical trials, if any, or receive marketing approval;

•

The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming, and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for FX-322 or any other product candidates, our business will be substantially harmed;

•

We may not be successful in our efforts to identify additional product candidates. Due to our limited resources and access to capital, we must prioritize development of certain product candidates, the choice of which may prove to be wrong and adversely affect our business;

•

If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business;

•

We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of FX-322 and additional product candidates;

•

We face significant competition from biotechnology, pharmaceutical, and medical device companies and our operating results will suffer if we fail to compete effectively; and

•

The COVID-19 pandemic could adversely impact our business, including our preclinical studies, clinical trials and operations.

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

Frequency Therapeutics, Inc.

Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(unaudited)

	September 30, 2020			December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	224,231		$	200,158
Short-term marketable securities		—			17,197
Prepaid expenses and other current assets		3,112			4,000
Total current assets		227,343			221,355
Property and equipment, net		3,255			1,762
Operating lease - right-of-use		1,907			—
Restricted cash		1,815			101
Total assets	$	234,320		$	223,218
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	4,089		$	1,219
Accrued expenses		4,380			3,239
Deferred revenue		24,018			48,152
Operating lease liability - right-of-use		432			—
Other current liabilities		—			170
Total current liabilities		32,919			52,780
Deferred revenue, net of current portion		—			2,900
Operating lease liability - right of use, net of current portion		1,809			—
Long-term liabilities		—			180
Total liabilities		34,728			55,860
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2020 and December 31, 2019, respectively		—			—
Common stock, $0.001 par value; 200,000,000 and 165,000,000 shares authorized, 33,732,290 and 30,844,507 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively		34			31
Additional paid-in capital		284,681			236,161
Accumulated other comprehensive income		44			54
Accumulated deficit		(85,167	)		(68,888	)
Total stockholders’ equity		199,592			167,358
Total liabilities and stockholders’ equity	$	234,320		$	223,218

See accompanying notes.

Frequency Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Revenue	$	11,247		$	24,238		$	27,034		$	24,238
Operating expenses:
Royalty		—			16,000			—			16,000
Research and development		10,153			5,221			25,587			12,588
General and administrative		6,512			4,269			18,720			9,837
Total operating expenses		16,665			25,490			44,307			38,425
Loss from operations		(5,418	)		(1,252	)		(17,273	)		(14,187	)
Interest income		74			624			962			842
Realized gain on investments		—			62			65			88
Foreign exchange gain (loss)		18			(9	)		27			4
Loss before income taxes		(5,326	)		(575	)		(16,219	)		(13,253	)
Income taxes		(15	)		—			(60	)		—
Net loss		(5,341	)		(575	)		(16,279	)		(13,253	)
Cumulative Series C convertible preferred stock dividends		—			(1,014	)		—			(1,014	)
Net loss attributable to common stockholders	$	(5,341	)	$	(1,589	)	$	(16,279	)	$	(14,267	)
Net loss per share attributable to common stockholders-basic and diluted	$	(0.16	)	$	(0.73	)	$	(0.51	)	$	(7.17	)
Weighted-average shares of common stock outstanding-basic and diluted		33,073,889			2,163,289			31,729,702			1,990,106

See accompanying notes.

Frequency Therapeutics, Inc.

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Net loss	$	(5,341	)	$	(575	)	$	(16,279	)	$	(13,253	)
Other comprehensive (loss) gain:
Unrealized (loss) gain on marketable securities		(16	)		(34	)		(10	)		116
Total comprehensive (loss) gain		(16	)		(34	)		(10	)		116
Comprehensive loss	$	(5,357	)	$	(609	)	$	(16,289	)	$	(13,137	)

See accompanying notes.

Frequency Therapeutics, Inc.

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

(in thousands, except share and per share amounts)

	Series C convertible preferred shares issued	Series C convertible preferred value		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	-	-		-	-		-	-		-	-		-	-		-		-			—		7,218		—			—			7,218
Issuance of common stock upon exercise of stock options	-	-		-	-		-	-		-	-		-	-		-		537,675			1		1,161		—			—			1,162
Issuance of common stock in Private Placement, net	-	-		-	-		-	-		-	-		-	-		-		2,350,108			2		40,141		—			—			40,143
Other comprehensive (loss)	-	-		-	-		-	-		-	-		-	-		-		-			—		—		(10	)		—			(10	)
Net loss	-	-		-	-		-	-		-	-		-	-		-		-			—		—		—			(16,279	)		(16,279	)
Balance, September 30, 2020	-	$	—	-	$	—	-	$	—	-	$	—	-	$	—	$	—	33,732,290		$	34	$	284,681	$	44		$	(85,167	)	$	199,592




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	-	-		-	-		-	-		-	-		-	-		-			—		—		2,456		—			—			2,456
Issuance of common stock upon exercise of stock options	-	-		-	-		-	-		-	-		-	-		-		297,599		-			325		—			—			325
Issuance of Series B convertible preferred stock	-	-		288,991		266	-	-		-	-		-	-		-			—		—		—		—			—			—
Issuance of Series C convertible preferred stock	39,492,960		61,687	-	-		-	-		-	-		-	-		-			—		—		—		—			—			—
Issuance of Series C preferred dividend	-		1,014	-	-		-	-		-	-		-	-		-												(1,014	)		(1,014	)
Other comprehensive income	-	-		-	-		-	-		-	-		-	-		-			—		—		—		116		-				116
Net loss	-	-		-	-		-	-		-	-		-	-		-			—		—		—		—			(13,253	)		(13,253	)
Balance, September 30, 2019	39,492,960	$	62,701	42,145,996	$	38,490	10,000	$	9	62,528,507	$	46,694	10,000	$	8	$	3,773		2,382,309	$	2	$	3,585	$	116		$	(63,355	)	$	(59,652	)

	Series C convertible preferred shares issued	Series C convertible preferred value		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, June 30, 2020	-	$	—	-	$	—	-	$	—	-	$	—	-	$	—	$	—	31,249,499	$	31	$	241,436	$	60	$	(79,826	)	$	161,701
Stock-based compensation expense	-	-		-	-		-	-		-	-		-	-		-		-		—		2,643		—		—			2,643
Issuance of common stock upon exercise of stock options	-	-		-	-		-	-		-	-		-	-		-		132,683		1		461		—		—			462
Issuance of common stock in Private Placement, net	-	-		-	-		-	-		-	-		-	-		-		2,350,108		2