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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, 2021

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: 001-39941

 

Sana Biotechnology, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

83-1381173

(State or other jurisdiction of

incorporation or organization)

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

188 East Blaine Street, Suite 400

Seattle, Washington 98102

(Address of principal executive offices)

Registrant’s telephone number, including area code: (206) 701-7914

 

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, $0.0001 par value

 

SANA

 

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 November 5, 2021, the registrant had 188,832,954 shares of common stock, $0.0001 par value per share, outstanding.

 

 


 

 

TABLE OF CONTENTS

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

5

 

Condensed Consolidated Balance Sheets

5

 

Condensed Consolidated Statements of Operations

6

 

Condensed Consolidated Statements of Comprehensive Income (Loss)

7

 

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

8

 

Condensed Consolidated Statements of Cash Flows

9

 

Notes to Unaudited Condensed Consolidated Financial Statements

10

Item 2.

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

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

33

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

34

Item 1A.

Risk Factors

34

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

91

Item 3.

Defaults Upon Senior Securities

91

Item 4.

Mine Safety Disclosures

91

Item 5.

Other Information

91

Item 6.

Exhibits

92

 

Signatures

93

 

 

 

 


 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify these statements by forward-looking words such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “should,” “would,” or “will,” the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, include, but are not limited to, statements about:

 

our expectations regarding the potential market size and size of the potential patient populations for our product candidates and any future product candidates, if approved for commercial use;

 

our clinical and regulatory development plans;

 

our expectations with regard to the results of our clinical studies, preclinical studies, and research and development programs, including the timing and availability of data from such studies;

 

the timing of commencement of future nonclinical studies, clinical trials, and research and development programs;

 

our ability to acquire, discover, develop, and advance product candidates into, and successfully complete, clinical trials;

 

our intentions with respect to and our ability to establish collaborations and/or partnerships;

 

the timing or likelihood of regulatory filings and approvals for our product candidates;

 

our commercialization, marketing, and manufacturing expectations, including the buildout of our manufacturing facility and capabilities and the timing thereof;

 

impact from future regulatory, judicial, and legislative changes or developments in the United States and foreign countries;

 

our intentions with respect to the commercialization of our product candidates;

 

the pricing and reimbursement of our product candidates, if approved;

 

the potential effects of public health crises, such as the COVID-19 pandemic, on our preclinical and clinical programs and business;

 

our expectations regarding the impact of the COVID-19 pandemic on our business;

 

the implementation of our business model and strategic plans for our business and product candidates, including additional indications which we may pursue;

 

our ability to effectively manage our growth, including our ability to retain and recruit personnel, and maintain our culture;

 

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates, including the projected terms of patent protection;

 

estimates of our expenses, future revenue, capital requirements, our needs for additional financing, and our ability to obtain additional capital;

 

our expected use of proceeds from our initial public offering and our existing cash, cash equivalents, and marketable securities;

 

the performance of our third-party suppliers and manufacturers;

 

our future financial performance;

 

our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; and

 

developments and projections relating to our competitors and our industry, including competing products.

3


 

 

We have based these forward-looking statements largely on our current expectations, estimates, forecasts, and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Other sections of this report may include additional factors that could harm our business and financial performance. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

4


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Sana Biotechnology, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except per share amounts)

 

 

 

September 30, 2021

 

 

December 31, 2020

 

 

 

(unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

433,670

 

 

$

124,806

 

Marketable securities

 

 

170,041

 

 

 

253,458

 

Prepaid expenses and other current assets

 

 

9,134

 

 

 

6,203

 

Total current assets

 

 

612,845

 

 

 

384,467

 

Property and equipment, net

 

 

63,445

 

 

 

46,775

 

Operating lease right-of-use assets

 

 

84,828

 

 

 

63,168

 

Restricted cash

 

 

8,819

 

 

 

2,143

 

Long-term marketable securities

 

 

262,401

 

 

 

33,731

 

Intangible asset

 

 

59,195

 

 

 

59,195

 

Goodwill

 

 

140,627

 

 

 

140,627

 

Other non-current assets

 

 

591

 

 

 

190

 

TOTAL ASSETS

 

$

1,232,751

 

 

$

730,296

 

LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,947

 

 

$

2,253

 

Accrued compensation

 

 

20,218

 

 

 

16,020

 

Accrued expenses and other current liabilities

 

 

12,884

 

 

 

9,466

 

Operating lease liabilities

 

 

6,502

 

 

 

3,712

 

Contingent consideration

 

 

43,459

 

 

 

-

 

Success payment liabilities

 

 

5,000

 

 

 

-

 

Total current liabilities

 

 

92,010

 

 

 

31,451

 

Operating lease liabilities, net of current portion

 

 

92,403

 

 

 

68,197

 

Contingent consideration, net of current portion

 

 

88,522

 

 

 

121,901

 

Success payment liabilities, net of current portion

 

 

129,192

 

 

 

76,494

 

Other non-current liabilities

 

 

539

 

 

 

540

 

Total liabilities

 

 

402,666

 

 

 

298,583

 

Commitments and contingencies (Note 10)

 

 

 

 

 

 

 

 

Convertible preferred stock, $0.0001 par value; zero and 537,786 shares authorized as of September 30, 2021 and December 31, 2020, respectively; zero and 134,113 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

 

 

-

 

 

 

852,897

 

Stockholders' equity (deficit):

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 50,000 and zero shares authorized as of September 30, 2021 and December 31, 2020, respectively; zero shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 750,000 and 707,000 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 182,908 and 16,170 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

 

 

18

 

 

 

2

 

Additional paid-in capital

 

 

1,504,778

 

 

 

8,216

 

Accumulated other comprehensive income (loss)

 

 

(82

)

 

 

30

 

Accumulated deficit

 

 

(674,629

)

 

 

(429,432

)

Total stockholders' equity (deficit)

 

 

830,085

 

 

 

(421,184

)

TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)

 

$

1,232,751

 

 

$

730,296

 

 

See accompanying notes.

 

5


 

 

Sana Biotechnology, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except per share amounts)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

53,245

 

 

$

40,056

 

 

$

140,121

 

 

$

96,453

 

Research and development related success payments and contingent consideration

 

 

16,753

 

 

 

4,489

 

 

 

67,778

 

 

 

57,309

 

General and administrative

 

 

13,433

 

 

 

7,099

 

 

 

37,731

 

 

 

19,063

 

Total operating expenses

 

 

83,431

 

 

 

51,644

 

 

 

245,630

 

 

 

172,825

 

Loss from operations

 

 

(83,431

)

 

 

(51,644

)

 

 

(245,630

)

 

 

(172,825

)

Interest income, net

 

 

158

 

 

 

148

 

 

 

409

 

 

 

622

 

Other income, net

 

 

10

 

 

 

44

 

 

 

24

 

 

 

68

 

Net loss

 

$

(83,263

)

 

$

(51,452

)

 

$

(245,197

)

 

$

(172,135

)

Net loss per common share - basic and diluted

 

$

(0.46

)

 

$

(3.76

)

 

$

(1.53

)

 

$

(14.05

)

Weighted-average number of common shares - basic and diluted

 

 

181,827

 

 

 

13,680

 

 

 

160,515

 

 

 

12,249

 

 

See accompanying notes.

6


 

Sana Biotechnology, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(unaudited)

(in thousands)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss

 

$

(83,263

)

 

 

(51,452

)

 

 

(245,197

)

 

 

(172,135

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities, net

 

 

(95

)

 

 

32

 

 

 

(112

)

 

 

29

 

Total comprehensive loss

 

$

(83,358

)

 

$

(51,420

)

 

$

(245,309

)

 

$

(172,106

)

 

See accompanying notes.

7


 

Sana Biotechnology, Inc.

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

(unaudited)

(in thousands)

 

 

Convertible Preferred

Stock

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

Equity

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

(Deficit)

 

Balance as of December 31, 2020

 

 

134,113

 

 

$

852,897

 

 

 

 

16,170

 

 

$

2

 

 

$

8,216

 

 

$

30

 

 

$

(429,432

)

 

$

(421,184

)

Conversion of convertible preferred stock into common stock upon initial public offering

 

 

(134,113

)

 

 

(852,897

)

 

 

 

134,113

 

 

 

13

 

 

 

852,884

 

 

 

-

 

 

 

-

 

 

 

852,897

 

Issuance of common stock in initial

public offering, net of $49,220 in

offering costs

 

 

-

 

 

 

-

 

 

 

 

27,025

 

 

 

3

 

 

 

626,402

 

 

 

-

 

 

 

-

 

 

 

626,405

 

Vesting of restricted stock

 

 

-

 

 

 

-

 

 

 

 

1,428

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

205

 

 

 

-

 

 

 

298

 

 

 

-

 

 

 

-

 

 

 

298

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

4,158

 

 

 

-

 

 

 

-

 

 

 

4,158

 

Unrealized gain on marketable

securities, net

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

26

 

 

 

-

 

 

 

26

 

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(180,617

)

 

 

(180,617

)

Balance as of March 31, 2021

 

 

-

 

 

$

-

 

 

 

 

178,941

 

 

$

18

 

 

$

1,491,958

 

 

$

56

 

 

$

(610,049

)

 

$

881,983

 

Vesting of restricted stock

 

 

-

 

 

 

-

 

 

 

 

1,423

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

212

 

 

 

-

 

 

 

333

 

 

 

-

 

 

 

-

 

 

 

333

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

4,941

 

 

 

-

 

 

 

-

 

 

 

4,941

 

Unrealized loss on marketable

securities, net

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(43

)

 

 

-

 

 

 

(43

)

Net income

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

18,683

 

 

 

18,683

 

Balance as of June 30, 2021

 

 

-

 

 

$

-

 

 

 

 

180,576

 

 

$

18

 

 

$

1,497,232

 

 

$

13

 

 

$

(591,366

)

 

$

905,897

 

Vesting of restricted stock

 

 

-

 

 

 

-

 

 

 

 

1,628

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

704

 

 

 

-

 

 

 

1,596

 

 

 

-

 

 

 

-

 

 

 

1,596

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

5,950

 

 

 

-

 

 

 

-

 

 

 

5,950

 

Unrealized loss on marketable

securities, net

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(95

)

 

 

-

 

 

 

(95

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(83,263

)

 

 

(83,263

)

Balance as of September 30, 2021

 

 

-

 

 

$

-

 

 

 

 

182,908

 

 

$

18

 

 

$

1,504,778

 

 

$

(82

)

 

$

(674,629

)

 

$

830,085

 

 

 

 

Convertible Preferred

Stock

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Deficit

 

Balance as of December 31, 2019

 

 

106,890

 

 

$

417,359

 

 

 

 

10,003

 

 

$

1

 

 

$

1,558

 

 

$

26

 

 

$

(144,127

)

 

$

(142,542

)

Vesting of restricted stock

 

 

-

 

 

 

-

 

 

 

 

1,427

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

2

 

 

 

-

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

2

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

755

 

 

 

-

 

 

 

-

 

 

 

755

 

Unrealized loss on marketable

securities, net

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(10

)

 

 

-

 

 

 

(10

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(32,875

)

 

 

(32,875

)

Balance as of March 31, 2020

 

 

106,890

 

 

$

417,359

 

 

 

 

11,432

 

 

$

1

 

 

$

2,315

 

 

$

16

 

 

$

(177,002