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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, 2022  

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 per share

 

SANA

 

The Nasdaq Stock Market LLC

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 October 27, 2022, the registrant had 190,726,445 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 Loss

7

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity

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

32

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

96

Item 3.

Defaults Upon Senior Securities

96

Item 4.

Mine Safety Disclosures

96

Item 5.

Other Information

96

Item 6.

Exhibits

97

 

Signatures

99

 

 

 

 


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (Quarterly Report) contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report could be deemed forward-looking statements, including those statements highlighted below. 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 preclinical studies, future clinical trials, and research and development programs, including the timing and availability of data from such studies and trials;

 

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

 

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

 

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

 

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

 

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

 

impact of 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 ongoing COVID-19 pandemic, on our preclinical and clinical programs and business;

 

our expectations regarding the impact of the ongoing 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, needs for additional financing, and ability to obtain additional capital;

 

our expected use of 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 Jumpstart Our Business Startups Act of 2012 (JOBS Act); and

 

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


 

 

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 Quarterly 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 in a timely manner or 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 Quarterly 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. 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.

 

 

 


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Sana Biotechnology, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except per share amounts)

 

 

 

September 30, 2022

 

 

December 31, 2021

 

 

 

(unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

163,343

 

 

$

253,029

 

Marketable securities

 

 

322,407

 

 

 

297,967

 

Restricted cash

 

 

6,100

 

 

 

-

 

Prepaid expenses and other current assets

 

 

8,400

 

 

 

7,105

 

Total current assets

 

 

500,250

 

 

 

558,101

 

Long-term marketable securities

 

 

25,823

 

 

 

195,881

 

Property and equipment, net

 

 

67,349

 

 

 

65,464

 

Operating lease right-of-use assets

 

 

95,733

 

 

 

96,320

 

Long-term restricted cash

 

 

4,408

 

 

 

8,819

 

Intangible asset

 

 

59,195

 

 

 

59,195

 

Goodwill

 

 

140,627

 

 

 

140,627

 

Other non-current assets

 

 

4,717

 

 

 

5,000

 

TOTAL ASSETS

 

$

898,102

 

 

$

1,129,407

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,993

 

 

$

2,219

 

Accrued compensation

 

 

24,500

 

 

 

21,131

 

Accrued expenses and other current liabilities

 

 

14,970

 

 

 

10,344

 

Operating lease liabilities

 

 

11,921

 

 

 

9,159

 

Contingent consideration

 

 

59,429

 

 

 

51,382

 

Success payment liabilities

 

 

-

 

 

 

5,000

 

Total current liabilities

 

 

114,813

 

 

 

99,235

 

Operating lease liabilities, net of current portion

 

 

99,859

 

 

 

101,784

 

Contingent consideration, net of current portion

 

 

81,701

 

 

 

102,361

 

Success payment liabilities, net of current portion

 

 

35,710

 

 

 

97,525

 

Total liabilities

 

 

332,083

 

 

 

400,905

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 50,000 shares authorized; zero shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 750,000 shares authorized; 189,885 and 184,929 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively

 

 

19

 

 

 

18

 

Additional paid-in capital

 

 

1,546,807

 

 

 

1,515,210

 

Accumulated other comprehensive loss

 

 

(6,414

)

 

 

(1,366

)

Accumulated deficit

 

 

(974,393

)

 

 

(785,360

)

Total stockholders' equity

 

 

566,019

 

 

 

728,502

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

 

$

898,102

 

 

$

1,129,407

 

 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

76,735

 

 

$

53,245

 

 

$

221,964

 

 

$

140,121

 

Research and development related success payments and contingent consideration

 

 

(6,062

)

 

 

16,753

 

 

 

(79,428

)

 

 

67,778

 

General and administrative

 

 

15,514

 

 

 

13,433

 

 

 

48,240

 

 

 

37,731

 

Total operating expenses

 

 

86,187

 

 

 

83,431

 

 

 

190,776

 

 

 

245,630

 

Loss from operations

 

 

(86,187

)

 

 

(83,431

)

 

 

(190,776

)

 

 

(245,630

)

Interest income, net

 

 

1,173

 

 

 

158

 

 

 

2,149

 

 

 

409

 

Other income (expense), net

 

 

(106

)

 

 

10

 

 

 

(406

)

 

 

24

 

Net loss

 

$

(85,120

)

 

$

(83,263

)

 

$

(189,033

)

 

$

(245,197

)

Net loss per common share - basic and diluted

 

$

(0.45

)

 

$

(0.46

)

 

$

(1.01

)

 

$

(1.53

)

Weighted-average number of common shares - basic and diluted

 

 

189,303

 

 

 

181,827

 

 

 

187,645

 

 

 

160,515

 

 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(85,120

)

 

$

(83,263

)

 

$

(189,033

)

 

$

(245,197

)

Other comprehensive loss, net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on marketable securities, net

 

 

(67

)

 

 

(95

)

 

 

(5,048

)

 

 

(112

)

Total comprehensive loss

 

$

(85,187

)

 

$

(83,358

)

 

$

(194,081

)

 

$

(245,309

)

 

See accompanying notes.

7


 

Sana Biotechnology, Inc.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity

(unaudited)

(in thousands)

 

 

 

Convertible Preferred

Stock

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance as of December 31, 2021

 

 

-

 

 

$

-

 

 

 

 

184,929

 

 

$

18

 

 

$

1,515,210

 

 

$

(1,366

)

 

$

(785,360

)

 

$

728,502

 

Vesting of restricted stock

 

 

-

 

 

 

-

 

 

 

 

1,419

 

 

 

1

 

 

 

(1

)

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

284

 

 

 

-

 

 

 

652

 

 

 

-

 

 

 

-

 

 

 

652

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

7,755

 

 

 

-

 

 

 

-

 

 

 

7,755

 

Unrealized loss on marketable

securities, net

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,806

)

 

 

-

 

 

 

(3,806

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(31,448

)

 

 

(31,448

)

Balance as of March 31, 2022

 

 

-

 

 

$

-

 

 

 

 

186,632

 

 

$

19

 

 

$

1,523,616

 

 

$

(5,172

)

 

$

(816,808

)

 

$

701,655

 

Vesting of restricted stock

 

 

-

 

 

 

-

 

 

 

 

1,243

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

320

 

 

 

-

 

 

 

571

 

 

 

-

 

 

 

-

 

 

 

571

 

Issuance of common stock related to employee stock purchase plan

 

 

-

 

 

 

-

 

 

 

 

235

 

 

 

-

 

 

 

1,008

 

 

 

-

 

 

 

-

 

 

 

1,008

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

9,911

 

 

 

-

 

 

 

-

 

 

 

9,911

 

Unrealized loss on marketable

securities, net

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,175

)

 

 

-

 

 

 

(1,175

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(72,465

)

 

 

(72,465

)

Balance as of June 30, 2022

 

 

-

 

 

$

-

 

 

 

 

188,430

 

 

$

19

 

 

$

1,535,106

 

 

$

(6,347

)

 

$

(889,273

)

 

$

639,505

 

Issuance of common stock from at the market offering, net of issuance costs of $540

 

 

-

 

 

 

-

 

 

 

 

149

 

 

 

-

 

 

 

724

 

 

 

-

 

 

 

-

 

 

 

724

 

Vesting of restricted stock

 

 

-

 

 

 

-

 

 

 

 

927

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of stock options

 

 

-

 

 

 

-

 

 

 

 

379

 

 

 

-

 

 

 

897

 

 

 

-

 

 

 

-

 

 

 

897

 

Stock-based compensation expense

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

10,080

 

 

 

-

 

 

 

-

 

 

 

10,080

 

Unrealized loss on marketable

securities, net

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(67

)

 

 

-

 

 

 

(67

)

Net loss

 

 

-

 

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(85,120

)

 

 

(85,120

)

Balance as of September 30, 2022

 

 

-

 

 

$

-

 

 

 

 

189,885

 

 

$

19

 

 

$

1,546,807

 

 

$

(6,414

)

 

$

(974,393

)

 

$

566,019

 

 

 

 

Convertible Preferred

Stock

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

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

 

 

-

 

 

 

-