10-Q 1 onvo-20221231.htm 10-Q 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

Form 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended December 31, 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 001-35996

 

Organovo Holdings, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

27-1488943

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

11555 Sorrento Valley Rd, Suite 100,

San Diego, CA 92121

 

(858) 224-1000

(Address of principal executive offices and zip code)

 

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

Trading symbol

Name of Each Exchange on which registered

Common Stock, $0.001 par value

ONVO

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, a 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 February 1, 2023, a total of 8,714,590 shares of the registrant’s Common Stock, $0.001 par value, were outstanding.

 

 

 


 

ORGANOVO HOLDINGS, INC.

INDEX

PART I. FINANCIAL INFORMATION

 

Item 1.

 

Financial Statements

 

3

 

 

Condensed Consolidated Balance Sheets as of December 31, 2022 (Unaudited) and March 31, 2022

 

3

 

 

Unaudited Condensed Consolidated Statements of Operations and Other Comprehensive Loss for the Three and Nine Months Ended December 31, 2022 and 2021

 

4

 

 

Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended December 31, 2022 and 2021

 

5

 

 

Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended December 31, 2022 and 2021

 

6

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

7

Item 2.

 

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

 

18

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

25

Item 4.

 

Controls and Procedures

 

25

 

PART II. OTHER INFORMATION

Item 1.

 

Legal Proceedings

 

26

Item 1A.

 

Risk Factors

 

26

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

43

Item 3.

 

Defaults Upon Senior Securities

 

43

Item 4.

 

Mine Safety Disclosure

 

43

Item 5.

 

Other Information

 

43

Item 6.

 

Exhibits

 

44

 

 

 

2


 

PART I—FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

Organovo Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands except for share and per share data)

 

 

 

December 31, 2022

 

 

March 31, 2022

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

20,196

 

 

$

28,675

 

Accounts receivable

 

 

76

 

 

 

 

Investment in equity securities

 

 

554

 

 

 

 

Prepaid expenses and other current assets

 

 

788

 

 

 

858

 

Total current assets

 

 

21,614

 

 

 

29,533

 

Fixed assets, net

 

 

742

 

 

 

662

 

Restricted cash

 

 

143

 

 

 

143

 

Operating lease right-of-use assets

 

 

1,803

 

 

 

2,153

 

Prepaid expenses and other assets, net

 

 

777

 

 

 

805

 

Total assets

 

$

25,079

 

 

$

33,296

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

Accounts payable

 

$

242

 

 

$

415

 

Accrued expenses

 

 

646

 

 

 

489

 

Operating lease liability, current portion

 

 

488

 

 

 

479

 

Total current liabilities

 

 

1,376

 

 

 

1,383

 

Operating lease liability, net of current portion

 

 

1,414

 

 

 

1,704

 

Total liabilities

 

 

2,790

 

 

 

3,087

 

Stockholders’ Equity

 

 

 

 

 

 

Common stock, $0.001 par value; 200,000,000 shares authorized, 8,714,590
   and
8,710,627 shares issued and outstanding at December 31, 2022 and
   March 31, 2022, respectively

 

 

9

 

 

 

9

 

Additional paid-in capital

 

 

339,817

 

 

 

337,940

 

Accumulated deficit

 

 

(317,539

)

 

 

(307,739

)

Accumulated other comprehensive income

 

 

3

 

 

 

 

Treasury stock, 46 shares at cost

 

 

(1

)

 

 

(1

)

Total stockholders’ equity

 

 

22,289

 

 

 

30,209

 

Total Liabilities and Stockholders’ Equity

 

$

25,079

 

 

$

33,296

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3


 

Organovo Holdings, Inc.

Unaudited Condensed Consolidated Statements of Operations and Other Comprehensive Loss

(in thousands except share and per share data)

 

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Nine Months Ended

 

 

 

December 31, 2022

 

 

December 31, 2021

 

 

December 31, 2022

 

 

December 31, 2021

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

131

 

 

$

 

 

$

208

 

 

$

 

Total Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

1,185

 

 

 

926

 

 

 

3,436

 

 

 

2,185

 

Selling, general and administrative expenses

 

 

2,305

 

 

 

2,574

 

 

 

6,724

 

 

 

7,381

 

Total costs and expenses

 

 

3,490

 

 

 

3,500

 

 

 

10,160

 

 

 

9,566

 

Loss from Operations

 

 

(3,359

)

 

 

(3,500

)

 

 

(9,952

)

 

 

(9,566

)

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

 

Loss on investment in equity securities

 

 

(48

)

 

 

 

 

 

(123

)

 

 

 

Interest income

 

 

143

 

 

 

2

 

 

 

277

 

 

 

6

 

Other income

 

 

 

 

 

 

 

 

 

 

 

25

 

Total Other Income

 

 

95

 

 

 

2

 

 

 

154

 

 

 

31

 

Income Tax Expense

 

 

 

 

 

(2

)

 

 

(2

)

 

 

(2

)

Net Loss

 

$

(3,264

)

 

$

(3,500

)

 

$

(9,800

)

 

$

(9,537

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale debt securities

 

 

3

 

 

 

 

 

 

3

 

 

 

 

Comprehensive loss

 

$

(3,261

)

 

$

(3,500

)

 

$

(9,797

)

 

$

(9,537

)

Net loss per common share—basic and diluted

 

$

(0.37

)

 

$

(0.40

)

 

$

(1.13

)

 

$

(1.10

)

Weighted average shares used in computing
   net loss per common share—basic and
   diluted

 

 

8,713,617

 

 

 

8,705,503

 

 

 

8,712,294

 

 

 

8,702,959

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4


 

Organovo Holdings, Inc.

Unaudited Condensed Consolidated Statements of Stockholders’ Equity

(in thousands)

 

 

 

Three and Nine Months Ended December 31, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

Treasury Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Shares

 

 

Amount

 

 

Accumulated Deficit

 

 

Accumulated Other Comprehensive Income

 

 

Total

 

Balance at March 31, 2021

 

 

8,671

 

 

$

9

 

 

$

335,479

 

 

 

 

 

$

(1

)

 

$

(296,291

)

 

$

 

 

$

39,196

 

Issuance of common stock from public offering, net

 

 

27

 

 

 

 

 

 

251

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

251

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

415

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

415

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,532

)

 

 

 

 

 

(2,532

)

Balance at June 30, 2021 (Unaudited)

 

 

8,698

 

 

$

9

 

 

$

336,145

 

 

 

 

 

$

(1

)

 

$

(298,823

)

 

$

 

 

$

37,330

 

Issuance of common stock under employee and
   director stock option, RSU, and purchase plans

 

 

7

 

 

 

 

 

 

(45

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(45

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

426

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

426

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,505

)

 

 

 

 

 

(3,505

)

Balance at September 30, 2021 (Unaudited)

 

 

8,705

 

 

$

9

 

 

$

336,526

 

 

 

 

 

$

(1

)

 

$

(302,328

)

 

$

 

 

$

34,206

 

Issuance of common stock under employee and
   director stock option, RSU, and purchase plans

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

588

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

588

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,500

)

 

 

 

 

 

(3,500

)

Balance at December 31, 2021 (Unaudited)

 

 

8,705

 

 

$

9

 

 

$

337,113

 

 

 

 

 

$

(1

)

 

$

(305,828

)

 

$

 

 

$

31,293

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three and Nine Months Ended December 31, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

Treasury Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Shares

 

 

Amount

 

 

Accumulated Deficit

 

 

Accumulated Other Comprehensive Income

 

 

Total

 

Balance at March 31, 2022

 

 

8,711

 

 

$

9

 

 

$

337,940

 

 

 

 

 

$

(1

)

 

$

(307,739

)

 

$

 

 

$

30,209

 

Issuance of common stock under employee and
   director stock option, RSU, and purchase plans

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

660

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

660

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,215

)

 

 

 

 

 

(3,215

)

Balance at June 30, 2022 (Unaudited)

 

 

8,712

 

 

$

9

 

 

$

338,600

 

 

 

 

 

$

(1

)

 

$

(310,954

)

 

$

 

 

$

27,654

 

Issuance of common stock under employee and
   director stock option, RSU, and purchase plans

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

673

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

673

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,321

)

 

 

 

 

 

(3,321

)

Balance at September 30, 2022 (Unaudited)

 

 

8,713

 

 

$

9

 

 

$

339,273

 

 

 

 

 

$

(1

)

 

$

(314,275

)

 

$

 

 

$

25,006

 

Issuance of common stock under employee and
   director stock option, RSU, and purchase plans

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

544

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

544

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,264

)

 

 

 

 

 

(3,264

)

Unrealized gain on available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

3

 

Balance at December 31, 2022 (Unaudited)

 

 

8,714

 

 

$

9

 

 

$

339,817

 

 

 

 

 

$

(1

)

 

$

(317,539

)

 

$

3

 

 

$

22,289

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


 

Organovo Holdings, Inc.

Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)

 

 

 

Nine Months Ended

 

 

Nine Months Ended