onvo-10q_20210630.htm

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 June 30, 2021

☐	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.)

440 Stevens Ave, Suite 200, Solana Beach, CA 92075		(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 August 1, 2021, a total of 8,705,358 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 June 30, 2021 (Unaudited) and March 31, 2021	3
	Unaudited Condensed Consolidated Statements of Operations and Other Comprehensive Loss for the Three Months Ended June 30, 2021 and 2020	4
	Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended June 30, 2021 and 2020	5
	Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months Ended June 30, 2021 and 2020	6
	Notes to Unaudited Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	20
Item 4.	Controls and Procedures	20
PART II. OTHER INFORMATION
Item 1.	Legal Proceedings	21
Item 1A.	Risk Factors	21
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	38
Item 3.	Defaults Upon Senior Securities	38
Item 4.	Mine Safety Disclosure	38
Item 5.	Other Information	38
Item 6.	Exhibits	39

PART I—FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

Organovo Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands except for share and per share data)

	June 30, 2021			March 31, 2021
	(Unaudited)
Assets
Current Assets
Cash and cash equivalents	$	36,008		$	37,364
Prepaid expenses and other current assets		650			1,034
Total current assets		36,658			38,398
Fixed assets, net		554			381
Restricted cash		111			111
Prepaid expenses and other assets, net		971			1,027
Total assets	$	38,294		$	39,917
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable	$	577		$	281
Accrued expenses		387			440
Total current liabilities		964			721
Stockholders’ Equity
Common stock, $0.001 par value; 200,000,000 shares authorized, 8,698,128 and 8,670,492 shares issued and outstanding at June 30, 2021 and March 31, 2021, respectively		9			9
Additional paid-in capital		336,145			335,479
Accumulated deficit		(298,823	)		(296,291	)
Treasury stock, 46 shares at cost		(1	)		(1	)
Total stockholders’ equity		37,330			39,196
Total Liabilities and Stockholders’ Equity	$	38,294		$	39,917

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

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
	June 30, 2021			June 30, 2020
Operating Expenses
Research and development expenses	$	580		$	-
Selling, general and administrative expenses		1,979			2,786
Total costs and expenses		2,559			2,786
Loss from Operations		(2,559	)		(2,786	)
Other Income (Expense)
Gain on fixed asset disposals		—			6
Interest income		2			8
Other income		25			5
Total Other Income (Expense)		27			19
Income Tax Expense		—			(2	)
Net Loss	$	(2,532	)	$	(2,769	)
Net loss per common share—basic and diluted	$	(0.29	)	$	(0.40	)
Weighted average shares used in computing net loss per common share—basic and diluted		8,696,683			6,529,424
Comprehensive Loss:
Net loss	$	(2,532	)	$	(2,769	)
Comprehensive loss	$	(2,532	)	$	(2,769	)

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

Organovo Holdings, Inc.

Unaudited Condensed Consolidated Statements of Stockholders’ Equity

(in thousands)

	Three Months Ended June 30, 2020
					Additional
	Common Stock				Paid-in			Treasury Stock				Accumulated
	Shares		Amount		Capital			Shares		Amount		Deficit			Total
Balance at March 31, 2020		6,528	$	7	$	306,089			—	$	—	$	(279,465	)	$	26,631
Issuance of common stock under employee and director stock option, restricted stock units, and purchase plans		3		—		(1	)		—		—		—			(1	)
Stock-based compensation expense		—		—		925			—		—		—			925
Net loss		—		—		—			—		—		(2,769	)		(2,769	)
Balance at June 30, 2020 (Unaudited)		6,531	$	7	$	307,013			—	$	—	$	(282,234	)	$	24,786


	Three Months Ended June 30, 2021
					Additional
	Common Stock				Paid-in			Treasury Stock				Accumulated

SEC Form 10-Q filed by Organovo Holdings, Inc.