SEC Filing | Biora Therapeutics, Inc.

View:

Download DOC

Download PDF

Download XLS

Download XBRL

10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 September 30, 2022


☐	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: 001-39334

Biora Therapeutics, Inc.

(Exact name of registrant as specified in its charter)


Delaware		27-3950390
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

4330 La Jolla Village Drive, Suite 300, San Diego, CA		92122
(Address of principal executive offices)		(Zip Code)

(833) 727-2841

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

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, par value $0.001 per share	BIOR	The Nasdaq Global 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 1, 2022, the registrant had 190,412,805 shares of common stock, par value $0.001 per share, outstanding.

Biora Therapeutics, Inc.

INDEX


PART I—FINANCIAL INFORMATION

Item 1.	Financial Statements (unaudited)	1

	Condensed Consolidated Balance Sheets	1

	Condensed Consolidated Statements of Operations	2

	Condensed Consolidated Statements of Stockholders’ Deficit	3

	Condensed Consolidated Statements of Cash Flows	5

	Notes to Condensed Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	39

Item 4.	Controls and Procedures	40

PART II—OTHER INFORMATION

Item 1.	Legal Proceedings	41

Item 1A.	Risk Factors	43

Item 6.	Exhibits	77

Signatures		78

TRADEMARKS AND CERTAIN TERMS

In this Quarterly Report on Form 10-Q, “Biora,” “Biora Therapeutics,” the “Company,” “we,” “us” and “our” refer to Biora Therapeutics, Inc., and our wholly-owned subsidiaries on a consolidated basis, unless the context otherwise provides.

Biora Therapeutics™ is a trademark of Biora Therapeutics, Inc. Any other brand names or trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective holders.

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements.

Biora Therapeutics, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)


	September 30, 2022			December 31, 2021
Assets
Current assets:
Cash and cash equivalents	$	37,060		$	88,397
Accounts receivable, net		—			653
Income tax receivable		828			—
Prepaid expenses and other current assets		6,259			7,232
Current assets of disposal group held for sale		2,213			2,147
Total current assets		46,360			98,429
Property and equipment, net		2,112			4,012
Right-of-use assets		1,843			—
Other assets		6,227			326
Goodwill		6,072			6,072
Total assets	$	62,614		$	108,839
Liabilities and Stockholders' Deficit
Current liabilities:
Accounts payable	$	2,356		$	8,709
Accrued expenses and other current liabilities		21,750			34,157
Warrant liability		3,285			18,731
Current portion of capital lease obligations		—			12
Total current liabilities		27,391			61,609
Convertible notes, net of unamortized discount of $5,280 and $6,333 as of September 30, 2022 and December 31, 2021, respectively		127,445			126,392
Other long-term liabilities		5,221			5,814
Total liabilities	$	160,057		$	193,815
Commitments and contingencies (Note 10)
Stockholders' deficit:
Common stock – $0.001 par value. 350,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 193,150,457 and 185,736,890 shares issued as of September 30, 2022 and December 31, 2021, respectively; 189,097,309 and 181,872,676 shares outstanding as of September 30, 2022 and December 31, 2021, respectively		153			146
Additional paid-in capital		734,607			722,646
Accumulated deficit		(813,121	)		(788,686	)
Treasury stock – at cost; 4,053,148 and 3,864,214 shares of common stock as of September 30, 2022 and December 31, 2021, respectively		(19,082	)		(19,082	)
Total stockholders' deficit		(97,443	)		(84,976	)
Total liabilities and stockholders' deficit	$	62,614		$	108,839

See accompanying notes to unaudited condensed consolidated financial statements.

Biora Therapeutics, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Revenues	$	80		$	182		$	291		$	812
Operating expenses:
Research and development		5,820			12,226			18,282			37,300
Selling, general and administrative		8,147			18,517			30,014			61,190
Total operating expenses		13,967			30,743			48,296			98,490
Loss from operations		(13,887	)		(30,561	)		(48,005	)		(97,678	)
Interest expense, net		(2,773	)		(3,458	)		(8,305	)		(10,450	)
Gain (loss) on warrant liability		2,044			(3,322	)		15,446			(5,818	)
Other (expense) income, net		(100	)		467			4,824			18,211
Loss before income taxes		(14,716	)		(36,874	)		(36,040	)		(95,735	)
Income tax (expense) benefit		(158	)		—			679			—
Loss from continuing operations		(14,874	)		(36,874	)		(35,361	)		(95,735	)
Gain (loss) from discontinued operations		9,760			(6,870	)		10,926			(58,804	)
Net loss		(5,114	)		(43,744	)		(24,435	)		(154,539	)

Net loss per share from continuing operations, basic and diluted	$	(0.08	)	$	(0.38	)	$	(0.19	)	$	(1.32	)
Net gain (loss) per share from discontinued operations, basic and diluted	$	0.05		$	(0.07	)	$	0.06		$	(0.81	)
Net loss per share, basic and diluted	$	(0.03	)	$	(0.46	)	$	(0.13	)	$	(2.13	)
Weighted average shares outstanding, basic and diluted		186,953,741			95,846,672			184,856,087			72,590,873

See accompanying notes to unaudited condensed consolidated financial statements.

Biora Therapeutics, INC.

Condensed Consolidated Statements of Stockholders’ Deficit

(In thousands, except share data)

(Unaudited)


	Common Stock				Additional Paid-In			Accumulated			Treasury Stock						Total Stockholders'
	Shares		Amount		Capital			Deficit			Shares			Amount			Deficit
Balance at December 31, 2021		185,736,890	$	146	$	722,646		$	(788,686	)		(3,864,214	)	$	(19,082	)	$	(84,976	)
Issuance of common stock, net		2,130,327		2		3,624			—			—			—			3,626
Issuance of common stock upon vesting of restricted stock units		288,003		—		(80	)		—			(93,076	)		—			(80	)
Stock-based compensation expense		—		—		2,053			—			—			—			2,053
Net loss		—		—		—			(13,808	)		—			—			(13,808	)
Balance at March 31, 2022		188,155,220	$	148	$	728,243		$	(802,494	)		(3,957,290	)	$	(19,082	)	$	(93,185	)
Issuance of common stock, net		1,725,723		2		1,166			—			—			—			1,168
Issuance of common stock under employee stock purchase plan		125,059		—		89			—			—			—			89
Issuance of common stock upon vesting of restricted stock unit awards		316,686		—		(111	)		—			(75,420	)		—			(111	)
Stock-based compensation expense		—		—		1,446			—			—			—			1,446
Net loss		—		—		—			(5,513	)		—			—			(5,513	)
Balance at June 30, 2022		190,322,688	$	150	$	730,833		$	(808,007	)		(4,032,710	)	$	(19,082	)	$	(96,106	)

Issuance of common stock, net		2,757,331		3		1,656			—			—			—			1,659
Issuance of common stock upon vesting of restricted stock unit awards		70,438		—		(21	)		—			(20,438	)		—			(21	)
Stock-based compensation expense		—		—		2,139			—			—			—			2,139
Net loss		—		—		—			(5,114	)		—			—			(5,114	)
Balance at September 30, 2022		193,150,457	$	153	$	734,607		$	(813,121	)		(4,053,148	)	$	(19,082	)	$	(97,443	)


	Common Stock				Additional Paid-In			Accumulated			Treasury Stock						Total Stockholders'
	Shares		Amount		Capital			Deficit			Shares			Amount			Deficit
Balance at December 31, 2020		59,287,331	$	59	$	452,992		$	(541,274	)		(3,515,028	)	$	(18,771	)	$	(106,994	)
Issuance of common stock, net		4,370,629		4		11,258			—			—			—			11,262
Exercise of common stock options		71,284		—		88			—			—			—			88
Issuance of common stock upon vesting of restricted stock units		174,730		—		(228	)		—			(48,581	)		(1	)		(229	)
Stock-based compensation expense		—		—		2,630			—			—			—			2,630
Net loss		—		—		—			(32,264	)		—			—			(32,264	)
Balance at March 31, 2021		63,903,974	$	63	$	466,740		$	(573,538	)		(3,563,609	)	$	(18,772	)	$	(125,507	)
Issuance of common stock, net		15,694,332		16		11,991			—			—			—			12,007
Issuance of common stock upon exercise of options		25,498		—		26			—			(5,050	)		(6	)		20
Issuance of common stock under employee stock purchase plan		254,832		1		560			—			—			—			561
Issuance of common stock upon vesting of restricted stock unit awards		237,388		—		(251	)		—			(79,442	)		—