10-Q
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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 June 30, 2023

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: 001-39334

 

 

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 August 7, 2023, the registrant had 13,883,762 shares of common stock, par value $0.001 per share, outstanding.

 

 


 

Table of Contents

 

 

 

 

 

Page

PART 1

 

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

 

4

 

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements

 

5

 

 

 

 

 

Item 2.

 

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

 

21

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

27

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

27

 

PART II

 

OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

28

 

 

 

 

 

Item 1A.

 

Risk Factors

 

29

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

60

 

 

 

 

 

Item 3.

 

Default Upon Senior Securities

 

61

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

61

 

 

 

 

 

Item 5.

 

Other Information

 

61

 

 

 

 

 

Item 6.

 

Exhibits

 

62

 

 

 

 

Signatures

 

63

EXPLANATORY NOTE

All share and per share information included in this Quarterly Report on Form 10-Q has been retroactively adjusted to reflect a 1-for-25 reverse stock split effected on January 3, 2023.

TRADEMARKS

Biora TherapeuticsTM, BIOJETTM, NAVICAPTM, and GITRACTM are trademarks 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.

 

 

i


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements.

Biora Therapeutics, INC.

CONDENSED Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

 

 

 

June 30, 2023

 

 

December 31, 2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash, cash equivalents and restricted cash

 

$

26,452

 

 

$

30,486

 

Income tax receivable

 

 

819

 

 

 

828

 

Prepaid expenses and other current assets

 

 

4,105

 

 

 

4,199

 

Current assets of disposal group held for sale

 

 

2,509

 

 

 

2,603

 

Total current assets

 

 

33,885

 

 

 

38,116

 

Property and equipment, net

 

 

1,351

 

 

 

1,654

 

Right-of-use assets

 

 

1,887

 

 

 

1,482

 

Other assets

 

 

6,478

 

 

 

6,201

 

Goodwill

 

 

6,072

 

 

 

6,072

 

Total assets

 

$

49,673

 

 

$

53,525

 

Liabilities and Stockholders' Deficit

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,042

 

 

$

3,606

 

Accrued expenses and other current liabilities

 

 

21,791

 

 

 

16,161

 

Warrant liabilities

 

 

10,835

 

 

 

3,538

 

Total current liabilities

 

 

37,668

 

 

 

23,305

 

Convertible notes, net of unamortized discount of $4,157 and $4,914 as of June 30, 2023
   and December 31, 2022, respectively

 

 

128,568

 

 

 

127,811

 

Other long-term liabilities

 

 

4,318

 

 

 

4,696

 

Total liabilities

 

$

170,554

 

 

$

155,812

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders' deficit:

 

 

 

 

 

 

Common stock – $0.001 par value; 164,000,000 shares authorized; 13,686,964 and 9,098,844
   shares issued as of June 30, 2023 and December 31, 2022, respectively;
13,420,859 and
   
8,928,498 shares outstanding as of June 30, 2023 and December 31, 2022, respectively

 

 

11

 

 

 

8

 

Additional paid-in capital

 

 

760,277

 

 

 

743,626

 

Accumulated deficit

 

 

(862,091

)

 

 

(826,843

)

Treasury stock – at cost; 266,105 and 170,346 shares as of June 30, 2023 and
   December 31, 2022, respectively

 

 

(19,078

)

 

 

(19,078

)

Total stockholders' deficit

 

 

(120,881

)

 

 

(102,287

)

Total liabilities and stockholders' deficit

 

$

49,673

 

 

$

53,525

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

1


 

Biora Therapeutics, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenues

 

$

2

 

 

$

104

 

 

$

4

 

 

$

211

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

5,983

 

 

 

5,904

 

 

 

13,173

 

 

 

12,462

 

Selling, general and administrative

 

 

8,953

 

 

 

8,410

 

 

 

17,309

 

 

 

21,867

 

Total operating expenses

 

 

14,936

 

 

 

14,314

 

 

 

30,482

 

 

 

34,329

 

Loss from operations

 

 

(14,934

)

 

 

(14,210

)

 

 

(30,478

)

 

 

(34,118

)

Interest expense, net

 

 

(2,703

)

 

 

(2,772

)

 

 

(5,383

)

 

 

(5,532

)

(Loss) gain on warrant liabilities

 

 

(161

)

 

 

4,413

 

 

 

703

 

 

 

13,402

 

Other (expense) income, net

 

 

(5

)

 

 

5,735

 

 

 

(86

)

 

 

4,924

 

Loss before income taxes

 

 

(17,803

)

 

 

(6,834

)

 

 

(35,244

)

 

 

(21,324

)

Income tax expense (benefit)

 

 

4

 

 

 

(837

)

 

 

4

 

 

 

(837

)

Loss from continuing operations

 

 

(17,807

)

 

 

(5,997

)

 

 

(35,248

)

 

 

(20,487

)

Gain from discontinued operations

 

 

 

 

 

484

 

 

 

 

 

 

1,166

 

Net loss

 

 

(17,807

)

 

 

(5,513

)

 

 

(35,248

)

 

 

(19,321

)

Net loss per share from continuing operations, basic and diluted

 

$

(1.47

)

 

$

(0.81

)

 

$

(3.01

)

 

$

(2.79

)

Net gain per share from discontinued operations, basic and diluted

 

$

 

 

$

0.06

 

 

$

 

 

$

0.16

 

Net loss per share, basic and diluted

 

$

(1.47

)

 

$

(0.75

)

 

$

(3.01

)

 

$

(2.63

)

Weighted average shares outstanding, basic and diluted

 

 

12,143,108

 

 

 

7,374,865

 

 

 

11,718,408

 

 

 

7,351,595

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

2


 

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, 2022

 

 

9,098,844

 

 

$

8

 

 

$

743,626

 

 

$

(826,843

)

 

 

(170,346

)

 

$

(19,078

)

 

$

(102,287

)

Issuance of common stock, net

 

 

2,853,109

 

 

 

3

 

 

 

12,521

 

 

 

 

 

 

 

 

 

 

 

 

12,524

 

Issuance of common stock upon vesting of restricted stock units

 

 

146,321

 

 

 

 

 

 

(178

)

 

 

 

 

 

(68,938

)

 

 

 

 

 

(178

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,384

 

 

 

 

 

 

 

 

 

 

 

 

2,384

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(17,441

)

 

 

 

 

 

 

 

 

(17,441

)

Balance at March 31, 2023

 

 

12,098,274

 

 

$

11

 

 

$

758,353

 

 

$

(844,284

)

 

 

(239,284

)

 

$

(19,078

)

 

$

(104,998

)

Issuance of common stock, net

 

 

1,509,434

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon vesting of restricted stock units

 

 

79,256

 

 

 

 

 

 

(90

)

 

 

 

 

 

(26,821

)

 

 

 

 

 

(90

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,014

 

 

 

 

 

 

 

 

 

 

 

 

2,014

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(17,807

)

 

 

 

 

 

 

 

 

(17,807

)

Balance at June 30, 2023

 

 

13,686,964

 

 

$

11

 

 

$

760,277

 

 

$

(862,091

)

 

 

(266,105

)

 

$

(19,078

)

 

$

(120,881

)

 

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Treasury Stock

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Shares

 

 

Amount

 

 

Deficit

 

Balance at December 31, 2021

 

 

7,429,458

 

 

$

6

 

 

$

722,782

 

 

$

(788,686

)

 

 

(154,569

)

 

$

(19,078

)

 

$

(84,976

)

Issuance of common stock, net

 

 

85,213

 

 

 

 

 

 

3,626

 

 

 

 

 

 

 

 

 

 

 

 

3,626

 

Issuance of common stock upon vesting of restricted stock units

 

 

11,520

 

 

 

 

 

 

(80

)

 

 

 

 

 

(3,723

)

 

 

 

 

 

(80

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,053

 

 

 

 

 

 

 

 

 

 

 

 

2,053

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(13,808

)

 

 

 

 

 

 

 

 

(13,808

)

Balance at March 31, 2022

 

 

7,526,191

 

 

$

6

 

 

$

728,381

 

 

$

(802,494

)

 

 

(158,292

)

 

$

(19,078

)

 

$

(93,185

)

Issuance of common stock, net

 

 

69,028

 

 

 

 

 

 

1,168

 

 

 

 

 

 

 

 

 

 

 

 

1,168

 

Issuance of common stock under employee stock purchase plan

 

 

5,002

 

 

 

 

 

 

89

 

 

 

 

 

 

 

 

 

 

 

 

89

 

Issuance of common stock upon vesting of restricted stock units

 

 

12,667

 

 

 

 

 

 

(111

)

 

 

 

 

 

(3,017

)

 

 

 

 

 

(111

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,446

 

 

 

 

 

 

 

 

 

 

 

 

1,446

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(5,513

)

 

 

 

 

 

 

 

 

(5,513

)

Balance at June 30, 2022

 

 

7,612,888

 

 

$

6

 

 

$

730,973

 

 

$

(808,007

)

 

 

(161,309

)

 

$

(19,078

)

 

$

(96,106

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

3


 

Biora Therapeutics, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Six Months Ended
June 30,

 

 

 

2023

 

 

2022

 

Operating Activities:

 

 

 

 

 

 

Net loss

 

$

(35,248

)

 

$

(19,321

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Gain from discontinued operations

 

 

 

 

 

(1,166

)

Non-cash revenue reserve

 

 

 

 

 

201

 

Depreciation and amortization

 

 

313

 

 

 

547

 

Stock-based compensation expense

 

 

4,398

 

 

 

3,499

 

Amortization of debt discount and non-cash interest

 

 

757

 

 

 

694

 

Loss on disposal of property and equipment

 

 

9

 

 

 

320

 

Impairment of property and equipment

 

 

100

 

 

 

545

 

Gain on investment in Enumera Molecular, Inc.

 

 

 

 

 

(5,731

)

Change in fair value of warrant liabilities

 

 

(703

)

 

 

(13,402

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Income tax receivable

 

 

10

 

 

 

(817

)

Prepaid expenses and other current assets

 

 

(59

)

 

 

(904

)

Accounts payable

 

 

1,437

 

 

 

(4,434

)

Accrued expenses and other liabilities

 

 

6,170

 

 

 

(4,486

)

Other long-term liabilities

 

 

(904

)

 

 

(958

)

Net cash used in operating activities - continuing operations

 

 

(