10-Q 1 prpo-20230630x10q.htm 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 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: 001-36439

PRECIPIO, INC.

(Exact name of registrant as specified in its charter)

Delaware

91-1789357

(State or other jurisdiction of

(I.R.S. Employer

incorporation or organization)

Identification No.)

4 Science Park, New Haven, CT

06511

(Address of principal executive offices)

(Zip Code)

(203) 787-7888

(Registrant’s telephone number, including area code)

a

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, $0.01 par value per share

PRPO

The Nasdaq Capital 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 8, 2023, the number of shares of common stock outstanding was 27,562,298.

PRECIPIO, INC. AND SUBSIDIARIES

INDEX

    

Page No.

PART I.

Financial Information

3

Item 1.

Condensed Consolidated Financial Statements

3

Condensed Consolidated Balance Sheets at June 30, 2023 (unaudited) and December 31, 2022

3

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2023 and 2022 (unaudited)

4

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022 (unaudited)

5

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022 (unaudited)

7

Notes to Unaudited Condensed Consolidated Financial Statements

9

Item 2.

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

28

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

34

PART II.

Other Information

35

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

39

Item 3.

Defaults Upon Senior Securities

39

Item 4.

Mine Safety Disclosures

39

Item 5.

Other Information

39

Item 6.

Exhibits

39

Signatures

41

2

PART 1. FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Dollars in thousands, except share data)

June 30, 2023

    

(unaudited)

    

December 31, 2022

ASSETS

CURRENT ASSETS:

Cash

$

2,573

$

3,445

Accounts receivable, net

 

884

1,036

Inventories

 

537

708

Other current assets

 

354

521

Total current assets

 

4,348

5,710

PROPERTY AND EQUIPMENT, NET

 

791

877

OTHER ASSETS:

Finance lease right-of-use assets, net

214

257

Operating lease right-of-use assets, net

722

763

Intangibles, net

 

13,293

13,768

Other assets

 

104

129

Total assets

$

19,472

$

21,504

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES:

Current maturities of long-term debt, less debt issuance costs

$

27

$

255

Current maturities of finance lease liabilities

 

155

162

Current maturities of operating lease liabilities

 

225

199

Accounts payable

 

2,402

2,042

Accrued expenses

 

1,895

1,584

Deferred revenue

 

17

119

Total current liabilities

 

4,721

4,361

LONG TERM LIABILITIES:

Long-term debt, less current maturities and debt issuance costs

 

120

134

Finance lease liabilities, less current maturities

 

31

68

Operating lease liabilities, less current maturities

 

509

574

Total liabilities

 

5,381

5,137

COMMITMENTS AND CONTINGENCIES (Note 5)

STOCKHOLDERS’ EQUITY:

Preferred stock - $0.01 par value, 15,000,000 shares authorized at June 30, 2023 and December 31, 2022, 47 shares issued and outstanding at June 30, 2023 and December 31, 2022, liquidation preference of $46 at June 30, 2023

 

Common stock, $0.01 par value, 150,000,000 shares authorized at June 30, 2023 and December 31, 2022, 27,562,298 and 22,820,260 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively

 

275

228

Additional paid-in capital

 

111,371

108,371

Accumulated deficit

 

(97,620)

(92,297)

Total Precipio, Inc. stockholders’ equity

 

14,026

16,302

Noncontrolling interest in joint venture

65

65

Total stockholders’ equity

14,091

16,367

Total liabilities and stockholders’ equity

$

19,472

$

21,504

See notes to unaudited condensed consolidated financial statements.

3

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Dollars in thousands, except per share data)

(unaudited)

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2023

    

2022

2023

    

2022

SALES:

 

  

 

  

  

 

  

Service revenue, net

$

2,768

$

2,226

$

4,836

$

4,231

Other revenue

 

877

 

220

 

1,638

 

742

Revenue, net of contractual allowances and adjustments

 

3,645

 

2,446

 

6,474

 

4,973

Adjustment for allowance for doubtful accounts

 

(112)

 

(87)

 

(124)

 

(167)

Net sales

 

3,533

 

2,359

 

6,350

 

4,806

COST OF SALES:

 

  

 

  

 

  

 

  

Cost of service revenue

 

1,880

 

1,366

 

3,649

 

2,902

Cost of other revenue

 

282

 

220

 

581

 

428

Total cost of sales

 

2,162

 

1,586

 

4,230

 

3,330

Gross profit

 

1,371

 

773

 

2,120

 

1,476

OPERATING EXPENSES:

 

  

 

  

 

  

 

  

Operating expenses

 

3,663

 

3,206

 

7,438

 

8,718

OPERATING LOSS

 

(2,292)

 

(2,433)

 

(5,318)

 

(7,242)

OTHER (EXPENSE) INCOME:

 

  

 

  

 

  

 

  

Interest expense, net

 

(1)

 

(2)

 

(5)

 

Warrant revaluation

 

 

297

 

 

519

Gain on settlement of liability

 

 

 

 

1

Total other (expense) income

 

(1)

 

295

 

(5)

 

520

LOSS BEFORE INCOME TAXES

 

(2,293)

 

(2,138)

 

(5,323)

 

(6,722)

INCOME TAX EXPENSE

 

 

 

 

NET LOSS

 

(2,293)

 

(2,138)

 

(5,323)

 

(6,722)

Less: Net income attributable to noncontrolling interest in joint venture

(6)

(12)

NET LOSS ATTRIBUTABLE TO PRECIPIO, INC. COMMON STOCKHOLDERS

$

(2,293)

$

(2,144)

$

(5,323)

$

(6,734)

BASIC AND DILUTED LOSS PER COMMON SHARE

$

(0.09)

$

(0.09)

$

(0.22)

$

(0.30)

BASIC AND DILUTED WEIGHTED-AVERAGE SHARES OF COMMON STOCK OUTSTANDING

 

24,362,785

 

22,708,708

 

23,790,491

 

22,708,648

See notes to unaudited condensed consolidated financial statements.

4

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Dollars in thousands)

(unaudited)

For the Three Months Ended June 30, 2023

Preferred Stock

Common Stock

Additional

Noncontrolling

Outstanding

Par

    

Outstanding

    

Par

Paid-in

Accumulated

Total

Interest in

    

Shares

    

Value

    

Shares

    

Value

    

Capital

    

Deficit

    

Precipio, Inc.

    

Joint Venture

    

Total

Balance, April 1, 2023

 

47

$

 

23,364,086

$

233

$

109,254

$

(95,327)

$

14,160

$

65

$

14,225

Net (loss) income

(2,293)

(2,293)

(2,293)

Issuance of common stock in connection with purchase agreements, net of issuance costs

4,125,000

41

1,719

1,760

1,760

Issuance of common stock in connection with at the market offering, net of issuance costs

73,212

1

46

47

47

Stock-based compensation

 

 

 

 

352

 

 

352

 

 

352

Balance, June 30, 2023

47

$

27,562,298

$

275

$

111,371

$

(97,620)

$

14,026

$

65

$

14,091

For the Six Months Ended June 30, 2023

Preferred Stock

Common Stock

Additional

Noncontrolling

Outstanding

Par

    

Outstanding

    

Par

Paid-in

Accumulated

Total

Interest in

Shares

    

Value

    

Shares

    

Value

    

Capital

    

Deficit

    

Precipio, Inc.

    

Joint Venture

    

Total

Balance, January 1, 2023

47

$

 

22,820,260

$

228

$

108,371

$

(92,297)

$

16,302

$

65

$

16,367

Net (loss) income

 

 

 

 

 

 

(5,323)

 

(5,323)

 

 

(5,323)

Issuance of common stock in connection with purchase agreements

4,125,000

41

1,719

1,760

1,760

Issuance of common stock in connection with at the market offering, net of issuance costs

617,038

6

479

485

485

Stock-based compensation

 

 

 

 

 

802

 

 

802

 

 

802

Balance, June 30, 2023

 

47

$

27,562,298

$

275

$

111,371

$

(97,620)

$

14,026

$

65

$

14,091

See notes to unaudited condensed consolidated financial statements.

5

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Dollars in thousands)

(unaudited)

For the Three Months Ended June 30, 2022

Preferred Stock

Common Stock

Additional

Noncontrolling

Outstanding

Par

    

Outstanding

    

Par

Paid-in

Accumulated

Total

Interest in

    

Shares

    

Value

    

Shares

    

Value

    

Capital

    

Deficit

    

Precipio, Inc.

    

Joint Venture

    

Total

Balance, April 1, 2022

47

$

22,708,708

$

227

$

106,663

$

(84,684)

$

22,206

$

46

$

22,252

Net loss

 

 

 

 

 

 

(2,144)

 

(2,144)

 

6

 

(2,138)

Stock-based compensation

 

 

 

 

 

451

 

 

451

 

 

451

Balance, June 30, 2022

 

47

$

 

22,708,708

$

227

$

107,114

$

(86,828)

$

20,513

$

52

$

20,565

For the Six Months Ended June 30, 2022

Preferred Stock

Common Stock

Additional

Noncontrolling

Outstanding

Par

    

Outstanding

    

Par

Paid-in

Accumulated

Total

Interest in

Shares

    

Value

    

Shares

    

Value

    

Capital

    

Deficit

    

Precipio, Inc.

    

Joint Venture

    

Total

Balance, January 1, 2022

47

$

22,708,442

$

227

$

104,431

$

(80,094)

$

24,564

$

40

$

24,604

Net loss

 

 

 

 

 

 

(6,734)

 

(6,734)

 

12

 

(6,722)

Proceeds upon issuance of common stock from exercise of warrants

266

Stock-based compensation

 

 

 

 

 

2,683

 

 

2,683

 

 

2,683

Balance, June 30, 2022

 

47

$

 

22,708,708

$

227

$

107,114

$

(86,828)

$

20,513

$

52

$

20,565

See notes to unaudited condensed consolidated financial statements

6

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Dollars in thousands)

(unaudited)

Six Months Ended June 30, 

    

2023

    

2022

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss

$

(5,323)

$

(6,722)

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

 

  

 

  

Depreciation and amortization

 

621

 

604

Amortization of operating lease right-of-use asset

99

93

Amortization of finance lease right-of-use asset

43

67

Amortization of deferred financing costs, debt discounts and debt premiums

 

1

 

2

Gain on settlement of liability

 

 

(1)

Stock-based compensation

 

802

 

2,683

Provision for losses on doubtful accounts

 

124

 

165

Warrant revaluation

 

 

(519)

Changes in operating assets and liabilities:

 

  

 

  

Accounts receivable

 

28

 

(595)

Inventories

 

171

 

(78)

Other assets

 

192

 

207

Accounts payable

 

353

 

692

Operating lease liabilities

(97)

(90)

Deferred revenue

(102)

(5)

Accrued expenses

 

311

 

(483)

Net cash used in operating activities

 

(2,777)

 

(3,980)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

  

 

Purchase of property and equipment

 

(54)

 

(106)

Net cash used in investing activities

 

(54)

 

(106)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

  

 

  

Principal payments on finance lease obligations

 

(44)

 

(95)

Issuance of common stock, net of issuance costs

2,245

Principal payments on long-term debt

 

(242)

 

(14)

Net cash flows provided by (used in) financing activities

 

1,959

 

(109)

NET CHANGE IN CASH

 

(872)

 

(4,195)

CASH AT BEGINNING OF PERIOD

 

3,445

 

11,668

CASH AT END OF PERIOD

$

2,573

$

7,473

See notes to unaudited condensed consolidated financial statements.

7

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS- CONTINUED

(Dollars in thousands)

(unaudited)

Six Months Ended June 30, 

2023

    

2022

SUPPLEMENTAL CASH FLOW INFORMATION

Cash paid during the period for interest

$

18

$

19

SUPPLEMENTAL DISCLOSURE OF CONSULTING SERVICES OR ANY OTHER NON-CASH COMMON STOCK RELATED ACTIVITY

 

  

 

  

Purchases of equipment financed through accounts payable

7

7

Operating lease right-of-use assets obtained in exchange for operating lease obligations

58

92

See notes to unaudited condensed consolidated financial statements.

8

PRECIPIO, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For the Three and Six Months Ended June 30, 2023 and 2022

1. BUSINESS DESCRIPTION

Business Description.

Precipio, Inc., and its subsidiaries, (collectively, “we”, “us”, “our”, the “Company” or “Precipio”) is a healthcare solutions company focused on cancer diagnostics.  The Company’s business mission is to address the pervasive problem of cancer misdiagnoses by developing solutions to mitigate the root causes of this problem in the form of diagnostic products, reagents and services.  Misdiagnoses originate from aged commercial diagnostic cancer testing technologies, lack of subspecialized expertise, and sub-optimal laboratory processes that are needed in today’s diagnostic cancer testing in order to provide accurate, rapid, and resource-effective results to treat patients.  Industry studies estimate 1 in 5 blood-cancer patients are misdiagnosed. As cancer diagnostic testing has evolved from cellular to molecular (genes and exons), laboratory testing has become extremely complex, requiring even greater diagnostic precision, attention to process and a more appropriate evaluation of the abundance of genetic data to effectively gather, consider, analyze and present information for the physician for patient treatment.  Precipio sees cancer diagnostics as requiring a holistic approach to improve diagnostic data for improved interpretations with the intent to reduce misdiagnoses. By delivering diagnostic products, reagents and services that improve the accuracy and efficiency of diagnostics, leading to fewer misdiagnoses, we believe patient outcomes can be improved through the selection of appropriate therapeutic options.  Furthermore, we believe that better patient outcomes will have a positive impact on healthcare expenses as misdiagnoses are reduced.  Better Diagnostic Results – Better Patient Outcome – Lower Healthcare Expenditures.

To deliver its strategy, the Company has structured its organization in order to drive development of diagnostic products.  Laboratory and R&D facilities located in New Haven, Connecticut and Omaha, Nebraska house development teams that collaborate on new products and services.  The Company operates CLIA laboratories in both the New Haven, Connecticut and Omaha, Nebraska locations providing essential blood cancer diagnostics to office-based oncologists in many states nationwide.  To deliver on our strategy of mitigating misdiagnoses we rely heavily on our CLIA laboratory to support R&D beta-testing of the products we develop, in a clinical environment.

Our operating structure promotes the harnessing of our proprietary technology and genetic diagnostic expertise to bring to market the Company’s robust pipeline of innovative solutions designed to address the root causes of misdiagnoses.

Joint Venture.

The Company has determined that it holds a variable interest in a joint venture formed in April 2020 (the “Joint Venture”) and is the primary beneficiary of the variable interest entity (“VIE”). See Note 2 - Summary of Significant Accounting Policies for further discussion regarding consolidation of variable interest entities.

The Company is working with Poplar Healthcare PLLC (“Poplar”) to dissolve the Joint Venture with an effective date of December 31, 2022. This is expected to be completed in Q4 2023.

Going Concern.

The condensed consolidated financial statements have been prepared using accounting principles generally accepted in the United States of America (“GAAP”) applicable for a going concern, which assume that the Company will realize its assets and discharge its liabilities in the ordinary course of business. The Company has incurred substantial operating losses and has used cash in its operating activities for the past several years. For the six months ended June 30, 2023, the Company had a net loss of $5.3 million and net cash used in operating activities of $2.8 million. As of June 30, 2023, the Company had an accumulated deficit of $97.6 million and a negative working capital of $0.4 million. The Company’s ability to continue as a going concern over the next twelve months from the date of issuance of these condensed consolidated financial statements in this Quarterly Report on Form 10-Q is dependent upon a combination of achieving its

9

business plan, including generating additional revenue and avoiding potential business disruption due to the macroeconomic environment and the coronavirus (“COVID-19”) pandemic, and raising additional financing to meet its debt obligations and paying liabilities arising from normal business operations when they come due.

To meet its current and future obligations the Company has taken the following steps to capitalize the business and successfully achieve its business plan:

On April 14, 2023, the Company entered into a sales agreement with AGP, pursuant to which the Company may offer and sell its common stock having aggregate sales proceeds of up to $5.8 million, to or through AGP, as sales agent (the “AGP 2023 Sales Agreement”). The sale of our shares of Common Stock to or through AGP, pursuant to the AGP 2023 Sales Agreement, will be made pursuant to the registration statement (the “2023 Registration Statement”) on Form S-3 (File No. 333-271277), filed by the Company with the SEC on April 14, 2023, as amended by Amendment No. 1 filed by the Company with the SEC on April 25, 2023, and declared effective on April 27, 2023. As of the date the condensed consolidated financial statements were issued, we have received less than $1 thousand in gross proceeds through the AGP 2023 Sales Agreement from the sale of 500 shares of common stock. The Company has approximately $3.8 million available for future sales pursuant to the AGP 2023 Sales Agreement. See Note 7 Stockholders’ Equity, AGP 2023 Sales Agreement, for further discussion.
On June 8, 2023, the Company entered into a securities purchase agreement pursuant to which it received $2.0 million in gross proceeds through the sale of 4,125,000 shares of common stock and warrants to purchase shares of our common stock. Issuance costs were approximately $0.2 million and the Company intends to use the net proceeds for working capital and general corporate purposes. See Note 7 Stockholders’ Equity, Registered Direct Offering, for further discussion.

Notwithstanding the aforementioned circumstances, there remains substantial doubt about the Company’s ability to continue as a going concern for the next twelve months from the date these condensed consolidated financial statements were issued. There can be no assurance that the Company will be able to successfully achieve its initiatives summarized above in order to continue as a going concern over the next twelve months from the date of issuance of this Quarterly Report Form 10-Q. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include any adjustments that might result should the Company be unable to continue as a going concern as a result of the outcome of this uncertainty.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation.

The accompanying condensed consolidated financial statements are presented in conformity with GAAP and, as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022, are unaudited and reflect all adjustments (consisting of only normal recurring adjustments) that are necessary for a fair presentation of the financial position and operating results for the interim periods. These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2022 contained in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 30, 2023. The results of operations for the interim periods presented are not necessarily indicative of the results for fiscal year 2023.

The condensed consolidated financial statements include the accounts of Precipio and its wholly owned subsidiaries, and the Joint Venture which is a VIE in which we are the primary beneficiary. Refer to the section titled “Consolidation of Variable Interest Entities” for further information related to our accounting for the Joint Venture. All intercompany balances have been eliminated in consolidation.

10

Reclassification.

Certain reclassifications were made to the statements of cash flows related to splitting accruals and deferred revenue to separate lines in order to conform to the 2023 presentation. These reclassifications had no effect on previously reported retained earnings, net income, total assets or liabilities, or cash flows used in operating activities.

Recently Adopted Accounting Pronouncements.

In June 2016, the FASB issued ASU 2016-13 “Measurement of Credit Losses on Financial Instruments”, which replaces current methods for evaluating impairment of financial instruments not measured at fair value, including trade accounts receivable and certain debt securities, with a current expected credit loss model. The Company adopted this guidance on January 1, 2023. The adoption of this standard was not material to our condensed consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted.

In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement (Topic 820) (“ASU 2022-03”). The amendments in ASU 2022-03 clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. The amendments also clarify that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction. The amendments in this Update also require additional disclosures for equity securities subject to contractual sale restrictions. The provisions in this Update are effective for fiscal years beginning after December 15, 2023. Early adoption is permitted. The Company does not expect to early adopt this ASU. The Company is currently assessing the potential impact that the adoption of this ASU will have on its condensed consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06 “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity.” This ASU amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related EPS guidance for both Subtopics. The ASU will be effective for annual reporting periods after December 15, 2023 and interim periods within those annual periods and early adoption is permitted in annual reporting periods ending after December 15, 2020. The Company is currently assessing the potential impact that the adoption of this ASU will have on its condensed consolidated financial statements.

Loss Per Share.

Basic loss per share is calculated based on the weighted-average number of common shares outstanding during each period. Diluted loss per share includes shares issuable upon exercise of outstanding stock options, warrants or conversion rights that have exercise or conversion prices below the market value of our common stock. Shares of the Company’s common stock underlying pre-funded warrants are included in the calculation of basic and diluted loss per share due to the negligible exercise price of the pre-funded warrants. Options, warrants and conversion rights pertaining to 14,183,186 and 4,600,457 shares of our common stock have been excluded from the computation of diluted loss per share at June 30, 2023 and 2022, respectively, because the effect is anti-dilutive due to the net loss.

The following table summarizes the outstanding securities not included in the computation of diluted net loss per share:

June 30, 

    

2023

    

2022

Stock options

 

4,636,043

 

3,660,457

Warrants

 

9,429,643

 

822,500

Preferred stock

 

117,500

 

117,500

Total

 

14,183,186

 

4,600,457

11

Consolidation of Variable Interest Entities.

We evaluate any entity in which we are involved to determine if the entity is a VIE and if so, whether we hold a variable interest and are the primary beneficiary. We consolidate VIEs that are subject to assessment when we are deemed to be the primary beneficiary of the VIE. The process for determining whether we are the primary beneficiary of the VIE is to conclude whether we are a party to the VIE holding a variable interest that meets both of the following criteria: (1) has the power to make decisions that most significantly affect the economic performance of the VIE, and (2) has the obligation to absorb losses or the right to receive benefits that in either case could potentially be significant to the VIE.

We have determined that we hold a variable interest in the Joint Venture, have the power to make significant operational decisions on behalf of the VIE and also have the obligation to absorb the majority of the losses from the VIE.  As such we have also determined that we are the primary beneficiary of the VIE. The following table presents information about the carrying value of the assets and liabilities of the Joint Venture which we consolidate and which are included on our condensed consolidated balance sheets. Intercompany balances are eliminated in consolidation and not reflected in the following table.

(dollars in thousands)

    

June 30, 2023

    

December 31, 2022

Assets:

Accounts receivable, net

$

224

$

335

Total assets

$

224

$

335

Liabilities:

Accrued expenses

$

17

$

50

Total liabilities

$

17

$

50

Noncontrolling interest in Joint Venture

$

65

$

65

Total stockholders' equity

$

127

$

127

3. LONG-TERM DEBT

Long-term debt consists of the following:

Dollars in Thousands

    

June 30, 2023

    

December 31, 2022

Connecticut Department of Economic and Community Development (DECD)

$

161

$

176

DECD debt issuance costs

 

(14)

 

(15)

Financed insurance loan

 

 

228

Total long-term debt

 

147

 

389

Current portion of long-term debt

 

(27)

 

(255)

Long-term debt, net of current maturities

$

120

$

134

Department of Economic and Community Development.

On January 8, 2018, the Company entered into an agreement with the Connecticut Department of Economic and Community Development (“DECD”) by which the Company received a loan of $300,000 secured by substantially all of the Company’s assets (the “DECD 2018 Loan”). The DECD 2018 Loan is a ten-year loan due on December 31, 2027 and includes interest paid monthly at 3.25%. The maturity date of the DECD 2018 Loan was extended to May 31, 2028 and the modification did not have a material impact on the Company’s cash flows.

Amortization of the debt issuance costs were less than $1 thousand for the three months ended June 30, 2023 and 2022, respectively, and $1 thousand and $2 thousand for the six months ended June 30, 2023 and 2022, respectively.

12

Financed Insurance Loan.

The Company finances certain of its insurance premiums (the “Financed Insurance Loans”). In July 2022, the Company financed $0.4 million with a 5.99% interest rate and is obligated to make payments on a monthly basis through June 2023. As of June 30 2023 and December 31, 2022, the Financed Insurance Loan’s outstanding balance of zero and $0.2 million, respectively, was included in current maturities of long-term debt in the Company’s condensed consolidated balance sheet. A corresponding prepaid asset was included in other current assets.

4. ACCRUED EXPENSES OTHER CURRENT LIABILITIES.

Accrued expenses at June 30, 2023 and December 31, 2022 are as follows:

(dollars in thousands)

    

June 30, 2023

    

December 31, 2022

Accrued expenses

$

1,004

$

983

Accrued compensation

 

758

 

491

Accrued franchise, property and sales and use taxes

114

91

Accrued interest

 

19

 

19

$

1,895

$

1,584

The Company recorded certain settled reductions in accrued expenses and accounts payable as gains which are included in gain on settlement of liability, net in the condensed consolidated statements of operations. During the three months ended June 30, 2023 and 2022, there were no gains recorded on settlements of liability. During the six months ended June 30, 2023 and 2022, zero and $1 thousand, respectively, were recorded as a gain on settlement of liability.

5. COMMITMENTS AND CONTINGENCIES

The Company is involved in legal proceedings related to matters, which are incidental to its business. Also, the Company is delinquent on the payment of outstanding accounts payable for certain vendors and suppliers who have taken or have threatened to take legal action to collect such outstanding amounts. See below for a discussion on these matters.

PURCHASE COMMITMENTS

The Company has entered into purchase commitments for reagents from suppliers. These agreements started in 2011 and run through 2025. The Company and the suppliers will true up the amounts on an annual basis. The future minimum purchase commitments under these and other purchase agreements are approximately $0.8 million and $1.3 million at June 30, 2023 and December 31, 2022, respectively.

LITIGATIONS

CPA Global provides us with certain patent management services. On February 6, 2017, CPA Global claimed that we owed approximately $0.2 million for certain patent maintenance services rendered. CPA Global has not filed claims against us in connection with this allegation. A liability of less than $0.1 million has been recorded and is reflected in accounts payable within the accompanying condensed consolidated balance sheets at June 30, 2023 and December 31, 2022.

LEGAL AND REGULATORY ENVIRONMENT

The healthcare industry is subject to numerous laws and regulations of federal, state and local governments. These laws and regulations include, but are not limited to, matters such as licensure, accreditation, government healthcare program participation requirement, reimbursement for patient services and Medicare and Medicaid fraud and abuse. Government activity has increased with respect to investigations and allegations concerning possible violations of fraud and abuse statutes and regulations by healthcare providers.

13

Violations of these laws and regulations could result in expulsion from government healthcare programs together with the imposition of significant fines and penalties, as well as significant repayments for patient services previously billed. Management believes that the Company is in compliance with fraud and abuse regulations, as well as other applicable government laws and regulations. While no material regulatory inquiries have been made, compliance with such laws and regulations can be subject to future government review and interpretation, as well as regulatory actions unknown or unasserted at this time.

6. LEASES

The Company leases administrative facilities and laboratory equipment through operating lease agreements. In addition, we rent various equipment used in our diagnostic lab and in our administrative offices through finance lease arrangements.  Our operating leases include both lease (e.g., fixed payments including rent) and non-lease components (e.g., common area or other maintenance costs). The facility leases include one or more options to renew, from 1 to 5 years or more. The exercise of lease renewal options is typically at our sole discretion, therefore, the renewals to extend the lease terms are not included in our right-of-use (“ROU”) assets and lease liabilities as they are not reasonably certain of exercise.  We regularly evaluate the renewal options and, when they are reasonably certain of exercise, we include the renewal period in our lease term.  As our leases do not provide an implicit rate, we use our collateralized incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments.

Operating leases result in the recognition of ROU assets and lease liabilities on the balance sheet. ROU assets represent our right to use the leased asset for the lease term and lease liabilities represent our obligation to make lease payments. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Lease expense is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less are not recorded on the balance sheet. The primary leases we enter into with initial terms of 12 months or less are for equipment.

The Company also recognizes ROU assets from finance leases in connection with its HemeScreen Reagent Rental (“HSRR”) program. For certain customers in the HSRR program, the Company leases diagnostic testing equipment and then subleases the equipment to the customer.  Finance lease ROU assets and finance lease liabilities are recognized at the lease commencement date, and at the sublease commencement date the finance lease ROU asset is derecognized and is recorded as cost of sales in the condensed consolidated statements of operations. There were no derecognized finance lease ROU assets for the three and six months ended June 30, 2023 and 2022, respectively. Where Precipio is the lessor, customers lease diagnostic testing equipment from the Company with the transfer of ownership to the customer at the end of the lease term at no additional cost.  For these contracts, the Company accounts for the arrangements as sales-type leases. The lease asset for sales-type leases is the net investment in leased asset, which is recorded once the finance lease ROU asset is derecognized and a related gain or loss is noted. The net investment in leased assets was $0.1 million as of June 30, 2023 and December 31, 2022, respectively, and is included in other current assets and other assets in our condensed consolidated balance sheets.

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The balance sheet presentation of our operating and finance leases is as follows:

(dollars in thousands)

Classification on the Condensed Consolidated Balance Sheet

June 30, 2023

December 31, 2022

Assets:

Operating lease right-of-use assets, net

$

722

$

763

Finance lease right-of-use assets, net (1)

214

257

Total lease assets

$

936

$

1,020

Liabilities:

Current:

Current maturities of operating lease liabilities

$

225

$

199

Current maturities of finance lease liabilities

155

162

Noncurrent:

Operating lease liabilities, less current maturities

509

574

Finance lease liabilities, less current maturities

31

68

Total lease liabilities

$

920

$

1,003

(1)As of June 30, 2023 and December 31, 2022, finance lease right-of-use assets included $5 thousand and $13 thousand, respectively, of assets related to finance leases associated with the HSRR program.

As of June 30, 2023 and December 31, 2022, the estimated future minimum lease payments, excluding non-lease components, are as follows:

(dollars in thousands)

    

Operating Leases

Finance Leases

Total

June 30,

June 30,

June 30,

2023

2023

2023

2023 (remaining)

$