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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 March 31, 2025

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 May 12, 2025, the number of shares of common stock outstanding was 1,512,011.

PRECIPIO, INC. AND SUBSIDIARIES

INDEX

    

Page No.

PART I.

Financial Information

3

Item 1.

Condensed Consolidated Financial Statements

3

Condensed Consolidated Balance Sheets at March 31, 2025 (unaudited) and December 31, 2024

3

Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2025 and 2024 (unaudited)

4

Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31, 2025 and 2024 (unaudited)

5

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024 (unaudited)

6

Notes to Unaudited Condensed Consolidated Financial Statements

8

Item 2.

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

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

Item 4.

Controls and Procedures

30

PART II.

Other Information

32

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

33

Item 3.

Defaults Upon Senior Securities

33

Item 4.

Mine Safety Disclosures

33

Item 5.

Other Information

33

Item 6.

Exhibits

34

Signatures

35

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)

(unaudited)

    

March 31, 2025

    

December 31, 2024

ASSETS

CURRENT ASSETS:

Cash

$

1,017

$

1,389

Accounts receivable (net of allowance for credit losses of $957 and $995, respectively)

 

976

799

Inventories

 

825

724

Other current assets

 

460

539

Total current assets

 

3,278

3,451

PROPERTY AND EQUIPMENT, NET

 

771

719

OTHER ASSETS:

Finance lease right-of-use assets, net

481

517

Operating lease right-of-use assets, net

1,573

395

Intangibles, net

 

11,631

11,869

Other assets

 

51

45

Total assets

$

17,785

$

16,996

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES:

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

$

147

$

297

Current maturities of finance lease liabilities

 

123

124

Current maturities of operating lease liabilities

 

207

201

Accounts payable

 

906

618

Accrued expenses

 

2,659

2,799

Deferred revenue

 

289

232

Total current liabilities

 

4,331

4,271

LONG TERM LIABILITIES:

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

 

70

77

Finance lease liabilities, less current maturities

 

316

348

Operating lease liabilities, less current maturities

 

1,370

206

Total liabilities

 

6,087

4,902

COMMITMENTS AND CONTINGENCIES (Note 5)

STOCKHOLDERS’ EQUITY:

Preferred stock - $0.01 par value, 15,000,000 shares authorized at March 31, 2025 and December 31, 2024, 47 shares issued and outstanding at March 31, 2025 and December 31, 2024, liquidation preference of $37 at March 31, 2025

 

Common stock, $0.01 par value, 150,000,000 shares authorized at March 31, 2025 and December 31, 2024, 1,504,312 and 1,493,639 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively

 

15

15

Additional paid-in capital

 

115,007

114,519

Accumulated deficit

 

(103,324)

(102,440)

Total stockholders’ equity

11,698

12,094

Total liabilities and stockholders’ equity

$

17,785

$

16,996

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 March 31, 

    

2025

    

2024

SALES:

 

  

 

  

Service revenue, net

$

4,257

$

2,821

Product revenue

 

654

 

657

Revenue, net of contractual allowances and adjustments

 

4,911

 

3,478

Adjustment for allowance for credit losses

 

18

 

(46)

Net sales

 

4,929

 

3,432

COST OF SALES:

 

  

 

  

Cost of service revenue

 

2,466

 

2,101

Cost of product revenue

 

323

 

411

Total cost of sales

 

2,789

 

2,512

Gross profit

 

2,140

 

920

OPERATING EXPENSES:

 

  

 

  

Operating expenses

 

2,999

 

2,994

OPERATING LOSS

 

(859)

 

(2,074)

OTHER EXPENSE:

 

  

 

  

Interest expense, net

 

(25)

 

(5)

LOSS BEFORE INCOME TAXES

 

(884)

 

(2,079)

INCOME TAX EXPENSE

 

 

NET LOSS

$

(884)

$

(2,079)

BASIC AND DILUTED LOSS PER COMMON SHARE

$

(0.59)

$

(1.46)

BASIC AND DILUTED WEIGHTED-AVERAGE SHARES OF COMMON STOCK OUTSTANDING

 

1,502,652

 

1,423,942

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 March 31, 2025

Preferred Stock

Common Stock

Additional

Outstanding

Par

    

Outstanding

    

Par

Paid-in

Accumulated

    

Shares

    

Value

    

Shares

    

Value

    

Capital

    

Deficit

    

Total

Balance, January 1, 2025

 

47

$

 

1,493,639

$

15

$

114,519

$

(102,440)

$

12,094

Net loss

(884)

(884)

Issuance of common stock for consulting services

10,673

65

65

Stock-based compensation

 

 

 

 

423

 

 

423

Balance, March 31, 2025

47

$

1,504,312

$

15

$

115,007

$

(103,324)

$

11,698

For the Three Months Ended March 31, 2024

Preferred Stock

Common Stock

Additional

Outstanding

Par

    

Outstanding

    

Par

Paid-in

Accumulated

    

Shares

    

Value

    

Shares

    

Value

    

Capital

    

Deficit

    

Total

Balance, January 1, 2024

47

$

1,420,125

$

14

$

112,565

$

(98,150)

$

14,429

Net loss

 

 

 

 

 

 

(2,079)

 

(2,079)

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

10,167

67

67

Stock-based compensation

 

 

 

 

 

357

 

 

357

Balance, March 31, 2024

 

47

$

 

1,430,292

$

14

$

112,989

$

(100,229)

$

12,774

See notes to unaudited condensed consolidated financial statements.

5

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Dollars in thousands)

(unaudited)

Three Months Ended March 31, 

    

2025

    

2024

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss

$

(884)

$

(2,079)

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

 

  

 

  

Depreciation and amortization

 

324

 

304

Amortization of operating lease right-of-use asset

57

56

Amortization of finance lease right-of-use asset

36

18

Stock-based compensation

 

423

 

357

Value of stock issued in payment of Board fees and consulting services

 

65

 

Provision for credit losses

 

(38)

 

83

Derecognition of operating lease right-of-use asset and liability

(11)

Changes in operating assets and liabilities:

 

  

 

  

Accounts receivable

 

(139)

 

312

Inventories

 

(101)

 

(148)

Other assets

 

73

 

126

Accounts payable

 

288

 

283

Operating lease liabilities

(54)

(57)

Deferred revenue

57

83

Accrued expenses

 

(140)

 

(5)

Net cash used in operating activities

 

(44)

 

(667)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

  

 

Purchase of property and equipment

 

(138)

 

Net cash used in investing activities

 

(138)

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

  

 

  

Principal payments on finance lease obligations

 

(33)

 

(17)

Issuance of common stock, net of issuance costs

67

Principal payments on long-term debt

 

(157)

 

(109)

Net cash flows used in financing activities

 

(190)

 

(59)

NET CHANGE IN CASH

 

(372)

 

(726)

CASH AT BEGINNING OF PERIOD

 

1,389

 

1,502

CASH AT END OF PERIOD

$

1,017

$

776

See notes to unaudited condensed consolidated financial statements.

6

PRECIPIO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS- CONTINUED

(Dollars in thousands)

(unaudited)

Three Months Ended March 31, 

2025

    

2024

SUPPLEMENTAL CASH FLOW INFORMATION

Cash paid during the period for interest

$

30

$

9

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

 

  

 

  

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

1,237

See notes to unaudited condensed consolidated financial statements.

7

PRECIPIO, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For the Three Months Ended March 31, 2025 and 2024

1. BUSINESS DESCRIPTION

Business Description.

Precipio, Inc., and its subsidiaries, (collectively, “we”, “us”, “our”, the “Company” or “Precipio”) is a healthcare biotechnology company focused on cancer diagnostics. Our mission is to address the pervasive problem of cancer misdiagnoses by developing solutions in the form of diagnostic products and services.

Our products and services aim to deliver higher accuracy, improved laboratory workflow, and ultimately better patient outcomes, which reduce healthcare expenses. We develop innovative technologies in our laboratory where we design, test, validate, and use these products clinically. We believe these technologies improve diagnostic outcomes across various diseases within the hematologic field. We then commercialize these technologies as proprietary products that serve the global laboratory community in furtherance of our mission to eliminate or greatly reduce the prevalence of misdiagnosis. To deliver our strategy, we have structured our organization to develop diagnostic products, including our laboratory and research and development (“R&D”) facilities located in New Haven, Connecticut and Omaha, Nebraska, respectively, which house teams that collaborate on the development of new products and services. We operate clinical laboratory improvement amendment (“CLIA”) laboratories in both New Haven, Connecticut and Omaha, Nebraska where we provide 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 laboratories to support R&D beta-testing of the products we develop, in a clinical environment.

The development of laboratory products involves a qualified facility; highly skilled laboratory staff; and access to viable patient specimens to conduct development and testing. Our CLIA laboratory in New Haven, which is operated by our pathology services division, encapsulates these components, and also generates revenue for us which covers costs associated with operating this laboratory. This structure of utilizing our clinical lab to obtain samples and utilize the equipment and staffing to develop, test and validate our products, significantly reduces the development costs and timeline for our products. This also enables us to accelerate the time to market of new product development and launch.

Furthermore, as a clinical laboratory, we are always the first user of every product we develop, which allows us to optimize important laboratory functions such as workflow, inventory management, regulatory and billing issues. As a vendor, this enables us to serve as a reputable user of our own products, and we believe this provides us with significant credibility with existing and prospective customers. Furthermore, because we use our products as part of our day-to-day operations, we are able to deliver a high level of hands-on, informed support to customers, improving their experience with our products.

Our Products Division commercial team generates direct sales and works with our key distributors. Global healthcare distributors, such as ThermoFisher, McKesson, Medline and Cardinal Health, have partnered with us to form the backbone of our go-to-market strategy and enable us to access laboratories around the country that can benefit from using our diagnostic products.

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

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 and do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company has incurred substantial operating losses and has used cash in its operating activities for the past several years. For the three months ended March

8

31, 2025, the Company had a net loss of $0.9 million and net cash used in operating activities of $0.1 million. As of March 31, 2025, the Company had an accumulated deficit of $103.3 million and a working capital deficit of $1.1 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 business plan, including generating additional revenue and avoiding potential business disruption due to the macroeconomic environment and geopolitical instability, and raising additional financing, if needed, 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 its business:

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 U.S. Securities and Exchange Commission (“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. On April 8, 2024, we filed a prospectus supplement to our prospectus dated April 25, 2023 registering the offer and sale of up to $1,061,478 of shares of our common stock (the “April 2024 Prospectus Supplement”). As of the date the condensed consolidated financial statements were issued, the Company has approximately $3.7 million available for future sales pursuant to the 2023 Registration Statement, which includes approximately $1.0 million of remaining availability pursuant to the April 2024 Prospectus Supplement. See Note 7 Stockholders’ Equity, AGP 2023 Sales Agreement, 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.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation.

The accompanying condensed consolidated financial statements are presented in conformity with GAAP and, as of March 31, 2025 and for the three months ended March 31, 2025 and 2024, 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, 2024 contained in our Annual Report on Form 10-K, filed with the SEC on March 27, 2025. The results of operations for the interim periods presented are not necessarily indicative of the results for fiscal year 2025.

9

Recent Accounting Pronouncements Not Yet Adopted.

In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”) which amends the Codification to enhance the transparency and decision usefulness of income tax disclosures. ASU 2023-09 requires additional disaggregation of the reconciliation between the statutory and effective tax rate for an entity and of income taxes paid, both of which are disclosures required by current GAAP. The amendments improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. The amendments in ASU 2023-09 apply to all entities that are subject to Topic 740, Income Taxes. For public business entities, the amendments in ASU 2023-09 are effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The enhanced disclosures required by ASU 2023-09 will be included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. The Company is currently evaluating the impact of this standard on its annual disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income (Topic 220): Expense Disaggregation Disclosures (ASU 2024-03”). This update requires entities to disaggregate operating expenses into specific categories, such as purchases of inventory, compensation, depreciation, and amortization, to provide enhanced transparency into the nature and function of expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, with early adoption permitted. ASU 2024-03 may be applied retrospectively or prospectively. The Company is currently evaluating the impact of this standard on its financial statement presentation and disclosures.

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 831,501 and 695,550 shares of our common stock have been excluded from the computation of diluted loss per share at March 31, 2025 and 2024, 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:

March 31, 

    

2025

    

2024

Stock options

 

381,182

 

230,140

Warrants

 

444,444

 

459,535

Preferred stock

 

5,875

 

5,875

Total

 

831,501

 

695,550

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3. LONG-TERM DEBT

Long-term debt consists of the following:

Dollars in Thousands

    

March 31, 2025

    

December 31, 2024

Connecticut Department of Economic and Community Development (DECD)

$

108

$

115

DECD debt issuance costs

 

(9)

 

(9)

Financed insurance loan

 

89

 

177

Business loan agreement

29

91

Total long-term debt

 

217

 

374

Current portion of long-term debt

 

(147)

 

(297)

Long-term debt, net of current maturities

$

70

$

77

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 March 31, 2025 and 2024, respectively.

Financed Insurance Loan.

The Company finances certain of its insurance premiums (the “Financed Insurance Loans”). In July 2024, the Company financed $0.3 million with a 9.99% interest rate and is obligated to make payments on a monthly basis through June 2025. As of March 31, 2025 and December 31, 2024, the Financed Insurance Loan’s outstanding balance of $0.1 million and $0.2 million, respectively, was included in current maturities of long-term debt in the Company’s condensed consolidated balance sheets. A corresponding prepaid asset was included in other current assets.

Business Loan Agreement.

On May 1, 2024, the Company entered into a Business Loan and Security Agreement (the “Loan Agreement”) with Altbanq Lending LLC, pursuant to which the Company obtained a loan in the principal amount of $250,000 (the “Secured Loan”). According to the Loan Agreement, the Company granted the lender a continuing security interest in certain collateral (as defined in the Loan Agreement). Furthermore, the Company’s Chief Executive Officer provided a personal guaranty for the Secured Loan. The Secured Loan has a term of one year and an interest rate of 20%, such that pursuant to the Loan Agreement, the Company is obligated to pay the Lender 52 payments of $5,769 on a weekly basis and the total sum of the Secured Loan and interest (not including any fees) shall equal a total repayment amount of $300,000. If the Company defaults on payments then a default fee of $15,000 shall be payable to the lender.

 

The Company has the right, at its discretion, to request the lender to loan an additional amount of up to $250,000 on the same terms and conditions as set forth in the Loan Agreement, provided that there has been no material change in the Company’s finances.

As of March 31, 2025 and December 31, 2024, the outstanding balance of less than $0.1 million and $0.1 million, respectively, under the Loan Agreement, was included in current maturities of long-term debt in the Company’s condensed consolidated balance sheets.

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4. ACCRUED EXPENSES

Accrued expenses at March 31, 2025 and December 31, 2024 are as follows:

(dollars in thousands)

    

March 31, 2025

    

December 31, 2024

Accrued expenses

$

396

$

595

Accrued compensation

 

1,038

 

955

Accrued franchise, property and sales and use taxes

195

173

CHC temporary funding assistance

1,011

1,057

Accrued interest

 

19

 

19

$

2,659

$

2,799

The Company uses Change Healthcare (“CHC”), a healthcare technology company owned by UnitedHealth Group, to process some of its patient claims billings. In February 2024, CHC announced that it had experienced a cyberattack and as a result had to temporarily shut down some of its information technology systems. This system shut down caused delays in billing and reimbursement processes to CHC’s customers and, as a result, CHC established a Temporary Funding Assistance Program to help bridge the gap in short-term cash flow needs for customers affected by the disruption of its services due to the cyberattack. Funding distributed through this program is interest free and has no other fees or costs associated with it.  

During the year ended December 31, 2024, the Company received approximately $1.1 million through CHC’s Temporary Assistance Program. On October 28, 2024, the Company received a notice from CHC stating that they have restored the connectivity of their systems and are requesting repayment of the funds the Company received through the Temporary Assistance Program. The repayment date contained in the notice is January 2, 2025.

From January 1, 2025 through the date of issuance of this Quarterly Report on Form 10-Q, we have made approximately $0.2 million in repayments to CHC and written off another $0.1 million, leaving a balance of approximately $0.8 million. The Company will make equal monthly payments of approximately $83,000 from May 2025 to January 2026 to settle this balance.

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 2031. 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 $2.7 million at March 31, 2025.

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 March 31, 2025 and December 31, 2024.

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The Company is currently involved in a legal proceeding brought by a former employee before the court in San Antonio, Texas alleging unfair dismissal where the former employee seeks monetary damages. The Company disputes these allegations and intends to defend itself vigorously. While the outcome remains uncertain, management does not currently expect the case to have a material impact on its financial results.

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.

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 months ended March 31, 2025 and 2024, 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 less than $0.1 million as of March 31, 2025 and December 31, 2024, 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

March 31, 2025

December 31, 2024

Assets:

Operating lease right-of-use assets, net

$

1,573

$

395

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

481

517

Total lease assets

$

2,054

$

912

Liabilities:

Current:

Current maturities of operating lease liabilities

$

207

$

201

Current maturities of finance lease liabilities

123

124

Noncurrent:

Operating lease liabilities, less current maturities

1,370

206

Finance lease liabilities, less current maturities

316

348

Total lease liabilities

$

2,016

$

879

(1)As of March 31, 2025 and December 31, 2024, finance lease right-of-use assets included zero, respectively, of assets related to finance leases associated with the HSRR program.

As of March 31, 2025, the estimated future minimum lease payments, excluding non-lease components, are as follows:

(dollars in thousands)

    

Operating Leases

Finance Leases

Total

March 31,

March 31,

March 31,

2025

2025

2025

2025 (remaining)

$

265

$

125

$

390

2026

 

350

 

133

 

483

2027

 

395

 

107

 

502

2028

 

429

67

 

496

2029

461

38

499

Thereafter

 

130

 

73

 

203

Total lease obligations

 

2,030

 

543

 

2,573

Less: Amount representing interest

 

(453)

 

(104)

 

(557)

Present value of net minimum lease obligations

 

1,577

 

439

 

2,016

Less, current portion

 

(207)

 

(123)

 

(330)

Long term portion

$

1,370

$

316

$

1,686

Other information as of March 31, 2025 and December 31, 2024 is as follows:

March 31,

December 31,

2025

2024

Weighted-average remaining lease term (years):

Operating leases

5.1

1.9

Finance leases

4.4

4.4

Weighted-average discount rate:

Operating leases

9.99%

8.00%

Finance leases

11.02%

11.20%

During the three months ended March 31, 2025 and 2024, operating cash flows from operating leases was $0.1 million, respectively, and operating lease ROU assets obtained in exchange for operating lease liabilities was $1.2 million and zero, respectively.

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During the three months ended March 31, 2025 and 2024, there were no finance lease ROU assets obtained in exchange for finance lease liabilities.

Operating Lease Costs

Operating lease costs were approximately $0.1 million during the three months ended March 31, 2025 and 2024, respectively. These costs are primarily related to long-term operating leases for the Company’s facilities and laboratory equipment. Short-term and variable lease costs were less than $0.1 million for the three months ended March 31, 2025 and 2024, respectively.

Finance Lease Costs

Finance lease amortization and interest expenses are included in the condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024. The balances within these accounts are less than $0.1 million, respectively.

7. STOCKHOLDERS’ EQUITY

Common Stock.

Pursuant to our Third Amended and Restated Certificate of Incorporation, as amended, we currently have 150,000,000 shares of common stock authorized for issuance. On December 20, 2018, the Company’s shareholders approved the proposal to authorize the Company’s Board of Directors to, in its discretion, amend the Company’s Third Amended and Restated Certificate of Incorporation to increase the total number of authorized shares of common stock from 150,000,000 shares to 250,000,000 shares. The Company has not yet implemented this increase.

During the three months ended March 31, 2025, the Company issued 10,673 shares of its common stock in connection with consulting services of approximately $0.1 million.

At The Market Offering Agreement

AGP 2023 Sales Agreement

On April 14, 2023, the Company entered into a sales agreement (the “AGP 2023 Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP), in an “at the market offering” (as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended) of the shares of Common Stock. AGP will be entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares of Common Stock pursuant to the AGP 2023 Sales Agreement.

The sales of our shares of Common Stock to or through AGP, pursuant to the AGP 2023 Sales Agreement, are made pursuant to 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, for an aggregate offering price of up to $5.8 million.

On April 8, 2024, we filed a prospectus supplement (the “April 2024 Prospectus Supplement”) to our prospectus dated April 25, 2023 registering the offer and sale of up to $1,061,478 of shares of our common stock.

During the three months ended March 31, 2025 and 2024, we received net proceeds of zero and $0.1 million, respectively, from the sale of zero and 10,167 shares of common stock, respectively, pursuant to the AGP 2023 Sales Agreement.

As of the date of issuance of this Quarterly Report on Form 10-Q, we have received an aggregate of $0.1 million in net proceeds, after issuance costs of approximately $2 thousand, from the sales of 11,847 shares of common stock

15

through AGP. We have approximately $1.0 million of remaining availability pursuant to the 2024 Prospectus Supplement and 43.7 million of remaining availability under the 2023 Registration Statement.

Preferred Stock.

The Company’s Board of Directors is authorized to issue up to 15,000,000 shares of preferred stock in one or more series, from time to time, with such designations, powers, preferences and rights and such qualifications, limitations and restrictions as may be provided in a resolution or resolutions adopted by the Board of Directors.

Series B Preferred Stock.

The Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (“Series B Preferred Stock”) with the State of Delaware, which designates 6,900 shares of our preferred stock as Series B Preferred Stock. The Series B Preferred Stock has a stated value of $1 thousand per share and a par value of $0.01 per share. The Series B Preferred Stock includes a beneficial ownership blocker but has no dividend rights (except to the extent dividends are also paid on the common stock). On August 28, 2017, the Company completed an underwritten public offering consisting of the Company’s Series B Preferred Stock and warrants.

The conversion price of the Series B Preferred Stock contains a down round feature. The Company will recognize the effect of the down round feature when it is triggered. At that time, the effect would be treated as a deemed dividend and as a reduction of income available to common shareholders in our basic earnings per share calculation.

There were no conversions of Series B Preferred Stock during the three months ended March 31, 2025 and 2024, respectively. At March 31, 2025 and December 31, 2024, the Company had 6,900 shares of Series B Preferred Stock designated and issued and 47 shares of Series B Preferred Stock outstanding. Based on the stated value of $1 thousand per share and a conversion price of $8.00 per share, the outstanding shares of Series B Preferred Stock at March 31, 2025 were convertible into 5,875 shares of common stock.

Common Stock Warrants.

The following represents a summary of the warrants outstanding as of March 31, 2025:

    

    

    

Underlying

    

Exercise

Issue Year

Expiration

Shares 

Price

Warrants

(1)

2023

December 2028

444,444

$

12.60

(1) These warrants were issued in connection with a June 8, 2023 registered direct offering (the “Registered Direct Offering”) and concurrent private placement and are the RDO common warrants discussed below.

RDO Common Warrants. In connection with the Registered Direct Offering and concurrent private placement in June 2023, the Company issued 444,444 RDO Common Warrants to purchase up to 444,444 shares of Common Stock. The RDO Common Warrants are exercisable beginning six months after the date of issuance, have an exercise price of $12.60 per share, and will expire December 12, 2028.

8. FAIR VALUE

FASB guidance on fair value measurements, which defines fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements for our financial assets and liabilities, as well as for other assets and liabilities that are carried at fair value on a recurring basis in our condensed consolidated financial statements.

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FASB guidance establishes a three-level fair value hierarchy based upon the assumptions (inputs) used to price assets or liabilities. The three levels of inputs used to measure fair value are as follows:

Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities;

Level 2—Observable inputs other than those included in Level 1, such as quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets or liabilities in inactive markets; and

Level 3—Unobservable inputs reflecting our own assumptions and best estimate of what inputs market participants would use in pricing the asset or liability.

Common Stock Warrant Liabilities.

Certain of our issued and outstanding warrants to purchase shares of common stock do not qualify to be treated as equity and, accordingly, are recorded as a liability. We are required to record these instruments at fair value at each reporting date and changes are recorded as a non-cash adjustment to earnings. The gains or losses included in earnings are reported in other income (expense) in our condensed consolidated statements of operations.

Bridge Note Warrant Liabilities

During 2018 and 2019, the Company issued warrants in connection with the issuance of convertible notes. All of these warrants issuances were classified as warrant liabilities (the “Bridge Note Warrant Liabilities”).

The Bridge Note Warrant Liabilities are considered Level 3 financial instruments and were valued using the Black Scholes model. During the year ended December 31, 2024, the last remaining warrants related to Bridge Note Warrant Liabilities expired and thus at March 31, 2025 and December 31, 2024, there were no warrant liabilities to be valued.

During the three months ended March 31, 2024, the changes in the fair value of the warrant liabilities measured using significant unobservable inputs (Level 3) were zero.

9. EQUITY INCENTIVE PLAN

The Company currently issues stock awards under its 2017 Stock Option and Incentive Plan, as amended (the “2017 Plan”) which will expire on June 5, 2027. The shares authorized for issuance under the 2017 Plan were 395,380 at March 31, 2025, of which 11,637 were available for future grant. The shares authorized under the 2017 Plan are subject to annual increases on January 1 by 5% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or such lessor number of shares determined by the Company’s Board of Directors or Compensation Committee. During the three months ended March 31, 2025, the shares authorized for issuance increased by 74,681 shares.

Stock Options.

The Company accounts for all stock-based compensation payments to employees and directors, including grants of employee stock options, at fair value at the date of grant and expenses the benefit in operating expense in the condensed consolidated statements of operations over the service period of the awards. The Company records the expense for stock-based compensation awards subject to performance-based milestone vesting over the remaining service period when management determines that achievement of the milestone is probable based on the expected satisfaction of the performance conditions as of the reporting date. The Company records the expense for stock-based compensation awards subject to market-condition vesting over a derived service period which is calculated at the grant date. The fair value of each stock option granted is estimated on the date of grant using the Black-Scholes or other option pricing models, which requires various assumptions including estimating stock price volatility, expected life of the stock option, risk free interest rate and estimated forfeiture rate.

17

During the three months ended March 31, 2025, the Company granted stock options to purchase up to 77,500 shares of common stock at a weighted average exercise price of $6.06 per share. The stock options granted have either time-based or market-condition vesting.

The awards with time-based vesting have vesting periods of up to four years and had grant date fair values between $5.24 and $5.46. The fair value was calculated using the Black-Scholes option pricing model and used the following assumptions: risk free interest rate of 4.60% to 4.65%, based on the U.S. Treasury yield in effect at the time of grant; expected life of five to six years; and volatility of 124% to 128% based on historical volatility of the Company’s common stock over a time that is consistent with the expected life of the option.

The awards with market-condition vesting have a derived service period of 1.6 years and had a grant date fair value of $5.70. The fair value was calculated using a Monte Carlo Simulation and used the following assumptions: risk free interest rate of 4.67%; remaining term of ten years; and volatility of 121%.

The following table summarizes stock option activity under our plans during the three months ended March 31, 2025:

    

Number of

    

Weighted-Average

Options

Exercise Price

Outstanding at January 1, 2025

 

303,932

$

7.18

Granted

 

77,500

 

6.06

Forfeited

 

(250)

 

6.06

Outstanding at March 31, 2025

 

381,182

$

6.96

Exercisable at March 31, 2025

 

208,034

$

7.51

As of March 31, 2025, there were 337,895 options that were vested or expected to vest with aggregate intrinsic value of $0.1 million and a remaining weighted average contractual life of 7.1 years.

Restricted Stock Awards.

Restricted stock awards are subject to vesting restrictions. If a grantee’s service with the Company is terminated prior to vesting of the restricted stock, all unvested shares shall be forfeited and returned to the Company. Upon vesting, the restricted stock award shall no longer be deemed restricted.

As of March 31, 2025 and December 31, 2024, there were 2,492 and zero restricted stock awards that were vested and unvested, respectively.

There were no restricted stock awards granted during the three months ended March 31, 2025 and 2024, respectively.

Stock Compensation.

For the three months ended March 31, 2025 and 2024, we recorded non-cash stock-based compensation expense for all stock awards of $0.4 million, respectively, within operating expense in the accompanying statements of operations. As of March 31, 2025, the unrecognized compensation expense related to unvested stock awards was $1.4 million, which is expected to be recognized over a weighted-average period of 1.7 years.

10. SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE

ASC Topic 606, “Revenue from contracts with customers”

The Company follows the guidance of ASC 606 for the recognition of revenue from contracts with customers to transfer goods and services. The Company performed a comprehensive review of its existing revenue arrangements following the five-step model:

18

Step 1: Identification of the contract with the customer.  Sub-steps include determining the customer in a contract, initial contract identification and determining if multiple contracts should be combined and accounted for as a single transaction.  

Step 2: Identify the performance obligation in the contract.  Sub-steps include identifying the promised goods and services in the contract and identifying which performance obligations within the contract are distinct.

Step 3: Determine the transaction price.  Sub-steps include variable consideration, constraining estimates of variable consideration, the existence of a significant financing component in the contract, noncash consideration and consideration payable to a customer.

Step 4: Allocate transaction price.  Sub-steps include assessing the amount of consideration to which the Company expects to be entitled in exchange for transferring the promised goods or services to the customer.

Step 5: Satisfaction of performance obligations.  Sub-steps include ascertaining the point in time when an asset is transferred to the customer and when the customer obtains control of the asset upon which time the Company recognizes revenue.

Nature of Contracts and Customers

The Company’s contracts and related performance obligations are similar for its customers and the sales process for all customers starts upon the receipt of requisition forms from the customers for patient diagnostic testing and the execution of contracts for biomarker testing and clinical research.  Payment terms for the services provided are 30 days, unless separately negotiated.

Diagnostic testing

Control of the laboratory testing services is transferred to the customer at a point in time. As such, the Company recognizes revenue for laboratory testing services at a point in time based on the delivery method (web-portal access or fax) for the patient’s laboratory report, per the contract.

Clinical research grants

Control of the clinical research services are transferred to the customer over time. The Company will recognize revenue utilizing the “effort based” method, measuring its progress toward complete satisfaction of the performance obligation.

Biomarker testing and clinical project services

Control of the biomarker testing and clinical project services are transferred to the customer over time.  The Company utilizes an “effort based” method of assessing performance and measures progress towards satisfaction of the performance obligation based upon the delivery of results.

The Company generates revenue from the provision of diagnostic testing provided to patients, biomarker testing provided to bio-pharma customers and clinical research grants funded by both bio-pharma customers and government health programs.

Reagents and other diagnostic products

Control of reagents and other diagnostic products are transferred to the customer at a point in time and, as such, the Company recognizes these revenues at a point in time based on the delivery method. These revenues include revenues from reagent sets for our HSRR program and other product sales and are included in product revenue in our condensed consolidated statements of operations.

19

Disaggregation of Revenues by Transaction Type

We operate in one business segment and, therefore, the results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Service revenue, net for the three months ended March 31, 2025 and 2024 was as follows:

For the Three Months Ended March 31, 

(dollars in thousands)

Diagnostic Testing

    

2025

    

2024

Medicaid

$

5

$

5

Medicare

 

1,904

 

1,091

Self-pay

 

5

 

18

Third party payers

 

2,325

 

1,705

Contract diagnostics and other

 

18

 

2

Service revenue, net

$

4,257

$

2,821

Revenue from the Medicare and Medicaid programs account for a portion of the Company’s patient diagnostic service revenue. Laws and regulations governing those programs are extremely complex and subject to interpretation. As a result, there is at least a reasonable possibility that recorded estimates will change by a material amount in the near term.

Revenue Recognition

Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the expected value method based on historical experience. The Company does not typically enter arrangements where multiple contracts can be combined as the terms regarding services are generally found within a single agreement/requisition form. The Company derives its revenues from the following types of transactions: diagnostic testing (“Diagnostic”), revenues from the Company’s ICP technology and bio-pharma projects encompassing genetic diagnostics (collectively “Biomarker”), revenues from clinical research grants from state and federal research programs and diagnostic product sales, including revenues from equipment leases and reagent sales associated with our HSRR program.

Deferred revenue

Deferred revenue, or unearned revenue, refers to advance payments for products or services that are to be delivered in the future. The Company records such prepayment of unearned revenue as a liability, as revenue that has not yet been earned, but represents products or services that are owed to a customer. As the product or service is delivered over time, the Company recognizes the appropriate amount of revenue from deferred revenue. For the periods ended March 31, 2025 and December 31, 2024, the deferred revenue was $0.3 million and $0.2 million, respectively.

20

Contractual Allowances and Adjustments

We are reimbursed by payers for services we provide. Payments for services covered by payers average less than billed charges. We monitor revenue and receivables from payers and record an estimated contractual allowance for certain revenue and receivable balances as of the revenue recognition date to properly account for anticipated differences between amounts estimated in our billing system and amounts ultimately reimbursed by payers. Accordingly, the total revenue and receivables reported in our condensed consolidated financial statements are recorded at the amounts expected to be received from these payers. For service revenue, the contractual allowance is estimated based on several criteria, including unbilled claims, historical trends based on actual claims paid, current contract and reimbursement terms and changes in customer base and payer/product mix. The billing functions for the remaining portion of our revenue are contracted and fixed fees for specific services and are recorded without an allowance for contractual discounts. The following table presents our revenues initially recognized for each associated payer class during the three months ended March 31, 2025 and 2024.

For the Three Months Ended March 31, 

(dollars in thousands)

Contractual Allowances and

Revenues, net of Contractual

Gross Revenues

adjustments

Allowances and adjustments

    

2025

    

2024

    

2025

    

2024

    

2025

    

2024

Medicaid

$

5

$

5

$

$

$

5

$

5

Medicare

 

1,904

 

1,091

 

 

 

1,904

 

1,091

Self-pay

 

5

 

18

 

 

 

5

 

18

Third party payers

 

8,138

 

5,968

 

(5,813)

 

(4,263)

 

2,325

 

1,705

Contract diagnostics and other

 

18

 

2

 

 

 

18

 

2

 

10,070

 

7,084

 

(5,813)

 

(4,263)

 

4,257

 

2,821

Product

 

654

 

657

 

 

 

654

 

657

$

10,724

$

7,741

$

(5,813)

$

(4,263)

$

4,911

$

3,478

21

Allowance for Credit Losses

The Company provides for a general allowance for collectability of services when recording net sales. The Company has adopted the policy of recognizing net sales to the extent it expects to collect that amount. Reference is made to FASB 954-605-45-5 and ASU 2011-07, Health Care Entities: Presentation and Disclosure of Patient Service Revenue, Provision for Credit Loss, and the Allowance for Credit Losses. The change in the allowance for credit losses is directly related to the increase in patient service revenues. The following table presents our reported revenues net of the collection allowance and adjustments for the three months ended March 31, 2025 and 2024.

For the Three Months Ended March 31, 

Revenues, net of

 

(dollars in thousands)

Contractual Allowances

Allowances for credit

 

and adjustments

losses

Total

    

2025

    

2024

    

2025

    

2024

    

2025

    

2024

Medicaid

$

5

$

5

$

18

$

(2)

$

23

$

3

Medicare

 

1,904

 

1,091

 

 

(16)

 

1,904

 

1,075

Self-pay

 

5

 

18

 

 

(2)

 

5

 

16

Third party payers

 

2,325

 

1,705

 

 

(26)

 

2,325

 

1,679

Contract diagnostics and other

 

18

 

2

 

 

 

18

 

2

 

4,257

 

2,821

 

18

 

(46)

 

4,275

 

2,775

Product

 

654

 

657

 

 

 

654

 

657

$

4,911

$

3,478

$

18

$

(46)

$

4,929

$

3,432

Costs to Obtain or Fulfill a Customer Contract

Sales commissions are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in operating expenses in the condensed consolidated statements of operations.

Shipping and handling costs are comprised of inbound and outbound freight and associated labor. The Company accounts for shipping and handling activities related to contracts with customers as fulfillment costs which are included in cost of sales in the condensed consolidated statements of operations.

Accounts Receivable

The Company has provided an allowance for potential credit losses, which has been determined based on management’s industry experience. The Company grants credit without collateral to its patients, most of who are insured under third party payer agreements.

The following summarizes the mix of receivables outstanding related to payer categories:

(dollars in thousands)

    

March 31, 2025

    

December 31, 2024

Medicaid

$

5

$

(12)

Medicare

 

1,291

 

1,086

Self-pay

 

15

 

13

Third party payers

 

534

 

530

Contract diagnostic services, product and other

 

88

 

177

$

1,933

$

1,794

Less allowance for credit losses

 

(957)

 

(995)

Accounts receivable, net

$

976

$

799

22

The following table presents the roll-forward of the allowance for credit losses for the three months ended March 31, 2025.

    

Three Months Ended March 31,

(dollars in thousands)

2025

2024

Balance, January 1

 

$

(995)

$

(2,572)

Provision for credit losses:

 

  

  

Medicaid

18

(2)

Medicare

 

 

(16)

Self-pay

(2)

Third party payers

 

 

(26)

 

18

 

(46)

Credit loss income (expense)

20

(37)

Total charges

 

38

 

(83)

Balance, December 31

$

(957)

$

(2,655)

Customer Revenue and Accounts Receivable Concentration

Our customers are oncologists, hospitals, reference laboratories, physician-office laboratories, and pharma and biotech companies. Customers that accounted for 10% or greater of our net sales or accounts receivable for the identified periods is as follows:

Net sales

Accounts receivable, as of

Three Months Ended

March 31,

March 31,

December 31,

2025

2024

2025

2024

Customer A

*

11

%

*

*

Customer B

*

10

%

*

*

Customer C

26

%

*

34

%

29

%

* represents less than 10%

11. SEGMENT REPORTING

The Company’s chief operating decision maker (the “CODM”) is its Chief Executive Officer. The Company has no segment managers who are held accountable by the CODM for operations, operating results, and planning for levels or components below the consolidated unit level. Accordingly, the Company has determined it has a single operating segment.

The CODM uses consolidated net loss for purposes of allocating resources and assessing segment performance, including monitoring actual results versus historical periods. Cost of revenue and operating expenses are considered significant segment expenses that are regularly provided to the CODM and included within consolidated net loss. The measure of segment assets is the total assets on the Company’s condensed consolidated balance sheets. Capital expenditures are reported on a consolidated basis on the Company’s condensed consolidated statements of cash flows. The following table includes the Company's segment revenue, significant segment expenses, and other segment items to reconcile to net loss.

23

Dollars in Thousands

Three Months Ended

March 31, 

    

2025

    

2024

Net sales

$

4,929

$

3,432

Less expense (income):

Cost of sales

 

2,789

 

2,512

Operating expenses (1)

2,999

2,994

Other segment items (2)

 

25

 

5

Net loss

$

(884)

$

(2,079)

(1) Operating expenses include sales and marketing expenses, general and administrative expenses, research and development expenses and stock-based compensation.

(2) Other segment items include interest income, interest expense, gain on write-off of liability and other income.

12. SUBSEQUENT EVENTS

The Company has evaluated events and transactions subsequent to March 31, 2025 through the date of this Quarterly Report on Form 10-Q, and any material subsequent events are reported below.

On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Under the provisions of the CARES Act, and the subsequent extensions, the Company became eligible to apply for a refundable Employee Retention Credit (the “ERC”) subject to certain criteria, which could be used to offset payroll tax liabilities.

In November 2022, the Company submitted an ERC claim totaling approximately $1.5 million. In April 2025, the Company received an initial payment of approximately $0.4 million. The Company anticipates recording this amount as other income in the condensed consolidated statements of operations for the second quarter 2025.

The Company retains all rights to pursue and receive the remaining balance of approximately $1.1 million and is actively evaluating the likelihood and timing of any additional disbursements. The Company has not waived any claims to the unpaid portion of the ERC and is taking reasonable steps to secure the remaining balance. However, there can be no assurance as to the timing, amount, or certainty of receipt of additional funds, and the Company will continue to assess the collectability of the remaining claim in accordance with applicable accounting standards.

24

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

Forward-Looking Information

This Quarterly Report on Form 10-Q, including this Management’s Discussion and Analysis, contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, which statements involve substantial risks and uncertainties. These statements are based on management’s current views, assumptions or beliefs of future events and financial performance and are subject to uncertainty and changes in circumstances. Readers of this report should understand that these statements are not guarantees of performance or results. Many factors could affect our actual financial results and cause them to vary materially from the expectations contained in the forward-looking statements. These factors include, among other things: our expected revenue, income (loss), receivables, operating expenses, supplier pricing, availability and prices of raw materials, insurance reimbursements, product pricing, foreign currency exchange rates, sources of funding operations and acquisitions, our ability to raise funds, sufficiency of available liquidity, future interest and inflation costs, future economic circumstances, business strategy, industry conditions and key trends, our ability to execute our operating plans, the success of our cost savings initiatives, competitive environment and related market conditions, our ability to comply with the listing requirements of the Nasdaq Capital Market, expected financial and other benefits from our organizational restructuring activities, geopolitical uncertainties including increased U.S. trade tariffs, reciprocal and retaliatory tariffs from other countries, and trade disputes with other countries, the ongoing Russia and Ukraine conflict and the Israel-Hamas war, actions of governments and regulatory factors affecting our business, projections of future earnings, revenues, synergies, accretion or other financial items, any statements of the plans, strategies and objectives of management for future operations, retaining key employees and other risks as described in our reports filed with the SEC. In some cases these statements are identifiable through the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “target,” “can,” “could,” “may,” “should,” “will,” “would” or the negative of such terms and other similar expressions.

You are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements we make are not guarantees of future performance and are subject to various assumptions, risks and other factors that could cause actual results to differ materially from those suggested by these forward-looking statements. Actual results may differ materially from those suggested by the forward-looking statements that we make for a number of reasons, including those described in Part II, Item 1A, “Risk Factors,” of this Quarterly Report on Form 10-Q and our prior filings with the Securities and Exchange Commission.

We expressly disclaim any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

The following discussion should be read together with our condensed consolidated financial statements and related notes contained in this Quarterly Report on Form 10-Q and with the audited financial statements, related notes and Management’s Discussion and Analysis included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which we filed with the Securities and Exchange Commission on March 27, 2025. Results for the three months ended March 31, 2025 are not necessarily indicative of results that may be attained in the future.

Overview

We are a healthcare biotechnology company focused on cancer diagnostics.  Our business mission is to address the pervasive problem of cancer misdiagnoses by developing solutions in the form of diagnostic products and services.      

Our products and services aim to deliver higher accuracy, improved laboratory workflow, and ultimately better patient outcomes, which reduce healthcare expenses. We develop innovative technologies in our laboratory where we design, test, validate, and use these products clinically. We believe these technologies improve diagnostic outcomes across various diseases within the hematologic field. We then commercialize these technologies as proprietary products that serve the global laboratory community in furtherance of our mission to eliminate or greatly reduce the prevalence of misdiagnoses. To deliver our strategy, we have structured our organization to develop diagnostic products, including our laboratory and research and development (“R&D”) facilities located in New Haven, Connecticut and Omaha, Nebraska, respectively, which house teams that collaborate on the development of new products and services. We operate Clinical

25

Laboratory Improvement Amendments (“CLIA”) compliant laboratories in both New Haven, Connecticut and Omaha, Nebraska, from which we provide essential blood cancer diagnostics to oncologists nationwide. To deliver on our strategy of mitigating misdiagnoses, we rely heavily on our CLIA laboratories to support R&D beta-testing of the products we develop, in a clinical environment.

The development of laboratory products involves a qualified facility; highly skilled laboratory staff; and access to viable patient specimens to conduct development and testing. Our CLIA laboratory in New Haven, which is operated by our pathology services division, encapsulates these components, and also generates revenue for us which covers costs associated with operating this laboratory. This structure of utilizing our clinical lab to obtain samples and utilize the equipment and staffing to develop, test and validate our products, significantly reduces the development costs and timeline for our products. This also enables us to accelerate the time to market of new product development and launch.

Furthermore, as a clinical laboratory, we are always the first user of every product we develop, which allows us to optimize important laboratory functions such as workflow, inventory management, regulatory and billing issues. As a vendor, this enables us to serve as a reputable user of our own products, and we believe this provides us with significant credibility with existing and prospective customers. Furthermore, because we use our products as part of our day-to-day operations, we can deliver a high level of hands-on, expert support to customers, improving their experience with our products.

Our Products Division commercial team generates direct sales and works with our key distributors. Global healthcare distributors, such as ThermoFisher, McKesson, Medline and Cardinal Health, have partnered with us to form the backbone of our go-to-market strategy and enable us to access laboratories around the country that can benefit from using our diagnostic products.

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

Recent Developments

Change Healthcare

Change Healthcare (“CHC”), a subsidiary of UnitedHealth Group, experienced a cybersecurity breach in February 2024 which resulted in the temporary shut-down of some of its systems. Precipio uses CHC to process its billings for pathology services. Thus, when CHC shut down its business operations our pathology billings were halted. Our ability to process billings, accept payer remittances, process medical and billing benefit notices, bill secondary insurers, as well as patients, and communicate with commercial payers was severely impacted. Starting shortly after the breach, we redirected a significant amount of our internal resources to internally handle the billing services that CHC was no longer delivering. This resulted in billing and cash reimbursement delays during the year ended December 31, 2024.

Along with the delays in billing and cash reimbursements, we incurred approximately $0.3 million of expenses during the year ended December 31, 2024, as we incurred lost collections and used alternative methods for claims processing. CHC established a Temporary Funding Assistance Program to help bridge the gap in short-term cash flow needs for its customers affected by the disruption of its services due to the cyberattack. On October 28, 2024, the Company received a notice from CHC stating that they had restored the connectivity of their systems. During the year ended December 31, 2024, we received approximately $1.1 million from CHC through this program.

From January 1, 2025 through the date of issuance of this Quarterly Report on Form 10-Q, we have made approximately $0.2 million in repayments to CHC and in May 2025, we wrote off another $0.1 million. See Note 4 – “Accrued Expenses and Other Current Liabilities” for further discussion.

26

Employee Retention Credit (ERC)

On March 27, 2020, the U.S. government enacted the CARES Act. Under the provisions of the CARES Act, and its subsequent extensions, the Company became eligible to apply for a refundable Employee Retention Credit (the “ERC”), subject to certain criteria, which could be used to offset payroll tax liabilities.

In November 2022, the Company submitted an ERC claim totaling approximately $1.5 million. In April 2025, the Company received an initial payment of approximately $0.4 million. The Company anticipates recording this amount as other income in the condensed consolidated statements of operations for the second quarter of 2025.

The Company retains all rights to pursue and receive the remaining balance of approximately $1.1 million and is actively evaluating the likelihood and timing of any additional disbursements. The Company has not waived any claims to the unpaid portion of the ERC and is taking reasonable steps to secure the remaining balance. However, there can be no assurance as to the timing, amount, or certainty of receipt of additional funds, and the Company will continue to assess the collectability of the remaining claim in accordance with applicable accounting standards.

The $0.4 million ERC refund and the $0.1 million CHC write-off discussed above are non-recurring items and, as a result of these non-recurring items, we expect to record approximately $0.5 million of other income in the condensed consolidated statements of operations for the second quarter of 2025.

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 we will realize our assets and discharge our liabilities in the ordinary course of business and do not include any adjustments that might result should the Company be unable to continue as a going concern. We have incurred substantial operating losses and has used cash in its operating activities for the past several years. For the three months ended March 31, 2025, we had a net loss of $0.9 million and net cash used in operating activities of $0.1 million. As of March 31, 2025, we had an accumulated deficit of $103.3 million and a working capital deficit of $1.1 million. Our ability to continue as a going concern over the next twelve months from the date the condensed consolidated financial statements were issued is dependent upon a combination of achieving its business plan, including generating additional revenue, and raising additional financing to meet its debt obligations and paying liabilities arising from normal business operations when they come due.

To meet our current and future obligations we have taken the following steps to capitalize our business:

On April 14, 2023, the Company entered into a sales agreement with AGP, pursuant to which we may offer and sell our 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. On April 8, 2024, we filed a prospectus supplement to our prospectus dated April 25, 2023 registering the offer and sale of up to $1,061,478 of shares of our common stock (the “April 2024 Prospectus Supplement”). As of the date the condensed consolidated financial statements were issued, we have approximately $3.7 million available for future sales pursuant to the 2023 Registration Statement, which includes approximately $1.0 million of remaining availability pursuant to the April 2024 Prospectus Supplement.

Notwithstanding the aforementioned circumstances, there remains substantial doubt about our ability to continue as a going concern over the next twelve months from the date of issuance of this Quarterly Report on Form 10-Q. There can be no assurance that we will be able to successfully achieve our initiatives summarized above in order to continue as a going concern.

27

Results of Operations for the Three Months Ended March 31, 2025 and 2024

Net Sales. Net sales were as follows:

Dollars in Thousands

 

Three Months Ended

March 31, 

Change

 

    

2025

    

2024

    

$

    

%

 

Service revenue, net, less allowance for credit loss

$

4,275

$

2,775

$

1,500

54

%

Product revenue

 

654

 

657

(3)

-

%

Net Sales

$

4,929

$

3,432

$

1,497

44

%

Net sales for the three months ended March 31, 2025 were approximately $4.9 million, an increase of $1.5 million as compared to the same period in 2024. During the three months ended March 31, 2025, patient diagnostic service revenue increased $1.5 million as compared to the same period in 2024. This increase was due to a greater number of cases processed in the current year period. We processed 3,021 cases during the three months ended March 31, 2025 as compared to 2,062 cases during the same period in 2024, or a 47% increase in cases. The benefit of the increase in cases billed during the first quarter of 2025 as compared to the same period in 2024 was partially offset by a lower average price per case during the current year as a result of a different product mix. Product revenue for the three months ended March 31, 2025 was similar to the same period in 2024.

Cost of Sales. Cost of sales includes material and supply costs for the patient tests performed, costs related to products and other direct costs (primarily personnel costs, pathologist interpretation costs and rent) associated with the operations of our laboratory. Cost of sales increased by $0.3 million for the three months ended March 31, 2025 as compared to the same period in 2024. The increase is primarily attributable to increases in reagents, operating supplies, personnel costs and pathologist interpretation costs all due to the higher number of cases processed, as discussed above.

Gross Profit. Gross profit and gross margins were as follows:

    

Dollars in Thousands

 

Three Months Ended

March 31, 

Margin %

 

    

2025

    

2024

    

2025

    

2024

 

Gross Profit

$

2,140

$

920

 

43

%

27

%

Gross margin was 43% and 27% of total net sales for the three months ended March 31, 2025 and 2024, respectively. Gross profit was approximately $2.1 million and $0.9 million during the three months ended March 31, 2025 and 2024, respectively. The gross profit increased during the three months ended March 31, 2025, as compared to the prior year period, as a result of increases in case volume and revenue. We operate a fully staffed CLIA and College of American Pathologists (“CAP”) certified clinical pathology and molecular laboratory. As such, it is necessary to maintain appropriate staffing levels to provide industry standard laboratory processing and reporting to ordering physicians. The increase in case volume enabled our laboratory to yield economies of scale and to leverage fixed expenses.

Operating Expenses. Operating expenses primarily consist of personnel costs, professional fees, travel costs, facility costs, stock-based compensation costs and depreciation and amortization. Our operating expenses remained flat at $3.0 million for the three months ended March 31, 2025 as compared to the same period in 2024. For the three months ended March 31, 2025: (1) stock-based compensation increased by 0.1 million, (2) general and administrative expenses were flat as compared to the same period in the previous year and included an increase of less than $0.1 million in personnel costs offset by a decrease of less than $0.1 million in bad debt expense, (3) sales and marketing expenses decreased by $0.1 million due to a decrease in professional fees, and (4) research and development expenses were flat as compared to the same period in the previous year and included an increase of less than $0.1 million in personnel costs offset by a decrease of less than $0.1 million in operating supplies.

28

Other (Expense) Income. We recorded net other expense of $25 thousand and $5 thousand for the three months ended March 31, 2025 and 2024, respectively, which was related to net interest expense.

Liquidity and Capital Resources

Our working capital positions were as follows (in thousands):

    

March 31, 2025

    

December 31, 2024

    

Change

Current assets (including cash of $1,017 and $1,389 respectively)

$

3,278

$

3,451

$

(173)

Current liabilities

 

4,331

 

4,271

 

60

Working capital

$

(1,053)

$

(820)

$

(233)

Analysis of Cash Flows – Three Months Ended March 31, 2025 and 2024

    

Dollars in Thousands

Three Months Ended March 31,

    

2025

    

2024

    

Change

Net cash used in operating activities

$

(44)

$

(667)

$

623

Net cash used in investing activities

(138)

(138)

Net cash used in financing activities

 

(190)

 

(59)

 

(131)

Net change in cash

$

(372)

$

(726)

$

354

Cash Flows Used in Operating Activities. The cash flows used in operating activities of less than $0.1 million during the three months ended March 31, 2025 included a net loss of $0.9 million, an increase in accounts receivables of $0.1 million, an increase in inventories of $0.1 million, a decrease in operating lease liabilities of $0.1 million and a decrease in accrued expenses of $0.1 million. These were partially offset by a decrease in other assets of $0.1 million, an increase in accounts payable of $0.2 million, an increase in deferred revenues of $0.1 million, and non-cash adjustments of $0.9 million. The non-cash adjustments included less than $0.1 million for the change in provision for credit losses. We routinely provide a reserve for credit losses as a result of having limited in-network payer contracts. The other non-cash adjustments to net loss of approximately $0.7 million include, among other things, depreciation and amortization, and stock-based compensation. The cash flows used in operating activities of approximately $0.7 million during the three months ended March 31, 2024 included a net loss of $2.1 million, an increase in inventories of $0.1 million and a decrease in operating lease liabilities and accrued expenses of $0.1 million. These were partially offset by a decrease in accounts receivables of $0.3 million, a decrease in other assets of $0.1 million, an increase in accounts payable of $0.3 million, an increase in deferred revenues of $0.1 million, and non-cash adjustments of $0.8 million.

Cash Flows Used In Investing Activities. Cash flows used in investing activities were approximately $0.1 million and zero for the three months ended March 31, 2025 and 2024, respectively, resulting from purchases of property and equipment.

Cash Flows Used in or Provided by Financing Activities. Cash flows used in financing activities totaled $0.2 million for the three months ended March 31, 2025, which included $0.2 million in payments on our long-term debt and finance lease obligations. Cash flows used in financing activities totaled less than $0.1 million for the three months ended March 31, 2024, which included $0.1 million in payments on our long-term debt and finance lease obligations partially offset by less than $0.1 million of proceeds from the issuance of common stock.

For further information regarding the Company’s future funding requirements, see the Going Concern disclosure in Note 1 of the notes to the Unaudited Condensed Consolidated Financial Statements included with this Quarterly Report on Form 10-Q.

29

Off-Balance Sheet Arrangements

At each of March 31, 2025 and December 31, 2024, other than certain purchase commitments of approximately $2.7 million and $3.1 million, respectively, we did not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. The purchase commitments are mostly for laboratory reagents used in our normal operating business.

Contractual Obligations and Commitments

No significant changes to contractual obligations and commitments occurred during the three months ended March 31, 2025, as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.

Critical Accounting Estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statement and the reported amounts of revenues and expenses during the reporting period. Actual financial results based on judgments or estimates may vary under different assumptions or circumstances. Our critical accounting estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.

Recently Issued Accounting Pronouncements

See the accompanying unaudited condensed consolidated financial statements and Note 2 - “Summary of Significant Accounting Policies” in the notes to unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, for additional information regarding recently issued accounting pronouncements.

Impact of Inflation

Inflationary factors, such as increases in our cost of goods, labor, or other operating expenses, may adversely affect our operating results. While it is difficult to accurately measure the impact of inflation due to the imprecise nature of the estimates required, we do not believe inflation had a material effect on our financial condition or results of operations during the three months ended March 31, 2025 and 2024. We cannot assure you, however, that we will be able to increase the prices of our products or reduce our operating expenses in an amount sufficient to offset the effects future inflationary pressures may have on our gross margin. Accordingly, we cannot assure you that our financial condition and results of operations will not be materially impacted by inflation in the future.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required under this item.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Quarterly Report on Form 10-Q, management performed, with the participation of our Chief Executive Officer and Chief Financial Officer, an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed,

30

summarized, and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to management including our Chief Executive Officer and our Chief Financial Officer, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and no evaluation of controls and procedures can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025.

Changes in Internal Control over Financial Reporting

There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

31

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

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.

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.

The outcome of legal proceedings and claims brought against us are subject to significant uncertainty. If one or more of these legal matters were resolved against us in the same reporting period for amounts in excess of management’s expectations, our financial statements for such reporting period could be materially and adversely affected. In general, the resolution of a legal matter resolved against us, could also prevent us from offering our services or products to others, could be material to our financial condition or cash flows, or both, or could otherwise adversely affect our operating results.

From time to time, the Company is involved in legal proceedings related to matters, which are incidental to our business. Although the results of litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of these ordinary course matters will not have a material adverse effect on our business, but, regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

We are currently involved in a legal proceeding brought by a former employee before the court in San Antonio, Texas alleging unfair dismissal where the former employee seeks monetary damages. We dispute these allegations and intend to defend ourselves vigorously. While the outcome remains uncertain, management does not currently expect the case to have a material impact on its financial results.

For a fulsome discussion of legal proceedings, see Note 8 - “Commitment and Contingencies” in the notes to the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025. This discussion is incorporated herein by reference.

Item 1A. Risk Factors

As disclosed in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, there are a number of risks and uncertainties that may have a material effect on the operating results of our business and our financial condition. The following information updates, and should be read in conjunction with, the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and other filings we make with the Securities and Exchange Commission, which could materially affect our business, financial condition or future results. The risks described in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially and adversely affect our business, financial condition or operating results.

There have been no material changes from the risk factors disclosed in “Part I, Item 1A—Risk Factors” of our most recent Annual Report.

32

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

During the three months ended March 31, 2025, we did not have any sales of unregistered securities.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

(a)None
(b)None
(c)None of our directors or “officers,” as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K, during the fiscal quarter covered by this report.

33

Item 6. Exhibits

(a)Exhibits

3.1

Third Amended and Restated Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.1 of the Company’s 8-K filed on June 30, 2017).

3.2

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the Company’s Form 8-K filed on June 30, 2017).

31.1

Certification of Principal Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended.

31.2

Certification of Principal Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended.

32.1*

Certification of Principal Executive Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended.

32.2*

Certification of Principal Financial Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended.

101.INS

Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

Cover Page Interactive Data File – formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.

*     This certification is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except to the extent that the Registrant specifically incorporates it by reference.

34

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

PRECIPIO, INC.

Date:   May 14, 2025

By:

/S/ ILAN DANIELI

Ilan Danieli

Chief Executive Officer (Principal Executive
Officer)

Date:   May 14, 2025

By:

/S/ MATTHEW GAGE

Matthew Gage

Chief Financial Officer (Principal Financial and Accounting Officer)

35

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

I, Ilan Danieli, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of Precipio, Inc. (the Registrant);
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiary, is made known to me by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and
5.The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's board of directors (or persons performing the equivalent function):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

/s/ ILAN DANIELI

Ilan Danieli

Chief Executive Officer (Principal Executive Officer)

Date: May 14, 2025


Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

I, Matthew Gage, certify that:

1.I have reviewed this Quarterly Report on Form 10-Q of Precipio, Inc. (the Registrant);
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The Registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and we have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiary, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter (the Registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and
5.The Registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's board of directors (or persons performing the equivalent function):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

MATHEW

/s/ MATTHEW GAGE

Matthew Gage

Chief Financial Officer (Principal Financial and Accounting Officer)

Date: May 14, 2025


Exhibit 32.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350

In connection with the accompanying Quarterly Report on Form 10-Q of Precipio, Inc. for the period ended March 31, 2025, I, Ilan Danieli, Chief Executive Officer of Precipio, Inc., hereby certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:

(1)Such Quarterly Report on Form 10-Q of Precipio, Inc. for the period ended March 31, 2025, fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)The information contained in such Quarterly Report on Form 10-Q of Precipio, Inc. for the period ended March 31, 2025, fairly presents, in all material respects, the financial condition and results of operations of Precipio, Inc.

/s/ ILAN DANIELI

Ilan Danieli

Chief Executive Officer (Principal Executive Officer)

Date: May 14, 2025

A signed original of the certification required by Section 906 has been provided to Precipio, Inc. and will be retained by Precipio, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.


Exhibit 32.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350

In connection with the accompanying Quarterly Report on Form 10-Q of Precipio, Inc. for the period ended March 31, 2025, I, Matthew Gage, Chief Financial Officer of Precipio, Inc., hereby certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:

(1)Such Quarterly Report on Form 10-Q of Precipio, Inc. for the period ended March 31, 2025, fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)The information contained in such Quarterly Report on Form 10-Q of Precipio, Inc. for the period ended March 31, 2025, fairly presents, in all material respects, the financial condition and results of operations of Precipio, Inc.

/s/ MATTHEW GAGE

Matthew Gage

Chief Financial Officer (Principal Financial and Accounting Officer)

Date: May 14, 2025

A signed original of the certification required by Section 906 has been provided to Precipio, Inc. and will be retained by Precipio, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.


v3.25.1
DOCUMENT AND ENTITY INFORMATION - shares
3 Months Ended
Mar. 31, 2025
May 12, 2025
Document and Entity Information [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Mar. 31, 2025  
Document Transition Report false  
Entity File Number 001-36439  
Entity Registrant Name PRECIPIO, INC.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 91-1789357  
Entity Address, Address Line One 4 Science Park  
Entity Address, City or Town New Haven  
Entity Address, State or Province CT  
Entity Address, Postal Zip Code 06511  
City Area Code 203  
Local Phone Number 787-7888  
Title of 12(b) Security Common Stock, $0.01 par value per share  
Trading Symbol PRPO  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   1,512,011
Entity Central Index Key 0001043961  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2025  
Document Fiscal Period Focus Q1  
Amendment Flag false  
v3.25.1
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)
$ in Thousands
Mar. 31, 2025
Dec. 31, 2024
CURRENT ASSETS:    
Cash $ 1,017 $ 1,389
Accounts receivable (net of allowance for credit losses of $957 and $995, respectively) 976 799
Inventories 825 724
Other current assets 460 539
Total current assets 3,278 3,451
PROPERTY AND EQUIPMENT, NET 771 719
OTHER ASSETS:    
Finance lease right-of-use assets, net 481 517
Operating lease right-of-use assets, net 1,573 395
Intangibles, net 11,631 11,869
Other assets 51 45
Total assets 17,785 16,996
CURRENT LIABILITIES:    
Current maturities of long-term debt, less debt issuance costs 147 297
Current maturities of finance lease liabilities 123 124
Current maturities of operating lease liabilities 207 201
Accounts payable 906 618
Accrued expenses 2,659 2,799
Deferred revenue 289 232
Total current liabilities 4,331 4,271
LONG TERM LIABILITIES:    
Long-term debt, less current maturities and debt issuance costs 70 77
Finance lease liabilities, less current maturities 316 348
Operating lease liabilities, less current maturities 1,370 206
Total liabilities 6,087 4,902
COMMITMENTS AND CONTINGENCIES (Note 5)
STOCKHOLDERS' EQUITY:    
Preferred stock - $0.01 par value, 15,000,000 shares authorized at March 31, 2025 and December 31, 2024, 47 shares issued and outstanding at March 31, 2025 and December 31, 2024, liquidation preference of $37 at March 31, 2025
Common stock, $0.01 par value, 150,000,000 shares authorized at March 31, 2025 and December 31, 2024, 1,504,312 and 1,493,639 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 15 15
Additional paid-in capital 115,007 114,519
Accumulated deficit (103,324) (102,440)
Total stockholders' equity 11,698 12,094
Total liabilities and stockholders' equity $ 17,785 $ 16,996
v3.25.1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)
$ in Thousands
Mar. 31, 2025
Dec. 31, 2024
CONDENSED CONSOLIDATED BALANCE SHEETS [Abstract]    
Allowance for credit losses $ 957 $ 995
Preferred stock, par value (in dollars per share) $ 0.01 $ 0.01
Preferred stock, shares authorized (in shares) 15,000,000 15,000,000
Preferred stock, shares issued (in shares) 47 47
Preferred stock, shares outstanding (in shares) 47 47
Preferred stock, liquidation preference $ 37  
Common stock, par value (in $ per share) $ 0.01 $ 0.01
Common stock, shares authorized (in shares) 150,000,000 150,000,000
Common stock, shares issued (in shares) 1,504,312 1,493,639
Common stock, shares outstanding (in shares) 1,504,312 1,493,639
v3.25.1
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Revenue, net of contractual allowances and adjustments $ 4,911 $ 3,478
Adjustment for allowance for credit losses 18 (46)
Net sales 4,929 3,432
Total cost of sales 2,789 2,512
Gross profit 2,140 920
OPERATING EXPENSES:    
Operating expenses 2,999 2,994
OPERATING LOSS (859) (2,074)
OTHER EXPENSE:    
Interest expense, net (25) (5)
LOSS BEFORE INCOME TAXES (884) (2,079)
NET LOSS $ (884) $ (2,079)
LOSS PER COMMON SHARE, BASIC $ (0.59) $ (1.46)
LOSS PER COMMON SHARE, DILUTED $ (0.59) $ (1.46)
WEIGHTED-AVERAGE SHARES OF COMMON STOCK OUTSTANDING, BASIC 1,502,652 1,423,942
WEIGHTED-AVERAGE SHARES OF COMMON STOCK OUTSTANDING, DILUTED 1,502,652 1,423,942
Service revenue, net    
Revenue, net of contractual allowances and adjustments $ 4,257 $ 2,821
Adjustment for allowance for credit losses 18 (46)
Net sales 4,275 2,775
Total cost of sales 2,466 2,101
Product revenue    
Revenue, net of contractual allowances and adjustments 654 657
Net sales 654 657
Total cost of sales $ 323 $ 411
v3.25.1
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($)
$ in Thousands
Preferred stock
Common Stock
Additional Paid-in Capital
Accumulated Deficit
Total
Balance at beginning of period at Dec. 31, 2023   $ 14 $ 112,565 $ (98,150) $ 14,429
Balance at beginning of period (in shares) at Dec. 31, 2023 47 1,420,125      
Increase (Decrease) in Stockholders' Equity          
Net loss       (2,079) (2,079)
Issuance of common stock in connection with at the market offering, net of issuance costs     67   67
Issuance of common stock in connection with at the market offering, net of issuance costs (in shares)   10,167      
Stock-based compensation     357   357
Balance at end of period at Mar. 31, 2024   $ 14 112,989 (100,229) 12,774
Balance at end of period (in shares) at Mar. 31, 2024 47 1,430,292      
Balance at beginning of period at Dec. 31, 2024   $ 15 114,519 (102,440) 12,094
Balance at beginning of period (in shares) at Dec. 31, 2024 47 1,493,639      
Increase (Decrease) in Stockholders' Equity          
Net loss       (884) (884)
Issuance of common stock for consulting services     65   65
Issuance of common stock for consulting services (in shares)   10,673      
Stock-based compensation     423   423
Balance at end of period at Mar. 31, 2025   $ 15 $ 115,007 $ (103,324) $ 11,698
Balance at end of period (in shares) at Mar. 31, 2025 47 1,504,312      
v3.25.1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
CASH FLOWS FROM OPERATING ACTIVITIES:    
Net loss $ (884) $ (2,079)
Adjustments to reconcile net loss to net cash flows used in operating activities:    
Depreciation and amortization 324 304
Amortization of operating lease right-of-use asset 57 56
Amortization of finance lease right-of-use asset 36 18
Stock-based compensation 423 357
Value of stock issued in payment of Board fees and consulting services 65  
Provision for credit losses (38) 83
Derecognition of operating lease right-of-use asset and liability (11)  
Changes in operating assets and liabilities:    
Accounts receivable (139) 312
Inventories (101) (148)
Other assets 73 126
Accounts payable 288 283
Operating lease liabilities (54) (57)
Deferred revenue 57 83
Accrued expenses (140) (5)
Net cash used in operating activities (44) (667)
CASH FLOWS FROM INVESTING ACTIVITIES:    
Purchase of property and equipment (138)  
Net cash used in investing activities (138)  
CASH FLOWS FROM FINANCING ACTIVITIES:    
Principal payments on finance lease obligations (33) (17)
Issuance of common stock, net of issuance costs   67
Principal payments on long-term debt (157) (109)
Net cash flows used in financing activities (190) (59)
NET CHANGE IN CASH (372) (726)
CASH AT BEGINNING OF PERIOD 1,389 1,502
CASH AT END OF PERIOD 1,017 776
SUPPLEMENTAL CASH FLOW INFORMATION    
Cash paid during the period for interest 30 9
SUPPLEMENTAL DISCLOSURE OF CONSULTING SERVICES OR ANY OTHER NON-CASH COMMON STOCK RELATED ACTIVITY    
Operating lease right-of-use assets obtained in exchange for operating lease obligations $ 1,237 $ 0
v3.25.1
BUSINESS DESCRIPTION
3 Months Ended
Mar. 31, 2025
BUSINESS DESCRIPTION [Abstract]  
BUSINESS DESCRIPTION

1. BUSINESS DESCRIPTION

Business Description.

Precipio, Inc., and its subsidiaries, (collectively, “we”, “us”, “our”, the “Company” or “Precipio”) is a healthcare biotechnology company focused on cancer diagnostics. Our mission is to address the pervasive problem of cancer misdiagnoses by developing solutions in the form of diagnostic products and services.

Our products and services aim to deliver higher accuracy, improved laboratory workflow, and ultimately better patient outcomes, which reduce healthcare expenses. We develop innovative technologies in our laboratory where we design, test, validate, and use these products clinically. We believe these technologies improve diagnostic outcomes across various diseases within the hematologic field. We then commercialize these technologies as proprietary products that serve the global laboratory community in furtherance of our mission to eliminate or greatly reduce the prevalence of misdiagnosis. To deliver our strategy, we have structured our organization to develop diagnostic products, including our laboratory and research and development (“R&D”) facilities located in New Haven, Connecticut and Omaha, Nebraska, respectively, which house teams that collaborate on the development of new products and services. We operate clinical laboratory improvement amendment (“CLIA”) laboratories in both New Haven, Connecticut and Omaha, Nebraska where we provide 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 laboratories to support R&D beta-testing of the products we develop, in a clinical environment.

The development of laboratory products involves a qualified facility; highly skilled laboratory staff; and access to viable patient specimens to conduct development and testing. Our CLIA laboratory in New Haven, which is operated by our pathology services division, encapsulates these components, and also generates revenue for us which covers costs associated with operating this laboratory. This structure of utilizing our clinical lab to obtain samples and utilize the equipment and staffing to develop, test and validate our products, significantly reduces the development costs and timeline for our products. This also enables us to accelerate the time to market of new product development and launch.

Furthermore, as a clinical laboratory, we are always the first user of every product we develop, which allows us to optimize important laboratory functions such as workflow, inventory management, regulatory and billing issues. As a vendor, this enables us to serve as a reputable user of our own products, and we believe this provides us with significant credibility with existing and prospective customers. Furthermore, because we use our products as part of our day-to-day operations, we are able to deliver a high level of hands-on, informed support to customers, improving their experience with our products.

Our Products Division commercial team generates direct sales and works with our key distributors. Global healthcare distributors, such as ThermoFisher, McKesson, Medline and Cardinal Health, have partnered with us to form the backbone of our go-to-market strategy and enable us to access laboratories around the country that can benefit from using our diagnostic products.

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

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 and do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company has incurred substantial operating losses and has used cash in its operating activities for the past several years. For the three months ended March

31, 2025, the Company had a net loss of $0.9 million and net cash used in operating activities of $0.1 million. As of March 31, 2025, the Company had an accumulated deficit of $103.3 million and a working capital deficit of $1.1 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 business plan, including generating additional revenue and avoiding potential business disruption due to the macroeconomic environment and geopolitical instability, and raising additional financing, if needed, 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 its business:

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 U.S. Securities and Exchange Commission (“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. On April 8, 2024, we filed a prospectus supplement to our prospectus dated April 25, 2023 registering the offer and sale of up to $1,061,478 of shares of our common stock (the “April 2024 Prospectus Supplement”). As of the date the condensed consolidated financial statements were issued, the Company has approximately $3.7 million available for future sales pursuant to the 2023 Registration Statement, which includes approximately $1.0 million of remaining availability pursuant to the April 2024 Prospectus Supplement. See Note 7 Stockholders’ Equity, AGP 2023 Sales Agreement, 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.

v3.25.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3 Months Ended
Mar. 31, 2025
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation.

The accompanying condensed consolidated financial statements are presented in conformity with GAAP and, as of March 31, 2025 and for the three months ended March 31, 2025 and 2024, 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, 2024 contained in our Annual Report on Form 10-K, filed with the SEC on March 27, 2025. The results of operations for the interim periods presented are not necessarily indicative of the results for fiscal year 2025.

Recent Accounting Pronouncements Not Yet Adopted.

In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”) which amends the Codification to enhance the transparency and decision usefulness of income tax disclosures. ASU 2023-09 requires additional disaggregation of the reconciliation between the statutory and effective tax rate for an entity and of income taxes paid, both of which are disclosures required by current GAAP. The amendments improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. The amendments in ASU 2023-09 apply to all entities that are subject to Topic 740, Income Taxes. For public business entities, the amendments in ASU 2023-09 are effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The enhanced disclosures required by ASU 2023-09 will be included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. The Company is currently evaluating the impact of this standard on its annual disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income (Topic 220): Expense Disaggregation Disclosures (ASU 2024-03”). This update requires entities to disaggregate operating expenses into specific categories, such as purchases of inventory, compensation, depreciation, and amortization, to provide enhanced transparency into the nature and function of expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, with early adoption permitted. ASU 2024-03 may be applied retrospectively or prospectively. The Company is currently evaluating the impact of this standard on its financial statement presentation and disclosures.

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 831,501 and 695,550 shares of our common stock have been excluded from the computation of diluted loss per share at March 31, 2025 and 2024, 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:

March 31, 

    

2025

    

2024

Stock options

 

381,182

 

230,140

Warrants

 

444,444

 

459,535

Preferred stock

 

5,875

 

5,875

Total

 

831,501

 

695,550

v3.25.1
LONG-TERM DEBT
3 Months Ended
Mar. 31, 2025
LONG-TERM DEBT [Abstract]  
LONG-TERM DEBT

3. LONG-TERM DEBT

Long-term debt consists of the following:

Dollars in Thousands

    

March 31, 2025

    

December 31, 2024

Connecticut Department of Economic and Community Development (DECD)

$

108

$

115

DECD debt issuance costs

 

(9)

 

(9)

Financed insurance loan

 

89

 

177

Business loan agreement

29

91

Total long-term debt

 

217

 

374

Current portion of long-term debt

 

(147)

 

(297)

Long-term debt, net of current maturities

$

70

$

77

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 March 31, 2025 and 2024, respectively.

Financed Insurance Loan.

The Company finances certain of its insurance premiums (the “Financed Insurance Loans”). In July 2024, the Company financed $0.3 million with a 9.99% interest rate and is obligated to make payments on a monthly basis through June 2025. As of March 31, 2025 and December 31, 2024, the Financed Insurance Loan’s outstanding balance of $0.1 million and $0.2 million, respectively, was included in current maturities of long-term debt in the Company’s condensed consolidated balance sheets. A corresponding prepaid asset was included in other current assets.

Business Loan Agreement.

On May 1, 2024, the Company entered into a Business Loan and Security Agreement (the “Loan Agreement”) with Altbanq Lending LLC, pursuant to which the Company obtained a loan in the principal amount of $250,000 (the “Secured Loan”). According to the Loan Agreement, the Company granted the lender a continuing security interest in certain collateral (as defined in the Loan Agreement). Furthermore, the Company’s Chief Executive Officer provided a personal guaranty for the Secured Loan. The Secured Loan has a term of one year and an interest rate of 20%, such that pursuant to the Loan Agreement, the Company is obligated to pay the Lender 52 payments of $5,769 on a weekly basis and the total sum of the Secured Loan and interest (not including any fees) shall equal a total repayment amount of $300,000. If the Company defaults on payments then a default fee of $15,000 shall be payable to the lender.

 

The Company has the right, at its discretion, to request the lender to loan an additional amount of up to $250,000 on the same terms and conditions as set forth in the Loan Agreement, provided that there has been no material change in the Company’s finances.

As of March 31, 2025 and December 31, 2024, the outstanding balance of less than $0.1 million and $0.1 million, respectively, under the Loan Agreement, was included in current maturities of long-term debt in the Company’s condensed consolidated balance sheets.

v3.25.1
ACCRUED EXPENSES
3 Months Ended
Mar. 31, 2025
ACCRUED EXPENSES [Abstract]  
ACCRUED EXPENSES

4. ACCRUED EXPENSES

Accrued expenses at March 31, 2025 and December 31, 2024 are as follows:

(dollars in thousands)

    

March 31, 2025

    

December 31, 2024

Accrued expenses

$

396

$

595

Accrued compensation

 

1,038

 

955

Accrued franchise, property and sales and use taxes

195

173

CHC temporary funding assistance

1,011

1,057

Accrued interest

 

19

 

19

$

2,659

$

2,799

The Company uses Change Healthcare (“CHC”), a healthcare technology company owned by UnitedHealth Group, to process some of its patient claims billings. In February 2024, CHC announced that it had experienced a cyberattack and as a result had to temporarily shut down some of its information technology systems. This system shut down caused delays in billing and reimbursement processes to CHC’s customers and, as a result, CHC established a Temporary Funding Assistance Program to help bridge the gap in short-term cash flow needs for customers affected by the disruption of its services due to the cyberattack. Funding distributed through this program is interest free and has no other fees or costs associated with it.  

During the year ended December 31, 2024, the Company received approximately $1.1 million through CHC’s Temporary Assistance Program. On October 28, 2024, the Company received a notice from CHC stating that they have restored the connectivity of their systems and are requesting repayment of the funds the Company received through the Temporary Assistance Program. The repayment date contained in the notice is January 2, 2025.

From January 1, 2025 through the date of issuance of this Quarterly Report on Form 10-Q, we have made approximately $0.2 million in repayments to CHC and written off another $0.1 million, leaving a balance of approximately $0.8 million. The Company will make equal monthly payments of approximately $83,000 from May 2025 to January 2026 to settle this balance.

v3.25.1
COMMITMENTS AND CONTINGENCIES
3 Months Ended
Mar. 31, 2025
COMMITMENTS AND CONTINGENCIES [Abstract]  
COMMITMENTS AND CONTINGENCIES

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 2031. 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 $2.7 million at March 31, 2025.

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 March 31, 2025 and December 31, 2024.

The Company is currently involved in a legal proceeding brought by a former employee before the court in San Antonio, Texas alleging unfair dismissal where the former employee seeks monetary damages. The Company disputes these allegations and intends to defend itself vigorously. While the outcome remains uncertain, management does not currently expect the case to have a material impact on its financial results.

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.

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.

v3.25.1
LEASES
3 Months Ended
Mar. 31, 2025
LEASES [Abstract]  
LEASES

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 months ended March 31, 2025 and 2024, 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 less than $0.1 million as of March 31, 2025 and December 31, 2024, respectively, and is included in other current assets and other assets in our condensed consolidated balance sheets.

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

(dollars in thousands)

Classification on the Condensed Consolidated Balance Sheet

March 31, 2025

December 31, 2024

Assets:

Operating lease right-of-use assets, net

$

1,573

$

395

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

481

517

Total lease assets

$

2,054

$

912

Liabilities:

Current:

Current maturities of operating lease liabilities

$

207

$

201

Current maturities of finance lease liabilities

123

124

Noncurrent:

Operating lease liabilities, less current maturities

1,370

206

Finance lease liabilities, less current maturities

316

348

Total lease liabilities

$

2,016

$

879

(1)As of March 31, 2025 and December 31, 2024, finance lease right-of-use assets included zero, respectively, of assets related to finance leases associated with the HSRR program.

As of March 31, 2025, the estimated future minimum lease payments, excluding non-lease components, are as follows:

(dollars in thousands)

    

Operating Leases

Finance Leases

Total

March 31,

March 31,

March 31,

2025

2025

2025

2025 (remaining)

$

265

$

125

$

390

2026

 

350

 

133

 

483

2027

 

395

 

107

 

502

2028

 

429

67

 

496

2029

461

38

499

Thereafter

 

130

 

73

 

203

Total lease obligations

 

2,030

 

543

 

2,573

Less: Amount representing interest

 

(453)

 

(104)

 

(557)

Present value of net minimum lease obligations

 

1,577

 

439

 

2,016

Less, current portion

 

(207)

 

(123)

 

(330)

Long term portion

$

1,370

$

316

$

1,686

Other information as of March 31, 2025 and December 31, 2024 is as follows:

March 31,

December 31,

2025

2024

Weighted-average remaining lease term (years):

Operating leases

5.1

1.9

Finance leases

4.4

4.4

Weighted-average discount rate:

Operating leases

9.99%

8.00%

Finance leases

11.02%

11.20%

During the three months ended March 31, 2025 and 2024, operating cash flows from operating leases was $0.1 million, respectively, and operating lease ROU assets obtained in exchange for operating lease liabilities was $1.2 million and zero, respectively.

During the three months ended March 31, 2025 and 2024, there were no finance lease ROU assets obtained in exchange for finance lease liabilities.

Operating Lease Costs

Operating lease costs were approximately $0.1 million during the three months ended March 31, 2025 and 2024, respectively. These costs are primarily related to long-term operating leases for the Company’s facilities and laboratory equipment. Short-term and variable lease costs were less than $0.1 million for the three months ended March 31, 2025 and 2024, respectively.

Finance Lease Costs

Finance lease amortization and interest expenses are included in the condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024. The balances within these accounts are less than $0.1 million, respectively.

v3.25.1
STOCKHOLDERS' EQUITY
3 Months Ended
Mar. 31, 2025
STOCKHOLDERS' EQUITY [Abstract]  
STOCKHOLDERS' EQUITY

7. STOCKHOLDERS’ EQUITY

Common Stock.

Pursuant to our Third Amended and Restated Certificate of Incorporation, as amended, we currently have 150,000,000 shares of common stock authorized for issuance. On December 20, 2018, the Company’s shareholders approved the proposal to authorize the Company’s Board of Directors to, in its discretion, amend the Company’s Third Amended and Restated Certificate of Incorporation to increase the total number of authorized shares of common stock from 150,000,000 shares to 250,000,000 shares. The Company has not yet implemented this increase.

During the three months ended March 31, 2025, the Company issued 10,673 shares of its common stock in connection with consulting services of approximately $0.1 million.

At The Market Offering Agreement

AGP 2023 Sales Agreement

On April 14, 2023, the Company entered into a sales agreement (the “AGP 2023 Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP), in an “at the market offering” (as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended) of the shares of Common Stock. AGP will be entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares of Common Stock pursuant to the AGP 2023 Sales Agreement.

The sales of our shares of Common Stock to or through AGP, pursuant to the AGP 2023 Sales Agreement, are made pursuant to 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, for an aggregate offering price of up to $5.8 million.

On April 8, 2024, we filed a prospectus supplement (the “April 2024 Prospectus Supplement”) to our prospectus dated April 25, 2023 registering the offer and sale of up to $1,061,478 of shares of our common stock.

During the three months ended March 31, 2025 and 2024, we received net proceeds of zero and $0.1 million, respectively, from the sale of zero and 10,167 shares of common stock, respectively, pursuant to the AGP 2023 Sales Agreement.

As of the date of issuance of this Quarterly Report on Form 10-Q, we have received an aggregate of $0.1 million in net proceeds, after issuance costs of approximately $2 thousand, from the sales of 11,847 shares of common stock

through AGP. We have approximately $1.0 million of remaining availability pursuant to the 2024 Prospectus Supplement and 43.7 million of remaining availability under the 2023 Registration Statement.

Preferred Stock.

The Company’s Board of Directors is authorized to issue up to 15,000,000 shares of preferred stock in one or more series, from time to time, with such designations, powers, preferences and rights and such qualifications, limitations and restrictions as may be provided in a resolution or resolutions adopted by the Board of Directors.

Series B Preferred Stock.

The Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (“Series B Preferred Stock”) with the State of Delaware, which designates 6,900 shares of our preferred stock as Series B Preferred Stock. The Series B Preferred Stock has a stated value of $1 thousand per share and a par value of $0.01 per share. The Series B Preferred Stock includes a beneficial ownership blocker but has no dividend rights (except to the extent dividends are also paid on the common stock). On August 28, 2017, the Company completed an underwritten public offering consisting of the Company’s Series B Preferred Stock and warrants.

The conversion price of the Series B Preferred Stock contains a down round feature. The Company will recognize the effect of the down round feature when it is triggered. At that time, the effect would be treated as a deemed dividend and as a reduction of income available to common shareholders in our basic earnings per share calculation.

There were no conversions of Series B Preferred Stock during the three months ended March 31, 2025 and 2024, respectively. At March 31, 2025 and December 31, 2024, the Company had 6,900 shares of Series B Preferred Stock designated and issued and 47 shares of Series B Preferred Stock outstanding. Based on the stated value of $1 thousand per share and a conversion price of $8.00 per share, the outstanding shares of Series B Preferred Stock at March 31, 2025 were convertible into 5,875 shares of common stock.

Common Stock Warrants.

The following represents a summary of the warrants outstanding as of March 31, 2025:

    

    

    

Underlying

    

Exercise

Issue Year

Expiration

Shares 

Price

Warrants

(1)

2023

December 2028

444,444

$

12.60

(1) These warrants were issued in connection with a June 8, 2023 registered direct offering (the “Registered Direct Offering”) and concurrent private placement and are the RDO common warrants discussed below.

RDO Common Warrants. In connection with the Registered Direct Offering and concurrent private placement in June 2023, the Company issued 444,444 RDO Common Warrants to purchase up to 444,444 shares of Common Stock. The RDO Common Warrants are exercisable beginning six months after the date of issuance, have an exercise price of $12.60 per share, and will expire December 12, 2028.

v3.25.1
FAIR VALUE
3 Months Ended
Mar. 31, 2025
FAIR VALUE [Abstract]  
FAIR VALUE

8. FAIR VALUE

FASB guidance on fair value measurements, which defines fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements for our financial assets and liabilities, as well as for other assets and liabilities that are carried at fair value on a recurring basis in our condensed consolidated financial statements.

FASB guidance establishes a three-level fair value hierarchy based upon the assumptions (inputs) used to price assets or liabilities. The three levels of inputs used to measure fair value are as follows:

Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities;

Level 2—Observable inputs other than those included in Level 1, such as quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets or liabilities in inactive markets; and

Level 3—Unobservable inputs reflecting our own assumptions and best estimate of what inputs market participants would use in pricing the asset or liability.

Common Stock Warrant Liabilities.

Certain of our issued and outstanding warrants to purchase shares of common stock do not qualify to be treated as equity and, accordingly, are recorded as a liability. We are required to record these instruments at fair value at each reporting date and changes are recorded as a non-cash adjustment to earnings. The gains or losses included in earnings are reported in other income (expense) in our condensed consolidated statements of operations.

Bridge Note Warrant Liabilities

During 2018 and 2019, the Company issued warrants in connection with the issuance of convertible notes. All of these warrants issuances were classified as warrant liabilities (the “Bridge Note Warrant Liabilities”).

The Bridge Note Warrant Liabilities are considered Level 3 financial instruments and were valued using the Black Scholes model. During the year ended December 31, 2024, the last remaining warrants related to Bridge Note Warrant Liabilities expired and thus at March 31, 2025 and December 31, 2024, there were no warrant liabilities to be valued.

During the three months ended March 31, 2024, the changes in the fair value of the warrant liabilities measured using significant unobservable inputs (Level 3) were zero.

v3.25.1
EQUITY INCENTIVE PLAN
3 Months Ended
Mar. 31, 2025
EQUITY INCENTIVE PLAN [Abstract]  
EQUITY INCENTIVE PLAN

9. EQUITY INCENTIVE PLAN

The Company currently issues stock awards under its 2017 Stock Option and Incentive Plan, as amended (the “2017 Plan”) which will expire on June 5, 2027. The shares authorized for issuance under the 2017 Plan were 395,380 at March 31, 2025, of which 11,637 were available for future grant. The shares authorized under the 2017 Plan are subject to annual increases on January 1 by 5% of the number of shares of common stock issued and outstanding on the immediately preceding December 31, or such lessor number of shares determined by the Company’s Board of Directors or Compensation Committee. During the three months ended March 31, 2025, the shares authorized for issuance increased by 74,681 shares.

Stock Options.

The Company accounts for all stock-based compensation payments to employees and directors, including grants of employee stock options, at fair value at the date of grant and expenses the benefit in operating expense in the condensed consolidated statements of operations over the service period of the awards. The Company records the expense for stock-based compensation awards subject to performance-based milestone vesting over the remaining service period when management determines that achievement of the milestone is probable based on the expected satisfaction of the performance conditions as of the reporting date. The Company records the expense for stock-based compensation awards subject to market-condition vesting over a derived service period which is calculated at the grant date. The fair value of each stock option granted is estimated on the date of grant using the Black-Scholes or other option pricing models, which requires various assumptions including estimating stock price volatility, expected life of the stock option, risk free interest rate and estimated forfeiture rate.

During the three months ended March 31, 2025, the Company granted stock options to purchase up to 77,500 shares of common stock at a weighted average exercise price of $6.06 per share. The stock options granted have either time-based or market-condition vesting.

The awards with time-based vesting have vesting periods of up to four years and had grant date fair values between $5.24 and $5.46. The fair value was calculated using the Black-Scholes option pricing model and used the following assumptions: risk free interest rate of 4.60% to 4.65%, based on the U.S. Treasury yield in effect at the time of grant; expected life of five to six years; and volatility of 124% to 128% based on historical volatility of the Company’s common stock over a time that is consistent with the expected life of the option.

The awards with market-condition vesting have a derived service period of 1.6 years and had a grant date fair value of $5.70. The fair value was calculated using a Monte Carlo Simulation and used the following assumptions: risk free interest rate of 4.67%; remaining term of ten years; and volatility of 121%.

The following table summarizes stock option activity under our plans during the three months ended March 31, 2025:

    

Number of

    

Weighted-Average

Options

Exercise Price

Outstanding at January 1, 2025

 

303,932

$

7.18

Granted

 

77,500

 

6.06

Forfeited

 

(250)

 

6.06

Outstanding at March 31, 2025

 

381,182

$

6.96

Exercisable at March 31, 2025

 

208,034

$

7.51

As of March 31, 2025, there were 337,895 options that were vested or expected to vest with aggregate intrinsic value of $0.1 million and a remaining weighted average contractual life of 7.1 years.

Restricted Stock Awards.

Restricted stock awards are subject to vesting restrictions. If a grantee’s service with the Company is terminated prior to vesting of the restricted stock, all unvested shares shall be forfeited and returned to the Company. Upon vesting, the restricted stock award shall no longer be deemed restricted.

As of March 31, 2025 and December 31, 2024, there were 2,492 and zero restricted stock awards that were vested and unvested, respectively.

There were no restricted stock awards granted during the three months ended March 31, 2025 and 2024, respectively.

Stock Compensation.

For the three months ended March 31, 2025 and 2024, we recorded non-cash stock-based compensation expense for all stock awards of $0.4 million, respectively, within operating expense in the accompanying statements of operations. As of March 31, 2025, the unrecognized compensation expense related to unvested stock awards was $1.4 million, which is expected to be recognized over a weighted-average period of 1.7 years.

v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE
3 Months Ended
Mar. 31, 2025
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE [Abstract]  
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE

10. SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE

ASC Topic 606, “Revenue from contracts with customers”

The Company follows the guidance of ASC 606 for the recognition of revenue from contracts with customers to transfer goods and services. The Company performed a comprehensive review of its existing revenue arrangements following the five-step model:

Step 1: Identification of the contract with the customer.  Sub-steps include determining the customer in a contract, initial contract identification and determining if multiple contracts should be combined and accounted for as a single transaction.  

Step 2: Identify the performance obligation in the contract.  Sub-steps include identifying the promised goods and services in the contract and identifying which performance obligations within the contract are distinct.

Step 3: Determine the transaction price.  Sub-steps include variable consideration, constraining estimates of variable consideration, the existence of a significant financing component in the contract, noncash consideration and consideration payable to a customer.

Step 4: Allocate transaction price.  Sub-steps include assessing the amount of consideration to which the Company expects to be entitled in exchange for transferring the promised goods or services to the customer.

Step 5: Satisfaction of performance obligations.  Sub-steps include ascertaining the point in time when an asset is transferred to the customer and when the customer obtains control of the asset upon which time the Company recognizes revenue.

Nature of Contracts and Customers

The Company’s contracts and related performance obligations are similar for its customers and the sales process for all customers starts upon the receipt of requisition forms from the customers for patient diagnostic testing and the execution of contracts for biomarker testing and clinical research.  Payment terms for the services provided are 30 days, unless separately negotiated.

Diagnostic testing

Control of the laboratory testing services is transferred to the customer at a point in time. As such, the Company recognizes revenue for laboratory testing services at a point in time based on the delivery method (web-portal access or fax) for the patient’s laboratory report, per the contract.

Clinical research grants

Control of the clinical research services are transferred to the customer over time. The Company will recognize revenue utilizing the “effort based” method, measuring its progress toward complete satisfaction of the performance obligation.

Biomarker testing and clinical project services

Control of the biomarker testing and clinical project services are transferred to the customer over time.  The Company utilizes an “effort based” method of assessing performance and measures progress towards satisfaction of the performance obligation based upon the delivery of results.

The Company generates revenue from the provision of diagnostic testing provided to patients, biomarker testing provided to bio-pharma customers and clinical research grants funded by both bio-pharma customers and government health programs.

Reagents and other diagnostic products

Control of reagents and other diagnostic products are transferred to the customer at a point in time and, as such, the Company recognizes these revenues at a point in time based on the delivery method. These revenues include revenues from reagent sets for our HSRR program and other product sales and are included in product revenue in our condensed consolidated statements of operations.

Disaggregation of Revenues by Transaction Type

We operate in one business segment and, therefore, the results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Service revenue, net for the three months ended March 31, 2025 and 2024 was as follows:

For the Three Months Ended March 31, 

(dollars in thousands)

Diagnostic Testing

    

2025

    

2024

Medicaid

$

5

$

5

Medicare

 

1,904

 

1,091

Self-pay

 

5

 

18

Third party payers

 

2,325

 

1,705

Contract diagnostics and other

 

18

 

2

Service revenue, net

$

4,257

$

2,821

Revenue from the Medicare and Medicaid programs account for a portion of the Company’s patient diagnostic service revenue. Laws and regulations governing those programs are extremely complex and subject to interpretation. As a result, there is at least a reasonable possibility that recorded estimates will change by a material amount in the near term.

Revenue Recognition

Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the expected value method based on historical experience. The Company does not typically enter arrangements where multiple contracts can be combined as the terms regarding services are generally found within a single agreement/requisition form. The Company derives its revenues from the following types of transactions: diagnostic testing (“Diagnostic”), revenues from the Company’s ICP technology and bio-pharma projects encompassing genetic diagnostics (collectively “Biomarker”), revenues from clinical research grants from state and federal research programs and diagnostic product sales, including revenues from equipment leases and reagent sales associated with our HSRR program.

Deferred revenue

Deferred revenue, or unearned revenue, refers to advance payments for products or services that are to be delivered in the future. The Company records such prepayment of unearned revenue as a liability, as revenue that has not yet been earned, but represents products or services that are owed to a customer. As the product or service is delivered over time, the Company recognizes the appropriate amount of revenue from deferred revenue. For the periods ended March 31, 2025 and December 31, 2024, the deferred revenue was $0.3 million and $0.2 million, respectively.

Contractual Allowances and Adjustments

We are reimbursed by payers for services we provide. Payments for services covered by payers average less than billed charges. We monitor revenue and receivables from payers and record an estimated contractual allowance for certain revenue and receivable balances as of the revenue recognition date to properly account for anticipated differences between amounts estimated in our billing system and amounts ultimately reimbursed by payers. Accordingly, the total revenue and receivables reported in our condensed consolidated financial statements are recorded at the amounts expected to be received from these payers. For service revenue, the contractual allowance is estimated based on several criteria, including unbilled claims, historical trends based on actual claims paid, current contract and reimbursement terms and changes in customer base and payer/product mix. The billing functions for the remaining portion of our revenue are contracted and fixed fees for specific services and are recorded without an allowance for contractual discounts. The following table presents our revenues initially recognized for each associated payer class during the three months ended March 31, 2025 and 2024.

For the Three Months Ended March 31, 

(dollars in thousands)

Contractual Allowances and

Revenues, net of Contractual

Gross Revenues

adjustments

Allowances and adjustments

    

2025

    

2024

    

2025

    

2024

    

2025

    

2024

Medicaid

$

5

$

5

$

$

$

5

$

5

Medicare

 

1,904

 

1,091

 

 

 

1,904

 

1,091

Self-pay

 

5

 

18

 

 

 

5

 

18

Third party payers

 

8,138

 

5,968

 

(5,813)

 

(4,263)

 

2,325

 

1,705

Contract diagnostics and other

 

18

 

2

 

 

 

18

 

2

 

10,070

 

7,084

 

(5,813)

 

(4,263)

 

4,257

 

2,821

Product

 

654

 

657

 

 

 

654

 

657

$

10,724

$

7,741

$

(5,813)

$

(4,263)

$

4,911

$

3,478

Allowance for Credit Losses

The Company provides for a general allowance for collectability of services when recording net sales. The Company has adopted the policy of recognizing net sales to the extent it expects to collect that amount. Reference is made to FASB 954-605-45-5 and ASU 2011-07, Health Care Entities: Presentation and Disclosure of Patient Service Revenue, Provision for Credit Loss, and the Allowance for Credit Losses. The change in the allowance for credit losses is directly related to the increase in patient service revenues. The following table presents our reported revenues net of the collection allowance and adjustments for the three months ended March 31, 2025 and 2024.

For the Three Months Ended March 31, 

Revenues, net of

 

(dollars in thousands)

Contractual Allowances

Allowances for credit

 

and adjustments

losses

Total

    

2025

    

2024

    

2025

    

2024

    

2025

    

2024

Medicaid

$

5

$

5

$

18

$

(2)

$

23

$

3

Medicare

 

1,904

 

1,091

 

 

(16)

 

1,904

 

1,075

Self-pay

 

5

 

18

 

 

(2)

 

5

 

16

Third party payers

 

2,325

 

1,705

 

 

(26)

 

2,325

 

1,679

Contract diagnostics and other

 

18

 

2

 

 

 

18

 

2

 

4,257

 

2,821

 

18

 

(46)

 

4,275

 

2,775

Product

 

654

 

657

 

 

 

654

 

657

$

4,911

$

3,478

$

18

$

(46)

$

4,929

$

3,432

Costs to Obtain or Fulfill a Customer Contract

Sales commissions are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in operating expenses in the condensed consolidated statements of operations.

Shipping and handling costs are comprised of inbound and outbound freight and associated labor. The Company accounts for shipping and handling activities related to contracts with customers as fulfillment costs which are included in cost of sales in the condensed consolidated statements of operations.

Accounts Receivable

The Company has provided an allowance for potential credit losses, which has been determined based on management’s industry experience. The Company grants credit without collateral to its patients, most of who are insured under third party payer agreements.

The following summarizes the mix of receivables outstanding related to payer categories:

(dollars in thousands)

    

March 31, 2025

    

December 31, 2024

Medicaid

$

5

$

(12)

Medicare

 

1,291

 

1,086

Self-pay

 

15

 

13

Third party payers

 

534

 

530

Contract diagnostic services, product and other

 

88

 

177

$

1,933

$

1,794

Less allowance for credit losses

 

(957)

 

(995)

Accounts receivable, net

$

976

$

799

The following table presents the roll-forward of the allowance for credit losses for the three months ended March 31, 2025.

    

Three Months Ended March 31,

(dollars in thousands)

2025

2024

Balance, January 1

 

$

(995)

$

(2,572)

Provision for credit losses:

 

  

  

Medicaid

18

(2)

Medicare

 

 

(16)

Self-pay

(2)

Third party payers

 

 

(26)

 

18

 

(46)

Credit loss income (expense)

20

(37)

Total charges

 

38

 

(83)

Balance, December 31

$

(957)

$

(2,655)

Customer Revenue and Accounts Receivable Concentration

Our customers are oncologists, hospitals, reference laboratories, physician-office laboratories, and pharma and biotech companies. Customers that accounted for 10% or greater of our net sales or accounts receivable for the identified periods is as follows:

Net sales

Accounts receivable, as of

Three Months Ended

March 31,

March 31,

December 31,

2025

2024

2025

2024

Customer A

*

11

%

*

*

Customer B

*

10

%

*

*

Customer C

26

%

*

34

%

29

%

* represents less than 10%

v3.25.1
SEGMENT REPORTING
3 Months Ended
Mar. 31, 2025
SEGMENT REPORTING  
SEGMENT REPORTING

11. SEGMENT REPORTING

The Company’s chief operating decision maker (the “CODM”) is its Chief Executive Officer. The Company has no segment managers who are held accountable by the CODM for operations, operating results, and planning for levels or components below the consolidated unit level. Accordingly, the Company has determined it has a single operating segment.

The CODM uses consolidated net loss for purposes of allocating resources and assessing segment performance, including monitoring actual results versus historical periods. Cost of revenue and operating expenses are considered significant segment expenses that are regularly provided to the CODM and included within consolidated net loss. The measure of segment assets is the total assets on the Company’s condensed consolidated balance sheets. Capital expenditures are reported on a consolidated basis on the Company’s condensed consolidated statements of cash flows. The following table includes the Company's segment revenue, significant segment expenses, and other segment items to reconcile to net loss.

Dollars in Thousands

Three Months Ended

March 31, 

    

2025

    

2024

Net sales

$

4,929

$

3,432

Less expense (income):

Cost of sales

 

2,789

 

2,512

Operating expenses (1)

2,999

2,994

Other segment items (2)

 

25

 

5

Net loss

$

(884)

$

(2,079)

(1) Operating expenses include sales and marketing expenses, general and administrative expenses, research and development expenses and stock-based compensation.

(2) Other segment items include interest income, interest expense, gain on write-off of liability and other income.

v3.25.1
SUBSEQUENT EVENTS
3 Months Ended
Mar. 31, 2025
SUBSEQUENT EVENTS  
SUBSEQUENT EVENTS

12. SUBSEQUENT EVENTS

The Company has evaluated events and transactions subsequent to March 31, 2025 through the date of this Quarterly Report on Form 10-Q, and any material subsequent events are reported below.

On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Under the provisions of the CARES Act, and the subsequent extensions, the Company became eligible to apply for a refundable Employee Retention Credit (the “ERC”) subject to certain criteria, which could be used to offset payroll tax liabilities.

In November 2022, the Company submitted an ERC claim totaling approximately $1.5 million. In April 2025, the Company received an initial payment of approximately $0.4 million. The Company anticipates recording this amount as other income in the condensed consolidated statements of operations for the second quarter 2025.

The Company retains all rights to pursue and receive the remaining balance of approximately $1.1 million and is actively evaluating the likelihood and timing of any additional disbursements. The Company has not waived any claims to the unpaid portion of the ERC and is taking reasonable steps to secure the remaining balance. However, there can be no assurance as to the timing, amount, or certainty of receipt of additional funds, and the Company will continue to assess the collectability of the remaining claim in accordance with applicable accounting standards.

v3.25.1
Insider Trading Arrangements
3 Months Ended
Mar. 31, 2025
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.25.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
3 Months Ended
Mar. 31, 2025
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Basis of Presentation

Basis of Presentation.

The accompanying condensed consolidated financial statements are presented in conformity with GAAP and, as of March 31, 2025 and for the three months ended March 31, 2025 and 2024, 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, 2024 contained in our Annual Report on Form 10-K, filed with the SEC on March 27, 2025. The results of operations for the interim periods presented are not necessarily indicative of the results for fiscal year 2025.

Recent Accounting Pronouncements Not Yet Adopted

Recent Accounting Pronouncements Not Yet Adopted.

In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”) which amends the Codification to enhance the transparency and decision usefulness of income tax disclosures. ASU 2023-09 requires additional disaggregation of the reconciliation between the statutory and effective tax rate for an entity and of income taxes paid, both of which are disclosures required by current GAAP. The amendments improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. The amendments in ASU 2023-09 apply to all entities that are subject to Topic 740, Income Taxes. For public business entities, the amendments in ASU 2023-09 are effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The enhanced disclosures required by ASU 2023-09 will be included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. The Company is currently evaluating the impact of this standard on its annual disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income (Topic 220): Expense Disaggregation Disclosures (ASU 2024-03”). This update requires entities to disaggregate operating expenses into specific categories, such as purchases of inventory, compensation, depreciation, and amortization, to provide enhanced transparency into the nature and function of expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, with early adoption permitted. ASU 2024-03 may be applied retrospectively or prospectively. The Company is currently evaluating the impact of this standard on its financial statement presentation and disclosures.

Loss Per Share

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 831,501 and 695,550 shares of our common stock have been excluded from the computation of diluted loss per share at March 31, 2025 and 2024, 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:

March 31, 

    

2025

    

2024

Stock options

 

381,182

 

230,140

Warrants

 

444,444

 

459,535

Preferred stock

 

5,875

 

5,875

Total

 

831,501

 

695,550

v3.25.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
3 Months Ended
Mar. 31, 2025
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Schedule of outstanding securities not included in the computation of diluted net loss per share

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

March 31, 

    

2025

    

2024

Stock options

 

381,182

 

230,140

Warrants

 

444,444

 

459,535

Preferred stock

 

5,875

 

5,875

Total

 

831,501

 

695,550

v3.25.1
LONG-TERM DEBT (Tables)
3 Months Ended
Mar. 31, 2025
LONG-TERM DEBT [Abstract]  
Schedule of debt

Long-term debt consists of the following:

Dollars in Thousands

    

March 31, 2025

    

December 31, 2024

Connecticut Department of Economic and Community Development (DECD)

$

108

$

115

DECD debt issuance costs

 

(9)

 

(9)

Financed insurance loan

 

89

 

177

Business loan agreement

29

91

Total long-term debt

 

217

 

374

Current portion of long-term debt

 

(147)

 

(297)

Long-term debt, net of current maturities

$

70

$

77

v3.25.1
ACCRUED EXPENSES (Tables)
3 Months Ended
Mar. 31, 2025
ACCRUED EXPENSES [Abstract]  
Schedule of accrued expenses

Accrued expenses at March 31, 2025 and December 31, 2024 are as follows:

(dollars in thousands)

    

March 31, 2025

    

December 31, 2024

Accrued expenses

$

396

$

595

Accrued compensation

 

1,038

 

955

Accrued franchise, property and sales and use taxes

195

173

CHC temporary funding assistance

1,011

1,057

Accrued interest

 

19

 

19

$

2,659

$

2,799

v3.25.1
LEASES (Tables)
3 Months Ended
Mar. 31, 2025
LEASES [Abstract]  
Summary of balance sheet presentation of our operating and finance leases

(dollars in thousands)

Classification on the Condensed Consolidated Balance Sheet

March 31, 2025

December 31, 2024

Assets:

Operating lease right-of-use assets, net

$

1,573

$

395

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

481

517

Total lease assets

$

2,054

$

912

Liabilities:

Current:

Current maturities of operating lease liabilities

$

207

$

201

Current maturities of finance lease liabilities

123

124

Noncurrent:

Operating lease liabilities, less current maturities

1,370

206

Finance lease liabilities, less current maturities

316

348

Total lease liabilities

$

2,016

$

879

(1)As of March 31, 2025 and December 31, 2024, finance lease right-of-use assets included zero, respectively, of assets related to finance leases associated with the HSRR program.
Summary of estimated future minimum lease payments for operating leases

As of March 31, 2025, the estimated future minimum lease payments, excluding non-lease components, are as follows:

(dollars in thousands)

    

Operating Leases

Finance Leases

Total

March 31,

March 31,

March 31,

2025

2025

2025

2025 (remaining)

$

265

$

125

$

390

2026

 

350

 

133

 

483

2027

 

395

 

107

 

502

2028

 

429

67

 

496

2029

461

38

499

Thereafter

 

130

 

73

 

203

Total lease obligations

 

2,030

 

543

 

2,573

Less: Amount representing interest

 

(453)

 

(104)

 

(557)

Present value of net minimum lease obligations

 

1,577

 

439

 

2,016

Less, current portion

 

(207)

 

(123)

 

(330)

Long term portion

$

1,370

$

316

$

1,686

Summary of estimated future minimum lease payments for finance leases

As of March 31, 2025, the estimated future minimum lease payments, excluding non-lease components, are as follows:

(dollars in thousands)

    

Operating Leases

Finance Leases

Total

March 31,

March 31,

March 31,

2025

2025

2025

2025 (remaining)

$

265

$

125

$

390

2026

 

350

 

133

 

483

2027

 

395

 

107

 

502

2028

 

429

67

 

496

2029

461

38

499

Thereafter

 

130

 

73

 

203

Total lease obligations

 

2,030

 

543

 

2,573

Less: Amount representing interest

 

(453)

 

(104)

 

(557)

Present value of net minimum lease obligations

 

1,577

 

439

 

2,016

Less, current portion

 

(207)

 

(123)

 

(330)

Long term portion

$

1,370

$

316

$

1,686

Schedule of other information

March 31,

December 31,

2025

2024

Weighted-average remaining lease term (years):

Operating leases

5.1

1.9

Finance leases

4.4

4.4

Weighted-average discount rate:

Operating leases

9.99%

8.00%

Finance leases

11.02%

11.20%

v3.25.1
STOCKHOLDERS' EQUITY (Tables)
3 Months Ended
Mar. 31, 2025
STOCKHOLDERS' EQUITY [Abstract]  
Schedule of stockholders' equity, including warrants and rights

The following represents a summary of the warrants outstanding as of March 31, 2025:

    

    

    

Underlying

    

Exercise

Issue Year

Expiration

Shares 

Price

Warrants

(1)

2023

December 2028

444,444

$

12.60

(1) These warrants were issued in connection with a June 8, 2023 registered direct offering (the “Registered Direct Offering”) and concurrent private placement and are the RDO common warrants discussed below.

v3.25.1
EQUITY INCENTIVE PLAN (Tables)
3 Months Ended
Mar. 31, 2025
EQUITY INCENTIVE PLAN [Abstract]  
Summary of stock option activity

The following table summarizes stock option activity under our plans during the three months ended March 31, 2025:

    

Number of

    

Weighted-Average

Options

Exercise Price

Outstanding at January 1, 2025

 

303,932

$

7.18

Granted

 

77,500

 

6.06

Forfeited

 

(250)

 

6.06

Outstanding at March 31, 2025

 

381,182

$

6.96

Exercisable at March 31, 2025

 

208,034

$

7.51

v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Tables)
3 Months Ended
Mar. 31, 2025
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE [Abstract]  
Schedule of Net Revenues

For the Three Months Ended March 31, 

(dollars in thousands)

Diagnostic Testing

    

2025

    

2024

Medicaid

$

5

$

5

Medicare

 

1,904

 

1,091

Self-pay

 

5

 

18

Third party payers

 

2,325

 

1,705

Contract diagnostics and other

 

18

 

2

Service revenue, net

$

4,257

$

2,821

Schedule of Gross to Net Sales Adjustments

For the Three Months Ended March 31, 

(dollars in thousands)

Contractual Allowances and

Revenues, net of Contractual

Gross Revenues

adjustments

Allowances and adjustments

    

2025

    

2024

    

2025

    

2024

    

2025

    

2024

Medicaid

$

5

$

5

$

$

$

5

$

5

Medicare

 

1,904

 

1,091

 

 

 

1,904

 

1,091

Self-pay

 

5

 

18

 

 

 

5

 

18

Third party payers

 

8,138

 

5,968

 

(5,813)

 

(4,263)

 

2,325

 

1,705

Contract diagnostics and other

 

18

 

2

 

 

 

18

 

2

 

10,070

 

7,084

 

(5,813)

 

(4,263)

 

4,257

 

2,821

Product

 

654

 

657

 

 

 

654

 

657

$

10,724

$

7,741

$

(5,813)

$

(4,263)

$

4,911

$

3,478

Schedule of Reported Revenues Net of Collection Allowance

For the Three Months Ended March 31, 

Revenues, net of

 

(dollars in thousands)

Contractual Allowances

Allowances for credit

 

and adjustments

losses

Total

    

2025

    

2024

    

2025

    

2024

    

2025

    

2024

Medicaid

$

5

$

5

$

18

$

(2)

$

23

$

3

Medicare

 

1,904

 

1,091

 

 

(16)

 

1,904

 

1,075

Self-pay

 

5

 

18

 

 

(2)

 

5

 

16

Third party payers

 

2,325

 

1,705

 

 

(26)

 

2,325

 

1,679

Contract diagnostics and other

 

18

 

2

 

 

 

18

 

2

 

4,257

 

2,821

 

18

 

(46)

 

4,275

 

2,775

Product

 

654

 

657

 

 

 

654

 

657

$

4,911

$

3,478

$

18

$

(46)

$

4,929

$

3,432

Schedule of Receivables

(dollars in thousands)

    

March 31, 2025

    

December 31, 2024

Medicaid

$

5

$

(12)

Medicare

 

1,291

 

1,086

Self-pay

 

15

 

13

Third party payers

 

534

 

530

Contract diagnostic services, product and other

 

88

 

177

$

1,933

$

1,794

Less allowance for credit losses

 

(957)

 

(995)

Accounts receivable, net

$

976

$

799

Schedule of Allowance for Doubtful Accounts

The following table presents the roll-forward of the allowance for credit losses for the three months ended March 31, 2025.

    

Three Months Ended March 31,

(dollars in thousands)

2025

2024

Balance, January 1

 

$

(995)

$

(2,572)

Provision for credit losses:

 

  

  

Medicaid

18

(2)

Medicare

 

 

(16)

Self-pay

(2)

Third party payers

 

 

(26)

 

18

 

(46)

Credit loss income (expense)

20

(37)

Total charges

 

38

 

(83)

Balance, December 31

$

(957)

$

(2,655)

Schedule of Customer Revenue and Accounts Receivable Concentrations

Net sales

Accounts receivable, as of

Three Months Ended

March 31,

March 31,

December 31,

2025

2024

2025

2024

Customer A

*

11

%

*

*

Customer B

*

10

%

*

*

Customer C

26

%

*

34

%

29

%

* represents less than 10%

v3.25.1
SEGMENT REPORTING (Tables)
3 Months Ended
Mar. 31, 2025
SEGMENT REPORTING  
Schedule of segment revenue, significant segment expenses and other segment items to reconcile to net loss

Dollars in Thousands

Three Months Ended

March 31, 

    

2025

    

2024

Net sales

$

4,929

$

3,432

Less expense (income):

Cost of sales

 

2,789

 

2,512

Operating expenses (1)

2,999

2,994

Other segment items (2)

 

25

 

5

Net loss

$

(884)

$

(2,079)

(1) Operating expenses include sales and marketing expenses, general and administrative expenses, research and development expenses and stock-based compensation.

(2) Other segment items include interest income, interest expense, gain on write-off of liability and other income.

v3.25.1
BUSINESS DESCRIPTION (Narrative) (Details) - USD ($)
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Dec. 31, 2024
Apr. 08, 2024
Apr. 14, 2023
Business Acquisition [Line Items]          
Net loss $ 900,000        
Net cash used in operating activities (44,000) $ (667,000)      
Accumulated deficit (103,324,000)   $ (102,440,000)    
Working capital 1,100,000        
Aggregate authorized offering price       $ 1,061,478  
Amount available for future sale of shares pursuant to the sales agreement 1,000,000        
AGP 2023 Sales Agreement          
Business Acquisition [Line Items]          
Aggregate authorized offering price       $ 1,061,478 $ 5,800,000
Amount available for future sale of shares pursuant to the sales agreement 3,700,000        
Equity purchase agreement value remaining available $ 1,000,000        
Maximum | AGP 2023 Sales Agreement          
Business Acquisition [Line Items]          
Aggregate authorized offering price         $ 5,800,000
v3.25.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - shares
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]    
Securities not included in the computation of diluted net loss per share (in shares) 831,501 695,550
v3.25.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Outstanding Securities) (Details) - shares
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Securities not included in the computation of diluted net loss per share (in shares) 831,501 695,550
Employee Stock Option    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Securities not included in the computation of diluted net loss per share (in shares) 381,182 230,140
Warrants    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Securities not included in the computation of diluted net loss per share (in shares) 444,444 459,535
Preferred stock    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Securities not included in the computation of diluted net loss per share (in shares) 5,875 5,875
v3.25.1
LONG-TERM DEBT (Schedule of Debt) (Details) - USD ($)
$ in Thousands
Mar. 31, 2025
Dec. 31, 2024
Debt Instrument [Line Items]    
Total long-term debt $ 217 $ 374
Current portion of long-term debt (147) (297)
Long-term debt, net of current maturities 70 77
Connecticut Department of Economic and Community Development (DECD)    
Debt Instrument [Line Items]    
Total long-term debt 108 115
Debt issuance costs (9) (9)
Financed insurance loan    
Debt Instrument [Line Items]    
Total long-term debt 89 177
Current portion of long-term debt (100) (200)
Business loan agreement    
Debt Instrument [Line Items]    
Total long-term debt $ 29 $ 91
v3.25.1
LONG-TERM DEBT (Narrative) (Details) - USD ($)
3 Months Ended
Jan. 08, 2018
Mar. 31, 2025
Mar. 31, 2024
Jul. 31, 2024
Financed Insurance Loan [Member]        
Debt Instrument [Line Items]        
Interest rate (as a percent)       9.99%
Term loan | Department of Economic and Community Development (DECD) Loan        
Debt Instrument [Line Items]        
Proceeds from long-term debt $ 300,000      
Debt instrument, term 10 years      
Debt instrument, maturity date Dec. 31, 2027 May 31, 2028    
Interest rate (as a percent) 3.25%      
Term loan | Department of Economic and Community Development (DECD) Loan | Maximum        
Debt Instrument [Line Items]        
Amortization of debt issuance cost   $ 1,000 $ 1,000  
v3.25.1
LONG-TERM DEBT (Financed Insurance Loan) (Details) - USD ($)
$ in Thousands
Mar. 31, 2025
Dec. 31, 2024
Jul. 31, 2024
Debt Instrument [Line Items]      
Current maturities of long-term debt, less debt issuance costs $ 147 $ 297  
Financed insurance loan      
Debt Instrument [Line Items]      
Debt instrument, face amount     $ 300
Interest rate (as a percent)     9.99%
Current maturities of long-term debt, less debt issuance costs $ 100 $ 200  
v3.25.1
LONG-TERM DEBT (Business Loan Agreement) (Details)
May 01, 2024
USD ($)
item
Mar. 31, 2025
USD ($)
Dec. 31, 2024
USD ($)
Debt Instrument [Line Items]      
Current maturities of long-term debt, less debt issuance costs   $ 147,000 $ 297,000
Loan Agreement      
Debt Instrument [Line Items]      
Debt Instrument, Face Amount $ 250,000    
Debt Instrument, Term 1 year    
Interest rate (as a percent) 20.00%    
Number of periodic payments | item 52    
Debt Instrument, Periodic Payment $ 5,769    
Convertible notes 300,000    
Additional borrowing capacity 250,000    
Current maturities of long-term debt, less debt issuance costs   $ 100,000 $ 100,000
Loan Agreement | Default Fees      
Debt Instrument [Line Items]      
Fee $ 15,000    
v3.25.1
ACCRUED EXPENSES (Details) - USD ($)
4 Months Ended 9 Months Ended
May 15, 2025
Jan. 31, 2026
Mar. 31, 2025
Dec. 31, 2024
Accrued expenses     $ 396,000 $ 595,000
Accrued compensation     1,038,000 955,000
Accrued franchise, property and sales and use taxes     195,000 173,000
CHC temporary funding assistance     1,011,000 1,057,000
Accrued interest     19,000 19,000
Total accrued expenses     $ 2,659,000 2,799,000
Subsequent Events        
Amount received from Temporary Assistance Program $ 800,000      
Repayments to CHC 200,000      
Temporary funding assistance program, write off $ 100,000      
Monthly repayment of fund   $ 83,000    
Maximum        
Amount received from Temporary Assistance Program       $ 1,100,000
v3.25.1
COMMITMENTS AND CONTINGENCIES (Narrative) (Details) - USD ($)
$ in Millions
Feb. 06, 2017
Mar. 31, 2025
Dec. 31, 2024
Loss Contingencies [Line Items]      
Other Commitment   $ 2.7  
CPA Global      
Loss Contingencies [Line Items]      
Loss contingency, damages sought $ 0.2    
CPA Global | Maximum      
Loss Contingencies [Line Items]      
Loss contingency accrual   $ 0.1 $ 0.1
v3.25.1
LEASES - Narrative (Details)
$ in Thousands
3 Months Ended
Mar. 31, 2025
USD ($)
item
Mar. 31, 2024
USD ($)
Dec. 31, 2024
USD ($)
Lessee, Lease, Description [Line Items]      
Finance lease ROU assets $ 36 $ 18  
Operating leases 100 100  
Operating lease right-of-use assets obtained in exchange for operating lease obligations 1,237 0  
Finance lease right-of-use assets obtained in exchange for finance lease obligations $ 0 0  
Minimum      
Lessee, Lease, Description [Line Items]      
Facility leases | item 1    
Renewal term 1 year    
Maximum      
Lessee, Lease, Description [Line Items]      
Renewal term 5 years    
HemeScreen Reagent Rental      
Lessee, Lease, Description [Line Items]      
Finance lease ROU assets $ 0 $ 0  
HemeScreen Reagent Rental | Maximum      
Lessee, Lease, Description [Line Items]      
Net investment in leased assets $ 100   $ 100
v3.25.1
LEASES - Operating and Financing leases (Details) - USD ($)
$ in Thousands
Mar. 31, 2025
Dec. 31, 2024
Balance sheet presentation of our operating and financing leases    
Operating lease right-of-use assets, net $ 1,573 $ 395
Finance lease right-of-use assets, net 481 517
Total lease assets 2,054 912
Current maturities of operating lease liabilities 207 201
Current maturities of finance lease liabilities 123 124
Operating lease liabilities, less current maturities 1,370 206
Finance lease liabilities, less current maturities 316 348
Present value of net minimum lease obligations 2,016 879
HemeScreen Reagent Rental    
Balance sheet presentation of our operating and financing leases    
Finance lease right-of-use assets, net $ 0 $ 0
v3.25.1
LEASES - Future Minimum Lease Payments (Details) - USD ($)
$ in Thousands
Mar. 31, 2025
Dec. 31, 2024
Operating leases, estimated future minimum lease payments    
2025 (remaining) $ 265  
2026 350  
2027 395  
2028 429  
2029 461  
Thereafter 130  
Total lease obligations 2,030  
Less: Amount representing interest (453)  
Present value of net minimum lease obligations 1,577  
Less, current portion (207) $ (201)
Long term portion 1,370 206
Finance leases, estimated future minimum lease payments    
2025 (remaining) 125  
2026 133  
2027 107  
2028 67  
2029 38  
Thereafter 73  
Total lease obligations 543  
Less: Amount representing interest (104)  
Present value of net minimum lease obligations 439  
Less, current portion (123) (124)
Long term portion 316 348
2025 (remaining) 390  
2026 483  
2027 502  
2028 496  
2029 499  
Thereafter 203  
Total lease obligations 2,573  
Less: Amount representing interest (557)  
Present value of net minimum lease obligations 2,016 $ 879
Less, current portion (330)  
Long term portion $ 1,686  
v3.25.1
LEASES - Other Information (Details)
Mar. 31, 2025
Dec. 31, 2024
LEASES [Abstract]    
Operating leases (in years) 5 years 1 month 6 days 1 year 10 months 24 days
Finance leases (in years) 4 years 4 months 24 days 4 years 4 months 24 days
Operating leases discount rate 9.99% 8.00%
Finance leases discount rate 11.02% 11.20%
v3.25.1
LEASES - Operating and Financing Lease Cost (Details) - USD ($)
$ in Millions
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Lessee, Lease, Description [Line Items]    
Operating lease costs $ 0.1 $ 0.1
Maximum    
Lessee, Lease, Description [Line Items]    
Short-term lease costs 0.1 0.1
Finance lease amortization and interest expenses $ 0.1 $ 0.1
v3.25.1
STOCKHOLDERS' EQUITY (Common Stock) (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Dec. 31, 2024
Dec. 20, 2018
Dec. 19, 2018
Class of Stock [Line Items]        
Common stock, shares authorized (in shares) 150,000,000 150,000,000 250,000,000 150,000,000
Issuance of common stock for consulting services $ 65      
Common Stock        
Class of Stock [Line Items]        
Issuance of common stock for consulting services (in shares) 10,673      
Issuance of common stock for consulting services $ 100      
v3.25.1
STOCKHOLDERS' EQUITY (At The Market Offering Agreement) (Details) - USD ($)
3 Months Ended 24 Months Ended
Apr. 14, 2023
Mar. 31, 2025
Mar. 31, 2024
Mar. 31, 2025
Dec. 31, 2024
Apr. 08, 2024
Class of Stock [Line Items]            
Common stock, par value (in $ per share)   $ 0.01   $ 0.01 $ 0.01  
Aggregate authorized offering price           $ 1,061,478
Proceeds from issuance of common stock     $ 67,000      
AGP 2023 Sales Agreement            
Class of Stock [Line Items]            
Aggregate authorized offering price $ 5,800,000         $ 1,061,478
Percentage of cash fee 3.00%          
Proceeds from issuance of common stock   $ 0 $ 100,000 $ 100,000    
Shares issued (in shares)   0 10,167 11,847    
Payments of Stock Issuance Costs       $ 2,000    
Equity Purchase Agreement Value Remaining Available   $ 1,000,000   1,000,000    
Registered Direct Offering            
Class of Stock [Line Items]            
Equity Purchase Agreement Value Remaining Available   $ 43,700,000   $ 43,700,000    
Maximum | AGP 2023 Sales Agreement            
Class of Stock [Line Items]            
Aggregate authorized offering price $ 5,800,000          
v3.25.1
STOCKHOLDERS' EQUITY (Preferred Stock) (Details) - shares
Mar. 31, 2025
Dec. 31, 2024
STOCKHOLDERS' EQUITY [Abstract]    
Preferred stock, shares authorized (in shares) 15,000,000 15,000,000
v3.25.1
STOCKHOLDERS' EQUITY (Series B Preferred Stock) (Details) - $ / shares
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Dec. 31, 2024
Aug. 28, 2017
Class of Stock [Line Items]        
Preferred stock, shares authorized (in shares) 15,000,000   15,000,000  
Preferred stock, shares issued (in shares) 47   47  
Preferred stock, shares outstanding (in shares) 47   47  
Preferred stock, par value (in dollars per share) $ 0.01   $ 0.01  
Preferred Class B        
Class of Stock [Line Items]        
Preferred stock, shares authorized (in shares) 6,900   6,900 6,900
Preferred stock, shares issued (in shares) 6,900   6,900  
Preferred stock, shares outstanding (in shares) 47   47  
Preferred stock, liquidation preference (in dollars per share) $ 1,000     $ 1,000
Preferred stock, par value (in dollars per share)       $ 0.01
Preferred stock, dividend rate (percentage) 0.00%      
Number of shares converted (in shares) 0 0    
Conversion price (in dollars per share) $ 8      
Number of common shares issuable upon conversion of preferred stock 5,875      
v3.25.1
STOCKHOLDERS' EQUITY (Schedule of Warrants) (Details) - RDO Common Warrants - $ / shares
Mar. 31, 2025
Jun. 30, 2023
Class of Stock [Line Items]    
Underlying shares (in shares) 444,444 444,444
Exercise price (in dollars per share) $ 12.6 $ 12.6
v3.25.1
STOCKHOLDERS' EQUITY (RDO Common Warrants) (Details) - RDO Common Warrants - $ / shares
1 Months Ended
Jun. 30, 2023
Mar. 31, 2025
Class of Warrant or Right [Line Items]    
Number of warrants issued 444,444  
Class of warrant, number of securities called by warrants 444,444 444,444
Period from issuance after which the warrants become exercisable 6 months  
Exercise price (in dollars per share) $ 12.6 $ 12.6
v3.25.1
FAIR VALUE (Narratives) (Details) - Warrant Liabilities - USD ($)
3 Months Ended
Mar. 31, 2024
Mar. 31, 2025
Dec. 31, 2024
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]      
Warrants and rights outstanding   $ 0 $ 0
Revaluation recognized in earnings $ 0    
v3.25.1
EQUITY INCENTIVE PLAN (Narrative) (Details) - USD ($)
$ / shares in Units, $ in Millions
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Dec. 31, 2024
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Stock-based compensation $ 0.4 $ 0.4  
Unrecognized compensation expense related to unvested stock awards $ 1.4    
Unvested stock options, unrecognized compensation expense weighted average recognition period (in years) 1 year 8 months 12 days    
Employee Stock Option      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Granted (in shares) 77,500    
Granted (in dollars per share) $ 6.06    
Stock options, expected to vest, outstanding (in shares) 337,895    
Stock options, expected to vest, outstanding, aggregate intrinsic value $ 0.1    
Stock options, expected to vest remaining contractual term 7 years 1 month 6 days    
Employee Stock Option | Time-based vesting      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Risk free interest rate, minimum 4.60%    
Risk free interest rate, maximum 4.65%    
Employee Stock Option | Market-condition vesting      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Service period (in years) 1 year 7 months 6 days    
Weighted average grant date fair value (in dollars per share) $ 5.7    
Term 10 years    
Volatility rate 121.00%    
Risk-free interest rate (as a percent) 4.67%    
Restricted Stock      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Awards outstanding (in shares) 2,492   0
Restricted stock granted 0 0  
Minimum | Employee Stock Option | Time-based vesting      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Weighted average grant date fair value (in dollars per share) $ 5.24    
Term 5 years    
Volatility rate 124.00%    
Maximum | Employee Stock Option | Time-based vesting      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Stock options, unvested options, vesting period 4 years    
Weighted average grant date fair value (in dollars per share) $ 5.46    
Term 6 years    
Volatility rate 128.00%    
Equity Incentive Plan 2017      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Number of shares authorized 395,380    
Shares available for grant 11,637    
Percentage of annual increase in number of shares authorized for grant 5.00%    
Number of additional shares authorized 74,681    
Equity Incentive Plan 2017 | Employee Stock Option      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Plan expiration date Jun. 05, 2027    
v3.25.1
EQUITY INCENTIVE PLAN (Summary of Stock Option Activity) (Details) - Stock options
3 Months Ended
Mar. 31, 2025
$ / shares
shares
Number of Options  
Outstanding at beginning of period (in shares) | shares 303,932
Granted (in shares) | shares 77,500
Forfeited (in shares) | shares (250)
Outstanding at end of period (in shares) | shares 381,182
Exercisable at end of period (in shares) | shares 208,034
Weighted-Average Exercise Price  
Outstanding at beginning of period (in dollars per share) | $ / shares $ 7.18
Granted (in dollars per share) | $ / shares 6.06
Forfeited (in dollars per share) | $ / shares 6.06
Outstanding at end of period (in dollars per share) | $ / shares 6.96
Exercisable at end of period (in dollars per share) | $ / shares $ 7.51
v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Narrative) (Details)
$ in Thousands
3 Months Ended
Mar. 31, 2025
USD ($)
segment
Mar. 31, 2024
segment
Dec. 31, 2024
USD ($)
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE [Abstract]      
Number of segments | segment 1 1  
Deferred revenue | $ $ 289   $ 232
v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Schedule of Net Revenues) (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments $ 4,911 $ 3,478
Service revenue, net    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 4,257 2,821
Medicaid | Service revenue, net    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 5 5
Medicaid | Diagnostic Testing    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 5 5
Medicare | Service revenue, net    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 1,904 1,091
Medicare | Diagnostic Testing    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 1,904 1,091
Self-pay | Service revenue, net    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 5 18
Self-pay | Diagnostic Testing    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 5 18
Third party payers | Service revenue, net    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 2,325 1,705
Third party payers | Diagnostic Testing    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 2,325 1,705
Contract diagnostics and other | Service revenue, net    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 18 2
Contract diagnostics and other | Diagnostic Testing    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 18 2
Service revenue, net | Diagnostic Testing    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments $ 4,257 $ 2,821
v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Schedule of Gross to Net Sales Adjustments) (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Disaggregation of Revenue [Line Items]    
Gross Revenues $ 10,724 $ 7,741
Contractual Allowances and adjustments (5,813) (4,263)
Revenues, net of Contractual Allowances and adjustments 4,911 3,478
Service revenue, net    
Disaggregation of Revenue [Line Items]    
Gross Revenues 10,070 7,084
Contractual Allowances and adjustments (5,813) (4,263)
Revenues, net of Contractual Allowances and adjustments 4,257 2,821
Service revenue, net | Medicaid    
Disaggregation of Revenue [Line Items]    
Gross Revenues 5 5
Revenues, net of Contractual Allowances and adjustments 5 5
Service revenue, net | Medicare    
Disaggregation of Revenue [Line Items]    
Gross Revenues 1,904 1,091
Revenues, net of Contractual Allowances and adjustments 1,904 1,091
Service revenue, net | Self-pay    
Disaggregation of Revenue [Line Items]    
Gross Revenues 5 18
Revenues, net of Contractual Allowances and adjustments 5 18
Service revenue, net | Third party payers    
Disaggregation of Revenue [Line Items]    
Gross Revenues 8,138 5,968
Contractual Allowances and adjustments (5,813) (4,263)
Revenues, net of Contractual Allowances and adjustments 2,325 1,705
Service revenue, net | Contract diagnostics and other    
Disaggregation of Revenue [Line Items]    
Gross Revenues 18 2
Revenues, net of Contractual Allowances and adjustments 18 2
Product    
Disaggregation of Revenue [Line Items]    
Gross Revenues 654 657
Revenues, net of Contractual Allowances and adjustments $ 654 $ 657
v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Schedule of Sales, Net of Collection Allowance) (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments $ 4,911 $ 3,478
Allowance for credit losses 18 (46)
Net sales 4,929 3,432
Medicaid    
Disaggregation of Revenue [Line Items]    
Allowance for credit losses 18 (2)
Medicare    
Disaggregation of Revenue [Line Items]    
Allowance for credit losses   (16)
Self-pay    
Disaggregation of Revenue [Line Items]    
Allowance for credit losses   (2)
Third party payers    
Disaggregation of Revenue [Line Items]    
Allowance for credit losses   (26)
Service revenue, net    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 4,257 2,821
Allowance for credit losses 18 (46)
Net sales 4,275 2,775
Service revenue, net | Medicaid    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 5 5
Allowance for credit losses 18 (2)
Net sales 23 3
Service revenue, net | Medicare    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 1,904 1,091
Allowance for credit losses   (16)
Net sales 1,904 1,075
Service revenue, net | Self-pay    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 5 18
Allowance for credit losses   (2)
Net sales 5 16
Service revenue, net | Third party payers    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 2,325 1,705
Allowance for credit losses   (26)
Net sales 2,325 1,679
Service revenue, net | Contract diagnostics and other    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 18 2
Net sales 18 2
Product    
Disaggregation of Revenue [Line Items]    
Revenue, net of contractual allowances and adjustments 654 657
Net sales $ 654 $ 657
v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Schedule of Receivables) (Details) - USD ($)
$ in Thousands
Mar. 31, 2025
Dec. 31, 2024
Mar. 31, 2024
Dec. 31, 2023
Disaggregation of Revenue [Line Items]        
Accounts receivable, gross $ 1,933 $ 1,794    
Less allowance for credit losses (957) (995) $ (2,655) $ (2,572)
Accounts receivable, net 976 799    
Medicaid        
Disaggregation of Revenue [Line Items]        
Accounts receivables, gross of allowance for credit losses 5 (12)    
Medicare        
Disaggregation of Revenue [Line Items]        
Accounts receivable, gross 1,291 1,086    
Self-pay        
Disaggregation of Revenue [Line Items]        
Accounts receivable, gross 15 13    
Third party payers        
Disaggregation of Revenue [Line Items]        
Accounts receivable, gross 534 530    
Contract diagnostic services, product and other        
Disaggregation of Revenue [Line Items]        
Accounts receivable, gross $ 88 $ 177    
v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Schedule of Allowance for Doubtful Accounts) (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Allowance for Credit Losses, Beginning balance $ (995) $ (2,572)
Adjustment for allowance for credit losses 18 (46)
Credit loss income (expense) 20 (37)
Total charges 38 (83)
Allowance for Credit Losses, Ending balance (957) (2,655)
Medicaid    
Adjustment for allowance for credit losses $ 18 (2)
Medicare    
Adjustment for allowance for credit losses   (16)
Self-pay    
Adjustment for allowance for credit losses   (2)
Third party payers    
Adjustment for allowance for credit losses   $ (26)
v3.25.1
SALES SERVICE REVENUE, NET AND ACCOUNTS RECEIVABLE (Schedule of Customer Revenue and Accounts Receivable Concentrations) (Details) - Customer Concentration Risk
3 Months Ended 12 Months Ended
Mar. 31, 2025
Mar. 31, 2024
Dec. 31, 2024
Net sales | Customer A      
Concentration Risk [Line Items]      
Concentration risk, percentage   11.00%  
Net sales | Customer B      
Concentration Risk [Line Items]      
Concentration risk, percentage   10.00%  
Net sales | Customer C      
Concentration Risk [Line Items]      
Concentration risk, percentage 26.00%    
Accounts receivable | Customer C      
Concentration Risk [Line Items]      
Concentration risk, percentage 34.00%   29.00%
v3.25.1
SEGMENT REPORTING (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2025
Mar. 31, 2024
SEGMENT REPORTING    
Net sales $ 4,929 $ 3,432
Less expense (income):    
Cost of sales 2,789 2,512
Operating expenses 2,999 2,994
NET LOSS (884) (2,079)
Single reportable segment    
SEGMENT REPORTING    
Net sales 4,929 3,432
Less expense (income):    
Cost of sales 2,789 2,512
Operating expenses 2,999 2,994
Other segment items 25 5
NET LOSS $ (884) $ (2,079)
Segment Reporting, Other Segment Item, Composition, Description Other segment items include interest income, interest expense, gain on write-off of liability and other income. Other segment items include interest income, interest expense, gain on write-off of liability and other income.
v3.25.1
SUBSEQUENT EVENTS (Details) - USD ($)
$ in Millions
1 Months Ended
Apr. 30, 2025
Nov. 30, 2022
SUBSEQUENT EVENTS    
Employee retention credit receivable   $ 1.5
Subsequent Events    
SUBSEQUENT EVENTS    
Employee retention credit receivable $ 1.1  
Proceeds from Employee Retention Credit $ 0.4  

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