UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 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: 000-24249
Interpace
Biosciences, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
22-2919486
(State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization)
Identification
No.)
Waterview
Plaza , Suite 310 , 2001 Route 46 , Parsippany , NJ 07054
(Address
of principal executive offices and zip code)
(855)
776-6419
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
None
N/A
N/A
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”,
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
Emerging
Growth Company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate
the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:
Class
Shares
Outstanding August 1, 2025
Common
Stock, par value $ 0.01 per share
4,423,093
INTERPACE
BIOSCIENCES, INC.
FORM
10-Q FOR PERIOD ENDED JUNE 30, 2025
TABLE
OF CONTENTS
Page
No.
PART I - FINANCIAL INFORMATION
Item
1.
Unaudited
Interim Condensed Consolidated Financial Statements
3
Condensed Consolidated Balance Sheets at June 30, 2025 (unaudited) and December 31, 2024
3
Condensed Consolidated Statements of Operations for the three and six-month periods ended June 30, 2025 and 2024 (unaudited)
4
Condensed Consolidated Statements of Stockholders’ Deficit for the three and six-month periods ended June 30, 2025 and 2024 (unaudited)
5
Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, 2025 and 2024 (unaudited)
6
Notes to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
21
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
30
Item
4.
Controls and Procedures
31
PART II - OTHER INFORMATION
Item
1.
Legal Proceedings
31
Item
1A.
Risk Factors
31
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
31
Item
3.
Defaults Upon Senior Securities
31
Item
4.
Mine Safety Disclosures
31
Item
5.
Other Information
31
Item
6.
Exhibits
32
Signatures
33
2
PART
I. FINANCIAL INFORMATION
INTERPACE
BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)
June 30,
December 31,
2025
2024
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 502
$ 1,461
Accounts receivable
7,231
8,544
Other current assets
1,771
1,768
Total current assets
9,504
11,773
Property and equipment, net
1,366
1,361
Operating lease right of use assets
1,420
1,613
Other long-term assets
45
45
Total assets
$ 12,335
$ 14,792
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable
$ 1,250
$ 1,659
Accrued salary and bonus
2,045
2,207
Other accrued expenses
1,422
1,799
Note payable at fair value
1,772
4,290
Current liabilities of discontinued operations
660
660
Total current liabilities
7,149
10,615
Operating lease liabilities, net of current portion
974
1,183
Other long-term liabilities
5,425
5,211
Total liabilities
13,548
17,009
Commitments and contingencies (Note 8)
-
-
Stockholders’ deficit:
Redeemable preferred stock, $ .01 par value; 5,000,000 shares authorized, 47,000 shares Series C issued and outstanding
-
-
Common stock, $ .01 par value; 100,000,000 shares authorized; 4,560,999 and
4,539,663 shares issued, respectively; 4,423,093 and 4,409,323 shares outstanding, respectively
407
406
Additional paid-in capital
234,822
234,811
Accumulated deficit
( 234,373 )
( 235,380 )
Treasury stock, at cost ( 137,906 and 130,340 shares, respectively)
( 2,069 )
( 2,054 )
Total stockholders’ deficit
( 1,213 )
( 2,217 )
Total liabilities and stockholders’ deficit
12,335
14,792
Total liabilities, preferred stock and stockholders’ deficit
$ 12,335
$ 14,792
The
accompanying notes are an integral part of these condensed consolidated financial statements
3
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited,
in thousands, except for per share data)
2025
2024
2025
2024
For The Three Months
For The Six Months
Ended June 30,
Ended June 30,
2025
2024
2025
2024
Revenue, net
$ 9,232
$ 12,042
$ 20,747
$ 22,219
Cost of revenue
3,956
4,236
8,101
8,102
Gross profit
5,276
7,806
12,646
14,117
Operating expenses:
Sales and marketing
2,910
2,887
5,723
5,707
Research and development
173
146
350
283
General and administrative
2,661
2,141
5,211
4,381
Total operating expenses
5,744
5,174
11,284
10,371
Operating (loss) income from continuing operations
( 468 )
2,632
1,362
3,746
Interest accretion expense
-
( 12 )
-
( 30 )
Note payable interest
( 49 )
( 176 )
( 127 )
( 373 )
Other (expense) income, net
( 16 )
71
4
( 12 )
(Loss) income from continuing operations before tax
( 533 )
2,515
1,239
3,331
Provision for income taxes
-
4
18
8
(Loss) income from continuing operations
( 533 )
2,511
1,221
3,323
Loss from discontinued operations, net of tax
( 107 )
( 74 )
( 214 )
( 178 )
Net (loss) income
$ ( 640 )
$ 2,437
$ 1,007
$ 3,145
Basic income (loss) per share of common stock:
From continuing operations
$ ( 0.12 )
$ 0.57
$ 0.28
$ 0.76
From discontinued operations
( 0.02 )
( 0.02 )
( 0.05 )
( 0.04 )
Net income (loss) per basic share of common stock
$ ( 0.14 )
$ 0.56
$ 0.23
$ 0.72
Diluted income (loss) per share of common stock:
From continuing operations
$ ( 0.12 )
$ 0.57
$ 0.04
$ 0.76
From discontinued operations
( 0.02 )
( 0.02 )
( 0.01 )
( 0.04 )
Net income (loss) per diluted share of common stock
$ ( 0.14 )
$ 0.55
$ 0.04
$ 0.72
Weighted average number of common shares and common share equivalents outstanding:
Basic
4,423
4,376
4,422
4,373
Diluted
4,423
4,401
27,697
4,393
The
accompanying notes are an integral part of these condensed consolidated financial statements
4
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(unaudited,
in thousands)
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Additional
Common Stock
Treasury Stock
Paid in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance -December 31, 2023
4,447,489
$ 405
96,044
$ ( 2,008 )
$ 188,146
$ ( 242,082 )
$ ( 55,539 )
Issuance of common stock
39,668
1
-
-
( 1 )
-
-
Treasury stock purchased
-
14,715
( 16 )
-
-
( 16 )
Stock-based compensation expense
-
-
-
-
79
-
79
Net income
-
-
-
-
-
708
708
Balance -March 31, 2024
4,487,157
$ 406
110,759
$ ( 2,024 )
$ 188,224
$ ( 241,374 )
$ ( 54,768 )
Stock-based compensation expense
-
-
-
-
53
-
53
Net income
-
-
-
-
-
2,437
2,437
Balance -June 30, 2024
4,487,157
$ 406
110,759
$ ( 2,024 )
$ 188,277
$ ( 238,937 )
$ ( 52,278 )
Balance -December 31, 2024
4,539,663
$ 406
130,340
$ ( 2,054 )
$ 234,811
$ ( 235,380 )
$ ( 2,217 )
Balance
4,539,663
$ 406
130,340
$ ( 2,054 )
$ 234,811
$ ( 235,380 )
$ ( 2,217 )
Issuance of common stock
21,336
1
-
-
-
-
1
Treasury stock purchased
-
-
7,566
( 15 )
-
-
( 15 )
Series C issuance costs
-
-
-
-
( 13 )
-
( 13 )
Stock-based compensation expense
-
-
-
-
15
-
15
Net income
-
-
-
-
-
1,647
1,647
Balance -March 31, 2025
4,560,999
$ 407
137,906
$ ( 2,069 )
$ 234,813
$ ( 233,733 )
$ ( 582 )
Balance
4,560,999
$ 407
137,906
$ ( 2,069 )
$ 234,813
$ ( 233,733 )
$ ( 582 )
Stock-based compensation expense
-
-
-
-
9
-
9
Net loss
-
-
-
-
-
( 640 )
( 640 )
Net Income (loss)
-
-
-
-
-
( 640 )
( 640 )
Balance -June 30, 2025
4,560,999
$ 407
137,906
$ ( 2,069 )
$ 234,822
$ ( 234,373 )
$ ( 1,213 )
Balance
4,560,999
$ 407
137,906
$ ( 2,069 )
$ 234,822
$ ( 234,373 )
$ ( 1,213 )
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited,
in thousands)
2025
2024
For The Six Months Ended June 30,
2025
2024
Cash Flows From Operating Activities
Net income
$ 1,007
$ 3,145
Adjustments to reconcile net income to net cash
provided by operating activities:
Depreciation and amortization
196
119
Interest accretion expense
-
30
Amortization of deferred financing fees
26
-
Stock-based compensation
24
132
Bad debt expense reversal
-
( 100 )
Credit loss expense
-
26
Asset impairment - lab supplies
198
-
Change in fair value of note payable
( 18 )
41
Amortization on operating lease right of use asset
193
229
Other changes in operating assets and liabilities:
Accounts receivable
1,313
( 1,154 )
Other current assets
( 227 )
-
Accounts payable
( 409 )
( 13 )
Accrued salaries and bonus
( 176 )
( 726 )
Other accrued expenses
( 401 )
( 373 )
Operating lease liabilities
( 185 )
( 188 )
Other long-term liabilities
214
178
Net cash provided by operating activities
1,755
1,346
Cash Flows From Investing Activity
Purchase of property and equipment
( 201 )
( 225 )
Net cash used in investing activities
( 201 )
( 225 )
Cash Flows From Financing Activities
Payments made on note payable
( 2,500 )
( 2,600 )
Series C conversion costs
( 13 )
-
Net cash used in financing activities
( 2,513 )
( 2,600 )
Net decrease in cash and cash equivalents
( 959 )
( 1,479 )
Cash and cash equivalents from continuing operations– beginning
1,461
3,498
Cash and cash equivalents from discontinued operations– beginning
-
-
Cash and cash equivalents – beginning
$ 1,461
$ 3,498
Cash and cash equivalents from continuing operations– ending
$ 502
$ 2,019
Cash and cash equivalents from discontinued operations– ending
-
-
Cash and cash equivalents – ending
$ 502
$ 2,019
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
INTERPACE
BIOSCIENCES, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Tabular
information in thousands, except per share amounts)
1.
OVERVIEW
Nature
of Business
Interpace
Biosciences, Inc. (“Interpace” or the “Company”) is a company that provides molecular diagnostics, bioinformatics
and pathology services for evaluation of risk of cancer by leveraging the latest technology in personalized medicine for improved patient
diagnosis and management. The Company develops and commercializes genomic tests and related first line assays principally focused on
early detection of patients with indeterminate biopsies and at high risk of cancer using the latest technology.
2.
BASIS OF PRESENTATION
The
accompanying unaudited interim condensed consolidated financial statements and related notes (the “Interim Financial Statements”)
should be read in conjunction with the consolidated financial statements of the Company and its wholly-owned subsidiaries (Interpace
Diagnostics Lab Inc., Interpace Diagnostics Corporation, and Interpace Diagnostics, LLC), and related notes as included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities & Exchange Commission (“SEC”)
on March 31, 2025 and as amended on April 28, 2025.
The
Interim Financial Statements of the Company have been prepared in accordance with generally accepted accounting principles in the United
States (“GAAP”) for interim financial reporting and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by GAAP for complete financial statements. The Interim Financial Statements
include all normal recurring adjustments that, in the judgment of management, are necessary for a fair presentation of such interim financial
statements. Discontinued operations include the Company’s wholly owned subsidiaries: Group DCA, LLC, InServe Support Solutions;
and TVG, Inc., its Commercial Services business unit, which was sold on December 22, 2015 and its Interpace Pharma Solutions business
which was sold on August 31, 2022. All significant intercompany balances and transactions have been eliminated in consolidation. Operating
results for the three-month period ended June 30, 2025 are not necessarily indicative of the results that may be expected for the fiscal
year ending December 31, 2025.
3.
LIQUIDITY
In
October 2021, the Company entered into an $ 8.0 million term loan with BroadOak Fund V, L.P. (“BroadOak”) (the “Term
Loan”), the proceeds of which were used to repay in full at their maturity the existing secured promissory notes with Ampersand
Capital Partners (“Ampersand”) and 1315 Capital II, L.P (“1315 Capital”). In May 2022, the Company entered into
a Subordinated Convertible Promissory Note agreement with BroadOak for an additional $ 2.0 million (the “Convertible Note”),
which was converted into a subordinated term loan and was added to the outstanding Term Loan balance. The Term Loan has been subsequently
amended. See Note 13, Notes Payable , for more details. The balance of the Term Loan outstanding at June 30, 2025 was $ 1.9 million.
Further,
along with many laboratories, the Company has been negatively impacted by Local Coverage Determination (“LCD”) L39365, which
was finalized on April 24, 2025 by our local Medicare Administrative Contractor, Novitas. This LCD, which governs “Genetic Testing
for Oncology,” resulted in the loss of Medicare coverage for one of our molecular tests, PancraGEN ® .
On
January 9, 2025, the Company announced the new LCD established non-coverage for its PancraGEN ® test, and that it would
stop offering the test and would not accept specimens for first-line fluid chemistry and PancraGEN ® testing after February
7, 2025. As a result of the established non-coverage for PancraGEN ® , the Company announced, in January 2025, that its
board of directors had approved a restructuring and cost-savings plan to reduce operating costs and better align its workforce with the
loss of PancraGEN ® (the “Restructuring Plan”).
7
On
January 27, 2025, the Company announced that CMS had directed its Medicare Administrative Contractors, Novitas and First Coast Service
Options, Inc., to delay implementation of the Genetic Testing for Oncology LCD (L39365), from February 23, 2025 until April 24, 2025.
On April 24, 2025, the Company announced that the LCD would take effect immediately and that specimens for first-line fluid chemistry
and PancraGEN ® testing will not be accepted by the Company after May 2, 2025. On April 25, 2025, the Company announced
implementation of its previously approved Restructuring Plan.
Under
the Restructuring Plan, the Company reduced its workforce and impacted employees received severance benefits. For the three months ended
June 30, 2025, the Company incurred severance and related costs of $ 0.5 million and recorded $ 0.7 million for the six months ended June
30, 2025.
For
the six months ended June 30, 2025, the Company had operating income from continuing operations of $ 1.4 million. As of the six months
ended June 30, 2024, the Company had cash and cash equivalents of $ 0.5 million, total current assets of $ 9.5 million and current liabilities
of $ 7.1 million. As of August 1, 2025, the Company had approximately $ 1.0 million of cash and cash equivalents.
The
Company intends to meet its ongoing capital needs by using its available cash, as well as through targeted margin improvement; collection
of accounts receivable; containment of costs; and the potential use of other financing options and other strategic alternatives.
The
Company continues to explore various strategic alternatives, dilutive and non-dilutive sources of funding, including equity and debt
financings, strategic alliances, business development and other sources in order to provide additional liquidity. With the delisting
of its common stock, par value $ 0.01 per share (“Common Stock”), from Nasdaq in February 2021, the Company’s ability
to raise additional capital on terms acceptable to it has been adversely impacted. There can be no assurance that the Company will be
successful in obtaining such funding on terms acceptable to it.
Even
with the loss of reimbursement coverage of PancraGEN ® , as of the date of this filing, the Company anticipates that current
cash and cash equivalents and forecasted cash receipts will be sufficient to meet its anticipated cash requirements through the next
twelve months from the date of the filing of this report.
4.
DISCONTINUED OPERATIONS
Liabilities
classified as discontinued operations as of both June 30, 2025 and December 31, 2024 consists of accrued expenses which are liabilities
related to the former Commercial Services business unit.
The
table below presents the significant components of its former discontinued operations results included within loss from discontinued
operations, net of tax in the condensed consolidated statements of operations for the three and six-months ended June 30, 2025 and 2024.
SCHEDULE
OF COMPONENTS OF ASSETS AND LIABILITIES AND REVENUE CLASSIFIED AS DISCONTINUED
2025
2024
2025
2024
For The Three Months Ended
For The Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Revenue, net
$ -
$ -
$ -
$ -
Loss from discontinued operations
-
-
-
-
Income tax expense
107
74
214
178
Loss from discontinued operations, net of tax
$ ( 107 )
$ ( 74 )
$ ( 214 )
$ ( 178 )
There
was no cash flow activity from discontinued operations for the six months ended June 30, 2025 or June 30, 2024. There was no depreciation
and amortization expense for the three or six months ended June 30, 2025 and June 30, 2024, respectively, in discontinued operations.
8
5.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Accounting
Estimates
The
preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts of assets and liabilities reported and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Management’s estimates are based on historical
experience, facts and circumstances available at the time, and various other assumptions that are believed to be reasonable under the
circumstances. Significant estimates include accounting for valuation allowances related to deferred income taxes, allowances for credit
losses, revenue recognition, and unrecognized tax benefits. The Company periodically reviews these matters and reflects changes in estimates
in earnings as appropriate. Actual results could materially differ from those estimates.
Revenue
Recognition
We
derive our revenues from the performance of proprietary assays or tests. The Company’s performance obligation is fulfilled upon
the completion, review and release of test results to the customer. We subsequently bill third-party payers or direct-bill payers for
the tests performed. Under Accounting Standards Codification 606, revenue is recognized based on the estimated transaction price or net
realizable value, which is determined based on historical collection rates by each payer category for each proprietary test offered by
the Company. To the extent the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary
tests, we estimate the amount of variable consideration that should be included in the transaction price using the expected value method
based on historical experience.
We
regularly review the ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates
and adjust the net realizable values (“NRVs”) and related contractual allowances accordingly. If actual collections and related
NRVs vary significantly from our estimates, we will adjust the estimates of contractual allowances, which affects net revenue in the
period such variances become known.
Financing
and Payment
For
non-Medicare claims, our payment terms vary by payer category. Payment terms for direct-payers in our clinical services are typically
thirty days. Commercial third-party-payers are required to respond to a claim within a time period established by their respective state
regulations, generally between thirty to sixty days. However, payment for commercial third-party claims may be subject to a denial and
appeal process, which could take up to two years in some instances where multiple appeals are submitted. The Company generally appeals
all denials from commercial third-party payers. We bill Medicare directly for tests performed for Medicare patients and must accept Medicare’s
fee schedule for the covered tests as payment in full.
Costs
to Obtain or Fulfill a Customer Contract
Sales
commissions are expensed in the period in which they have been earned. These costs are recorded in sales and marketing expense in the
condensed consolidated statements of operations.
9
Accounts
Receivable
The
Company’s accounts receivable represent unconditional rights to consideration and are generated using its clinical services. The
Company’s clinical services are fulfilled upon completion of the test, review and release of the test results. In conjunction with
fulfilling these services, the Company bills the third-party payer or direct-bill payer. Contractual adjustments represent the difference
between the list prices and the reimbursement rates set by third-party payers, including Medicare, commercial payers, and amounts billed
to direct-bill payers. Specific accounts may be written off after several appeals, which in some cases may take longer than twelve months.
Leases
The
Company determines if an arrangement contains a lease in whole or in part at the inception of the contract. Right-of-use (“ROU”)
assets represent the Company’s right to use an underlying asset for the lease term while lease liabilities represent our obligation
to make lease payments arising from the lease. All leases with terms greater than twelve months result in the recognition of a ROU asset
and a liability at the lease commencement date based on the present value of the lease payments over the lease term. Unless a lease provides
all of the information required to determine the implicit interest rate, we use our incremental borrowing rate based on the information
available at the commencement date in determining the present value of the lease payments. We use the implicit interest rate in the lease
when readily determinable.
Our
lease terms include all non-cancelable periods and may include options to extend (or to not terminate) the lease when it is reasonably
certain that we will exercise that option. Leases with terms of twelve months or less at the commencement date are expensed on a straight-line
basis over the lease term and do not result in the recognition of an asset or liability. See Note 7, Leases .
Other
Current Assets
Other
current assets consisted of the following as of June 30, 2025 and December 31, 2024:
SCHEDULE
OF OTHER CURRENT ASSETS
June 30, 2025
December 31, 2024
Lab supplies
$ 973
$ 1,211
Prepaid expenses
730
535
Other
68
22
Total other current assets
$ 1,771
$ 1,768
Basic
and Diluted Net Income (Loss) per Share
A
reconciliation of the number of shares of common stock, par value $ 0.01 per share, used in the calculation of basic and diluted income
(loss) per share for the three- and six-month periods ended June 30, 2025 and 2024 is as follows:
SCHEDULE
OF BASIC AND DILUTED NET LOSS PER SHARE
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Basic weighted average number of common shares
4,423
4,376
4,422
4,373
Potential dilutive effect of stock-based awards
-
25
8
20
Dilutive effect of preferred stock
-
-
23,267
-
Diluted weighted average number of common shares
4,423
4,401
27,697
4,393
10
For
the three- and six-month periods ended June 30, 2025 and 2024, the following outstanding stock-based awards were excluded from the
computation of the effect of dilutive securities on income (loss) per share for the following periods as they would have been anti-dilutive
(rounded to thousands):
SCHEDULE
OF ANTI-DILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF EARNINGS PER SHARE
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Options
265
288
265
288
Restricted stock units (RSUs)
158
182
150
187
Anti-dilutive securities
423
470
415
475
6.
FAIR VALUE MEASUREMENTS
Cash
and cash equivalents, accounts receivable and accounts payable approximate fair value due to their relative short-term nature. The Company’s
financial liabilities reflected at fair value in the condensed consolidated financial statements include note payable. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date. In determining fair value, the Company uses various methods including
market, income and cost approaches. Based on these approaches, the Company often utilizes certain assumptions that market participants
would use in pricing the asset or liability, including assumptions about risk and/or the risks inherent in the inputs to the valuation
technique. These inputs can be readily observable, market-corroborated, or generally unobservable inputs. The Company utilizes valuation
techniques that maximize the use of observable inputs and minimize the use of unobservable inputs. Based upon observable inputs used
in the valuation techniques, the Company is required to provide information according to the fair value hierarchy. The fair value hierarchy
ranks the quality and reliability of the information used to determine fair values into three broad levels as follows:
Level
1:
Valuations
for assets and liabilities traded in active markets from readily available pricing sources for market transactions involving identical
assets or liabilities.
Level
2:
Valuations
for assets and liabilities traded in less active dealer or broker markets. Valuations are obtained from third-party pricing services
for identical or similar assets or liabilities.
Level
3:
Valuations
incorporate certain assumptions and projections in determining the fair value assigned to such assets or liabilities.
11
In
instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy,
the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is
significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to
the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The valuation
methodologies used for the Company’s financial instruments measured on a recurring basis at fair value, including the general classification
of such instruments pursuant to the valuation hierarchy, are set forth in the tables below:
SCHEDULE
OF FINANCIAL INSTRUMENT MEASURED ON RECURRING BASIS
As of June 30, 2025
Fair Value Measurements
Carrying
Fair
As of June 30, 2025
Amount
Value
Level 1
Level 2
Level 3
Liabilities:
Note payable:
Term loan
1,900
1,772
-
-
1,772
$ 1,900
$ 1,772
$ -
$ -
$ 1,772
As of December 31, 2024
Fair Value Measurements
Carrying
Fair
As of December 31, 2024
Amount
Value
Level 1
Level 2
Level 3
Liabilities:
Note payable:
Term Loan
$ 4,400
$ 4,290
$ -
$ -
$ 4,290
$ 4,400
$ 4,290
$ -
$ -
$ 4,290
In
connection with the Term Loan, the Company records the loan at fair value. The fair value of the loan is determined by a probability-weighted
approach regarding the loan’s change in control feature. See Note 13, Notes Payable , for more details. The fair value measurement
is based on the estimated probability of a change in control and thus represents a Level 3 measurement.
A
roll forward of the carrying value of the Term Loan to June 30, 2025 is as follows :
SCHEDULE
OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION
December 31, 2024
Payments
Accretion/Interest
Accrued
Adjustment to Fair Value/Mark to Market
June 30, 2025
Term Loan
$ 4,290
$ ( 2,500 )
$ -
$ ( 18 )
$ 1,772
$ 4,290
$ ( 2,500 )
$ -
$ ( 18 )
$ 1,772
Certain
of the Company’s non-financial assets are measured at fair value on a nonrecurring basis when there is an indicator of impairment
and recorded at fair value only when an impairment charge is recognized.
12
7.
LEASES
The
table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:
SCHEDULE
OF LEASE RELATED ASSETS AND LIABILITIES
Classification on the Balance Sheet
June 30, 2025
December 31, 2024
Assets
Operating lease assets
Operating lease right of use assets
1,420
1,613
Total lease assets
$ 1,420
$ 1,613
Liabilities
Current
Operating lease liabilities
Other accrued expenses
406
383
Total current lease liabilities
$ 406
$ 383
Noncurrent
Operating lease liabilities
Operating lease liabilities, net of current portion
974
1,183
Total long-term lease liabilities
974
1,183
Total lease liabilities
$ 1,380
$ 1,566
The
weighted average remaining lease term for the Company’s operating lease was 3.0 years as of June 30, 2025 and the weighted average
discount rate for that lease was 12.0 %. Total operating lease expense from continuing operations under these agreements for the three
months ended June 30, 2025 and 2024 was approximately $ 0.1 million and $ 0.2 million, respectively, and for both the six months ended
June 30, 2025 and 2024 was approximately $ 0.3 million, respectively. Total cash paid under these agreements for the six months ended
June 30, 2025 and 2024 was approximately $ 0.3 million and $ 0.4 million, respectively. The Company’s operating lease expenses are
recorded within “Cost of revenue” and “General and administrative expenses.”
The
table below reconciles the cash flows to the lease liabilities recorded on the Company’s Condensed Consolidated Balance Sheet as
of June 30, 2025:
SCHEDULE
OF MATURITIES OF OPERATING LEASE LIABILITIES
Operating Leases
2025 - remaining six months
$ 275
2026
550
2027
550
2028
275
Total minimum lease payments
1,650
Less: amount of lease payments representing effects of discounting
270
Present value of future minimum lease payments
1,380
Less: current obligations under leases
406
Long-term lease obligations
$ 974
8.
COMMITMENTS AND CONTINGENCIES
Litigation
From
time to time, the Company may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business.
When the Company is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a
loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. In addition
to the estimated loss, the recorded liability includes probable and estimable legal costs associated with the claim or potential claim.
Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may
harm the Company’s business. There is no pending litigation involving the Company at this time.
13
Due
to the nature of the businesses in which the Company is engaged, it is subject to certain risks. Such risks include, among others, risk
of liability for personal injury or death to persons using products or services that the Company promotes or commercializes. There can
be no assurance that substantial claims or liabilities will not arise in the future due to the nature of the Company’s business
activities. There is also the risk of employment-related litigation and other litigation in the ordinary course of business.
The
Company could also be held liable for errors and omissions of its employees in connection with the services it performs that are outside
the scope of any indemnity or insurance policy. The Company could be materially adversely affected if it were required to pay damages
or incur defense costs in connection with a claim that is outside the scope of an indemnification agreement; if the indemnity, although
applicable, is not performed in accordance with its terms; or if the Company’s liability exceeds the amount of applicable insurance
or indemnity.
9.
OTHER ACCRUED EXPENSES
Other
accrued expenses consisted of the following as of June 30, 2025 and December 31, 2024:
SCHEDULE
OF OTHER ACCRUED EXPENSES
June 30, 2025
December 31, 2024
Operating lease liability
$ 406
$ 383
Accrued sales and marketing
28
22
Accrued lab costs
156
173
Accrued professional fees
180
458
Taxes payable
223
262
All others
429
501
Total other accrued expenses
$ 1,422
$ 1,799
10.
STOCK-BASED COMPENSATION
Historically,
stock options have been granted with an exercise price equal to the market value of the Common Stock on the date of grant, with expiration
10 years from the date they are granted, and generally vest over a one to three-year period for employees and members of the Board. Upon
exercise, new shares will be issued by the Company. The restricted shares and restricted stock units (“RSUs”) granted to
Board members and employees generally have a three-year graded vesting period and are subject to accelerated vesting and forfeiture under
certain circumstances.
There
were no stock option awards issued during the six months ended June 30, 2025 and June 30, 2024.
The
Company recognized approximately $ 9,000 and $ 0.1 million of stock-based compensation expense within continuing operations during the
three-month periods ended June 30, 2025 and 2024, respectively, and approximately $ 24,000 and $ 0.1 million for the six-month periods
ended June 30, 2025 and 2024, respectively. The following table has a breakout of stock-based compensation expense from continuing operations
by line item.
SCHEDULE OF SHARE-BASED COMPENSATION ARRANGEMENTS BY SHARE-BASED PAYMENT AWARD
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Cost of revenue
$ -
$ -
$ -
$ 4
Sales and marketing
6
23
15
53
General and administrative
3
30
9
75
Total stock compensation expense
$ 9
$ 53
$ 24
$ 132
14
11.
INCOME TAXES
Generally,
accounting standards require companies to provide for income taxes each quarter based on their estimate of the effective tax rate for
the full year. The authoritative guidance for accounting for income taxes allows use of the discrete method when it provides a better
estimate of income tax expense. Due to the Company’s valuation allowance position, it is the Company’s position that the
discrete method provides a more accurate estimate of income tax expense and therefore income tax expense for the current quarter has
been presented using the discrete method. As the year progresses, the Company refines its estimate based on the facts and circumstances
by each tax jurisdiction. The following table summarizes income tax expense on income from continuing operations and the effective tax
rate for the three- and six-month periods ended June 30, 2025 and 2024:
SCHEDULE OF EFFECTIVE INCOME TAX RATE
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
Provision for income tax
$ -
$ 4
$ 18
$ 8
Effective income tax rate
0.0 %
0.2 %
1.2 %
0.2 %
Income
tax expense for the six months ended June 30, 2025 was primarily due to state and federal income taxes. Income tax expense for the three-
and six- months ended June 30, 2024 was primarily due to state franchise taxes.
Other
long-term liabilities consisted of uncertain tax positions as of June 30, 2025 and December 31, 2024.
12.
SEGMENT INFORMATION
The
Company operates and manages its business as a single reporting segment. The business provides esoteric molecular diagnostic testing
and pathology services to aid physicians in their evaluation of cancer risk in patients with indeterminate biopsies and a perceived high
risk of cancer from clinical features. We develop and commercialize genomic tests and related first-line assays that can personalize
medicine to help improve patient diagnosis and management. The Company’s chief operating decision maker (“CODM”) is
the chief executive officer.
The
CODM assesses performance for the segment and decides how to allocate resources based on consolidated net income that is also reported
on the consolidated statements of operations. The monitoring of budgeted versus actual results is used in assessing performance of the
segment and in establishing resource allocation across the organization.
15
The
measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. All the Company’s long-lived
assets are located in the United States. The accounting policies of the segment are the same as those described in Note 1, Nature of
Business and Significant Accounting Policies included in our Annual Report on Form 10-K.
The
following table presents reportable segment profit and loss, including significant expense categories, attributable to the Company’s
reportable segment for the periods presented:
SCHEDULE
OF RECONCILIATION OF PROFIT (LOSS) FROM SEGMENTS TO CONSOLIDATED
For The Three Months
For The Six Months
Ended June 30,
Ended June 30,
2025
2024
2025
2024
Revenue, net:
$ 9,232
$ 12,042
$ 20,747
$ 22,219
Less:
Cost of revenue:
Fixed
1,694
1,619
3,384
3,197
Variable
2,262
2,617
4,717
4,905
Operating and other expenses:
Sales and marketing
2,910
2,887
5,723
5,707
Research and development
173
146
350
283
General and administrative
2,661
2,141
5,211
4,381
Interest & other expense, net
65
117
123
415
Provision for income taxes
-
4
18
8
Segment net (loss) income
( 533 )
2,511
1,221
3,323
Reconciliation of profit or loss:
Loss on discontinued operations
( 107 )
( 74 )
( 214 )
( 178 )
Consolidated net (loss) income
$ ( 640 )
$ 2,437
$ 1,007
$ 3,145
Adjusted
EBITDA, a non-GAAP financial measure, is a metric used by the CODM to measure cash flow of the ongoing business. Adjusted EBITDA is defined
as income or loss from continuing operations, plus depreciation and amortization, non-cash stock-based compensation, severance expense,
interest and taxes, and other non-cash expenses including change in fair value of notes payable. The table below includes a reconciliation
of this non-GAAP financial measure to the most directly comparable GAAP financial measure.
SCHEDULE
OF RECONCILIATION OF ADJUSTED EBITDA
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
(Loss) income from continuing operations (GAAP Basis)
$ ( 533 )
$ 2,511
$ 1,221
$ 3,323
Depreciation and amortization
101
67
196
119
Stock-based compensation
9
53
24
132
Severance & related expense
524
-
692
-
Asset impairment - lab supplies
198
-
198
-
Taxes expense
-
4
18
8
Interest accretion expense
-
12
-
30
Note payable interest
49
176
127
373
Other expense/income, net
10
( 14 )
14
( 29 )
Change in fair value of note payable
7
( 57 )
( 18 )
41
Adjusted EBITDA
$ 365
$ 2,752
$ 2,472
$ 3,997
16
13.
NOTES PAYABLE
BroadOak
Loan
On
October 29, 2021, the Company and its subsidiaries entered into the Term Loan with BroadOak, providing for a term loan in the aggregate
principal amount of $ 8,000,000 . Funding of the Term Loan took place on November 1, 2021. The Term Loan was scheduled to mature upon the
earlier of (i) October 31, 2024 or (ii) the occurrence of a change in control, and bears interest at the rate of 9 % per annum. The Term
Loan is secured by a security interest in substantially all of the Company’s and its subsidiaries’ assets and was subordinate
to the Company’s former $ 7,500,000 revolving credit facility with Comerica Bank. The Term Loan had an origination fee of 3 % of
the Term Loan amount, and a terminal payment equal to (i) 15% of the original principal amount of the Term Loan if the change of control
occurs on or prior to the first anniversary of the funding of the Term Loan, (ii) 20% of the original principal amount of the Term Loan
if the change of control occurs after the first anniversary but on or prior to the second anniversary of the funding of the Term Loan
and (iii) 30% of the original principal amount of the Term Loan if the change of control occurs after the second anniversary of the funding
of the Term Loan, or if the Term Loan is repaid on its maturity date.
The
Term Loan contains affirmative and negative restrictive covenants that are applicable from and after the date of the Term Loan advance.
These restrictive covenants, which include restrictions on certain mergers, acquisitions, investments, encumbrances, etc., could adversely
affect our ability to conduct our business. The Term Loan also contains customary events of default.
The
Company concluded that the Term Loan met the definition of a “recognized financial liability” which is an acceptable financial
instrument eligible for the fair value option under ASC 825-10-15-4, and did not meet the definition of any of the financial instruments
listed within ASC 825-10-15-5 that are not eligible for the fair value option. The Note is not convertible and does not have any component
recorded to stockholders’ deficit. Accordingly, the Company elected the fair value option for the Note.
In
May 2022, the Company issued a convertible note to BroadOak, pursuant to which BroadOak funded a term loan in the aggregate principal
amount of $ 2.0 million, which was converted into a subordinated term loan and was added to the outstanding balance of the Term Loan.
On
October 24, 2023, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) with
BroadOak. The primary changes to the original Term Loan were as follows:
●
The
Company made a one-time payment in an aggregate amount equal to $ 2,500,000 , on October 30, 2023 and applied the payment in full satisfaction
of the $ 3,000,000 Terminal Payment (as defined in the Term Loan). See above regarding the Terminal Payment.
●
Effective
November 1, 2023, the interest rate under the Term Loan was reduced from 9 % to 8 % through the maturity date of October 31, 2024 or
earlier, upon the occurrence of a change in control (“Loan Maturity Date”).
●
The
Company had the option to request an extension of the Loan Maturity Date in writing no less than sixty days prior to the Loan Maturity
Date. If BroadOak agreed to the extension, the Loan Maturity Date would automatically be extended.
The
Second Amendment was treated as a debt modification which is accounted for prospectively. Since the Term Loan is carried at fair value
under the fair value option, the Second Amendment did not result in any extinguishment gain or loss upon amendment, and the impact of
the revised terms was incorporated into the Company’s fourth quarter 2023 fair value calculation.
On
March 29, 2024, the Company entered into a Third Amendment to Loan and Security Agreement with BroadOak (the “Third Amendment”).
The primary changes to the Second Amendment were as follows:
●
The
maturity date was extended to June 30, 2025.
●
Beginning
April 1, 2024, the Company made $ 500,000 monthly payments with the remaining loan balance due on the new maturity date.
17
The
Third Amendment was treated as a debt modification which is accounted for prospectively. Since the Term Loan is carried at fair value
under the fair value option, the Third Amendment did not result in any extinguishment gain or loss upon amendment, and the impact of
the revised terms was incorporated into the Company’s first quarter 2024 fair value calculation.
On
January 14, 2025, the Company entered into a Fourth Amendment to the Loan and Security Agreement with BroadOak, extending the loan maturity
date to December 31, 2025. The primary changes to the Third Amendment were as follows:
●
The
maturity date was extended to December 31, 2025.
●
Beginning
July 1, 2025, and continuing through December 1, 2025, the Company will make monthly interest-only payments with the remaining loan
balance due on the new maturity date.
The
Fourth Amendment was treated as a debt modification which is accounted for prospectively. Since the Term Loan is carried at fair value
under the fair value option, the Fourth Amendment did not result in any extinguishment gain or loss upon amendment, and the impact of
the revised terms was incorporated into the Company’s first quarter 2025 fair value calculation.
The
balance of the Term Loan outstanding at June 30, 2025 was $ 1.9 million.
14.
SUPPLEMENTAL CASH FLOW INFORMATION
Supplemental
Disclosures of Non-Cash Activities
(in
thousands)
SUPPLEMENTAL
CASH FLOW INFORMATION
Six Months Ended
June 30,
2025
2024
Taxes accrued for repurchase of restricted shares
$ 15
$ 16
Purchase of property and equipment included in accounts payable
-
230
15.
PREFERRED STOCK
Redeemable
Preferred Stock
On
January 10, 2020, the Company entered into a Securities Purchase and Exchange Agreement (the “Securities Purchase and Exchange
Agreement”) with 1315 Capital and Ampersand (collectively, the “Investors”) pursuant to which the Company agreed to
sell to the Investors an aggregate of $ 20.0 million in Series B Preferred Stock of the Company, at an issuance price per share of $ 1,000 .
Pursuant to the Securities Purchase and Exchange Agreement, 1315 Capital agreed to purchase 19,000 shares of Series B Preferred Stock
at an aggregate purchase price of $ 19.0 million and Ampersand agreed to purchase 1,000 shares of Series B Preferred Stock at an aggregate
purchase price of $ 1.0 million.
In
addition, the Company agreed to exchange $ 27.0 million of the Company’s existing Series A convertible preferred stock, par value
$ 0.01 per share, held by Ampersand (the “Series A Preferred Stock”), represented by 270 shares of Series A Preferred Stock
with a stated value of $ 100,000 per share, which represents all of the Company’s issued and outstanding Series A Preferred Stock,
for 27,000 newly issued shares of Series B Preferred Stock (such shares of Series B Preferred Stock, the “Exchange Shares”
and such transaction, the “Exchange”). Following the Exchange, no shares of Series A Preferred Stock remained designated,
authorized, issued or outstanding. The Series B Preferred Stock had a conversion price of $ 6.00 .
18
On
October 10, 2024, the Company and the Investors entered into an Exchange Agreement (the “Exchange Agreement”) pursuant to
which the Investors exchanged (the “Exchange”) an aggregate of 47,000 shares of the Company’s Series B Preferred Stock,
comprised of 28,000 shares of Series B Preferred Stock held by Ampersand and 19,000 shares of Series B Preferred Stock held by 1315 Capital,
which represented all of the Company’s issued and outstanding Series B Preferred Stock, for 47,000 newly created shares of Series
C Preferred Stock, at an issuance price per share of $ 1,000 . In the Exchange, Ampersand received 28,000 shares of Series C Preferred
Stock and 1315 received 19,000 shares of Series C Preferred Stock. The Company recorded approximately $ 0.2 million in issuance costs
related to this transaction.
The
Series C Preferred Stock is convertible into the Company’s Common Stock at a conversion price of $ 2.02 per share of Common Stock
(subject to further adjustment in the event of any stock dividend, stock split, combination, or other similar recapitalization affecting
such shares) which was the closing price of the Common Stock on the date of the Exchange Agreement. The Series C Preferred Stock does
not have a liquidation preference over the Common Stock in the event of a sale or dissolution of the Company, does not have director
designation rights and includes limited customary protective provisions. The Series B Preferred Stock had a conversion price of $ 6.00
per share of Common Stock and included additional protective provisions not applicable to the Series C Preferred Stock, including (i)
limitations on the Board to declare dividends, (ii) director designation rights for each of the Investors, (iii) liquidation rights of
holders upon “deemed liquidation” events, including a liquidation preference over the Common Stock, (iv) limitations on the
ability to authorize, issue or create debt securities, (v) limitations on the ability to enter into mergers or acquisitions and (vi)
limitations on the ability to conduct public offerings of the Company’s Common Stock.
Voting
On
any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company
(or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series C Preferred Stock will be entitled
to cast the number of votes equal to the number of whole shares of Common Stock, into which the shares of Series C Preferred Stock held
by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter. Except as provided
by law or by the Certificate of Designation, holders of Series C Preferred Stock will vote together with the holders of Common Stock
as a single class and on an as-converted to Common Stock basis.
Director
Designation Rights
The
Series C Preferred Stock does not have director designation rights.
Conversion
The
Certificate of Designation provides that from and after the issuance date and subject to the terms of the Certificate of Designation,
each share of Series C Preferred Stock is convertible, at any time and from time to time, at the option of the holder into a number of
shares of Common Stock equal to the product of the Series C Conversion Ratio (the “Series C Conversion Ratio”) and the number
of shares of Series C Preferred Stock to be converted. The Series C Conversion Ratio is calculated by dividing the stated value of $ 1,000
per share of Series C Preferred Stock by the Series C Conversion Price (as defined in the Certificate of Designation). The Series C Conversion
Ratio is subject to adjustment in the event of any stock dividend, stock split, combination, or other similar recapitalization which
results in the adjustment of the Series C Conversion Price.
The
aggregate number of shares of Common Stock that may be issued through conversion of all of the Series C Preferred Stock is 23,267,326
shares (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization
affecting such shares).
19
Mandatory
Conversion
Immediately
prior to the Company’s listing of Common Stock on The Nasdaq Stock Market, all outstanding shares of Series C Preferred Stock shall
automatically convert into a number of shares of Common Stock equal to the product of the Series C Conversion Ratio and the number of
shares of Series C Preferred Stock owned by each holder.
Liquidation
Upon
any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of shares of Series C Preferred Stock
then outstanding will be entitled to be paid out of the assets of the Corporation available for distribution to its stockholders on a
pari passu basis with the holders of the Common Stock of the Company.
As
of both June 30, 2025 and December 31, 2024, there were 47,000 shares of Series C Preferred Stock issued and outstanding.
16. RESTRUCTURING EXPENSES
As a result of the established non-coverage
for PancraGEN ® , the Company announced in the first quarter of 2025 that its board of directors had approved a restructuring
and cost-savings plan to reduce operating costs and better align its workforce with the loss of PancraGEN ® . In connection
with this plan, the Company has incurred $ 0.7 million in restructuring expenses for the six months ended June 30, 2025, all of which are
severance and related costs. The expenses were paid in the quarter that they were incurred, and the Company has no restructuring liability
accrued for as of June 30, 2025. For the three months ended June 30, 2025, the Company recorded $ 0.5 million in severance costs that were
charged to sales and marketing expense in the Company’s statement of operations. For the six months ended June 30, 2025, the Company
recorded $ 0.5 million in severance costs that were charged to sales and marketing and $ 0.2 million that were charged to general and administrative
expenses in the Company’s consolidated statement of operations.
17.
RECENT ACCOUNTING STANDARDS
Accounting
Pronouncements Pending
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public
entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income
taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption
permitted. The Company is currently evaluating the impact of the adoption of this standard on its financial statements but does not expect
it to be material.
In
November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures”.
ASU 2024-03 will require disclosure of specific cost and expense information in the notes to the financial statements. Disclosure shall
include inventory purchases, employee compensation, depreciation and intangible asset amortization presented in the face of the income
statement for continuing operations. It shall also include certain amounts already disclosed under GAAP in the same disclosure as other
disaggregation requirements as well as disclose a qualitative description and the amount of selling expenses. ASU 2024-03 will be effective
for the Company in annual periods beginning after December 15, 2026. The amendment contemplates changes in disclosures only and the Company
continues to assess the impacts of the amendment.
20
INTERPACE
BIOSCIENCES, INC
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
FORWARD-LOOKING
STATEMENTS
This
quarterly report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). Statements that are not historical facts, including statements about our plans, objectives, beliefs and expectations, are
forward-looking statements. Forward-looking statements include statements preceded by, followed by or that include the words “believes,”
“expects,” “anticipates,” “plans,” “estimates,” “intends,” “projects,”
“should,” “could,” “may,” “will” or similar words and expressions. These forward-looking
statements are contained throughout this Form 10-Q.
Forward-looking
statements are only predictions and are not guarantees of future performance. These statements are based on current expectations and
assumptions involving judgments about, among other things, future economic, competitive and market conditions and future business decisions,
all of which are difficult or impossible to predict accurately and many of which are beyond our control. These predictions are also affected
by known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from those expressed
or implied by any forward-looking statement. Many of these factors are beyond our ability to control or predict. Our actual results could
differ materially from the results contemplated by these forward-looking statements due to a number of factors. Such factors include,
but are not limited to, the following:
●
our
expectations of future revenues, expenditures, capital or other funding requirements;
●
our
reliance on Medicare reimbursement for our clinical services and our being able to successfully restructure ourselves and maintain
profitability as a result of the decision of the Center for Medicare and Medicaid Services to cease reimbursement coverage of our
PancraGEN ® test on April 24, 2025 which resulted in specimens for first-line fluid chemistry and PancraGEN ®
testing not being accepted by the Company after May 2, 2025;
●
our
secured lender has the right to foreclose on substantially all of our assets if we are unable to timely repay our outstanding obligations;
●
our
dependence on sales and reimbursements from our clinical services for all of our revenue;
●
our
ability to continue to generate sufficient revenue from our clinical service products and other products and/or solutions that we
develop in the future is important for our ability to meet our financial and other targets;
●
our
ability to finance our business on acceptable terms in the future, which may limit the ability to grow our business, develop and
commercialize products and services, develop and commercialize new molecular clinical service solutions and technologies;
●
our
dependence on third parties for the supply of some of the materials used in our clinical services tests;
●
the
potential adverse impact of current and future laws, licensing requirements and governmental regulations upon our business operations,
including but not limited to the evolving U.S. regulatory environment related to laboratory developed tests (“LDTs”),
pricing of our tests and services and patient access limitations;
●
our
reliance on our sales and marketing activities for future business growth and our ability to continue to expand our sales and marketing
activities;
21
●
our
being subject to the controlling interests of our two private equity investors who control,
on an as-converted basis, as of August 1, 2025, an aggregate of 84.0% of our outstanding
shares of Common Stock through their holdings of our Series C Preferred Stock, and this concentration
of ownership may have a substantial influence on our decisions;
●
the
delisting of our Common Stock from Nasdaq has adversely affected and may continue to adversely affect our Common Stock and business
and financial condition;
●
the
effect of the impending removal of our Common Stock on August 18, 2025 from trading on the OTCQX for failure to meet market capitalization
requirements;
●
our
ability to remediate the material weakness identified in our internal control over financial reporting as of June 30, 2025;
●
our
determination to restate prior period consolidated financial statements and its impact on investor confidence and reputational issues;
●
any
impacts from current global, economic, sovereign and political conditions and uncertainties, including the effects of, and uncertainty
regarding, new or proposed tariff or trade regulations;
●
our
ability to implement our business strategy; and
●
the
potential impact of existing and future contingent liabilities on our financial condition.
Please
see Part I – Item 1A – “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31,
2024 filed with the SEC on March 31, 2025, and as amended on April 28, 2025, as well as other documents we file with the SEC from time-to-time,
for other important factors that could cause our actual results to differ materially from our current expectations as expressed in the
forward-looking statements discussed in this Form 10-Q. Because of these and other risks, uncertainties and assumptions, you should not
place undue reliance on these forward-looking statements. In addition, these statements speak only as of the date of the report in which
they are set forth and, except as may be required by law, we undertake no obligation to revise or update publicly any forward-looking
statements for any reason.
OVERVIEW
We
are a fully integrated commercial company that provides molecular diagnostics, bioinformatics and pathology services for evaluation of
risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. We develop
and commercialize genomic tests and related first line assays principally focused on early detection of patients with indeterminate biopsies
and at high risk of cancer using the latest technology.
Impact
of Our Reliance on CMS and Novitas
Along
with many laboratories, we have been negatively impacted by LCD DL39365, which was finalized on April 24, 2025 by our local Medicare
Administrative Contractor, Novitas. This LCD, which governs “Genetic Testing for Oncology,” resulted in the loss of existing
Medicare coverage for one of our molecular tests, PancraGEN ® .
On
January 9, 2025, the Company announced the new LCD established non-coverage for its PancraGEN ® test, and that it would
stop offering the test and would not accept specimens for first-line fluid chemistry and PancraGEN ® testing after February
7, 2025. As a result of the established non-coverage for PancraGEN ® , the Company announced that its board of directors
had approved a restructuring and cost-savings plan to reduce operating costs and better align its workforce with the loss of PancraGEN ® .
22
On
January 27, 2025, the Company announced that CMS had directed its Medicare Administrative Contractors, Novitas and First Coast Service
Options, Inc., to delay implementation of the Genetic Testing for Oncology LCD (L39365), from February 23, 2025 until April 24, 2025.
On April 24, 2025, the Company announced that the LCD would take effect immediately. Because PancraGEN ® is primarily ordered
for Medicare patients, the decision to end reimbursement coverage means that the Company will not be able to continue offering this test.
Specimens for first-line fluid chemistry and PancraGEN ® testing were not accepted by the Company after May 2, 2025. As
a result of the loss of PancraGEN ® , the Company implemented its Restructuring Plan whereby it reduced its workforce and
impacted employees received severance benefits. The Company incurred restructuring and related costs of approximately $0.5 million in
the second quarter of 2025 and approximately $0.7 million for the six months ended June 30, 2025.
Clinical
Services
Our
clinical services business commercializes clinically useful molecular diagnostic tests and molecular pathology services. We commercialize
genomic tests and related first-line assays principally focused on risk-stratification of cancer using the latest technology to help
personalize medicine and improve patient diagnosis and management. Our tests and services provide mutational analysis of genomic material
contained in suspicious cysts, nodules, and lesions with the goal of better informing surgery or surveillance treatment decisions in
patients suspected of thyroid, pancreatic, and other cancers. The molecular diagnostic tests we offer enable healthcare providers to
stratify cancer risk, helping to avoid unnecessary surgical treatment in patients at low risk, while also helping to identify patients
that would benefit from increased surveillance or surgical intervention.
We
currently have three commercialized molecular diagnostic tests in the marketplace: ThyGeNEXT ® , an expanded oncogenic mutation
panel that helps “rule-in” and “rule-out” malignancy in thyroid nodules; ThyraMIR ® v2, used
in combination with ThyGeNEXT ® , which further stratifies thyroid nodules for malignancy risk utilizing a proprietary microRNA
gene expression classifier; and RespriDx ® a genomic test that also utilizes our PathFinderTG ® platform,
to help physicians differentiate metastatic or recurrent lung cancer from the presence of newly formed primary lung cancer.
Revenue
Recognition
Clinical
services derive revenues from the performance of proprietary assays or tests. Our performance obligation is fulfilled upon completion,
review and release of test results to the customer, at which time we bill third-party payers or direct-bill payers for the tests performed.
Under Accounting Standards Codification 606, revenue is recognized based upon the estimated transaction price or net realizable value
(“NRV”), which is determined based on historical collection rates by each payer category for each proprietary test offered.
To the extent that the transaction price includes variable consideration, for all third party and direct-bill payers and proprietary
tests, we estimate the amount of variable consideration that should be included in the transaction price using the expected value method
based on historical experience.
The
ultimate amounts received from the third-party and direct-bill payers and related estimated reimbursement rates are regularly reviewed
and we adjust the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s vary significantly
from our estimates, we adjust the estimates of contractual allowances, which affects net revenue in the period such variances become
known.
Cost
of Revenue
Cost
of revenue consists primarily of the costs associated with operating our laboratory and other costs directly related to our tests. Personnel
costs, which constitute the largest portion of cost of services, include all labor-related costs, such as salaries, bonuses, fringe benefits
and payroll taxes for laboratory personnel. Other direct costs include, but are not limited to, laboratory supplies, certain consulting
expenses, royalty expenses, and facility expenses.
23
CONDENSED
CONSOLIDATED RESULTS OF OPERATIONS
The
following table sets forth, for the periods indicated, certain statements of operations data. The trends illustrated in this table may
not be indicative of future results.
Condensed
Consolidated Results of Continuing Operations for the Quarter Ended June 30, 2025 Compared to the Quarter Ended June 30, 2024 (unaudited,
in thousands)
Three Months Ended June 30,
2025
2025
2024
2024
% to
% to
revenue
revenue
Revenue, net
$
9,232
100.0
%
$
12,042
100.0
%
Cost of revenue
3,956
42.9
%
4,236
35.2
%
Gross profit
5,276
57.1
%
7,806
64.8
%
Operating expenses:
Sales and marketing
2,910
31.5
%
2,887
24.0
%
Research and development
173
1.9
%
146
1.2
%
General and administrative
2,661
28.8
%
2,141
17.8
%
Total operating expenses
5,744
62.2
%
5,174
43.0
%
Operating (loss) income
(468
)
-5.1
%
2,632
21.9
%
Interest accretion expense
-
0.0
%
(12
)
-0.1
%
Note payable interest
(49
)
-0.5
%
(176
)
-1.5
%
Other (expense) income, net
(16
)
-0.2
%
71
0.6
%
(Loss) income from continuing operations before tax
(533
)
-5.8
%
2,515
20.9
%
Provision for income taxes
-
0.0
%
4
0.0
%
(Loss) income from continuing operations
(533
)
-5.8
%
2,511
20.9
%
Loss from discontinued operations, net of tax
(107
)
-1.2
%
(74
)
-0.6
%
Net (loss) income
$
(640
)
-6.9
%
$
2,437
20.2
%
Revenue,
net
Revenue,
net for the three months ended June 30, 2025 decreased by $2.8 million, or 23%, to $9.2 million, compared to $12.0 million for the three
months ended June 30, 2024. The decrease in net revenue was primarily driven by the loss of reimbursement for PancraGEN ®
in April 2025 which resulted in specimens for PancraGEN ® testing no longer being accepted by the Company.
Cost
of revenue
Consolidated
cost of revenue for the three months ended June 30, 2025 was $4.0 million, as compared to $4.2 million for the three months ended June
30, 2024. As a percentage of revenue, cost of revenue increased to 43% for the three months ended June 30, 2025 as compared to 35% in
the comparable prior year period. This increase can be attributed to the decline in revenue mentioned above and fixed costs increasing
overall.
Gross
profit
Consolidated
gross profit was approximately $5.3 million for the three months ended June 30, 2025 and $7.8 million for the three months ended June
30, 2024. The decrease is attributed to the lower revenue discussed above.
24
Sales
and marketing expense
Sales
and marketing expense was approximately $2.9 million for both the three months ended June 30, 2025 and for the three months ended June
30, 2024, respectively. There was approximately $0.5 million in severance and related costs included in the three months ended June 30,
2025. These costs pertained to the loss of PancraGEN ® reimbursement as discussed previously. As a percentage of revenue,
sales and marketing expense was approximately 32% for the three months ended June 30, 2025 and 24% for the three months ended June 30,
2024.
Research
and development
Research
and development expense was approximately $0.2 million for the three months ended June 30, 2025 and $0.1 million for the three months
ended June 30, 2024. As a percentage of revenue, research and development expense increased to 2% from 1% in the comparable prior year
period.
General
and administrative
General
and administrative expense was approximately $2.7 million for the three months ended June 30, 2025 and $2.1 million for the three months
ended June 30, 2024. The increase can be primarily attributed to an increase in professional services costs as well as a $0.2 million asset impairment charge related to lab supplies associated with PancraGEN ® .
Operating
(loss) income
There
was an operating loss from continuing operations of $0.5 million for the three months ended June 30, 2025 as compared to operating income
from continuing operations of $2.6 million for the three months ended June 30, 2024. The decrease in operating income from continuing
operations was primarily attributable to the decrease in revenue associated with the loss of PancraGEN ® reimbursement
and the related severance costs.
Note
payable interest expense
Note
payable interest expense was $49,000 for the three months ended June 30, 2025 and $0.2 million for the three months ended June 30, 2024.
The interest expense was attributable to the Term Loan.
Provision
for income taxes
Income
tax expense was approximately $4,000 for the three months ended June 30, 2024. There was no income tax expense for the three months ended
June 30, 2025.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.1 million for both the three months ended June 30, 2025 and for the three
months ended June 30, 2024, respectively.
25
Condensed
Consolidated Results of Continuing Operations for the Six Months Ended June 30, 2025 Compared to the Six Months Ended June 30, 2024 (unaudited,
in thousands)
Six Months Ended June 30,
2025
2025
2024
2024
% to
% to
revenue
revenue
Revenue, net
$ 20,747
100.0 %
$ 22,219
100.0 %
Cost of revenue
8,101
39.0 %
8,102
36.5 %
Gross profit
12,646
61.0 %
14,117
63.5 %
Operating expenses:
Sales and marketing
5,723
27.6 %
5,707
25.7 %
Research and development
350
1.7 %
283
1.3 %
General and administrative
5,211
25.1 %
4,381
19.7 %
Total operating expenses
11,284
54.4 %
10,371
46.7 %
Operating income
1,362
6.6 %
3,746
16.9 %
Interest accretion expense
-
0.0 %
(30 )
-0.1 %
Note payable interest
(127 )
-0.6 %
(373 )
-1.7 %
Other income (expense), net
4
0.0 %
(12 )
-0.1 %
Income from continuing operations before tax
1,239
6.0 %
3,331
15.0 %
Provision for income taxes
18
0.1 %
8
0.0 %
Income from continuing operations
1,221
5.9 %
3,323
15.0 %
Loss from discontinued operations, net of tax
(214 )
-1.0 %
(178 )
-0.8 %
Net income
$ 1,007
4.9 %
$ 3,145
14.2 %
Revenue,
net
Revenue,
net for the six months ended June 30, 2025 decreased by $1.5 million, or 7%, to $20.7 million, compared to $22.2 million for the six
months ended June 30, 2024. The decrease in net revenue was largely driven by the loss of PancraGEN ® revenue discussed
above.
Cost
of revenue
Consolidated
cost of revenue for both the six months ended June 30, 2025 and June 30, 2024 was $8.1 million, respectively. As a percentage of revenue,
cost of revenue was approximately 39% for the six months ended June 30, 2025 as compared to 37% for the six months ended June 30, 2024.
Gross
profit
Consolidated
gross profit was approximately $12.6 million for the six months ended June 30, 2025 and $14.1 million for the six months ended June 30,
2024. The gross profit percentage was approximately 61% for the six months ended June 30, 3025 and 64% for the six months ended June
30, 2024. The decrease was primarily due to the decrease in PancraGEN ® revenue discussed above.
Sales
and marketing expense
Sales
and marketing expense was approximately $5.7 million for both the six months ended June 30, 2025 and June 30, 2024, respectively. The
six months ended included approximately $0.5 million in employee severance and related costs related to the implementation of the Restructuring
Plan. As a percentage of revenue, sales and marketing expense increased to 28% from 26% in the comparable prior year period due to the
decrease in revenue.
26
Research
and development
Research
and development expense was approximately $0.4 million for the six months ended June 30, 2025 and $0.3 million for the six months June
30, 2024, respectively. As a percentage of revenue, research and development expense increased to 2% from 1% in the comparable prior
year period.
General
and administrative
General
and administrative expense was approximately $5.2 million for the six months ended June 30, 2025 and $4.4 million for the three months
ended June 30, 2024. The increase can be primarily attributed to a $0.2 million asset impairment charge related to lab supplies associated
with PancraGEN ® for the six months ended June 30, 2025 and the reversal of $0.5 million in expense related to the Company’s
former contingent consideration liability for the six months ended June 30, 2024.
Operating
income
Operating
income from continuing operations was $1.4 million for the six months ended June 30, 2025 as compared to operating income from continuing
operations of $3.7 million for the six months ended June 30, 2024. The decrease in operating income from continuing operations was primarily
attributable to the loss of PancraGEN ® revenue discussed above.
Note
payable interest expense
Note
payable interest expense was $0.1 million for the six months ended June 30, 2025 and $0.4 million for the six months ended June 30, 2024.
The interest expense was attributable to the Term Loan.
Provision
for income taxes
Income
tax expense was approximately $18,000 for the six months ended June 30, 2025 and $8,000 for the six months ended June 30, 2024.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.2 million for both the six months ended June 30, 2025 and June 30, 2024,
respectively.
Non-GAAP
Financial Measures
In
addition to the GAAP results provided throughout this document, we have provided certain non-GAAP financial measures to help evaluate
the results of our performance. We believe that these non-GAAP financial measures, when presented in conjunction with comparable GAAP
financial measures, are useful to both management and investors in analyzing our ongoing business and operating performance. We believe
that providing the non-GAAP information to investors, in addition to the GAAP presentation, allows investors to view our financial results
in the way that management views financial results.
In
this Quarterly Report on Form 10-Q, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management
to measure cash flow of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation
and amortization, non-cash stock-based compensation, severance expense, interest and taxes, and other non-cash expenses including change
in fair value of notes payable. The table below includes a reconciliation of this non-GAAP financial measure to the most directly comparable
GAAP financial measure.
27
Reconciliation
of Adjusted EBITDA (Unaudited)
($
in thousands)
Three Months Ended
Six Months Ended
June 30,
June 30,
2025
2024
2025
2024
(Loss) income from continuing operations (GAAP Basis)
$ (533 )
$ 2,511
$ 1,221
$ 3,323
Depreciation and amortization
101
67
196
119
Stock-based compensation
9
53
24
132
Severance & related expense
524
-
692
-
Asset impairment - lab supplies
198
-
198
-
Taxes expense
-
4
18
8
Interest accretion expense
-
12
-
30
Note payable interest
49
176
127
373
Other expense/income, net
10
(14 )
14
(29 )
Change in fair value of note payable
7
(57 )
(18 )
41
Adjusted EBITDA
$ 365
$ 2,752
$ 2,472
$ 3,997
LIQUIDITY
AND CAPITAL RESOURCES
In
October 2021, the Company entered into the Term Loan with BroadOak, providing for a term loan in the aggregate principal amount of $8,000,000.
Funding of the Term Loan took place on November 1, 2021. The Term Loan was scheduled to mature upon the earlier of (i) October 31, 2024
or (ii) the occurrence of a change in control, and bears interest at the rate of 9% per annum. The Term Loan is secured by a security
interest in substantially all the Company’s and its subsidiaries’ assets and was subordinate to the Company’s former
$7,500,000 revolving credit facility with Comerica Bank. The Term Loan has an origination fee of 3% of the Term Loan amount, and a terminal
payment equal to (i) 15% of the original principal amount of the Term Loan if the change of control occurs on or prior to the first anniversary
of the funding of the Term Loan, (ii) 20% of the original principal amount of the Term Loan if the change of control occurs after the
first anniversary but on or prior to the second anniversary of the funding of the Term Loan and (iii) 30% of the original principal amount
of the Term Loan if the change of control occurs after the second anniversary of the funding of the Term Loan, or if the Term Loan is
repaid on its maturity date. Upon receipt of the term loan, the proceeds were used to repay in full at their maturity the notes extended
by Ampersand and 1315 Capital discussed above. See Note 13, Notes Payable, for more details. In May 2022, the Company issued a
Convertible Note to BroadOak, pursuant to which BroadOak funded a term loan in the aggregate principal amount of $2.0 million which was
converted into a subordinated term loan and was added to the outstanding balance of the Term Loan. See Note 13, Notes Payable ,
for more details.
On
October 24, 2023, the Company entered into a Second Amendment to the Loan and Security Agreement with BroadOak (the “Second Amendment”).
The primary changes to the Term Loan were as follows:
●
The
Company made a one-time payment in an aggregate amount equal to $2,500,000, on October 30, 2023 and applied the payment in full satisfaction
of the $3,000,000 Terminal Payment (as defined in the Term Loan). See Note 13, Notes Payable , regarding the Terminal Payment.
●
Effective
November 1, 2023, the interest rate under the Term Loan was reduced from 9% to 8% through the maturity date of October 31, 2024 or
earlier, upon the occurrence of a change in control (“Loan Maturity Date”).
●
The
Company has the option to request an extension of the Loan Maturity Date in writing no less than sixty days prior to the Loan Maturity
Date. If BroadOak agreed to the extension, the Loan Maturity Date would automatically be extended.
28
On
March 29, 2024, the Company entered into a Third Amendment to the Loan and Security Agreement with BroadOak (the “Third Amendment”),
extending the loan maturity date to June 30, 2025. The primary changes to the Second Amendment were as follows:
●
The
maturity date was extended to June 30, 2025.
●
Beginning
April 1, 2024, the Company will make $500,000 monthly payments with the remaining loan balance due on the new maturity date.
On
January 14, 2025, the Company entered into a Fourth Amendment to the Loan and Security Agreement with BroadOak (the “Fourth Amendment”),
extending the loan maturity date to December 31, 2025. The primary changes to the Third Amendment were as follows:
●
The
maturity date was extended to December 31, 2025.
●
Beginning
July 1, 2025, and continuing through December 1, 2025, the Company will make monthly interest-only payments with the remaining loan
balance due on the new maturity date.
The
Term Loan contains affirmative and negative restrictive covenants, including restrictions on certain mergers, acquisitions, investments
and encumbrances which could adversely affect our ability to conduct our business. The Term Loan also contains customary events of default.
The balance of the Term Loan outstanding at June 30, 2025 was $1.9 million.
For
the six months ended June 30, 2025, we had operating income from continuing operations of $1.4 million. As of the six months ended June
30, 2025, we had cash and cash equivalents of $0.5 million, total current assets of $9.5 million and current liabilities of $7.1 million.
As of August 1, 2025, we had approximately $1.0 million of cash and cash equivalents.
During
the six months ended June 30, 2025, net cash provided by operating activities was $1.8 million. The main component of cash provided by
operating activities was our net income of $1.0 million. During the six months ended June 30, 2024, net cash provided by operating activities
was $1.3 million. The main component of cash provided by operating activities was our net income of $2.5 million, partially offset by
an increase in accounts receivable of $1.2 million.
For
both periods net cash used in investing activities of $0.2 million was primarily related to the purchase of lab equipment.
For
the six months ended June 30, 2025, cash used in financing activities was $2.5 million, which were payments made on the Term Loan. For
the six months ended June 30, 2024, cash used in financing activities was $2.6 million, which were payments made on the Term Loan.
We
generated positive cash flows from operations for the six months ending June 30, 2025. We intend to meet our ongoing capital needs by
using our available cash as well as through targeted margin improvement; collection of accounts receivable; containment of costs; and
the potential use of other financing options and other strategic alternatives.
The
Company continues to explore various strategic alternatives, dilutive and non-dilutive sources of funding, including equity and debt
financings, strategic alliances, business development and other sources in order to provide additional liquidity. With the delisting
of the Common Stock from Nasdaq in February 2021, our ability to raise additional capital on terms acceptable to the Company has been
adversely impacted. There can be no assurance that the Company will be successful in obtaining such funding on terms acceptable to the
Company.
29
Further,
along with many laboratories, we have been negatively impacted by the LCD L39365, which was finalized on April 24, 2025 by our local
Medicare Administrative Contractor, Novitas. This LCD, which governs “Genetic Testing for Oncology,” resulted in the loss
of existing Medicare coverage for one of our molecular tests, PancraGEN ® .
On
January 9, 2025, we announced that the new LCD established non-coverage for the Company’s PancraGEN ® test, and that
we would stop offering the test and would not accept specimens for first-line fluid chemistry and PancraGEN ® testing after
February 7, 2025. As a result of the established non-coverage for PancraGEN ® , we announced, in January 2025, that our
board of directors had approved the Restructuring Plan to reduce operating costs and better align our workforce with the loss of PancraGEN ® .
See “Restructuring.”
On
January 27, 2025, the Company announced that CMS had directed its Medicare Administrative Contractors, Novitas and First Coast Service
Options, Inc., to delay implementation of the Genetic Testing for Oncology LCD (L39365), from February 23, 2025 until April 24, 2025.
On April 24, 2025, the Company announced that the LCD would take effect immediately and that specimens for first-line fluid chemistry
and PancraGEN ® testing will not be accepted by the Company after May 2, 2025. On April 25, 2025, the Company announced
implementation of its previously approved Restructuring Plan. The Company has incurred approximately $0.7 million in severance and related
costs as a result of this plan.
Even
with the loss of reimbursement coverage of PancraGEN ® , as of the date of this filing, the Company anticipates that current
cash and cash equivalents and forecasted cash receipts will be sufficient to meet its anticipated cash requirements through the next
twelve months from the date of the filing of this report.
Inflation
We
do not believe that inflation had a significant impact on our results of operations for the periods presented. However, inflation and
supply chain disruptions, whether caused by restrictions or slowdowns in shipping or logistics, increases in demand for certain goods
used in our operations, tariffs, or otherwise, could impact our operations in the near term.
Critical
Accounting Estimates
See
Note 5, Summary of Significant Accounting Policies and Note 16, Recent Accounting Standards to the Interim Financial Statements
included elsewhere in this Quarterly Report on Form 10-Q for information regarding newly adopted and recent accounting pronouncements.
See also Note 1, Nature of Business and Significant Accounting Policies to our financial statements included in our Annual Report
on Form 10-K for the year ended December 31, 2024, as amended, for a discussion of our critical accounting policies. There have been
no material changes to such critical accounting policies. We believe our most critical accounting policies include accounting for revenue
recognition, leases, income taxes and stock-based compensation expense.
Off-Balance
Sheet Arrangements
None.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
As
a smaller reporting company, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information
requested by this Item.
30
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures as
of June 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company
in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods
specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating
the cost-benefit relationship of possible controls and procedures. Disclosure controls and procedures include, without limitation, controls
and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under
the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial
officers, as appropriate, to allow timely decisions regarding required disclosure.
Based
on management’s evaluation of the Company’s disclosure controls and procedures, the principal executive officer and principal
financial officer of the Company have identified a material weakness in the Company’s internal control over financial reporting
in the quarterly period ended December 31, 2024 related to the accruing of royalty expense and the understanding of the complex agreements
associated with the royalties, and have concluded that the Company’s disclosure controls and procedures were not effective as of
June 30, 2025 as a result of such material weakness in the Company’s internal control over financial reporting.
The
Company has adopted a remediation plan, pursuant to which the Company is amending its internal controls to mitigate the material weakness
which was identified by management, including holding quarterly meetings between the accounting department and lab management to discuss
any agreements that may have been entered into during that quarter. The Company believes implementation of these processes and appropriate
testing of their effectiveness will remediate the material weakness in the Company’s internal control over financial reporting.
Changes
in Internal Control over Financial Reporting
Other
than the material weakness and the adoption of the remediation plan discussed above, there has been no change in our internal control
over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter covered
by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
In
addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A, “Risk
Factors” in our Annual Report on Form 10-K of the Company filed with the SEC on March 31, 2025, as amended, and as updated in subsequent filings. These risk factors could materially harm our business, operating results and financial
condition. Additional factors and uncertainties not currently known to us or that we currently consider immaterial also may materially
adversely affect our business, financial condition or future results.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
None.
Item
5. Other Information
None.
31
Item
6. Exhibits
Exhibit
No.
Description
3.1
Conformed version of Certificate of Incorporation of Interpace Biosciences, Inc., as amended most recently by the Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock, effective October 11, 2024, incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q, filed with the SEC on November 8, 2024.
3.2
Amended and Restated Bylaws of Interpace Biosciences, Inc., incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-K, filed with the SEC on November 14, 2019.
31.1*
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1+
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2+
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
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 and contained in Exhibits 101).
*
Filed
Herewith.
+
Exhibits
32.1 and 32.2 are being furnished herewith and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange
Act or otherwise subject to the liability of that section, nor shall such exhibits be deemed to be incorporated by reference to any
registration statement or other document filed under the Securities Act or the Exchange Act, except as otherwise stated in any such
filing.
32
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.
Date:
August 7, 2025
Interpace
Biosciences, Inc.
(Registrant)
/s/
Thomas W. Burnell
Thomas
W. Burnell
President
and Chief Executive Officer
(Principal
Executive Officer)
Date:
August 7, 2025
/s/
Christopher McCarthy
Christopher
McCarthy
Chief
Financial Officer
(Principal
Financial Officer)
33
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.