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, 2022
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
Incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
Morris
Corporate Center 1 , Building C
300
Interpace Parkway , 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 5, 2022
Common
Stock, par value $0.01 per share
4,246,297
INTERPACE
BIOSICENCES, INC.
FORM
10-Q FOR PERIOD ENDED JUNE 30, 2022
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, 2022 (unaudited) and December 31, 2021
3
Condensed
Consolidated Statements of Operations for the three- and six-month periods ended June 30, 2022 and 2021 (unaudited)
4
Condensed
Consolidated Statements of Stockholders’ Deficit for the three- and six-month periods ended June 30, 2022 and 2021 (unaudited)
5
Condensed
Consolidated Statements of Cash Flows for the six- month periods ended June 30, 2022 and 2021 (unaudited)
6
Notes
to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
24
Item
3.
Quantitative
and Qualitative Disclosures About Market Risk
34
Item
4.
Controls
and Procedures
34
PART
II - OTHER INFORMATION
Item
1.
Legal
Proceedings
35
Item
1A.
Risk
Factors
35
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds
35
Item
3.
Defaults
Upon Senior Securities
35
Item
4.
Mine
Safety Disclosures
35
Item
5.
Other
Information
35
Item
6.
Exhibits
36
Signatures
37
2
PART
I. FINANCIAL INFORMATION
INTERPACE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)
June
30,
December
31,
2022
2021
(unaudited)
ASSETS
Current
assets:
Cash
and cash equivalents
$ 1,865
$ 3,064
Restricted
cash
250
250
Accounts
receivable, net of allowance for doubtful accounts of $ 72
and $ 72 , respectively
6,446
6,158
Other
current assets
2,697
2,694
Total
current assets
11,258
12,166
Property
and equipment, net
5,970
6,349
Other
intangible assets, net
6,215
7,287
Goodwill
8,433
8,433
Operating
lease right of use assets
3,483
4,032
Other
long-term assets
129
160
Total
assets
$ 35,488
$ 38,427
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
Current
liabilities:
Accounts
payable
$ 3,522
$ 2,694
Accrued
salary and bonus
3,368
3,024
Other
accrued expenses
8,793
9,198
Convertible
debt
2,000
-
Current
liabilities from discontinued operations
766
766
Total
current liabilities
18,449
15,682
Contingent
consideration
762
1,383
Operating
lease liabilities, net of current portion
2,691
3,154
Line of credit
2,500
1,500
Note
payable at fair value
7,782
7,942
Other
long-term liabilities
4,720
4,648
Total
liabilities
36,904
34,309
Commitments
and contingencies (Note 8)
-
-
Redeemable
preferred stock, $ .01 par value; 5,000,000 shares authorized,
47,000 shares Series B issued and outstanding
46,536
46,536
Stockholders’
deficit:
Common
stock, $ .01 par value; 100,000,000 shares authorized;
4,277,317 and 4,228,169 shares issued, respectively;
4,229,948 and 4,195,412 shares outstanding, respectively
404
403
Additional
paid-in capital
186,823
186,106
Accumulated
deficit
( 233,245 )
( 227,059 )
Treasury
stock, at cost ( 47,369 and 32,757 shares, respectively)
( 1,934 )
( 1,868 )
Total
stockholders’ deficit
( 47,952 )
( 42,418 )
Total
liabilities and stockholders’ deficit
( 11,048 )
( 8,109 )
Total
liabilities, preferred stock and stockholders’ deficit
$ 35,488
$ 38,427
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)
2022
2021
2022
2021
Three
Months Ended June 30,
Six
Months Ended June 30,
2022
2021
2022
2021
Revenue,
net
$ 9,351
$ 11,155
$ 19,728
$ 20,989
Cost
of revenue (excluding amortization of $ 535 and $ 1,112 for the three months and $ 1,071 and $ 2,224 for the six months, respectively)
5,850
5,800
11,234
11,116
Gross
profit
3,501
5,355
8,494
9,873
Operating
expenses:
Sales
and marketing
2,774
2,776
5,190
5,128
Research
and development
267
424
566
1,060
General
and administrative
3,907
3,326
7,597
6,362
Transition
expense
61
858
146
2,111
Gain
on DiamiR transaction
-
( 235 )
-
( 235 )
Acquisition
related amortization expense
535
1,112
1,071
2,224
Change
in fair value of contingent consideration
( 311 )
-
( 311 )
( 57 )
Total
operating expenses
7,233
8,261
14,259
16,593
Operating
loss
( 3,732 )
( 2,906 )
( 5,765 )
( 6,720 )
Interest
accretion expense
36
( 135 )
( 85 )
( 270 )
Related
party interest
-
( 163 )
-
( 308 )
Note
payable interest
( 210 )
-
( 390 )
-
Other
income (expense), net
35
( 168 )
194
( 212 )
Loss
from continuing operations before tax
( 3,871 )
( 3,372 )
( 6,046 )
( 7,510 )
Provision
for income taxes
16
16
34
31
Loss
from continuing operations
( 3,887 )
( 3,388 )
( 6,080 )
( 7,541 )
Loss
from discontinued operations, net of tax
( 52 )
( 58 )
( 106 )
( 112 )
Net
loss
$ ( 3,939 )
$ ( 3,446 )
$ ( 6,186 )
$ ( 7,653 )
Basic
and diluted loss per share of common stock:
From
continuing operations
$ ( 0.92 )
$ ( 0.83 )
$ ( 1.44 )
$ ( 1.84 )
From
discontinued operations
( 0.01 )
( 0.01 )
( 0.03 )
( 0.03 )
Net
loss per basic and diluted share of common stock
$ ( 0.93 )
$ ( 0.84 )
$ ( 1.47 )
$ ( 1.87 )
Weighted average number
of common shares and
common share equivalents outstanding:
Basic
4,229
4,102
4,219
4,095
Diluted
4,229
4,102
4,219
4,095
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)
For
The Three and Six
For
The Three and Six
Months
Ended
Months
Ended
June
30, 2022
June
30, 2021
Shares
Amount
Shares
Amount
Common
stock:
Balance
at January 1
4,228
$ 403
4,075
$ 402
Common
stock issued
35
1
9
-
Restricted
stock issued
-
-
12
-
Common
stock issued through ESPP
9
-
36
-
Balance at March
31
4,272
404
4,132
402
Common
stock issued
5
-
10
-
Balance at June 30
4,277
404
4,142
402
Treasury
stock:
Balance at January
1
33
( 1,868 )
20
( 1,773 )
Treasury
stock purchased
13
( 60 )
-
-
Balance at March
31
46
( 1,928 )
20
( 1,773 )
Treasury
stock purchased
1
( 6 )
-
-
Balance at June 30
47
( 1,934 )
20
( 1,773 )
Additional
paid-in capital:
Balance at January
1
186,106
184,404
Common
stock issued
58
108
Stock-based
compensation expense
325
286
Balance at March
31
186,489
184,798
Stock-based
compensation expense
334
551
Balance at June 30
186,823
185,349
Accumulated
deficit:
Balance at January
1
( 227,059 )
( 212,116 )
Net
loss
( 2,247 )
( 4,207 )
Balance at March
31
( 229,306 )
( 216,323 )
Net
loss
( 3,939 )
( 3,446 )
Balance
at June 30
( 233,245 )
( 219,769 )
Balance at March
31
( 229,306 )
( 216,323 )
Net
loss
( 3,939 )
( 3,446 )
Total
stockholders’ deficit
$ ( 47,952 )
$ ( 35,791 )
Ending
balance at June 30
( 47,952 )
( 35,791 )
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)
2022
2021
For
The Six Months Ended June 30,
2022
2021
Cash
Flows From Operating Activities
Net
loss
$ ( 6,186 )
$ ( 7,653 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Depreciation
and amortization
1,571
2,943
Interest
accretion expense
85
270
Bad
debt recovery
-
( 140 )
Mark
to market on warrants
( 68 )
209
Amortization
of deferred financing fees
31
88
Interest
- note payable
-
220
Stock-based
compensation
613
777
ESPP
expense
46
60
Change
in fair value of note payable
( 160 )
-
Change
in fair value of contingent consideration
( 311 )
( 57 )
Gain
on DiamiR transaction
( 235 )
Other
gains and expenses, net
-
( 2 )
Changes
in operating assets and liabilities:
(Increase)
decrease in accounts receivable
( 288 )
841
Increase
in other current assets
( 3 )
( 548 )
Increase
(decrease) in accounts payable
794
( 2,032 )
Increase
(decrease) in accrued salaries and bonus
278
( 719 )
Decrease
in accrued liabilities
( 646 )
( 802 )
Increase
(decrease) in long-term liabilities
72
( 45 )
Net
cash used in operating activities
( 4,172 )
( 6,825 )
Cash
Flows From Investing Activity
Purchase
of property and equipment
( 86 )
( 48 )
Sale
of property and equipment
-
39
Net
cash used in investing activities
( 86 )
( 9 )
Cash
Flows From Financing Activities
Issuance
of common stock, net of expenses
59
108
Loan
proceeds - related parties
-
7,500
Financing
fees - related party
-
( 105 )
Proceeds
from convertible debt
2,000
-
Borrowings
on line of credit
1,000
-
Net
cash provided by financing activities
3,059
7,503
Net
(decrease) increase in cash, cash equivalents and restricted cash
( 1,199 )
669
Cash,
cash equivalents and restricted cash – beginning
3,314
3,372
Cash,
cash equivalents and restricted cash – ending
$ 2,115
$ 4,041
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
INTERPACE
BIOSCIENCES, INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Tabular
information in thousands, except per share amounts)
1.
OVERVIEW
Nature
of Business
Interpace
Biosciences, Inc. (“Interpace” or the “Company”) enables personalized medicine, offering specialized services
along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications and pharma services.
The Company 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 also provides pharmacogenomics
testing, genotyping, biorepository and other specialized services to the pharmaceutical and biotech industries. The Company advances
personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into
their drug development and clinical trial programs.
COVID-19
pandemic
There
continues to be widespread impact from the COVID-19 pandemic. Beginning in the first quarter of 2021, there has been a trend in many
parts of the world of increasing availability and administration of vaccines against COVID-19, as well as an easing of restrictions
on social, business, travel and government activities and functions. On the other hand, infection rates and regulations continue to
fluctuate in various regions and there are ongoing global impacts resulting from the pandemic, including challenges and increases in
costs for logistics and supply chains. We have also previously been affected by temporary laboratory closures,
employment and compensation adjustments and impediments to administrative activities. The level and nature of the disruption caused
by COVID-19 is unpredictable, may be cyclical and long-lasting and may vary from location to location.
In
addition, we have experienced and are experiencing varying levels of inflation resulting in part from various supply chain disruptions,
increased shipping and transportation costs, increased raw material and labor costs and other disruptions caused by the COVID-19 pandemic
and general global economic conditions.
The
continuing impact that the COVID-19 pandemic will have on our operations, including duration, severity and scope, remains highly uncertain
and cannot be fully predicted at this time. While we believe we have generally recovered from the adverse impact that the COVID-19 pandemic
had on our business during 2020, we believe that the COVID-19 pandemic could continue to adversely impact our results of operations,
cash flows and financial condition in the future.
We
continue to monitor the COVID-19 pandemic and the guidance that is being provided by relevant federal, state and local public health
authorities and may take additional actions based upon their recommendations. It is possible that we may have to make adjustments to
our operating plans in reaction to developments that are beyond our control.
Transition
costs
Transition
expenses are primarily related to the Rutherford, New Jersey lab closing and subsequent move to Morrisville, North Carolina, which was
completed during the first half of Fiscal 2021, as well as other cost-saving initiatives consisting primarily of reductions in headcount
and the implementation of a new laboratory information system. To optimize the operations of laboratory operations within our pharma
services, we transitioned activities from the Rutherford facility to our Morrisville facility. The transition included the transfer of
personnel, expansion of the Morrisville facility and validation of transferred processes.
7
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, Interpace Pharma Solutions, Inc. 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, 2021, as filed with the Securities
& Exchange Commission (“SEC”) on March 31, 2022 and as amended on April 29, 2022.
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. and its Commercial Services business unit which was sold on December 22, 2015. All significant intercompany balances and
transactions have been eliminated in consolidation. Operating results for the six-month period ended June 30, 2022 are not necessarily
indicative of the results that may be expected for the fiscal year ending December 31, 2022.
3.
GOING
CONCERN
The
accompanying consolidated financial statements have been prepared on a basis that assumes that the Company will continue as a going concern
and that contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in
the normal course of business. Accordingly, the accompanying consolidated financial statements do not include any adjustments relating
to the recoverability and classification of recorded asset amounts or amounts of liabilities that might result from the outcome of this
uncertainty.
In
October 2021, the Company entered into a $ 7.5
million revolving credit facility with Comerica.
See Note 18, Revolving Line of Credit , for more details. In addition, also in October 2021, the Company entered into the $ 8.0
million BroadOak Term Loan, the proceeds of which
were used to repay in full at their maturity the Ampersand Note and the 1315 Capital Note. In May 2022, the Company entered into a Convertible
Note agreement with BroadOak for an additional $ 2.0
million, which was converted into a subordinated
term loan and was added to the outstanding BroadOak Loan balance. See Note 14, Notes Payable , for more details.
In
January 2022, the Company’s registration statement for a rights offering filed with the Securities and Exchange Commission
(SEC) became effective; however, the rights offering was subsequently terminated later in January 2022 when the Company announced
that the Centers for Medicare & Medicaid Services, or CMS, issued a new billing policy whereby CMS will no longer reimburse for
the use of the Company’s ThyGeNEXT ® and ThyraMIR ® tests when billed together by the same
provider/supplier for the same beneficiary on the same date of service. On February 28, 2022, the Company announced that the
National Correct Coding Initiative (NCCI) program issued a response on behalf of CMS stating that the January 2022 billing policy
reimbursement change for ThyGeNEXT ® (0245U) and ThyraMIR ® (0018U) tests has been retroactively
reversed to January 1, 2022. In May 2022, the Company was notified by CMS/NCCI that processing of claims for dates of service after
January 1, 2022 would be completed beginning July 1, 2022. However, on June 9, 2022, the Company was notified that Novitas re-priced
ThyGeNEXT ® (0245U) from $ 2,919 to
$ 806.59 retroactively
effective to January 1, 2022. On July 20, 2022 the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel affirmed a gapfill
price of $ 806.59 .
As a result of the ThyGeNEXT pricing change, the Company reduced its net realizable value, or NRV rates for ThyGeNEXT Medicare
billing to reflect the $ 806.59 pricing
for tests performed during the second quarter of 2022. In addition, in order to reflect the retroactive pricing change to January 1,
2022, the Company recorded an NRV adjustment of $ 0.7 million
during the second quarter of 2022 to reduce revenue recorded during the first quarter of 2022. During July 2022, the Company began
implementing cost-savings initiatives including a reduction in headcount and incidental expenses and a freeze on all non-essential
travel and hiring.
For
the six months ended June 30, 2022, we had an operating loss of $ 5.8
million. As of June 30, 2022, we had cash, cash
equivalents and restricted cash of $ 2.1
million, total current assets of $ 11.3
million and current liabilities of $ 18.4
million. As of August 5, 2022, we had approximately
$ 2.0 million
of cash on hand, excluding restricted cash.
We
will not generate positive cash flows from operations for the year ending December 31, 2022. We intend to meet our ongoing capital
needs by using our available cash and availability under the Comerica Loan Agreement, as well as through targeted revenue growth and
margin improvement; collection of accounts receivable; containment of costs; and the potential use of other financing options and other strategic alternatives.
However, if we are unable to meet the financial covenants under the Comerica Loan Agreement, the revolving line of credit and notes
payable will become due and payable immediately.
The
Company is currently exploring 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 Company’s
delisting from Nasdaq in February 2021, its 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.
8
Management
has determined that certain factors raise substantial doubt about our ability to continue as a going concern. As of the date of this
filing, the Company currently anticipates that current cash and cash equivalents will be insufficient to meet its anticipated cash
requirements through the next twelve months. These factors include inadequate liquidity to sustain operations, our substantial
debts, margin deterioration and volatility, and historic net losses. Our consolidated financial statements assume we will continue
as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. Our ability to
continue as a going concern depends on having working capital for vendor payments, meeting short-term obligations on other accrued
liabilities, and amongst other requirements, making interest payments on our debt obligations. Without positive operating margins
and sufficient working capital and the ability to meet our debt obligations, our business will be jeopardized and we may not be able
to continue in our current structure, if at all. Under these circumstances, we would likely have to
consider other options, such as selling assets, raising additional debt or equity capital, cutting costs or otherwise reducing our
cash requirements, or negotiating with our creditors to restructure our applicable obligations, including the potential filing of a
petition for relief under the United States Bankruptcy Code (the “Bankruptcy Code”). Such a filing
would subject us to the risks and uncertainties associated with bankruptcy filing proceedings and may place investors in our stock at
significant risk of losing some or all of their investment. In a bankruptcy, holders of our common stock will be subordinated to our
Series B Preferred Stock, which is likely to increase the risk of total loss of investment for holders of our common stock. A
bankruptcy filing by us could cause a material adverse effect on our business, financial condition, results of operations and
liquidity.
4.
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, contingent consideration,
allowances for doubtful accounts, revenue recognition, unrecognized tax benefits, and asset impairments involving other intangible assets.
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
Our
clinical services derive its revenues from the performance of its proprietary assays or tests. The Company’s performance obligation
is fulfilled upon the completion, review and release of test results to the customer. The Company subsequently bills 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, the Company estimates the amount of variable consideration that should be included in the transaction price
using the expected value method based on historical experience.
For
our clinical services, we regularly review the ultimate amounts received from the third-party and direct-bill payers and related estimated
reimbursement rates and adjust the NRV’s and related contractual allowances accordingly. If actual collections and related NRV’s
vary significantly from our estimates, we will adjust the estimates of contractual allowances, which affects net revenue in the period
such variances become known. The Company recorded an NRV adjustment of $ 0.7 million as a reduction of revenue during the second quarter
of 2022 to record the impact on revenue recorded during the first quarter of 2022. See Note 3, Going Concern, for more details.
For
our pharma services, project level activities, including study setup and project management, are satisfied over the life of the contract
while performance-related obligations are satisfied at a point in time as the Company processes samples delivered by the customer. Revenues
are recognized at a point in time when the test results or other deliverables are reported to the customer.
9
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 and in our pharma services, up to sixty 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.
Accounts
Receivable
The
Company’s accounts receivable represent unconditional rights to consideration and are generated using its clinical services and
pharma 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. Pharma services represent, primarily, the performance of laboratory tests in support of clinical trials
for pharma services customers. The Company bills these services directly to the customer.
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, 2022 and December 31, 2021:
SCHEDULE OF OTHER CURRENT ASSETS
June
30, 2022
December
31, 2021
(unaudited)
Lab
supply inventory
$ 2,007
$ 1,786
Prepaid
expenses
582
800
Other
108
108
Total
other current assets
$ 2,697
$ 2,694
10
Long-Lived
Assets, including Finite-Lived Intangible Assets
Finite-lived
intangible assets are stated at cost less accumulated amortization. Amortization of finite-lived acquired intangible assets is recognized
on a straight-line basis, using the estimated useful lives of the assets of approximately two years to ten years in acquisition-related
amortization expense in the condensed consolidated statements of operations.
The
Company reviews the recoverability of long-lived assets and finite-lived intangible assets whenever events or changes in circumstances
indicate that the carrying value of such assets may not be recoverable. If the sum of the expected future undiscounted cash flows is
less than the carrying amount of the asset, an impairment loss is recognized by reducing the recorded value of the asset to its fair
value measured by future discounted cash flows. This analysis requires estimates of the amount and timing of projected cash flows and,
where applicable, judgments associated with, among other factors, the appropriate discount rate. Such estimates are critical in determining
whether any impairment charge should be recorded and the amount of such charge if an impairment loss is deemed to be necessary.
Basic
and Diluted Net 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 loss
per share for the three- and six-month periods ended June 30, 2022 and 2021 is as follows:
SCHEDULE OF BASIC AND DILUTED NET LOSS PER SHARE
2022
2021
2022
2021
Three
Months
Six
Months Ended
Ended
June 30,
June
30,
2022
2021
2022
2021
(unaudited)
(unaudited)
Basic weighted
average number of common shares
4,229
4,102
4,219
4,095
Potential
dilutive effect of stock-based awards
-
-
-
-
Diluted weighted average
number of common shares
4,229
4,102
4,219
4,095
The
Company’s Series B Redeemable Preferred Stock, on an as converted basis into common stock of 7,833,334 shares for the three- and
six-months ended June 30, 2022, and the following outstanding stock-based awards and warrants, were excluded from the computation of
the effect of dilutive securities on 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
Six
Months Ended
Ended
June 30,
June
30,
2022
2021
2022
2021
(unaudited)
(unaudited)
Options
641
747
641
747
Restricted
stock units (RSUs)
351
373
351
373
Warrants
63
1,405
63
1,405
1,055
2,525
1,055
2,525
11
5.
GOODWILL
AND OTHER INTANGIBLE ASSETS
Goodwill
is attributable to the acquisition of our pharma services in July 2019. The carrying value of the intangible assets acquired was $ 15.6
million, with goodwill of approximately $ 8.3 million and identifiable intangible assets of approximately $ 7.3 million. The goodwill balance
at June 30, 2022 was $ 8.4 million. The net carrying value of the identifiable intangible assets from all acquisitions as of June 30,
2022 and December 31, 2021 are as follows:
SCHEDULE OF IDENTIFIABLE INTANGIBLE ASSETS CARRYING VALUE
(Years)
Amount
Amount
As
of June 30, 2022
As
of December 31, 2021
Life
Carrying
Carrying
(Years)
Amount
Amount
(unaudited)
Asuragen
acquisition:
Thyroid
9
$ 8,519
$ 8,519
RedPath
acquisition:
Pancreas
test
7
16,141
16,141
Barrett’s
test
9
6,682
6,682
BioPharma
acquisition:
Trademarks
10
1,600
1,600
Customer
relationships
8
5,700
5,700
CLIA
Lab
2.3
609
609
Total
$ 39,251
$ 39,251
Accumulated
Amortization
( 33,036 )
( 31,964 )
Net
Carrying Value
$ 6,215
$ 7,287
Amortization
expense was approximately $ 0.5 million and $ 1.1 million for the three-month periods ended June 30, 2022 and 2021, and $ 1.1 million and
$ 2.2 million for the six-month periods ended June 30, 2022 and 2021, respectively. Estimated amortization expense for the remainder of
2022 and the next four years is as follows:
SCHEDULE OF FUTURE ESTIMATED AMORTIZATION EXPENSE
2022
2023
2024
2025
2026
$ 1,071
$ 1,734
$ 873
$ 873
$ 873
The
following table displays a roll forward of the carrying amount of goodwill from December 31, 2021 to June 30, 2022:
SCHEDULE OF GOODWILL CARRYING VALUE
Carrying
Amount
Balance
as of December 31, 2021
$ 8,433
Adjustments
-
Balance
as of June 30, 2022
$ 8,433
12
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 contingent consideration, warrant
liability and 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.
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, is set forth in the tables below:
SCHEDULE OF FINANCIAL INSTRUMENT MEASURED ON RECURRING BASIS
As
of June 30, 2022
Fair
Value Measurements
Carrying
Fair
As
of June 30, 2022
Amount
Value
Level
1
Level
2
Level
3
(unaudited)
Liabilities:
Contingent
consideration:
Asuragen
(1)
$ 1,281
$ 1,281
$ -
$ -
$ 1,281
Other
accrued expenses:
Warrant
liability (2)
3
3
-
-
3
Note
payable:
BroadOak
loan
7,782
7,782
-
-
7,782
BroadOak
convertible note
2,000
2,000
-
-
2,000
$ 11,066
$ 11,066
$ -
$ -
$ 11,066
(1)(2)
See
Note 9, Accrued Expenses and Long-Term Liabilities
(1)
See
Note 9, Accrued Expenses and Long-Term Liabilities
(2)
See
Note 9, Accrued Expenses and Long-Term Liabilities
As
of December 31, 2021
Fair
Value Measurements
Carrying
Fair
As
of December 31, 2021
Amount
Value
Level
1
Level
2
Level
3
Liabilities:
Contingent
consideration:
Asuragen
(1)
$ 1,871
$ 1,871
$ -
$ -
$ 1,871
Other
accrued expenses:
Warrant
liability (2)
71
71
-
-
71
Note
payable:
BroadOak
loan
7,942
7,942
-
-
7,942
$ 9,884
$ 9,884
$ -
$ -
$ 9,884
13
(1)(2)
See
Note 9, Accrued Expenses and Long-Term Liabilities
(1)
See
Note 9, Accrued Expenses and Long-Term Liabilities
(2)
See
Note 9, Accrued Expenses and Long-Term Liabilities
In
connection with the acquisition of certain assets from Asuragen, Inc., the Company recorded contingent consideration related to contingent
payments and other revenue-based payments. The Company determined the fair value of the contingent consideration based on a probability-weighted
income approach derived from revenue estimates. The fair value measurement is based on significant inputs not observable in the market
and thus represents a Level 3 measurement.
In
connection with the BroadOak 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 14, 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 Contingent Consideration Liability, 2017 Underwriters’ Warrants and BroadOak Loans to
June 30, 2022 is as follows:
SCHEDULE OF FAIR VALUE, ASSETS MEASURED ON RECURRING BASIS, UNOBSERVABLE INPUT RECONCILIATION
Adjustment
December
31, 2021
Issued
Earned
Accretion/
Interest
Accrued
to
Fair Value/ Mark
to Market
June
30, 2022
(unaudited)
Asuragen
$ 1,871
-
$ ( 364 )
$ 85
$ ( 311 )
$ 1,281
Underwriters
Warrants
71
-
-
( 68 )
3
BroadOak
Loan
7,942
-
-
( 160 )
7,782
BroadOak
Convertible Note
-
2,000
-
-
-
2,000
$ 9,884
$ 2,000
$ ( 364 )
$ 85
$ ( 539 )
$ 11,066
Certain
of the Company’s non-financial assets, such as other intangible assets and goodwill, 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.
7.
LEASES
Finance
lease assets are included in fixed assets, net of accumulated depreciation.
14
The
table below presents the lease-related assets and liabilities recorded in the Condensed Consolidated Balance Sheet:
SCHEDULE OF FINANCING AND OPERATING LEASES
Classification
on the Balance Sheet
June
30, 2022
(unaudited)
Assets
Financing
lease assets
Property
and equipment, net
$ 620
Operating
lease assets
Operating
lease right of use assets
3,483
Total
lease assets
$ 4,103
Liabilities
Current
Financing
lease liabilities
Other
accrued expenses
$ 68
Operating
lease liabilities
Other
accrued expenses
963
Total
current lease liabilities
$ 1,031
Noncurrent
Financing
lease liabilities
Other
long-term liabilities
24
Operating
lease liabilities
Operating
lease liabilities, net of current portion
2,691
Total
long-term lease liabilities
2,715
Total
lease liabilities
$ 3,746
The
weighted average remaining lease term for the Company’s operating leases was 6.3 years as of June 30, 2022 and the weighted average
discount rate for those leases was 6.5 % . 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, 2022:
SCHEDULE OF MATURITIES OF OPERATING AND FINANCING LEASE LIABILITIES
Operating
Leases
Financing
Leases
2022
$ 626
$ 36
2023
897
60
2024
567
-
2025
402
-
2026-2030
1,924
Total
minimum lease payments
4,416
96
Less:
amount of lease payments representing effects of discounting
762
4
Present
value of future minimum lease payments
3,654
92
Less:
current obligations under leases
963
68
Long-term
lease obligations
$ 2,691
$ 24
As
of June 30, 2022, contractual operating lease obligations with terms exceeding one year and estimated minimum future rental payments
required by non-cancelable operating leases with initial or remaining lease terms exceeding one year were as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS UNDER NON-CANCELABLE LEASES
Less
than
1
to 3
3
to 5
After
Total
1
Year
Years
Years
5
Years
Operating
lease obligations
$ 4,416
$ 626
$ 1,464
$ 816
$ 1,510
Total
$ 4,416
$ 626
$ 1,464
$ 816
$ 1,510
15
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.
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.
ACCRUED
EXPENSES AND LONG-TERM LIABILITIES
Other
accrued expenses consisted of the following as of June 30, 2022 and December 31, 2021:
SCHEDULE OF OTHER ACCRUED EXPENSES
June
30, 2022
December
31, 2021
(unaudited)
Accrued
royalties
$ 4,311
$ 3,890
Contingent
consideration
520
488
Operating
lease liability
963
1,041
Financing
lease liability
68
79
Deferred
revenue
18
40
Interest
payable
89
120
Warrant
liability
3
71
Accrued
sales and marketing - diagnostics
41
47
Accrued
lab costs - diagnostics
148
228
Accrued
professional fees
782
932
Taxes
payable
218
245
Unclaimed
property
565
565
All
others
1,067
1,452
Total
other accrued expenses
$ 8,793
$ 9,198
Long-term
liabilities consisted of the following as of June 30, 2022 and December 31, 2021:
SCHEDULE OF LONG TERM LIABILITIES
June
30, 2022
December
31, 2021
(unaudited)
Uncertain
tax positions
$ 4,683
$ 4,577
Deferred
revenue
13
13
Other
24
58
Total
other long-term liabilities
$ 4,720
$ 4,648
16
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 .
The
following table provides the weighted average assumptions used in determining the fair value of the stock option awards granted during
the six-month periods ended June 30, 2022 and 2021.
SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS
June
30, 2022
June
30, 2021
(unaudited)
Risk-free
interest rate
1.76 %
0.78 %
Expected
life
6.0
years
6.0
years
Expected
volatility
129.93 %
134.79 %
Dividend
yield
-
-
During
March 2021, the Company granted 312,500 stock options with an exercise price of $ 6.00 and 152,500 RSUs. The market value of the Company’s
common stock was $ 5.00 at the grant date of these awards. The Company recognized approximately $ 0.3 million and $ 0.6 million of stock-based
compensation expense during the three-month periods ended June 30, 2022 and 2021, respectively and approximately $ 0.7 million and $ 0.8
million of stock-based compensation expense during the six-month periods ended June 30, 2022 and 2021, respectively. The following table
has a breakout of stock-based compensation expense by line item.
SCHEDULE OF SHARE-BASED COMPENSATION ARRANGEMENTS BY SHARE-BASED PAYMENT AWARD
Three
Months Ended
Six
Months Ended
June
30
June
30
2022
2021
2022
2021
(unaudited)
(unaudited)
Cost
of revenue
$ 20
$ 52
$ 47
$ 102
Sales
and marketing
42
78
86
125
Research
and development
-
24
-
59
General
and administrative*
272
397
526
551
Total
stock compensation expense
$ 334
$ 551
$ 659
$ 837
*
Includes
ESPP expense
17
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 loss from continuing operations and the effective tax
rate for the three- and six-month periods ended June 30, 2022 and 2021:
SCHEDULE OF EFFECTIVE INCOME TAX RATE
2022
2021
2022
2021
Three
Months Ended
Six
Months Ended
June
30
June
30
2022
2021
2022
2021
(unaudited)
(unaudited)
Provision
for income tax
$ 16
$ 16
$ 34
$ 31
Effective
income tax rate
( 0.4 )%
( 0.5 )%
( 0.6 )%
( 0.4 )%
Income
tax expense for both the three- and six-month periods ended June 30, 2022 and 2021 was primarily due to minimum state and local taxes.
12.
SEGMENT
INFORMATION
We
operate under one segment which is the business of developing and selling clinical and pharma services.
13.
DISCONTINUED
OPERATIONS
The
components of liabilities classified as discontinued operations consist of the following as of June 30, 2022 and December 31, 2021:
SCHEDULE OF DISCONTINUED OPERATIONS
June
30, 2022
December
31, 2021
(unaudited)
Accrued
liabilities
766
766
Current
liabilities from discontinued operations
766
766
Total
liabilities
$ 766
$ 766
The
table below presents the significant components of its former Commercial Services business unit’s 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, 2022 and 2021.
2022
2021
2022
2021
Three
Months Ended
Six
Months Ended
June
30,
June
30,
2022
2021
2022
2021
(unaudited)
(unaudited)
Income
from discontinued operations, before tax
$ -
$ -
$ -
$ -
Income
tax expense
52
58
106
112
Loss
from discontinued operations, net of tax
$ ( 52 )
$ ( 58 )
$ ( 106 )
$ ( 112 )
18
14.
NOTES
PAYABLE
BroadOak
Loan
On
October 29, 2021, the Company and its subsidiaries entered into a Loan and Security Agreement (the “BroadOak Loan Agreement”)
with BroadOak, providing for a term loan in the aggregate principal amount of $ 8,000,000 (the “Term Loan”). Funding of the
Term Loan took place on November 1, 2021. The Term Loan matures 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 is subordinate to the Company’s $ 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
BroadOak Loan Agreement 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 BroadOak Loan Agreement also contains customary events of default.
In
connection with the BroadOak Loan Agreement, the Company and its subsidiaries entered into that certain First Amendment to Loan and Security
Agreement and Consent with Comerica, dated as of November 1, 2021 (the “Comerica Amendment”), pursuant to which Comerica
consented to the Company’s and its subsidiaries’ entry into the BroadOak Loan Agreement, and amended that certain Loan and
Security Agreement among Comerica, the Company and its subsidiaries (the “Comerica Loan Agreement”) to, among other things,
permit the indebtedness, liens and encumbrances contemplated by the BroadOak Loan Agreement.
As
a condition for BroadOak to extend the Term Loan to the Company and its subsidiaries, the Company’s existing creditor, Comerica,
and BroadOak entered into that certain Subordination and Intercreditor Agreement, dated as of November 1, 2021, pursuant to which BroadOak
agreed to subordinate all of the indebtedness and obligations of the Company and its subsidiaries owing to BroadOak to all of the indebtedness
and obligations of the Company and its subsidiaries owing to Comerica (the “Intercreditor Agreement”). BroadOak further agreed
to subordinate all of its respective security interests in assets or property of the Company and its subsidiaries to Comerica’s
security interests in such assets or property. The Intercreditor Agreement provides that it is solely for the benefit of BroadOak and
Comerica and is not for the benefit of the Company or any of its subsidiaries.
The
Company concluded that the Note 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 shareholders’ equity. Accordingly, the Company elected the fair value option for the Note.
BroadOak
Convertible Note
On
May 5, 2022, the Company issued a Subordinated Convertible Promissory Note (the “Convertible Note”) to BroadOak, pursuant
to which BroadOak funded a term loan in the aggregate principal amount of $ 2 million (the “Convertible Debt”). The Company
is using the proceeds of the Convertible Debt for general corporate purposes and working capital.
The
Convertible Note was to be converted into shares of common stock of the Company in connection with, and upon the consummation of, a private
placement transaction pursuant to which the Company would issue common stock to certain investors, and such conversion would be subject
to the same terms and conditions (including purchase price per share) applicable to the purchase of common stock of the Company by such
investors. Since the private placement transaction was not consummated by August 5, 2022 (the “Maturity Date”), the Convertible
Note will be converted into an additional term loan advance under the Company’s existing BroadOak Loan Agreement on the Maturity
Date and will thereafter be subject to the terms of the definitive financing agreements for the BroadOak Loan Agreement until repaid
in accordance with the terms thereof. The Convertible Debt bears interest at a fixed rate of interest equal to 9.0 %
per annum and is unsecured. There are no scheduled
amortization payments prior to the Maturity Date. The Convertible Note contains customary representations and warranties and customary
events of default. On August 5, 2022, the Convertible Note was converted into a subordinated term loan and was added to the outstanding
BroadOak Loan balance discussed above.
19
In
connection with the issuance of the Convertible Note, on May 5, 2022, the Company and its subsidiaries entered into a) a consent letter
(the “Comerica Consent”) with Comerica, pursuant to which Comerica consented to the issuance of the Convertible Note, the
incurrence of the Convertible Debt and the conversion of the Convertible Debt into common stock of the Company or an additional term
loan advance under the BroadOak Loan Agreement in accordance with the terms of the Convertible Note, and b) a First Amendment to Loan
and Security Agreement and Consent (the “BroadOak Amendment”) with BroadOak, pursuant to which, among other things, BroadOak
consented to the issuance of the Convertible Note, the incurrence of the Convertible Debt and the conversion of the Convertible Debt
into common stock of the Company or an additional term loan advance under the BroadOak Loan Agreement in accordance with the terms of
the Convertible Note.
The
Convertible Debt is subordinated in right of payment to all of the indebtedness and obligations of the Company owing to Comerica under
the Company’s existing senior secured credit facility with Comerica. In connection with the issuance of the Convertible Note, on
May 5, 2022, the Company, BroadOak and Comerica entered into a First Amendment to Subordination and Intercreditor Agreement (the “Intercreditor
Amendment”), pursuant to which, among other things, BroadOak agreed that the Convertible Debt is subordinated to all of the indebtedness
and obligations of the Company owing to Comerica on the same terms and conditions applicable to the indebtedness and obligations of the
Company under the BroadOak Loan Agreement.
Related
Party Secured Promissory Note
On
January 7, 2021, the Company entered into secured promissory notes in the amount of $ 3 million and $ 2 million with Ampersand and 1315
Capital, respectively. On May 10, 2021, the Company amended the Ampersand Note to increase the principal amount to $ 4.5 million and amended
the 1315 Capital Note to increase the principal amount to $ 3.0 million. The maturity dates of the Notes were the earlier of (a) June
30, 2021 and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Notes. On June
24, 2021, the Company and Ampersand amended the Ampersand Note to change its maturity date to the earlier of (a) August 31, 2021 and
(b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Ampersand Note. On June 25,
2021, the Company and 1315 Capital amended the 1315 Capital Note to change its maturity date in a similar manner. On August 31, 2021,
the Company and Ampersand amended the Ampersand Note to change its maturity date to the earlier of (a) September 30, 2021 and (b) the
date on which all amounts become due upon the occurrence of any event of default as defined in the Ampersand Note. On August 31, 2021,
the Company and 1315 Capital amended the 1315 Capital Note to change its maturity date in a similar manner.
On
September 29, 2021, the Company and Ampersand amended the Ampersand Note to change its maturity date to the earlier of (a) October 31,
2021 and (b) the date on which all amounts become due upon the occurrence of any event of default as defined in the Ampersand Note. On
September 29, 2021, the Company and 1315 Capital amended the 1315 Capital Note to change its maturity date in a similar manner. The
Company used the proceeds of the BroadOak Term Loan discussed above to repay in full at their maturity all outstanding indebtedness under
the promissory notes with Ampersand, dated January 7, 2021 and as last amended on September 29, 2021, in the amount of $ 4.5 million,
and 1315 Capital, dated January 7, 2021 and as last amended on September 29, 2021, in the amount of $ 3 million, respectively.
20
15.
SUPPLEMENTAL
CASH FLOW INFORMATION
Supplemental
Disclosures of Non Cash Activities
(in
thousands)
SUPPLEMENTAL CASH FLOW INFORMATION
2022
2021
Six
Months Ended
June
30,
2022
2021
Operating
Taxes
accrued for treasury stock purchased
$ 66
$ -
Investing
Investment
in DiamiR
$ -
$ 248
Purchase
of property and equipment included in accounts payable
34
295
Financing
Accrued
financing costs
$ -
$ 238
16.
EQUITY
Preferred
Stock Issuance: Securities Purchase and Exchange Agreement
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 has a conversion price of $ 6.00 .
In
April 2020, the Company entered into support agreements with each of the Series B Investors, pursuant to which Ampersand and 1315 Capital,
respectively, consented to, and agreed to vote (by proxy or otherwise), all shares of Series B Preferred Stock registered in its name
or beneficially owned by it and/or over which it exercises voting control as of the date of the Support Agreement and any other shares
of Series B Preferred Stock legally or beneficially held or acquired by such Series B Investor after the date of the Support Agreement
or over which it exercises voting control, in favor of any Fundamental Action desired to be taken by the Company as determined by the
Board. For purposes of each Support Agreement, “Fundamental Action” means any action proposed to be taken by the Company
and set forth in Section 4(d)(i), 4(d)(ii), 4(d)(v), 4(d)(vi), 4(d)(viii) or 4(d)(ix) of the Certificate of Designation of Series B Preferred
Stock or Section 8.5.1.1, 8.5.1.2, 8.5.1.5, 8.5.1.6, 8.5.1.8 or 8.5.1.9 of the Amended and Restated Investor Rights Agreement. The support
agreement between the Company and Ampersand was terminated by mutual agreement on July 9, 2020; however, the support agreement entered
into with 1315 Capital remains in effect. During October 2021, Ampersand and 1315 Capital provided consent to the Company to enter into
the Comerica Loan Agreement and the BroadOak Term Loan.
21
As
of June 30, 2022 and December 31, 2021, there were 47,000 Series B issued and outstanding shares of preferred stock, respectively.
17.
WARRANTS
Warrants
outstanding and warrant activity for the six-months ended June 30, 2022 are as follows:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS ACTIVITY
Classification
Exercise
Price
Expiration
Date
Warrants
Issued
Balance
December 31,
2021
Warrants
Exercised
Warrants
Cancelled/ Expired
Balance
June 30,
2022
Equity
$ 46.90
June
2022
85,500
85,500
-
( 85,500 )
-
Equity
$ 46.90
September
2022
10,000
10,000
-
-
10,000
Liability
$ 13.20
December
2022
57,500
53,500
-
-
53,500
Equity
$ 12.50
June
2022
1,437,500
870,214
( 9 )
( 870,205 )
-
Equity
$ 18.00
April
2022
320,000
320,000
-
( 320,000 )
-
Equity
$ 9.40
January
2022
65,434
65,434
-
( 65,434 )
-
1,975,934
1,404,648
( 9 )
( 1,341,139 )
63,500
As
of June 30, 2022, the weighted average exercise price of the outstanding warrants is $ 18.51 and the weighted average remaining contractual
life is approximately 0.4 years.
18.
REVOLVING
LINE OF CREDIT
On
October 13, 2021, the Company and its subsidiaries entered into a Loan and Security Agreement (the “Comerica Loan Agreement”)
with Comerica Bank (“Comerica”), providing for a revolving credit facility of up to $ 7,500,000 (the “Credit Facility”).
The Company may use the proceeds of the Credit Facility for working capital and other general corporate purposes.
The
amount that may be borrowed under the Credit Facility is the lower of (i) the revolving limit of $ 7,500,000 (the “Revolving Line”)
and (ii) 80 % of the Company’s eligible accounts receivable plus an applicable non-formula amount consisting of $ 2,000,000 of additional
availability at close not based upon the Company’s eligible accounts receivable, with such additional availability reducing by
$ 250,000 per quarter beginning with the quarter ending June 30, 2022. Borrowings on the Credit Facility are limited to $ 5,000,000 until
80% of the Company’s and its subsidiaries’ customers are paying into a collection account or segregated governmental account
with Comerica. The Revolving Line can also include, at the Company’s option, credit card services with a sublimit of $ 300,000 .
Borrowings on the Revolving Line are subject to an interest rate equal to prime plus 0.50 % , with prime being the greater of (x) Comerica’s
stated prime rate or (y) the sum of (A) the daily adjusting LIBOR rate plus (B) 2.5 % per annum. The Company is also required to pay an
unused facility fee quarterly in arrears in an amount equal to 0.25 % per annum on the average unused but available portion of the Revolving
Line for such quarter.
22
The
Credit Facility matures on September 30, 2023, and is secured by a first priority lien on substantially all of the assets of the Company
and its subsidiaries. As of June 30, 2022, the balance of the revolving line was $ 2.5 million.
The
Comerica Loan Agreement contains affirmative and negative restrictive covenants that are applicable whether or not any amounts are outstanding
under the Comerica Loan Agreement. These restrictive covenants, which include restrictions on certain mergers, acquisitions, investments,
encumbrances, etc., could adversely affect our ability to conduct our business. The Comerica Loan Agreement also contains financial covenants
requiring specified minimum liquidity and minimum revenue thresholds, which the Company was in compliance with as of June 30, 2022, and
also contains customary events of default. In April 2022, Comerica waived certain covenants specifically relating to the Company receiving
financial statements with a going concern comment or qualification. In April 2022 and August 2022, Comerica waived certain covenants
specifically relating to failure to maintain bank accounts outside of Comerica in an aggregate amount not to exceed $ 0.5 million during
the transition period. Additionally, in August 2022, Comerica waived certain covenants relating to failure to segregate collections
made from government account debtors from collections made from all other account debtors and customers.
As
a condition for Comerica to extend the Credit Facility to the Company and its subsidiaries, the Company’s existing creditors, Ampersand
and 1315 Capital (the “Existing Creditors”), entered into that certain Subordination Agreement, dated as of October 13, 2021,
pursuant to which each Existing Creditor agreed to subordinate all of the indebtedness and obligations of the Company and its subsidiaries
owing to such Existing Creditor to all of the indebtedness and obligations of the Company and its subsidiaries owing to Comerica (the
“Subordination Agreement”). Each Existing Creditor further agreed to subordinate all of its respective security interests
in assets or property of the Company and its subsidiaries to Comerica’s security interests in such assets or property. The Subordination
Agreement provides that it is solely for the benefit of Comerica and each of the Existing Creditors and is not for the benefit of the
Company or any of its subsidiaries.
19.
RECENT
ACCOUNTING STANDARDS
Accounting
Pronouncements Pending Adoption
In
February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments to SEC
Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 119 and Update to SEC Section on Effective Date Related to Accounting Standards
Update No. 2016-02, Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting companies.
ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after December
15, 2022. The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate
a material impact on results of operations. The Company is in the process of determining the effects adoption will have on its consolidated
financial statements.
In
August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging
– Contracts in Entity’s Own Equity (Subtopic 815 – 40), (“ASU 2020-06”). ASU 2020-06 simplifies the accounting
for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on
an entity’s own equity. The ASU 2020-06 amendments are effective for fiscal years beginning after December 15, 2023, and interim
periods within those fiscal years. Early adoption is permitted. The Company does not expect this will have any impact on its consolidated
financial statements.
20.
SUBSEQUENT
EVENTS
BroadOak
Convertible Note
On
August 5, 2022, the Convertible Note was converted into an additional term loan advance under the Company’s existing BroadOak Loan
Agreement. See Note 14, Notes Payable, for more details.
23
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:
●
the
substantial doubt about our ability to continue as a going concern due to our history of operating losses, declining cash position
and other liquidity factors, which in the absence of additional short term financing is causing us to reduce headcount and other
expenses and may cause us to cease or scale back operations; without sufficient working capital and the ability to meet our debt obligations, our business will be jeopardized
and we may not be able to continue in our current structure, if at all. Under these circumstances, we would likely have to consider other
options, such as selling assets, raising additional debt or equity capital, cutting costs or otherwise reducing our cash requirements,
or negotiating with our creditors to restructure our applicable obligations, including the potential filing of a petition for relief under
the United States Bankruptcy Code;
●
the
effect of the Coronavirus (COVID-19) pandemic which has materially and adversely affected our business and financial results, particularly
during portions of 2020, due to the slowdown in demand for our clinical services and pharma services, a reduction in samples received
and testing volume and delayed third party collections and other factors and which may continue to have an adverse effect on our
future business;
●
our
expectations of future revenues, expenditures, capital or other funding requirements;
●
our
reliance on Medicare reimbursement for our clinical services and our being subject to decisions of the Centers for Medicare and Medicaid
Services (“CMS”) regarding reimbursement and pricing of our clinical services which could have a material adverse effect
on our business and financial results, the reduction in reimbursement for our ThyGeNEXT ® test is expected to have
an approximate $5.0 million impact to Fiscal 2022 revenues;
●
our
secured lenders have 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 more than 50% of our revenue; the ability to continue to generate
sufficient revenue from these 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
revenue recognition is based, in part, on our estimates for future collections which may prove to be incorrect with the changes in
reimbursement rates for ThyGeNEXT ® by Medicare causing us to revise our NRV’s which will reduce revenues in
future periods;
●
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 and expand
our pharma services offerings;
24
●
our
obligations to make royalty and milestone payments to our licensors;
●
our
dependence on third parties for the supply of some of the materials used in our clinical and pharma 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;
●
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,
2021 filed with the SEC on March 31, 2022, 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 an emerging leader in enabling precision medicine principally in oncology by offering specialized services along the therapeutic
value chain from early diagnosis and prognostic planning to targeted therapeutic applications through our clinical and pharma services.
Through our clinical services, we enable physicians to personalize the clinical management of each individual patient by providing genomic
information to better diagnose, monitor and inform cancer treatment. Our clinical services provide clinically useful molecular diagnostic
tests, bioinformatics and pathology services for evaluating the risk of cancer by leveraging the latest technology in personalized medicine
for improved patient diagnosis and management. Through our pharma services, we develop, commercialize and provide molecular- and biomarker-based
tests and services and provide companies with customized solutions for patient stratification and treatment selection through an extensive
suite of molecular and biomarker-based testing services, DNA and RNA extraction and customized assay development and trial design consultation.
Our pharma services provide pharmacogenomics testing, genotyping, biorepository and other specialized services to the pharmaceutical
and biotech industries and advance personalized medicine by partnering with pharmaceutical, academic and technology leaders to effectively
integrate pharmacogenomics into drug development and clinical trial programs with the goals of delivering safer, more effective drugs
to market more quickly, and improving patient care.
Impact
of Our Reliance on CMS
In
January 2022, CMS stated they would no longer reimburse for the use of the Company’s ThyGeNEXT ® and ThyraMIR ®
tests when billed together by the same provider/supplier for the same beneficiary on the same date of service. However, on February
28, 2022, the Company announced that the National Correct Coding Initiative (NCCI) program issued a response on behalf of CMS stating
that the January 2022 billing policy reimbursement change for ThyGeNEXT ® (0245U) and ThyraMIR ® (0018U)
tests has been retroactively reversed to January 1, 2022. In May 2022, the Company was notified by CMS/NCCI that processing of claims
for dates of service after January 1, 2022 would be completed beginning July 1, 2022. However, on June 9, 2022, the Company was notified
that Novitas re-priced ThyGeNEXT ® (0245U) from $2,919 to $806.59 retroactively effective to January 1, 2022. On July 20,
2022 the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel affirmed a gapfill price of $806.59. As a result of the ThyGeNEXT
pricing change, the Company reduced its NRV rates for ThyGeNEXT Medicare billing to reflect the $806.59 pricing for tests performed during
the second quarter of 2022. In addition, in order to reflect the retroactive pricing change to January 1, 2022, the Company recorded
an NRV adjustment of $0.7 million during the second quarter of 2022 to reduce revenue recorded during the first quarter of 2022. The
Company estimates the ThyGeNEXT pricing change will negatively impact Fiscal 2022 revenue by approximately $5.0 million. During July
2022, the Company began implementing cost-savings initiatives including a reduction in headcount and incidental expenses and a freeze
on all non-essential travel and hiring. The Company is targeting an overall reduction of approximately $2.7 million in expenses year-over
year by December 31, 2022.
25
Impact
of COVID-19 Pandemic
There
continues to be widespread impact from the COVID-19 pandemic. Beginning in the first quarter of 2021, there has been a trend in many
parts of the world of increasing availability and administration of vaccines against COVID-19, as well as an easing of restrictions on
social, business, travel and government activities and functions. On the other hand, infection rates and regulations continue to fluctuate
in various regions and there are ongoing global impacts resulting from the pandemic, including challenges and increases in costs for
logistics and supply chains. We have also previously been affected by temporary laboratory closures, employment and
compensation adjustments and impediments to administrative activities. The level and nature of the disruption caused by COVID-19 is unpredictable,
may be cyclical and long-lasting and may vary from location to location.
In
addition, we have experienced and are experiencing varying levels of inflation resulting in part from various supply chain disruptions,
increased shipping and transportation costs, increased raw material and labor costs and other disruptions caused by the COVID-19 pandemic
and general global economic conditions.
The
continuing impact that the COVID-19 pandemic will have on our operations, including duration, severity and scope, remains highly uncertain
and cannot be fully predicted at this time. While we believe we have generally recovered from the adverse impact that the COVID-19 pandemic
had on our business during 2020, we believe that the COVID-19 pandemic could continue to adversely impact our results of operations,
cash flows and financial condition in the future.
We
continue to monitor the COVID-19 pandemic and the guidance that is being provided by relevant federal, state and local public health
authorities and may take additional actions based upon their recommendations. It is possible that we may have to make adjustments to
our operating plans in reaction to developments that are beyond our control.
Impact
of the ongoing military conflict between Russia and Ukraine.
In
late February 2022, Russia invaded Ukraine, significantly amplifying already existing geopolitical tensions among Russia and other countries
in the region and in the west, including the U.S. Russia’s invasion, the responses of countries and political bodies to Russia’s
actions, the larger overarching tensions, and Ukraine’s military response and the potential for wider conflict have resulted in
financial market volatility and capital markets disruption, potentially increasing in magnitude, and could have severe adverse effects
on regional and global economic markets and international relations. The extent and duration of the military action, sanctions and resulting
market disruptions, including inflation, are impossible to predict, but could be substantial.
Following
Russia’s actions, various countries, including the U.S., Canada and the United Kingdom, as well as the European Union, issued broad-ranging
economic sanctions against Russia. Such sanctions included, among other things, a prohibition on doing business with certain Russian
companies, officials and oligarchs; a commitment by certain countries and the European Union to remove selected Russian banks from the
Society for Worldwide Interbank Financial Telecommunications (SWIFT) electronic banking network that connects banks globally; a ban on
Russian oil and gas imports to the U.S.; and restrictive measures to prevent the Russian Central Bank from undermining the impact of
the sanctions. The current sanctions (and potential further sanctions in response to continued Russian military activity) and other actions
may have adverse effects on regional and global economic markets and lead to instability and lack of liquidity in capital markets, potentially
making it more difficult for us to obtain additional funds and increasing the volatility of our stock price. Any of the abovementioned
factors could affect our business, prospects, financial condition, and operating results.
26
Revenue
Recognition
Clinical
services derive its revenues from the performance of its 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.
With
respect to our pharma services, customer performance obligations are satisfied at a point in time as the Company processes samples delivered
by the customer. Project level activities, including study setup and project management, are satisfied over the life of the contract.
Revenues are recognized at a point in time when the test results or other deliverables are reported to the customer.
Cost
of Revenue
Cost
of revenue consists primarily of the costs associated with operating our laboratories 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.
Transition
costs
Transition
expenses are primarily related to the Rutherford, New Jersey lab closing and subsequent move to Morrisville, North Carolina, which was
completed during the first half of Fiscal 2021, as well as other cost-saving initiatives consisting primarily of reductions in headcount
and the implementation of a new laboratory information system. To optimize the operations of laboratory operations within our pharma
services, we transitioned activities from the Rutherford facility to our Morrisville facility. The transition included the transfer of
personnel, expansion of the Morrisville facility and validation of transferred processes.
27
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, 2022 Compared to the Quarter Ended June 30, 2021 (unaudited,
in thousands)
Three
Months Ended June 30,
2022
2022
2021
2021
%
to
%
to
revenue
revenue
Revenue,
net
$ 9,351
100.0 %
$ 11,155
100.0 %
Cost of revenue
5,850
62.6 %
5,800
52.0 %
Gross
profit
3,501
37.4 %
5,355
48.0 %
Operating
expenses:
Sales
and marketing
2,774
29.7 %
2,776
24.9 %
Research
and development
267
2.9 %
424
3.8 %
General
and administrative
3,907
41.8 %
3,326
29.8 %
Transition
expense
61
0.7 %
858
7.7 %
Gain
on DiamiR transaction
-
0.0 %
(235 )
-2.1 %
Acquisition
related amortization expense
535
5.7 %
1,112
10.0 %
Change
in fair value of contingent consideration
(311 )
-3.3 %
-
0.0 %
Total
operating expenses
7,233
77.4 %
8,261
74.1 %
Operating
loss
(3,732 )
-39.9 %
(2,906 )
-26.1 %
Interest
accretion expense
36
0.4 %
(135 )
-1.2 %
Related
party interest
-
0.0 %
(163 )
-1.5 %
Note
payable interest
(210 )
-2.2 %
-
0.0 %
Other
income (expense), net
35
0.4 %
(168 )
-1.5 %
Loss
from continuing operations before tax
(3,871 )
-41.4 %
(3,372 )
-30.2 %
Provision
for income taxes
16
0.2 %
16
0.1 %
Loss
from continuing operations
(3,887 )
-41.6 %
(3,388 )
-30.4 %
Loss
from discontinued operations, net of tax
(52 )
-0.6 %
(58 )
-0.5 %
Net
loss
$ (3,939 )
-42.1 %
$ (3,446 )
-30.9 %
Revenue,
net
Consolidated
revenue, net for the three months ended June 30, 2022 decreased by $1.8 million, or 16%, to $9.4 million, compared to $11.2 million for
the three months ended June 30, 2021. The decrease in net revenue was largely driven by the NRV adjustment related to the Medicare pricing
change on ThyGeNEXT ® . The pricing adjustment was retroactive to January 1, 2022 and the impact was approximately $0.7
million for revenue that was attributable to the first quarter.
Cost
of revenue
Consolidated
cost of revenue for the three months ended June 30, 2022 was $5.9 million, as compared to $5.8 million for the three months ended June
30, 2021. As a percentage of revenue, cost of revenue was approximately 63% for the three months ended June 30, 2022 and 52% for the
three months ended June 30, 2021, the percentage increase was due to the decrease in revenue discussed above.
Gross
profit
Consolidated
gross profit was approximately $3.5 million for the three months ended June 30, 2022 and $5.4 million for the three months ended June
30, 2021. The gross profit percentage was approximately 37% for the three months ended June 30, 3022 and 48% for the three months ended
June 30, 2021.
28
Sales
and marketing expense
Sales
and marketing expense was approximately $2.8 million for the three months ended June 30, 2022 and $2.8 million for the three months ended
June 30, 2021. As a percentage of revenue, sales and marketing expense increased to 30% from 25% in the comparable prior year period
due to the decrease in revenue.
Research
and development
Research
and development expense was $0.3 million for the three months ended June 30, 2022 and $0.4 million for the three months ended June 30,
2021. As a percentage of revenue, research and development expense decreased to 3% from 4% in the comparable prior year period.
General
and administrative
General
and administrative expense was approximately $3.9 million for the three months ended June 30, 2022 and $3.3 million for the three months
ended June 30, 2021. The increase can be primarily attributed to an increase in employee compensation costs and an increase in professional
fees.
Transition
expense
Transition
expense was approximately $0.1 million for the three months ended June 30, 2022 and $0.9 million for the three months ended June 30,
2021. In 2021, these expenses were related to the Rutherford, NJ lab closing and subsequent move to North Carolina as well as other cost-saving
initiatives, primarily reductions in headcount. In 2022, these expenses were related to laboratory information management system implementation
costs.
Acquisition
amortization expense
During
the three months ended June 30, 2022 and June 30, 2021, we recorded amortization expense of approximately $0.5 million and $1.1 million,
respectively, which is related to intangible assets associated with prior acquisitions.
Change
in fair value of contingent consideration
During
the three months ended June 30 2022, there was a $0.3 million decrease in the contingent consideration liability due to the impact of
the ThyGeNEXT ® pricing change on future projected revenues.
Operating
loss
Operating
loss from continuing operations was $3.7 million for the three months ended June 30, 2022 as compared to $2.9 million for the three months
ended June 30, 2021. The higher operating loss was primarily attributable to the reduction in revenue discussed above.
Provision
for income taxes
Income
tax expense was approximately $16,000 for the three months ended June 30, 2022 and $16,000 for the three months ended June 30, 2021.
Income tax expense for both periods was primarily driven by minimum state and local taxes.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.1 million for the three months ended June 30, 2022 and a loss from discontinued
operations of approximately $0.1 million for the three months ended June 30, 2021.
29
Condensed
Consolidated Results of Continuing Operations for the Six Months Ended June 30, 2022 Compared to the Six Months Ended June 30, 2021 (unaudited,
in thousands)
Six
Months Ended June 30,
2022
2022
2021
2021
%
to
%
to
revenue
revenue
Revenue,
net
$ 19,728
100.0 %
$ 20,989
100.0 %
Cost of revenue
11,234
56.9 %
11,116
53.0 %
Gross
profit
8,494
43.1 %
9,873
47.0 %
Operating
expenses:
Sales
and marketing
5,190
26.3 %
5,128
24.4 %
Research
and development
566
2.9 %
1,060
5.1 %
General
and administrative
7,597
38.5 %
6,362
30.3 %
Transition
expense
146
0.7 %
2,111
10.1 %
Gain
on DiamiR transaction
-
0.0 %
(235 )
-1.1 %
Acquisition
related amortization expense
1,071
5.4 %
2,224
10.6 %
Change
in fair value of contingent consideration
(311 )
-1.6 %
(57 )
-0.3 %
Total
operating expenses
14,259
72.3 %
16,593
79.1 %
Operating
loss
(5,765 )
-29.2 %
(6,720 )
-32.0 %
Interest
accretion expense
(85 )
-0.4 %
(270 )
-1.3 %
Related
party interest
-
0.0 %
(308 )
-1.5 %
Note
payable interest
(390 )
-2.0 %
-
0.0 %
Other
income (expense), net
194
1.0 %
(212 )
-1.0 %
Loss
from continuing operations before tax
(6,046 )
-30.6 %
(7,510 )
-35.8 %
Provision
for income taxes
34
0.2 %
31
0.1 %
Loss
from continuing operations
(6,080 )
-30.8 %
(7,541 )
-35.9 %
Loss
from discontinued operations, net of tax
(106 )
-0.5 %
(112 )
-0.5 %
Net
loss
$ (6,186 )
-31.4 %
$ (7,653 )
-36.5 %
Revenue,
net
Consolidated
revenue, net for the six months ended June 30, 2022 decreased by $1.3 million, or 6%, to $19.7 million, compared to $21.0 million for
the three months ended June 30, 2021. The decrease in net revenue was largely driven by the NRV adjustment related to the Medicare pricing
change on ThyGeNEXT ® discussed above.
Cost
of revenue
Consolidated
cost of revenue for the six months ended June 30, 2022 was $11.2 million, as compared to $11.1 million for the six months ended June
30, 2021. As a percentage of revenue, cost of revenue was approximately 57% for the six months ended June 30, 2022 and 53% for the six
months ended June 30, 2021, the percentage increase was due to the decrease in revenue discussed above.
Gross
profit
Consolidated
gross profit was approximately $8.5 million for the six months ended June 30, 2022 and $9.9 million for the six months ended June 30,
2021. The gross profit percentage was approximately 43% for the six months ended June 30, 3022 and 47% for the six months ended June
30, 2021. The decrease was a result of the NRV pricing adjustment discussed above.
30
Sales
and marketing expense
Sales
and marketing expense was approximately $5.2 million for the six months ended June 30, 2022 and $5.1 million for the six months ended
June 30, 2021. As a percentage of revenue, sales and marketing expense increased to 26% from 24% in the comparable prior year period
primarily due to the decrease in revenue.
Research
and development
Research
and development expense was $0.6 million for the six months ended June 30, 2022 and $1.1 million for the six months ended June 30, 2021.
As a percentage of revenue, research and development expense decreased to 3% from 5% in the comparable prior year period.
General
and administrative
General
and administrative expense was approximately $7.6 million for the three months ended June 30, 2022 and $6.3 million for the three months
ended June 30, 2021. The increase can be primarily attributed to an increase in employee compensation costs and an increase in professional
fees.
Transition
expense
Transition
expense was approximately $0.1 million for the six months ended June 30, 2022 and $2.1 million for the six months ended June 30, 2021.
In 2021, these expenses were related to the Rutherford, NJ lab closing and subsequent move to North Carolina as well as other cost-saving
initiatives, primarily reductions in headcount. In 2022, these expenses were related to laboratory information management system implementation
costs.
Acquisition
amortization expense
During
the six months ended June 30, 2022 and June 30, 2021, we recorded amortization expense of approximately $1.1 million and $2.2 million,
respectively, which is related to intangible assets associated with prior acquisitions.
Change
in fair value of contingent consideration
During
the six months ended June 30 2022, there was a $0.3 million decrease in the contingent consideration liability and a $0.1 million decrease
for the six months ended June 30, 2021.
Operating
loss
Operating
loss from continuing operations was $5.8 million for the six months ended June 30, 2022 as compared to $6.7 million for the six months
ended June 30, 2021. The lower operating loss was primarily attributable to the reduction in transition expenses discussed above.
Provision
for income taxes
Income
tax expense was approximately $34,000 for the six months ended June 30, 2022 and $31,000 for the six months ended June 30, 2021. Income
tax expense for both periods was primarily driven by minimum state and local taxes.
Loss
from discontinued operations, net of tax
We
had a loss from discontinued operations of approximately $0.1 million for the six months ended June 30, 2022 and a loss from discontinued
operations of approximately $0.1 million for the six months ended June 30, 2021.
Non-GAAP
Financial Measures
In
addition to the United States generally accepted accounting principles, or GAAP, results provided throughout this document, we have provided
certain non-GAAP financial measures to help evaluate the results of our performance. We believe that these non-GAAP financial measures,
when presented in conjunction with comparable GAAP financial measures, are useful to both management and investors in analyzing our ongoing
business and operating performance. We believe that providing the non-GAAP information to investors, in addition to the GAAP presentation,
allows investors to view our financial results in the way that management views financial results.
31
In
this 10-Q, we discuss Adjusted EBITDA, a non-GAAP financial measure. Adjusted EBITDA is a metric used by management to measure cash flow
of the ongoing business. Adjusted EBITDA is defined as income or loss from continuing operations, plus depreciation and amortization,
acquisition related expenses, transition expenses, noncash stock based compensation, interest and taxes, and other non-cash expenses
including asset impairment costs, bad debt expense, loss on extinguishment of debt, goodwill impairment and change in fair value of contingent
consideration, and warrant liability. The table below includes a reconciliation of this non-GAAP financial measure to the most directly
comparable GAAP financial measure.
Reconciliation
of Adjusted EBITDA (Unaudited)
($
in thousands)
Three
Months Ended
Six
Months Ended
June
30,
June
30,
2022
2021
2022
2021
Loss
from continuing operations (GAAP Basis)
$ (3,887 )
$ (3,388 )
$ (6,080 )
$ (7,541 )
Bad
debt (recovery) expense
-
-
-
(140 )
Transition
expenses
61
858
146
2,111
Depreciation
and amortization
790
1,411
1,571
2,943
Stock-based
compensation
334
551
659
837
Tax
expense
16
16
34
31
Interest
accretion expense
(36 )
135
85
270
Financing
interest and related costs
210
163
390
308
Gain
on DiamiR transaction
-
(235 )
-
(235 )
Mark
to market on warrant liability
(5 )
168
(68 )
209
Change
in fair value of note payable
(53 )
-
(160 )
-
Change
in fair value of contingent consideration
(311 )
-
(311 )
(57 )
Adjusted
EBITDA
$ (2,881 )
$ (321 )
$ (3,734 )
$ (1,264 )
LIQUIDITY
AND CAPITAL RESOURCES
The
accompanying consolidated financial statements have been prepared on a basis that assumes that the Company will continue as a going concern
and that contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in
the normal course of business. Accordingly, the accompanying consolidated financial statements do not include any adjustments relating
to the recoverability and classification of recorded asset amounts or amounts of liabilities that might result from the outcome of this
uncertainty.
In
October 2021, the Company and its subsidiaries entered into a Loan and Security Agreement (the “Comerica Loan Agreement”)
with Comerica Bank (“Comerica”), providing for a revolving credit facility of up to $7,500,000 (the “Credit Facility”).
The Company may use the proceeds of the Credit Facility for working capital and other general corporate purposes.
The
amount that may be borrowed under the Credit Facility is the lower of (i) the revolving limit of $7,500,000 (the “Revolving Line”)
and (ii) 80% of the Company’s eligible accounts receivable plus an applicable non-formula amount consisting of $2,000,000 of additional
availability at close not based upon the Company’s eligible accounts receivable, with such additional availability reducing by
$250,000 per quarter beginning with the quarter ending June 30, 2022. Borrowings on the Credit Facility are limited to $5,000,000 until
80% of the Company’s and its subsidiaries’ customers are paying into a collection account or segregated governmental account
with Comerica. The Revolving Line can also include, at the Company’s option, credit card services with a sublimit of $300,000.
Borrowings on the Revolving Line are subject to an interest rate equal to prime plus 0.50%, with prime being the greater of (x) Comerica’s
stated prime rate or (y) the sum of (A) the daily adjusting LIBOR rate plus (B) 2.5% per annum. The Company is also required to pay an
unused facility fee quarterly in arrears in an amount equal to 0.25% per annum on the average unused but available portion of the Revolving
Line for such quarter. See Note 18, Revolving Line of Credit , for more details. Comerica has a first priority security interest
in substantially all of the Company’s and its subsidiaries’ assets.
32
In
addition, also in October 2021, the Company entered into a Loan and Security Agreement (the “BroadOak Loan Agreement”) with
BroadOak, providing for a term loan in the aggregate principal amount of $8,000,000 (the “Term Loan”). Funding of the Term
Loan took place on November 1, 2021. The Term Loan matures 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 is subordinate to the Company’s $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 14, 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. See Note 14, Notes Payable , for
more details. The Company will use the proceeds of the Convertible Debt for general corporate purposes and working capital.
The
BroadOak Loan Agreement 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 BroadOak Loan Agreement also contains
customary events of default. The Comerica Loan Agreement contains affirmative and negative restrictive covenants that are applicable
whether or not any amounts are outstanding under the Comerica loan agreement. These restrictive covenants, which include restrictions
on certain mergers, acquisitions, investments, encumbrances, etc., could adversely affect our ability to conduct our business. The Comerica
Loan Agreement also contains financial covenants requiring specified minimum liquidity and minimum revenue thresholds and also contains
customary events of default. However, if we are unable to meet the financial covenants under the Comerica Loan Agreement, the revolving
line of credit and notes payable will become due and payable immediately.
In
January 2022, the Company’s registration statement for a rights offering filed with the Securities and Exchange Commission (SEC)
became effective; however, the rights offering was subsequently terminated later in January 2022 when the Company announced that the
Centers for Medicare & Medicaid Services, or CMS, issued a new billing policy whereby CMS will no longer reimburse for the use of
the Company’s ThyGeNEXT ® and ThyraMIR ® tests when billed together by the same provider/supplier for
the same beneficiary on the same date of service. On February 28, 2022, the Company announced that the National Correct Coding Initiative
(NCCI) program issued a response on behalf of CMS stating that the January 2022 billing policy reimbursement change for ThyGeNEXT ®
(0245U) and ThyraMIR ® (0018U) tests has been retroactively reversed to January 1, 2022. In May 2022, the Company
was notified by CMS/NCCI that processing of claims for dates of service after January 1, 2022 would be completed beginning July 1, 2022.
However, on June 9, 2022, the Company was notified that Novitas re-priced ThyGeNEXT ® (0245U) from $2,919 to $806.59 retroactively
effective to January 1, 2022. On July 20, 2022 the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel affirmed a gapfill price
of $806.59. As a result of the ThyGeNEXT pricing change, the Company reduced its net realizable value, or NRV rates for ThyGeNEXT Medicare
billing to reflect the $806.59 pricing for tests performed during the second quarter of 2022. In addition, in order to reflect the retroactive
pricing change to January 1, 2022, the Company recorded an NRV adjustment of $0.7 million during the second quarter of 2022 to reduce
revenue recorded during the first quarter of 2022. During July 2022, the Company began implementing cost-savings initiatives including
a reduction in headcount and incidental expenses and a freeze on all non-essential travel and hiring.
For
the six months ended June 30, 2022, we had an operating loss of $5.8 million. As of June 30, 2022, we had cash and cash equivalents of
$1.9 million, net of restricted cash, total current assets of $11.0 million, net of restricted cash, and current liabilities of $18.4
million. As of August 5, 2022, we had approximately $2.0 million of cash on hand, net of restricted cash.
During
the six months ended June 30, 2022, net cash used in operating activities was $4.2 million. The main component of cash used in operating
activities was our net loss of $6.2 million, partially offset by depreciation and amortization expense of $1.6 million. During
the six months ended June 30, 2021, net cash used in operating activities was $6.8 million. The main component of cash used in operating
activities was our net loss of $7.7 million.
For
the six months ended June 30, 2022, cash provided from financing activities was $3.1 million, of which $1.0 million was from the drawdown
on the revolving line of credit and $2.0 million was the Convertible Debt agreement entered into with BroadOak. See Note 14, Notes
Payable, for more details. For the six months ended June 30, 2021, cash provided from financing
activities was $7.5 million, of which $7.4 million were the net proceeds from the Company’s secured promissory notes with Ampersand
and 1315. See Note 14, Notes Payable, for more details.
We
will not generate positive cash flows from operations for the year ending December 31, 2022. We intend to meet our ongoing capital needs
by using our available cash and availability under the Comerica Loan Agreement, as well as through targeted revenue growth and margin
improvement; collection of accounts receivable; containment of costs; and the potential use of other financing options and other strategic
alternatives. However, if we are unable to meet the financial covenants under the Comerica Loan Agreement, the revolving line of credit
and notes payable will become due and payable immediately.
The
Company is currently exploring 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 Company’s
delisting from Nasdaq in February 2021, its 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.
33
Management
has determined that certain factors raise substantial doubt about our ability to continue as a going concern. As of the date of this
filing, the Company currently anticipates that current cash and cash equivalents will be insufficient to meet its anticipated cash requirements
through the next twelve months. These factors include inadequate liquidity to sustain operations, our substantial debts, margin deterioration
and volatility, and historic net losses. Our consolidated financial statements assume we will continue as a going concern and do not
include any adjustments that might result from the outcome of this uncertainty. Our ability to continue as a going concern depends on
having working capital for vendor payments, meeting short-term obligations on other accrued liabilities, and amongst other requirements,
making interest payments on our debt obligations. Without positive operating margins and sufficient working capital and the ability to
meet our debt obligations, our business will be jeopardized and we may not be able to continue in our current structure, if at all. Under
these circumstances, we would likely have to consider other options, such as selling assets, raising additional debt or equity capital,
cutting costs or otherwise reducing our cash requirements, or negotiating with our creditors to restructure our applicable obligations,
including the potential filing of a petition for relief under the United States Bankruptcy Code (the “Bankruptcy Code”).
Such a filing would subject us to the risks and uncertainties associated with bankruptcy filing proceedings and may place investors in
our stock at significant risk of losing some or all of their investment. In a bankruptcy, holders of our common stock will be subordinated
to our Series B Preferred Stock, which is likely to increase the risk of total loss of investment for holders of our common stock. A
bankruptcy filing by us could cause a material adverse effect on our business, financial condition, results of operations and liquidity.
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, or otherwise, could impact our operations in the near term.
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.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures pursuant to Rule 13a-15 under the Exchange Act as of the end of the period covered by this Form 10-Q. In designing
and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed
and operated, can provide only reasonable assurance of achieving the desired control objectives including that information we are required
to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time
periods specified in the SEC rules and forms, and that such information is accumulated and communicated to our management, including
our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In
addition, management is required to apply its judgment in evaluating the benefits of possible disclosure controls and procedures relative
to their costs to implement and maintain.
Based
on the evaluation of the Company’s disclosure controls and procedures, as that term is defined in Rule 13a-15(e) under the Exchange
Act the Chief Executive Officer of the Company and the Chief Financial Officer of the Company have concluded that the Company’s
disclosure controls and procedures were effective as of June 30, 2022.
Reference
should be made to our Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022 for additional information
regarding discussion of the effectiveness of the Company’s controls and procedures.
Changes
in Internal Controls
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.
34
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
Not
applicable as we are a smaller reporting company.
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.
35
Item
6. Exhibits
Exhibit
No.
Description
3.1
Conformed
version of Certificate of Incorporation of Interpace Biosciences, Inc., as amended by the Certificate of Amendment, effective January
15, 2020, and the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock, filed
January 17, 2020, incorporated by reference to Exhibit 3.1 of the Company’s Annual Report on Form 10-K for the year ended December
31, 2019, filed with the SEC on April 22, 2020, as amended from time to time.
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.
10.1*&
Robert Gorman Letter Agreement dated April 16, 2020
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
The
following financial information from this Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 formatted in XBRL
(Extensible Business Reporting Language) and furnished electronically herewith: (i) the Condensed Consolidated Balance Sheets; (ii)
the Condensed Consolidated Statements of Operations; (iii) the Condensed Consolidated Statements of Stockholders’ Deficit;
(iv) the Condensed Consolidated Statements of Cash Flows; and (v) the Notes to Condensed Consolidated Financial Statements.
+
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.
&
Denotes
compensatory plan, compensation arrangement or management contract.
*
Filed
herewith
36
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 15, 2022
Interpace
Biosciences, Inc.
(Registrant)
/s/
Thomas W. Burnell
Thomas
W. Burnell
President
and Chief Executive Officer
(Principal
Executive Officer)
Date:
August 15, 2022
/s/
Thomas Freeburg
Thomas
Freeburg
Chief
Financial Officer
(Principal
Financial Officer)
37
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.