Interpace Biosciences, Inc 10-K for FY2021

Interpace Biosciences, Inc. (IDXG)

10-K 2022-03-31 For: 2021-12-31

Added on April 06, 2026

About this 10-K

Interpace Biosciences, Inc filed this 10-K on March 31, 2022, covering the fiscal year ended December 31, 2021 (FY2021).

Headline figures

Fiscal year ended December 31, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $41.31M; up 27.5% from $32.4M a year earlier
Net loss: $14.94M; compared with a net loss of $26.45M a year earlier

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Title of each class		Trading Symbol(s)		Name of each exchange on which registered
None		N/A		N/A

Large accelerated filer ☐	Accelerated filer ☐	Non-accelerated filer ☒	Smaller reporting company ☒
Emerging growth company ☐

			Page
PART I
	Item 1.	Business	5
	Item 1A.	Risk Factors	30
	Item 1B.	Unresolved Staff Comments	67
	Item 2.	Properties	67
	Item 3.	Legal Proceedings	67
	Item 4.	Mine Safety Disclosures	67

PART II
	Item 5.	Market for our Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	68
	Item 6.	Selected Financial Data	69
	Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	69
	Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	80
	Item 8.	Financial Statements and Supplementary Data	80
	Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	80
	Item 9A.	Controls and Procedures	80
	Item 9B.	Other Information	81
	Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	81

PART III
	Item 10.	Directors, Executive Officers and Corporate Governance	82
	Item 11.	Executive Compensation	82
	Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	82
	Item 13.	Certain Relationships and Related Transactions, and Director Independence	82
	Item 14.	Principal Accounting Fees and Services	82

PART IV
	Item 15.	Exhibits, Financial Statement Schedules	83
	Item 16.	Form 10-K Summary	89

Signatures			90

	●	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 may cause us to cease or scale back operations;

	●	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 Center 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, which has temporarily had a material adverse effect on our business due to a new billing policy issued by CMS in January 2022 whereby 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; while this decision was subsequently reversed in February 2022, the Company has not yet realized the full cash collection benefit of current and retroactive Thyroid testing and such cash collections may be temporarily reduced or delayed until we resolved the matter with CMS;

	●	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 and such estimates may prove to be incorrect;

	●	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;

	●	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.

Customer Category	Types of Customers	Nature of Services
Clinical services	● Hospitals ● Physicians ● Cancer Centers ● Clinics	Clinical services provide information on diagnosis, prognosis and predicting treatment outcomes of cancers to guide patient management.
	● Commercial laboratories
	● Pathology groups

Pharma services	● Pharmaceutical companies ● Biotech companies ● Contract Research Organizations ● Academic Researchers ● Diagnostic companies	Pharma services provide expert-based collaborative solutions, customized assays and high quality services in support of their pharmaceutical and biotechnology clients’ therapeutic development programs. By deploying deep scientific and medical expertise, pharma services support all phases of drug development and accelerate their clients’ clinical programs.

Cancer Type	Estimated New Cases	Estimated Deaths
Bladder	81,180	17,100
Breast (Female – Male)	287,858 – 2,710	43,250 – 530
Colon and Rectal (Combined)	151,030	52,580
Kidney (Renal Cell and Renal Pelvis)	79,000	13,920
Leukemia (All Type)	60,650	24,000
Liver and Intrahepatic Bile Duct	41,260	30,520
Lung (Including Bronchus)	236,740	130,180
Melanoma	99,780	7,650
Non-Hodgkin’s Lymphoma	80,470	20,250
Pancreatic	62,210	49,830
Prostate	268,490	34,500
Thyroid	43,800	2,230

	●	Expanding our existing commercial products, especially PancraGEN^®, ThyGeNEXT^® and ThyraMIR^®, focusing on personalized medicine and early intervention related to cancer risk;

	●	Accelerating the clinical development and commercialization of BarreGEN^®, our esophageal cancer risk classifier for Barrett’s Esophagus, working with our recently developed Key Opinion Leaders (“KOL’s”) and expanding clinical studies to seek key reimbursement support while seeking partners to collaborate with us;

	●	Implementation of automation and focus on improved operating efficiencies in the clinical laboratories to provide consistent superior quality testing and reporting at reduced costs;

	○	Initiating and expanding studies to demonstrate that our tests are effective;

	○	Meeting standards necessary to be consistent with leading clinical guidelines;

	○	Executing by our internal managed care team;

	○	Collaborating with KOL’s; and

	○	Establishing payer relationship and in-network contracts serving our diagnostic customers.

	●	Targeting synergistic product and service opportunities developed for our clinical customers for use by our pharmaceutical and biotech customers;

	●	Developing and commercializing other related first-line clinical assays and expanding our service offerings such as PanDNA^®, a DNA only version of PancraGEN^®, and markers for aggressive thyroid cancer;

	●	Expanding our commercial sales staff rationally, while supporting our products with high quality data and studies;

	●	Exploring partnering opportunities to acquire new technologies;

	●	Expanding our bioinformatics data collected (currently from over 60,000 patients), utilizing registries to improve our assays and leveraging our data with potential collaborators;

	●	Expanding internationally; and

	●	Expanding our average contract revenue from pharmaceutical and biotech customers by growing our services and product offerings while providing dependable and timely service and unique solutions.

Flow cytometry	Selection of individual antibodies in multiple myeloma, leukemia, lymphomas, and therapy response.

Karyotyping	Genome-wide detection of aberrations at low resolution that have a diagnostic or prognostic significance.

FISH	Fluorescent in-situ hybridization (FISH) probe library for the detection of gene abnormalities in chromosomes indicated in hematological and solid tumors.

Anatomic pathology	Full IHC library with over 180 antibodies available.

Exome sequencing	Sequencing of the protein-encoding genes in a genome.

DNA and RNA sequencing	Sequencing to determine the presence and quantity of RNA or DNA in a specimen.

Next Generation sequencing	Proprietary and custom-designed panels to deep sequence genomic material to identify genetic mutations, substitutions, insertions and deletions, and rearrangements of genetic material.

Cell-free DNA analysis	Multi-gene next generation sequencing panel for lung cancer to detect tumor-derived cell-free DNA obtained from a blood draw.

DNA and RNA microarray	Measures select genomic information for large number of genes simultaneously.

Sanger sequencing	DNA sequencing for validation of next generation sequencing results, and for smaller scale sequencing projects.

Fragment size analysis	Analysis technique where DNA fragments are separated by size and used for mutation detection.

DNA and RNA extraction and purification	Extraction and isolation of DNA and RNA from a wide variety of sample types for immediate testing or for storage.

Biostatistics and Bioinformatics	Design and review of client assays and analysis of datasets.

●	In January 2021, we announced an agreement with Blue Cross Blue Shield of Florida under which ThyGeNEXT^® and ThyraMIR^®tests are now covered in-network services for their 5 million members.

●	In February 2021, we announced an agreement with Blue Cross Blue Shield of Illinois that makes ThyGeNEXT^® and ThyraMIR^®tests covered in-network services for their more than 8 million members in Illinois.

●	In April 2021, we announced that Novitas, our Medicare Administrative Contractor, has agreed to recognize the new Proprietary Laboratory Analysis (“PLA”) code that specifically identifies ThyGeNEXT^® as a distinct test from any other test or service. The new PLA code for ThyGeNEXT^® is 0245U and the reimbursement for this code remains $2,919, representing a significant price increase over the prior reimbursement level of $560.

●	In May 2021, we announced that eviCore Healthcare (“eviCore”), a wholly owned subsidiary of Cigna, has updated their laboratory management guidelines to include positive coverage for ThyGeNEXT^® and ThyraMIR^®. This update, which impacts approximately 27 health plans nationwide covering 100 million lives, is effective on July 1, 2021. This means that after the effective date, claims for ThyGeNEXT and ThyraMIR which meet eviCore’s criteria for coverage will be considered medically necessary and processed as a covered service.

●	In November 2021, CMS announced that it had assigned 0245U for Medicare rate-setting via the gapfill process. Under gapfill, the Medicare payment rate for 0245U will be established by Novitas during CY 2022. Effective January 1, 2023, the Medicare payment rate will be established as the median of the payment amounts established by all Medicare contractors.

	●	denial of payment for the services provided in violation of the prohibition;

	●	refunds of amounts collected by an entity in violation of the Stark Law;

	●	a civil penalty of up to $26,125 for each service arising out of the prohibited referral;

	●	possible exclusion from federal healthcare programs, including Medicare and Medicaid; and

	●	a civil penalty of up to $174,172 against parties that enter into a scheme to circumvent the Stark Law’s prohibition.

	●	Our operating history of net losses, negative working capital and insufficient cash flows, and lack of liquidity to pay our current obligations raise doubts about our ability to continue as a going concern.

	●	The COVID-19 global pandemic may continue to materially and adversely impact our business, financial condition and results of operations.

	●	We have and may continue to experience intangible asset or other long-lived asset impairment charges.

	●	We have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

	●	Due to how we recognize revenue, our quarterly revenue and operating results are likely to fluctuate.

	●	A deterioration in the collectability of our accounts receivable could have a material adverse effect on our business, financial condition and results of operations.

	●	We depend on sales and reimbursements from our clinical services for more than 50% of our revenue, and we will need to generate sufficient revenue from these and other products and/or solutions that we develop or acquire to grow our business.

	●	Two private equity firms and their affiliates’ control, on an as-converted basis, an aggregate of 65% of our outstanding shares of common stock through their holdings of our Series B Preferred Stock, and this concentration of ownership along with their authority for designation rights for a majority of our directors and their right to approve certain of our actions has a substantial influence on our decisions.

	●	Our secured lenders have the right to foreclose on substantially all of our assets if we are unable to timely repay our outstanding obligations.

	●	Billing for our clinical services tests is complex, and we must dedicate substantial time and resources to the billing process to be paid for our clinical services tests.

	●	We depend on a few payers for a significant portion of our revenue for our clinical services, and if one or more significant payers, including CMS, stops providing reimbursement or decreases the amount of reimbursement for our tests, or if we are unable to successfully negotiate additional reimbursement contracts for our clinical services tests, our revenue could decline and our commercial success could be compromised. Our reliance on Medicare reimbursement for our clinical services and our being subject to decisions of the Center 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, which has temporarily had a material adverse effect on our business due to a new billing policy issued by CMS in January 2022 whereby 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; while this decision was subsequently reversed in February 2022, the Company has not yet realized the full cash collection benefit of current and retroactive Thyroid testing and such cash collections may be temporarily reduced or delayed until we resolved the matter with CMS;

	●	We rely on third-parties to process and transmit claims to payers for our clinical services, and any delay in processing or transmitting could have an adverse effect on our revenue and financial condition.

	●	We may experience a decline in demand for our clinical services tests and/or our pharma services products, which may result in a reduction in revenue.

	●	If we are unable to increase sales of our clinical services and the tests and services in our pharma services, we may be unable to achieve profitability.

	●	Our profitability will be impaired by our obligations to make royalty and milestone payments to our licensors for our clinical services tests.

	●	We depend on third parties for the supply of some of the materials used in our clinical and pharma services tests, and we may not be able to find replacements or transition to alternative suppliers in a timely manner.

	●	The markets that our clinical services and pharma services operate in is competitive, and our ability to compete successfully in this market depends on a variety of reasons, including our ability to keep up with rapid technological, medical, and scientific changes or our ability to enter into new clinical study collaborations. If we are unable to compete successfully in the markets our clinical services and pharma services operate in, we may be unable to increase or sustain our revenue or achieve profitability.

	●	If the FDA changes its enforcement policy as to laboratory developed tests (LDTs) or disagrees with our position that our clinical services tests are LDTs covered by the FDA’s current enforcement discretion policy, we could be subject to a number of enforcement actions, any of which could have a material adverse effect on our clinical services and/or incur substantial costs and delays associated with trying to obtain pre-market clearance or approval and comply with applicable post-market requirements.

	●	A failure to comply with federal and state laws and regulations, including but not limited to those laws related to billing practices, fraud, abuse, and payer regulations, could result in our being excluded from participation in Medicare, Medicaid or other governmental payer programs and/or significant monetary fines, and additionally may decrease our revenues and adversely affect our results of operations and financial condition for our clinical services.

	●	We may not realize all of the anticipated benefits of the acquisition of our pharma services or those benefits may take longer to realize than expected.

	●	If we are unable to successfully utilize, integrate, and/or promote our pharma services in the market, we may be unable to generate sufficient revenue to sustain our pharma services.

	●	If we fail to perform our pharma services in accordance with contractual and regulatory requirements, and ethical considerations, we could be subject to significant costs, legal liabilities and could experience a decline in revenue.

	●	The loss of members of our senior management team or our inability to attract and retain key personnel could adversely affect our business.

	●	If we fail to comply with federal, state and foreign laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business.

	●	Legislation reforming the U.S. healthcare system may have a material adverse effect on our financial condition and operations.

	●	If we do not increase our revenues and successfully manage the size of our operations, our business, financial condition and results of operations could be materially and adversely affected.

	●	The risks associated with penny stock classification could affect the marketability of the Company’s common stock and stockholders could find it difficult to sell their shares.

	●	We believe the delisting of our common stock from Nasdaq and trading on OTCQX^® has adversely affected trading in our common stock and our ability to seek financing.

	●	If we are unable to maintain and implement effective internal controls over financial reporting, investors may lose confidence in the accuracy and completeness of our reported financial information and the market price of our common stock may be negatively affected.

	●	uncertainty of cash collections which could impact or affect net realizable values of sales of our tests and services;

	●	inability of one or more of our laboratories to perform tests;

	●	progress or lack of progress in developing and commercializing tests and services;

	●	favorable or unfavorable decisions about our tests or services or reimbursement rates from government regulators, insurances companies, customers, or other third party payers;

	●	the commencement, delay, cancellation or completion of sales and marketing programs;

	●	timing and amount of expenses for implementing new programs and accuracy of estimates of resources required for ongoing programs;

	●	adoption of and coverage and reimbursement for our tests;

	●	changes in our relationships with key collaborators, suppliers, customers and third parties;

	●	fluctuations in net revenue due to changes in the valuation of our patient accounts;

	●	periodic stock-based compensation and awards;

	●	mark to market fluctuations in the valuation of our warrant liabilities;

	●	changes in valuation for contingent consideration related to acquired assets;

	●	fluctuations in R&D, business development and spending for clinical trials;

	●	timing and integration of any acquisitions; and

	●	changes in regulations related to diagnostics, pharmaceutical, biotechnology and healthcare companies.

	●	differences between the list price for our molecular diagnostic tests and the reimbursement rates of payers;

	●	compliance with complex federal and state regulations related to billing Medicare;

	●	changes in billing policy reimbursement by CMS;

	●	disputes among payers as to which party is responsible for payment;

	●	differences in coverage among payers and the effect of patient co-payments or co-insurance;

	●	differences in information and billing requirements among payers;

	●	incorrect or missing billing information;

	●	the resources required to manage the billing and claims appeals process including those of our billing service providers;

	●	our inability to bill timely and accurate requisitions and process denials efficiently may result in delayed collections and reduced reimbursement rates; and

	●	the overall performance and effectiveness of our billing service providers.

	●	expend significant funds to conduct substantial research and development;

	●	conduct successful analytical and clinical studies;

	●	scale our laboratory processes to accommodate new tests and services; and

	●	build and maintain the commercial infrastructure to market and sell new tests and services.

	●	diversion of management’s attention from the management of daily operations to integration matters;

	●	difficulties in achieving anticipated cost savings, synergies, business opportunities and growth prospects from combining our pharma services with our clinical services operations;

	●	difficulties entering new markets or new laboratory or data management services where we have no or limited direct prior experience;

	●	difficulties in the integration of operations and systems;

	●	difficulties in the assimilation of employees and in the retention of key employees;

	●	difficulties in retaining employees who may be vital to the integration of departments, information technology systems, including accounting systems, technologies, books and records, and procedures, and maintaining uniform standards, such as internal accounting controls, procedures, and policies;

	●	difficulties in the assimilation of different corporate cultures and business practices;

	●	difficulties in managing the expanded operations of a significantly larger and more complex company;

	●	potential deterioration in the sales and revenues of the tests and services of our pharma services;

	●	costs and expenses associated with any undisclosed or potential liabilities;

	●	successfully managing relationships with our new strategic partners, suppliers and customer base;

	●	challenges in maintaining existing, and establishing new business relationships; and

	●	challenges as a result of the COVID-19 pandemic.

	●	manage our clinical studies effectively;

	●	integrate additional management, administrative, manufacturing and regulatory personnel;

	●	maintain sufficient administrative, accounting and management information systems and controls; and

	●	hire and train additional qualified personnel.

	●	The Food, Drug and Cosmetic Act, as supplemented by various other statutes;

	●	CLIA and state licensing requirements;

	●	Manufacturing and promotion laws;

	●	Medicare and Medicaid billing and payment regulations applicable to clinical laboratories;

	●	The Eliminating Kickbacks in Recovery Act of 2018 (EKRA), which prohibits the solicitation, receipt, payment or offer of any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory for services covered by both government and private payers;

	●	The Federal Anti-Kickback Statute (and state equivalents), which prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal healthcare program;

	●	The Federal physician self-referral law, commonly referred to as the “Stark Law,” (and state equivalents), which prohibits a physician from making a referral for certain designated health services covered by the Medicare program, including laboratory and pathology services, if the physician or an immediate family member has a financial relationship with the entity providing the designated health services, unless the financial relationship falls within an applicable exception to the prohibition;

	●	HIPAA, which established comprehensive federal standards with respect to the privacy and security of PHI and requirements for the use of certain standardized electronic transactions, and amendments made in 2013 to HIPAA under the Health Information Technology for Economic and Clinical Health Act, which strengthen and expand HIPAA privacy and security compliance requirements, increase penalties for violators, extend enforcement authority to state attorneys general, and impose requirements for breach notification;

	●	The FTC Act and various state consumer privacy laws, which require regulated entities to take reasonable steps to safeguard the personal information of consumers, minimize its use and provide consumers with certain rights as to their personal data such as the right to correct or delete their personal information;

	●	The Federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

	●	The Federal False Claims Act (and state equivalents), which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government;

	●	The federal transparency requirements under the PPACA, including the provisions commonly referred to as the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members;

	●	Other federal and state fraud and abuse laws, prohibitions on self-referral and kickbacks, fee-splitting restrictions, prohibitions on the provision of products at no or discounted cost to induce physician or patient adoption, and false claims acts, transparency, reporting, and disclosure requirements, which may extend to services reimbursable by any third-party payer, including private insurers;

	●	The prohibition on reassignment of Medicare claims, which, subject to certain exceptions, precludes the reassignment of Medicare claims to any other party;

	●	The Protecting Access to Medicare Act of 2014, which requires us to report private payer rates and test volumes for specific CPT codes on a triennial basis and imposes penalties for failures to report, omissions, or misrepresentations;

	●	The rules regarding billing for diagnostic tests reimbursable by the Medicare program, which prohibit a physician or other supplier from marking up the price of the technical component or professional component of a diagnostic test ordered by the physician or other supplier and supervised or performed by a physician who does not “share a practice” with the billing physician or supplier; and

	●	State laws that prohibit other specified practices related to billing such as billing physicians for testing that they order, waiving coinsurance, co-payments, deductibles, and other amounts owed by patients, and billing a State Medicaid program at a price that is higher than what is charged to other payers.

	●	we may not be able to accurately estimate the financial impact of an acquisition on our overall business;

	●	an acquisition may require us to incur debt or other obligations, incur large and immediate write-offs, issue capital stock potentially dilutive to our stockholders or spend significant cash, or may negatively affect our operating results and financial condition;

	●	if we spend significant funds or incur additional debt or other obligations, our ability to obtain financing for working capital or other purposes could decline;

	●	worse than expected performance of an acquired business may result in the impairment of intangible assets;

	●	we may be unable to realize the anticipated benefits and synergies from acquisitions as a result of inherent risks and uncertainties, including difficulties integrating acquired businesses or retaining key personnel, partners, customers or other key relationships, and risks that acquired entities may not operate profitably or that acquisitions may not result in improved operating performance;

	●	we may fail to successfully manage relationships with customers, distributors and suppliers;

	●	our customers may not accept new molecular diagnostic tests or pharma services from our acquired businesses;

	●	we may fail to effectively coordinate sales and marketing efforts of our acquired businesses;

	●	we may fail to combine product offerings and product lines of our acquired businesses timely and efficiently;

	●	an acquisition may involve unexpected costs or liabilities, including as a result of pending and future shareholder lawsuits relating to acquisitions or exercise by stockholders of their statutory appraisal rights, or the effects of purchase accounting may be different from our expectations;

	●	an acquisition may involve significant contingent payments that may adversely affect our future liquidity or capital resources;

	●	accounting for contingent payments requires significant judgment and changes to the assumptions used in determining the fair value of our contingent payments could lead to significant volatility in earnings;

	●	acquisitions and subsequent integration of these companies may disrupt our business and distract our management from other responsibilities; and

	●	the costs of an unsuccessful acquisition may adversely affect our financial performance.

	●	differing information technology, internal control, financial reporting and record-keeping systems;

	●	differences in accounting policies and procedures;

	●	unanticipated additional transaction and integration-related costs;

	●	facilities or operations of acquired businesses in remote locations and the inherent risks of operating in unfamiliar legal and regulatory environments; and

	●	new products, including the risk that any underlying intellectual property associated with such products may not have been adequately protected or that such products may infringe on the proprietary rights of others.

	●	general volatility in the trading markets;

	●	the impact of the delisting of our common stock from Nasdaq and listing on the OTCQX;

	●	adverse research and development results;

	●	significant fluctuations in our quarterly operating results;

	●	significant changes in our cash and cash equivalent reserves;

	●	our liquidity and ability to obtain additional capital, including the market’s reaction to any announced capital-raising transactions;

	●	market assessments of any announced strategic transaction, including the likelihood that it would be completed and the timing for completion;

	●	potential negative market reaction to the terms or volume of any issuance of shares of our common stock, preferred stock or other securities to new investors, pursuant to strategic or capital-raising transactions or to employees, directors or other service providers;

	●	sales of substantial amounts of our common stock, or the perception that substantial amounts of our common stock may be sold, by stockholders in the public market;

	●	announcements regarding our business or the business of our competitors;

	●	announcements regarding our equity offerings;

	●	strategic actions by us or our competitors, such as acquisitions or restructurings;

	●	industry and/or regulatory developments;

	●	changes in revenue mix;

	●	changes in revenue and revenue growth rates for us and for the industries in which we operate;

	●	changes in accounting standards, policies, guidance, interpretations or principles;

	●	statements or changes in opinions, ratings or earnings estimates made, or the failure to make, by brokerage firms or industry analysts relating to the markets in which we operate or expect to operate; and

	●	general market and economic conditions.

	Years Ended December 31,
	2021			2021			2020			2020

Revenue, net	$	41,314			100.0	%	$	32,398			100.0	%
Cost of revenue		23,369			56.6	%		21,673			66.9	%
Gross profit		17,945			43.4	%		10,725			33.1	%
Operating expenses:
Sales and marketing		10,067			24.4	%		9,254			28.6	%
Research and development		1,882			4.6	%		2,795			8.6	%
General and administrative		13,669			33.1	%		18,192			56.2	%
Transition expense		2,585			6.3	%		2,578			8.0	%
Loss on DiamiR transaction		13			0.0	%		-			0.0	%
Acquisition related amortization expense		4,064			9.8	%		4,461			13.8	%
Change in fair value of contingent consideration		(338	)		-0.8	%		(489	)		-1.5	%
Total operating expenses		31,942			77.3	%		36,791			113.6	%

Operating loss		(13,997	)		-33.9	%		(26,066	)		-80.5	%
Interest accretion expense		(496	)		-1.2	%		(549	)		-1.7	%
Related party interest		(424	)		-1.0	%		-			0.0	%
Other (expense) income, net		(496	)		-1.2	%		467			1.4	%
Loss from continuing operations before tax		(15,413	)		-37.3	%		(26,148	)		-80.7	%
(Benefit) provision for income taxes		(667	)		-1.6	%		53			0.2	%
Loss from continuing operations		(14,746	)		-35.7	%		(26,201	)		-80.9	%

Loss from discontinued operations, net of tax		(197	)		-0.5	%		(250	)		-0.8	%

Net loss	$	(14,943	)		-36.2	%	$	(26,451	)		-81.6	%

	Years Ended
	December 31,
	2021			2020
Loss from continuing operations (GAAP Basis)	$	(14,746	)	$	(26,201	)
Bad debt (recovery) expense		(140	)		585
Loss on DiamiR transaction		13			-
Receipt of HHS stimulus grant		-			(650	)
Transition expenses		2,585			2,578
Legal and professional services		-			495
Depreciation and amortization		5,374			5,501
Stock-based compensation		1,368			2,242
Taxes (benefit)/expense		(667	)		53
Interest accretion expense		496			549
Financing interest and related costs		950			-
Mark to market on warrant liability		50			(61	)
Change in fair value of note payable		(58	)		-
Change in fair value of contingent consideration		(338	)		(489	)
Adjusted EBITDA	$	(5,113	)	$	(15,398	)

			Less than		1 to 3		3 to 5		After
	Total		1 Year		Years		Years		5 Years
Operating lease obligations	$	5,085	$	1,295	$	1,464	$	816	$	1,510
Total	$	5,085	$	1,295	$	1,464	$	816	$	1,510

ITEM 9B.	OTHER INFORMATION

	None.

ITEM 9C.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

	Not applicable.

ITEM 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

	Information relating to directors and executive officers of the registrant that is responsive to Item 10 of this Annual Report on Form 10-K will be included in an amendment hereto or will be included in our Proxy Statement for our 2022 annual meeting of stockholders and such information is incorporated by reference herein.

ITEM 11.	EXECUTIVE COMPENSATION

	Information relating to executive compensation of the registrant that is responsive to Item 11 of this Annual Report on Form 10-K will be included in an amendment hereto or will be included in our Proxy Statement for our 2022 annual meeting of stockholders, and such information is incorporated by reference herein.

ITEM 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

	Information relating to security ownership of certain beneficial owners and management of the registrant that is responsive to Item 12 of this Annual Report on Form 10-K will be included in an amendment hereto or will be included in our Proxy Statement for our 2022 annual meeting of stockholders and such information is incorporated by reference herein.