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What changed in Axe Compute Inc.'s 10-K2022 vs 2023

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Paragraph-level year-over-year comparison of Axe Compute Inc.'s 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+414 added525 removedSource: 10-K (2024-03-28) vs 10-K (2023-03-21)

Top changes in Axe Compute Inc.'s 2023 10-K

414 paragraphs added · 525 removed · 139 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

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Biggest changeCosts related to such shipping and handling billing are classified as cost of goods sold. This revenue stream is reported under the Skyline reportable segment. Revenue from Clinical Testing C linic diagnostic testing is comprised of our Tumor Drug Response Testing (ChemoFx) and Genomic Profiling (BioSpeciFx) tests.
Biggest changeClinical diagnostic testing is comprised of our Tumor Drug Response Testing (ChemoFx™), Genomic Profiling Testing (BioSpeciFx), and other biomarker tests.
The Tumor Drug Response Testing test determines how a patient’s tumor specimen reacts to a panel of various chemotherapy drugs, while the Genomic Profiling test evaluates the expression and/or status of a particular gene related to a patient’s tumor specimen.
The Tumor Drug Response Testing test determines how a patient’s tumor specimen reacts to a panel of various chemotherapy drugs, while the Genomic and biomarker profiling evaluates the expression and/or status of a particular gene or protein related to a patient’s tumor specimen.
The Soluble segment provides services using a self-contained, automated system that conducts high-throughput, self-interaction chromatography screens, using additives and excipients commonly included in protein formulations resulting in soluble and physically stable formulations for biologics. The Skyline segment consists of the STREAMWAY System product sales.
In our second business area, we provide services and research using a proprietary self-contained and automated system that conducts high-throughput, self-interaction chromatography screens using additives and excipients commonly included in protein formulations resulting in soluble and physically stable formulations of biologics.
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CONSOLIDATED BALANCE SHEETS December 31, 2022 December 31, 2021 ASSETS Current Assets: Cash and cash equivalents $ 22,071,523 $ 28,202,615 Accounts Receivable 331,196 354,196 Inventories 430,493 387,684 Prepaid Expense and Other Assets 526,801 513,778 Total Current Assets 23,360,013 29,458,273 Fixed Assets, net 1,833,255 2,511,571 Intangibles, net 253,865 3,962,118 Operating Lease Right-of-Use Assets 211,893 814,454 Other Long-Term Assets 75,618 167,065 Goodwill - 6,857,790 Total Assets $ 25,734,644 $ 43,771,271 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts Payable $ 943,452 $ 1,021,774 Accrued Expenses and other liabilities 2,229,075 1,262,641 Derivative Liability 13,833 129,480 Contract Liabilities 602,073 186,951 Operating Lease Liability – Net of Long-Term Portion 94,237 639,662 Total Current Liabilities 3,882,670 3,240,508 Other Long-Term Liabilities - 25,415 Operating Lease Liability, long-term portion 86,082 239,664 Total Liabilities 3,968,752 3,505,587 Stockholders’ Equity: Preferred Stock, 20,000,000 authorized inclusive of designated below - - Series B Convertible Preferred Stock, $ .01 par value, 2,300,000 authorized, 79,246 shares outstanding 792 792 Common Stock, $ .01 par value, 200,000,000 authorized, 78,762,701 and 65,614,597 outstanding 787,627 656,146 Additional Paid-in Capital 174,755,389 167,649,028 Accumulated Deficit (153,777,916 ) (128,040,282 ) Total Stockholders' Equity 21,765,892 40,265,684 Total Liabilities and Stockholders' Equity $ 25,734,644 $ 43,771,271 See Notes to Consolidated Financial Statements F-4 PREDICTIVE ONCOLOGY INC.
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ITEM 1. BUSINESS. General References in this annual report on Form 10-K to “ Predictive ” , “ Company ” , “ we ” , “ us ” , and “ our ” refer to the business of Predictive Oncology Inc. (NASDAQ: POAI) and its wholly-owned subsidiaries.
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CONSOLIDATED STATEMENTS OF NET LOSS Year Ended December 31, 2022 2021 Revenue $ 1,505,459 $ 1,420,680 Cost of sales 505,107 487,024 Gross profit 1,000,352 933,656 General and administrative expense 11,110,735 10,932,125 Operations expense 3,798,425 2,698,565 Sales and marketing expense 1,358,907 774,530 Loss on goodwill impairment 7,231,093 2,813,792 Loss on impairment of intangibles 3,349,375 2,893,548 Loss on impairment of tangible fixed assets 185,469 1,249,727 Total operating loss (26,033,652 ) (20,428,631 ) Other income 185,646 184,528 Other expense (5,275 ) (239,631 ) Gain on derivative instruments 115,647 164,902 Loss before income tax benefit $ (25,737,634 ) (20,318,832 ) Income tax benefit - (661,658 ) Net loss (25,737,634 ) $ (19,657,174 ) Loss per common share - basic and diluted $ (0.35 ) $ (0.36 ) Weighted average shares used in computation - basic and diluted 72,997,987 54,876,044 See Notes to Consolidated Financial Statements F-5 PREDICTIVE ONCOLOGY INC.
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Cautionary Statement Concerning Forward-Looking Statements This Annual Report on Form 10-K contains various "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").
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CONSOLIDATED STATEMENTS OF STOCKHOLDERS ’ EQUITY Series B Preferred Common Stock Additional Paid-In Accumulated Shares Amount Shares Amount Capital Deficit Total Balance at 12/31/2021 79,246 $ 792 65,614,597 $ 656,146 $ 167,649,028 $ (128,040,282 ) $ 40,265,684 Issuance of shares and warrants pursuant to May 2022 private placement, net 12,000,000 120,000 6,387,050 6,507,050 Shares issued pursuant to Equity Line 315,000 3,150 232,859 236,009 Share issuance to consultant and other 596,670 5,967 350,158 356,125 Vesting expense and option repricing 236,434 2,364 136,294 138,658 Net loss - - - (25,737,634 ) (25,737,634 ) Balance at 12/31/2022 79,246 $ 792 78,762,701 $ 787,627 $ 174,755,389 $ (153,777,916 ) $ 21,765,892 F-6 PREDICTIVE ONCOLOGY INC.
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Forward-looking statements represent our expectations and beliefs concerning future results or events, based on information available to us on the date of the filing of this Form 10-K, and are subject to various risks and uncertainties.
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CONSOLIDATED STATEMENTS OF STOCKHOLDERS ’ EQUITY Series B Preferred Common Stock Additional Paid-In Accumulated Shares Amount Shares Amount Capital Deficit Total Balance at 12/31/2020 79,246 $ 792 19,804,787 $ 198,048 $ 110,826,949 $ (108,383,108 ) $ 2,642,681 Shares issued pursuant to agreement with former CEO related to accrued interest 100,401 1,004 142,569 143,573 Issuance of shares and warrants pursuant to Shelf offerings, net 13,488,098 134,881 14,877,611 15,012,492 Issuance of shares and warrants pursuant to February 2021 private placement, net 9,043,766 90,438 15,974,301 16,064,739 Exercise of warrants 5,269,059 52,702 4,461,169 4,513,871 Shares issued pursuant to convertible debt 1,107,544 11,075 502,936 514,011 Issuance of shares and warrants pursuant to June 2021 direct placement, net 15,520,911 155,209 19,291,087 19,446,296 Shares issued pursuant to transition agreement with former CEO 400,000 4,000 (4,000 ) - Shares issued pursuant to Equity Line 647,504 6,475 669,115 675,590 Share issuance to consultant and other 174,954 1,750 203,443 205,193 Vesting expense and option repricing 57,573 564 703,848 704,412 Net loss - - - (19,657,174 ) (19,657,174 ) Balance at 12/31/2021 79,246 $ 792 65,614,597 $ 656,146 $ 167,649,028 $ (128,040,282 ) $ 40,265,684 See Notes to Consolidated Financial Statements F-7 PREDICTIVE ONCOLOGY INC.
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Factors that could cause actual results or events to differ materially from those referenced in the forward-looking statements are listed in Part I, Item 1A. Risk Factors and in Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
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CONSOLIDATED STATEMENTS OF CASH FLOWS Year Ended December 31, 2022 2021 Cash flow from operating activities: Net loss $ (25,737,634 ) $ (19,657,174 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 1,313,075 1,340,301 Vesting expense 166,312 715,938 Equity instruments issued for management, consulting, and other 356,125 205,193 Amortization of debt discount - 244,830 Gain on valuation of equity-linked instruments (115,647 ) (164,902 ) Benefit from release of valuation allowance - (661,658 ) Loss on goodwill impairment 7,231,093 2,813,792 Loss on intangible impairment 3,349,375 2,893,548 Loss on long-lived tangible asset impairment 185,469 1,249,727 Loss on fixed asset disposal 14,346 5,858 Changes in assets and liabilities: Accounts receivable 23,000 (20,769 ) Inventories (42,808 ) (98,149 ) Prepaid expense and other assets 78,425 (194,363 ) Accounts payable (78,322 ) (350,296 ) Accrued expenses 869,987 (499,563 ) Contract liabilities 41,819 54,548 Other liabilities (25,415 ) (85,790 ) Net cash used in operating activities: (12,370,800 ) (12,208,929 ) Cash flow from investing activities: Acquisition of zPREDICTA, net of cash acquired - (9,590,214 ) Purchase of fixed assets (419,869 ) (910,429 ) Acquisition of intangibles (55,828 ) (51,893 ) Loan activities - (55,000 ) Net cash used in investing activities (475,697 ) (10,607,536 ) Cash flow from financing activities: Proceeds from issuance of common stock, net 6,507,050 50,523,527 Proceeds from exercise of warrants into common stock - 4,513,871 Repayment of debt - (4,162,744 ) Payment penalties - (1,073,470 ) Proceeds from issuance of stock pursuant to equity line 236,009 675,590 Repurchase of common stock upon vesting of restricted stock units (27,654 ) (11,526 ) Other liabilities - (124,500 ) Net cash provided by financing activities 6,715,405 50,340,748 Net increase (decrease) in cash and cash equivalents (6,131,092 ) 27,524,283 Cash and cash equivalents at beginning of year 28,202,615 678,332 Cash and cash equivalents end of year $ 22,071,523 $ 28,202,615 See Notes to Consolidated Financial Statements F-8 PREDICTIVE ONCOLOGY INC.
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We disclaim any intent or obligation to update or revise any of the forward-looking statements, whether in response to new information, unforeseen events, changed circumstances or otherwise, except as required by applicable law.
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CONSOLIDATED STATEMENTS OF CASH FLOWS continued Year Ended December 31, 2022 2021 Non-cash transactions Shares issued pursuant to former CEO per agreement related to accrued interest $ - $ 143,573 Increase to operating lease right of use asset and lease liability due to new and modified leases - 77,128 Inducement shares issued pursuant to convertible debt - 514,011 Adjustment to goodwill for acquisition of zPREDICTA contract liabilities 373,303 - Cash paid during the period for: Interest paid on debt $ 3,821 $ 690,508 See Notes to Consolidated Financial Statements F-9 PREDICTIVE ONCOLOGY INC.
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Overview We are a knowledge and science-driven company that applies artificial intelligence (“AI”) to support the discovery and development of optimal cancer therapies, which can ultimately lead to more effective treatments and improved patient outcomes.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Operations and Continuance of Operations Predictive Oncology Inc., (the “Company” or “Predictive” or “we”) filed with the Secretary of State of Delaware a Certificate of Amendment to its Certificate of Incorporation to change the corporate name to Predictive Oncology Inc. on June 10, 2019, trading under the new ticker symbol “POAI,” effective June 13, 2019.
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We use AI and a proprietary biobank of 150,000+ tumor samples, categorized by tumor type, to provide actionable insights about drug compounds to improve the drug discovery process and increase the probability of drug compound success. We offer a suite of solutions for oncology drug development from early discovery to clinical trials.
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The Company operate in four primary business areas: first, the application of artificial intelligence (“AI”) for optimized, high-confidence drug-response predictions within a large experimental space that enables a more informed selection of drug/tumor combinations to increase the probability of success during development.; second, creation and development of tumor-specific 3D cell culture models driving accurate prediction of clinical outcomes; third, contract services and research focused on solubility improvements, stability studies, and protein production, and; fourth, production of the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System for automated, direct-to-drain medical fluid disposal and associated products.
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Our mission is to change the landscape of oncology drug discovery and enable the development of more effective therapies for the treatment of cancer. By harnessing the power of machine learning and scientific rigor, we believe that we can improve the probability of success of advancing pharmaceutical and biological drug candidates with a higher degree of confidence.
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The Company has four reportable segments: Helomics®, zPREDICTA®, SolubleTM and Skyline®. The Helomics segment includes contract services that include the application of AI, partnering projects and clinical testing. The zPREDICTA, Inc. (“zPREDICTA”) segment specializes in organ-specific disease models that provide 3D reconstruction of human tissues accurately representing each disease state and mimicking drug response enabling accurate testing of anticancer agents.
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We operate in three business areas. In our first area, we provide optimized, high-confidence drug-response predictions through the application of AI using our proprietary biobank of tumor samples to enable a more informed selection of drug/tumor combinations and increase the probability of success during development.
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Going forward, the Company has determined that it will focus its resources on applying AI to develop optimal cancer therapies, partnering with biopharma clients to prioritize drugs for development and identify biomarker-informed indications enabling a more informed selection of drug/tumor combinations to increase the probability of success during drug development.
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We also create and develop tumor-specific 3D cell culture models mimicking the physiological environment of human tissue enabling better-informed decision-making during development.
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As a result of this focused approach, the Company has consolidated its brand under Predictive Oncology name. Going forward, the Company will operate under the Predictive Oncology tradename with laboratory operations in Pittsburgh, Pennsylvania and Birmingham, Alabama.
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Our third business area produces the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal. As of January 1, 2023, we changed our reportable segments to align with these business areas.
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Impact of the Coronavirus Disease 2019 In response Coronavirus Disease 2019 (“COVID- 19” ), the Company continues to closely manage manufacturing and supply chain resources. The Company monitors its sites to protect the safety of its staff and employees. The Company continues to experience some disruption due to the global supply chain caused by COVID- 19.
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We have three reportable segments, which have been delineated by location and business area: ● Pittsburgh segment: provides services that include the application of AI using its proprietary biobank of 150,000+ tumor samples.
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As a result of COVID- 19, the Company is also experiencing disruption due staffing shortages within the service and healthcare industries and negative impacts on the demand for our products and services. For example, some customers are managing inventory and capital more conservatively and our suppliers continue to ask for pre-delivery deposits.
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Pittsburgh also creates proprietary 3D culture models used in drug development. ● Birmingham segment : provides contract services and research focused on solubility improvements, stability studies, and protein production. ● Eagan segment : produces the FDA-cleared STREAMWAY System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal. 4 PITTSBURGH Drug Discovery Solutions – PEDAL Patient-centric Drug Discovery using Active Learning (“PEDAL”™), our proprietary AI-driven platform, offered by our Pittsburgh segment, is designed to provide high-confidence drug-response predictions.
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The Company is monitoring and taking actions to mitigate potential risks of these shortages and delays which may impact the Company’s ability to obtain new contracts, the fulfillment of product demand and to meet its contract obligations.
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This platform combines our biobank of samples with a one-of-a-kind database of historical tumor data, and the power of AI to efficiently build predictive models of tumor drug response.
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The extent to which COVID- 19 may impact the Company’s financial condition and results of operations remains uncertain and is dependent on numerous evolving factors, including the measures being taken by authorities to mitigate against the spread of COVID- 19, the emergence of new variants and the effectiveness of vaccines and therapeutics.
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Our PEDAL asset is a unique technology that combines one of the largest privately held commercial biobanks of tumor samples, AI active machine learning, and multi-omic historical tumor data – complete with on-site Clinical Laboratory Improvement Amendments (“CLIA”) certified lab testing capabilities to inform drug/tumor model predictions.
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The continuation or re-implementation of these measures remains uncertain. These factors may remain prevalent for a significant period of time even after the pandemic subsides, including due to a continued or prolonged recession in the U.S. or other major economies.
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PEDAL offers researchers the opportunity to incorporate patient diversity early, efficiently, and cost-effectively into the drug discovery process by using data from hundreds of patient samples. PEDAL works by iterative cycles of active learning to guide the testing of patient samples against specific compounds.
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The impacts of the COVID- 19 pandemic, as with any adverse public health developments, could have a material adverse effect on our business, results of operations, liquidity or financial condition and heighten or exacerbate risks described in this Annual Report on Form 10 -K.
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This results in PEDAL efficiently building comprehensive predictive models of patient drug response in a matter of weeks. This predictive model can rank compounds against tumor samples of certain profiles that respond to specific drugs and can also predict the set of compounds that provide the best coverage across patient tumor samples.
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F- 10 Recently Adopted Accounting Standards The Company considers the applicability and impact of all Accounting Standards Updates (“ASUs”) issued by the Financial Accounting Standards Board (the “FASB”). Recently issued ASUs not listed below either were assessed and determined to be not applicable or are currently expected to have no impact on the condensed consolidated financial statements of the Company.
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We believe leveraging our unique, historical database of tumor drug responses, genomics, biomarkers, digitized pathology slides, and histopathology data with over 150,000 patient tumor samples to efficiently build AI driven predictive models of tumor drug response will provide actionable insights critical to new drug development.
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In June 2016, the FASB issued ASU 2016 - 13, “Financial Instruments – Credit Losses.” This ASU added a new impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses.
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Through the course of over 15 years of clinical testing of patient tumor responses to drugs, our Pittsburgh lab has amassed a huge proprietary knowledgebase of data. To provide for our patient-centric approach, this dataset has been rigorously de-identified and aggregated to inform our proprietary process to create models of tumor drug response.
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The CECL model applies to most debt instruments, trade receivables, lease receivables, financial guarantee contracts, and other loan commitments. The CECL model does not have a minimum threshold for recognition of impairment losses and entities will need to measure expected credit losses on assets that have a low risk of loss.
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PEDAL can significantly increase the probability of clinical success by introducing patient diversity early in the development process, while also decreasing the time and cost of oncology drug discovery programs.
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As a smaller reporting company pursuant to Rule 12b - 2 of the Securities Exchange Act of 1934, as amended, these changes become effective for the Company on January 1, 2023. Management is currently evaluating the potential impact of these changes on the consolidated financial statements of the Company.
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Our large knowledgebase of tumor drug response and other data, together with proven AI, has created a unique capability for oncology drug discovery, utilizing this highly efficient screening of drug responses against thousands of diverse, well-characterized patient primary tumor samples.
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Accounting Policies and Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S.
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With each iteration of a PEDAL campaign, the program learns, predicts, and then directs the most informative wet lab experimentation, while building the predictive model. This allows for a unique and streamlined approach in which AI-driven predictions are tested against samples from this expansive and diverse biobank to more efficiently and effectively narrow down viable drug-tumor pairings.
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GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities at the date of the financial statements and during the reporting period. Actual results could materially differ from those estimates.
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This novel disruptive approach is ideally suited to the early part of drug discovery while also being highly customizable to meet the needs of our collaborators. Our patient-centric drug discovery approach provides for the prioritization of drug compound candidates while accounting for patient tumor diversity.
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Cash and cash equivalents The Company considers all highly liquid instruments with maturities when purchased of three months or less to be cash equivalents. The Company places its cash with high quality financial institutions and believes its risk of loss is limited to amounts in excess of that which is insured by the Federal Deposit Insurance Corporation.
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This should dramatically improve the chances of successfully translating discoveries into successful therapies, while simultaneously lowering costs through shortened development timelines, and most importantly, enhanced “speed-to-patient” for new therapies.
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Receivables Receivables are reported at the amount the Company expects to collect on balances outstanding. The Company provides for probable uncollectible amounts through charges to earnings and credits to the valuation allowance based on management’s assessment of the current status of individual accounts.
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A key part of our commercialization strategy is the understanding that our AI-driven models of tumor drug response serve a key unmet need of pharmaceutical, diagnostic, and biotech industries for actionable multi-omic insights into cancer.
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Amounts recorded in accounts receivable on the consolidated balance sheets include amounts billed and currently due from customers. The amounts due are stated at their net estimated realizable value. An allowance for doubtful accounts is maintained to provide for the estimated amount of receivables that will not be collected.
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In collaboration with these companies, using the predictive models, we will accelerate the search for more effective cancer treatments through biomarker discovery, drug screening, drug repurposing, and ultimately clinical trials with higher probability of success. PEDAL, which incorporates CORE™, our active machine learning program, with tumor profile data and human tumor samples, provides optimized, efficient, high-confidence drug-response predictions.
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The Company reviews customers’ credit history before extending unsecured credit and establishes an allowance for uncollectible accounts based upon factors surrounding the credit risk of specific customers, historical trends and other information. Invoices are generally due 30 days after presentation. Accounts receivable over 30 days is generally considered past due.
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Our platform is designed to move molecules forward with a higher probability of clinical success.
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The Company does not accrue interest on past due accounts receivables. Receivables are written off once all collection attempts have failed and are based on individual credit evaluation and specific circumstances of the customer. The allowance for doubtful accounts balance was $0 as of both December 31, 2022 and 2021.
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The focus of our business strategy is to leverage and expand our portfolio of proprietary solutions to advance drug discovery and enable oncology drug development for our biopharma partners. 3D Modeling Our Pittsburgh segment also develops tumor-specific in vitro models for oncology drug discovery and research.
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F- 11 Fair Value Measurements As outlined in Accounting Standards Codification (“ASC”) 820, Fair Value Measurement , 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.
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Our 3D tumor-specific models accelerate the drug development process for our clients and partners by providing drug response predictions with high correlation to clinical response, enabling our biopharma clients to manage pipeline prioritization more efficiently. 5 The 3D models incorporate tissue-specific extracellular matrices and tumor-specific medium supplements allowing for a true reconstruction of tumor microenvironment.
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The accounting standards ASC 820 establishes a three -level fair value hierarchy that prioritizes information used in developing assumptions when pricing an asset or liability as follows: Level 1 – Observable inputs such as quoted prices in active markets; Level 2 – Inputs other than quoted prices in active markets, that are observable either directly or indirectly; and Level 3 – Unobservable inputs where there is little or no market data, which requires the reporting entity to develop its own assumptions.
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Our approach is compatible with multiple classes of immuno-oncology agents from antibody and antibody-drug conjugates to bi- and tri-specific compounds and CAR-T cells. The organ-specific disease models provide 3D reconstruction of human tissues accurately representing each disease state and mimicking drug response.
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The Company uses observable market data, when available, in making fair value measurements. Fair value measurements are classified according to the lowest level input that is significant to the valuation. The fair value of the Company’s investment securities, which consist of cash and cash equivalents, was determined based on Level 1 inputs.
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Our 3D platform maintains tumor-tumor and tumor-stroma interactions and incorporates both cellular and extracellular elements of tissue microenvironment including soluble factors in an organ- and disease-specific manner. It is compatible with multiple cell types, drug classes, and downstream analysis methods. Our models support proliferation of malignant and non-malignant cellular components of tissues.
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The fair value of the Company’s derivative liabilities and debt were determined based on Level 3 inputs. The Company generally uses Black Scholes method for determining the fair value of warrants classified as liabilities on a recurring basis.
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Applications include providing efficacy screening of anticancer compounds, evaluation of mechanisms of drug resistance, identification of new drug combinations, rescue of failed drug candidates, assessment of off-target toxicity, target discovery and biomarker discovery. Product offerings include preclinical testing services based on our proprietary models directly to clients in the biopharmaceutical industry.
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In addition, the Company uses the Monte Carlo method and other acceptable valuation methodologies when valuing the conversion feature and other embedded features classified as derivatives on a recurring basis. See Note 7 – Derivatives . When performing quantitative testing related to goodwill impairment analysis, the Company estimates the fair values of its reporting units using discounted cash flows.
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Clinical Testing Through our wholly owned subsidiary, Helomics Corporation (“Helomics”), reported under our Pittsburgh segment, we offer a group of clinically relevant, cancer-related tumor profiling and biomarker tests for gynecological cancers that determine how likely the patient is to respond to various types of available chemotherapy treatments and which therapies might be indicated by relevant tumor biomarkers.
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To determine fair values, the Company is required to make assumptions about a wide variety of internal and external factors.
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Testing involves obtaining tumor tissue during biopsy or surgery, which is then sent to our CLIA certified laboratory using a special collection kit. Tumor Drug Response Testing is a fresh tissue platform that uses the patient’s own live tumor cells to help physicians identify effective treatment options for each gynecologic cancer patient.
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Significant assumptions used in the impairment analysis include financial projections of free cash flow (including significant assumptions about operations including the rate of future revenue growth, capital requirements, and income taxes), long-term growth rates for determining terminal value and discount rates.
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Genomic Profiling offers a select group of clinically relevant protein expression and genomic mutation tests associated with drug response and disease prognosis. Physicians can select biomarkers for testing from carefully chosen panels of relevant tests, organized by cancer pathway and tumor type.
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The majority of the inputs used in the discounted cash flow model are unobservable and thus are considered to be Level 3 inputs. See Note 8 – Goodwill and Intangibles . The acquisition of zPREDICTA was accounted for as a business combination using the acquisition method of accounting.
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Results for these tests are presented in a clear, easy to understand format, including summaries of the clinical relevance of each marker. BIRMINGHAM Drug Development Solutions – Formulations for Biologics Our Birmingham segment focuses on contract services and research for biopharmaceutical company clients and academic collaborators, focused on solubility improvements, stability studies, and protein production.
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This method requires, among other things, that assets acquired and liabilities assumed be recognized at fair value as of the acquisition date. The fair value for the assets acquired and the liabilities assumed are based on information knowable and determined by management as of the acquisition date.
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Specifically, Birmingham provides optimized FDA-approved formulations for vaccines, antibodies, and other protein therapeutics in a faster and lower cost basis to its customers, as described below. In addition, our Birmingham segment enables protein degradation studies, which based on current projections, could be a substantial line of business for the Company.
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The majority of the inputs used in the discounted cash flow model, the relief-from-royalty method under the income approach, the distributor method under the income approach and the multi-period excess earnings method under the income approach, each are unobservable and thus are considered to be Level 3 inputs. See Note 2 – zPREDICTA Acquisition .
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The primary asset of our Birmingham segment is our proprietary automated High Throughput Self-Interaction Chromatography (“HSC”™) platform. Our HSC platform is a self-contained, automated system that conducts high-throughput, self-interaction chromatography screens on excipients previously approved by the FDA for protein formulations.
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Inventories Inventories are stated at the lower of cost or net realizable value, with cost determined on a first -in, first -out basis. Fixed Assets Fixed assets are stated at cost less accumulated depreciation. Depreciation of fixed assets is computed using the straight-line method over the estimated useful lives of the respective assets.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeFailure to attract and retain necessary technical, sales and marketing personnel, and skilled management could adversely affect our business. If we fail to attract, train, and retain sufficient numbers of these highly qualified people, our business, financial condition, and results of operations could be materially and adversely affected.
Biggest changeIf we fail to attract, train, and retain sufficient numbers of these highly qualified people, our business, financial condition, and results of operations could be materially and adversely affected. 28 Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code and may be subject to further limitation because of prior or future offerings of our stock or other transactions.
If a court were to find the choice of forum provision contained in our certificate of incorporation, as amended, to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
If a court were to find the choice of forum provision contained in our certificate of incorporation, as amended, to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, financial condition, and results of operations.
Our Certificate of Incorporation and Bylaws provide, with certain exceptions as permitted by governing state law, that a director or officer shall not be personally liable to us or our stockholders for breach of fiduciary duty as a Director, except for acts or omissions which involve intentional misconduct, fraud, knowing violation of law, or unlawful payments of dividends.
Our certificate of incorporation and bylaws provide, with certain exceptions as permitted by governing state law, that a director or officer shall not be personally liable to us or our stockholders for breach of fiduciary duty as a director, except for acts or omissions that involve intentional misconduct, fraud, knowing violation of law, or unlawful payments of dividends.
Any of the foregoing consequences could have a material adverse effect on our business, financial condition, and results of operations. If we use hazardous materials in a manner that causes contamination or injury, we could be liable for resulting damages.
Any of the foregoing consequences could have a material adverse effect on our business, financial condition, and results of operations. 24 If we use hazardous materials in a manner that causes contamination or injury, we could be liable for resulting damages.
Parts 203 and 205; CLIA and State licensing requirements; Manufacturing and promotion laws; Medicare and Medicaid billing and payment regulations applicable to clinical laboratories; The Federal Anti-Kickback Statute, 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 Stark physician self-referral 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; The Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which established comprehensive federal standards with respect to the privacy and security of protected health information 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 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, 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; Other Federal and State fraud and abuse laws, prohibitions on self-referral, fee-splitting restrictions, prohibitions on the provision of products at no or discounted cost to induce physician or patient adoption, and false claims acts, which may extend to services reimbursable by any third-party payor, including private insurers; 21 The prohibition on reassignment of Medicare claims, which, subject to certain exceptions, precludes the reassignment of Medicare claims to any other party; 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 payors.
Parts 203 and 205; CLIA and State licensing requirements; Manufacturing and promotion laws; Medicare and Medicaid billing and payment regulations applicable to clinical laboratories; The Federal Anti-Kickback Statute, 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 Stark physician self-referral 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; The Federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which established comprehensive federal standards with respect to the privacy and security of protected health information 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 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, 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; Other Federal and State fraud and abuse laws, prohibitions on self-referral, fee-splitting restrictions, prohibitions on the provision of products at no or discounted cost to induce physician or patient adoption, and false claims acts, which may extend to services reimbursable by any third-party payor, 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 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 being reimbursed at a higher amount from Medicare, Medicaid, and other Federal programs, than what we charge other payors.
If our operations are found to be in violation of any of these laws and regulations, we may be subject to civil and criminal penalties, damages, and fines, we could be required to refund payments received by it, we could face possible exclusion from Medicare, Medicaid and other Federal or State healthcare programs, and we could even be required to cease operations.
If our operations are found to be in violation of any of these laws and regulations, we may be subject to civil and criminal penalties, damages, and fines, we could be required to refund payments we received, we could face possible exclusion from Medicare, Medicaid and other Federal or State healthcare programs, and we could even be required to cease operations.
We face significant competition in the surgical fluid waste management industry, including competition from companies with considerably greater resources than ours, and if we are unable to compete effectively with these companies, our market share may decline, and our business could be harmed.
We face significant competition to our STREAMWAY System in the surgical fluid waste management industry, including competition from companies with considerably greater resources than ours, and if we are unable to compete effectively with these companies, our market share may decline, and our business could be harmed.
While we have not experienced any such attack or breach, if such event would occur and cause interruptions in our operations, our networks could be compromised and the information we store on those networks could be accessed by unauthorized parties, publicly disclosed, lost, or stolen.
While we do not believe we have not experienced any such attack or breach, if such event would occur and cause interruptions in our operations, our networks could be compromised and the information we store on those networks could be accessed by unauthorized parties, publicly disclosed, lost, or stolen.
Likewise, as demand for our molecular diagnostic tests grow, we will need to continue to scale our testing capacity and processing technology to expand our customer service, billing, and systems processes and to enhance our internal quality assurance program.
Likewise, as demand for our molecular diagnostic tests grows, we will need to continue to scale our testing capacity and processing technology to expand our customer service, billing, and systems processes and to enhance our internal quality assurance program.
We may pay for acquisitions with our common stock or with convertible securities, which may dilute shareholders’ investment in our common stock, or we may decide to pursue acquisitions that our investors may not agree with. In connection with potential acquisitions, we may agree to substantial earn-out arrangements.
We may pay for acquisitions with our common stock or with convertible securities, which may dilute stockholders’ investment in our common stock, or we may decide to pursue acquisitions that our investors may not agree with. In connection with potential acquisitions, we may agree to substantial earn-out arrangements.
The occurrence of any of these events could have a material adverse effect on our business, financial condition, and results of operations. If our R&D and commercialization efforts for our PEDAL platform takes longer than expected, the commercial revenues that use this platform could also be delayed.
The occurrence of any of these events could have a material adverse effect on our business, financial condition, and results of operations. 17 If our R&D and commercialization efforts for our PEDAL platform take longer than expected, the commercial revenues that use this platform could also be delayed.
Risks Related to Our Intellectual Property Our business is dependent upon proprietary intellectual property rights, which if we were unable to protect, could have a material adverse effect on our business. We rely on a combination of patent, trade secret and other intellectual property rights, contractual restrictions, and other measures to protect our intellectual property.
Risk Factors Related to Our Intellectual Property Our business is dependent upon proprietary intellectual property rights, which if we were unable to protect, could have a material adverse effect on our business. We rely on a combination of patent, trade secret and other intellectual property rights, contractual restrictions, and other measures to protect our intellectual property.
We could face delays in this R&D, for example: 15 we may not be able to secure access to and approval to use clinical data from academic hospital partners in a timely manner; clinical testing volume (number of specimens coming to us for testing) may not grow sufficiently to drive additional data generation as well as further development of the biobank; patient consent to use the patient’s data and tumor material for R&D may not be sufficient to support R&D; and we may not be able to attract and retain the appropriately qualified staff to perform the necessary R&D.
For example: we may not be able to secure access to and approval to use clinical data from academic hospital partners in a timely manner; clinical testing volume (number of specimens coming to us for testing) may not grow sufficiently to drive additional data generation as well as further development of the biobank; patient consent to use the patient’s data and tumor material for R&D may not be sufficient to support R&D; and we may not be able to attract and retain the appropriately qualified staff to perform the necessary R&D.
Our Board of Directors has the power to issue any or all of the shares of undesignated preferred stock, including the authority to establish one or more series and to fix the powers, preferences, rights, and limitations of such class or series, without seeking stockholder approval.
The remaining authorized shares are undesignated preferred stock. Our board of directors has the power to issue any or all of the shares of undesignated preferred stock, including the authority to establish one or more series and to fix the powers, preferences, rights, and limitations of such class or series, without seeking stockholder approval.
Our drug discovery solutions business offers various services to pharma, diagnostics, and biotech companies. These services use our PEDAL platform. This platform is the subject of active R&D to further improve them for commercial use in order to help our clients in their drug discovery, biomarker, and clinical trial activities.
Our drug discovery solutions business offers various services to pharma, diagnostics, and biotech companies. These services use our PEDAL platform. This platform is the subject of active R&D to further improve them for commercial use in order to help our clients in their drug discovery, biomarker, and clinical trial activities. We could face delays in this R&D.
Our payment of any future dividends will be at the discretion of our Board of Directors after taking into account various factors, including but not limited to, our financial condition, operating results, cash needs, growth plans, and the terms of any credit agreements that we may be a party to at the time.
Our payment of any future dividends will be at the discretion of our board of directors after considering various factors, including but not limited to, our financial condition, operating results, cash needs, growth plans, and the terms of any credit agreements that we may be a party to at the time.
There can be no assurance that we will be able to perform our testing on a timely basis at a level consistent with demand, or that our efforts to scale our operations will not negatively affect the quality of test results. 16 If we encounter difficulties in scaling our operations as a result of, among other things, quality control and quality assurance issues and availability of reagents and raw material supplies, we will likely experience reduced sales, increased repair or re-engineering costs, defects, and increased expenses due to switching to alternate suppliers.
We may not be able to perform our testing on a timely basis at a level consistent with demand, and our efforts to scale our operations may negatively affect the quality of test results. 18 If we encounter difficulties in scaling our operations as a result of, among other things, quality control and quality assurance issues and availability of reagents and raw material supplies, we will likely experience reduced sales, increased repair or re-engineering costs, defects, and increased expenses due to switching to alternate suppliers.
On May 13, 2022, we received a letter from the Listing Qualifications Department (the “Staff”) of The NASDAQ Stock Market LLC (“NASDAQ”) informing the Company that because the closing bid price for the Company’s common stock listed on NASDAQ was below $1.00 for 30 consecutive trading days, the Company does not comply with the minimum closing bid price requirement for continued listing on The NASDAQ Capital Market under NASDAQ Marketplace Rule 5550(a)(2), requiring a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”).
On May 13, 2022, we received a letter from the Listing Qualifications Department of Nasdaq informing us that because the closing bid price for our common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, we did not comply with the minimum closing bid price requirement for continued listing on the Nasdaq Capital Market under NASDAQ Marketplace Rule 5550(a)(2), requiring a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”).
In addition, acquisitions may expose us to operational challenges and risks, including: the ability to profitably manage acquired businesses or successfully integrate the operations of acquired businesses, as well as the acquired business’s financial reporting and accounting control systems into our existing platforms; ​increased indebtedness and contingent purchase price obligations associated with an acquisition; ​the ability to fund cash flow shortages that may occur if anticipated revenue is not realized or is delayed, whether by general economic or market conditions, or unforeseen internal difficulties; ​the availability of funding sufficient to meet increased capital needs; ​diversion of management’s time and attention from existing operations; and ​the ability to retain or hire qualified personnel required for expanded operations.
To the extent we defer the payment of the purchase price for any acquisition through a cash earn-out arrangement, cash flows could be reduced in subsequent periods. 29 In addition, acquisitions may expose us to operational challenges and risks, including: the ability to profitably manage acquired businesses or successfully integrate the operations of acquired businesses, as well as the acquired business’s financial reporting and accounting control systems into our existing platforms; ​increased indebtedness and contingent purchase price obligations associated with an acquisition; ​the ability to fund cash flow shortages that may occur if anticipated revenue is not realized or is delayed, whether by general economic or market conditions, or unforeseen internal difficulties; ​the availability of funding sufficient to meet increased capital needs; ​diversion of management’s time and attention from existing operations; and ​the ability to retain or hire qualified personnel required for expanded operations.
These intellectual property rights are important to our ongoing operations and no assurance can be given that any measure we implement will be sufficient to protect our intellectual property rights. 18 Further, competitors could willfully infringe upon our intellectual property rights, design around our protected technology, or develop their own competitive technologies that arguably fall outside of our intellectual property rights.
These intellectual property rights are important to our ongoing operations and any measure we implement may not be sufficient to protect our intellectual property rights. Further, competitors could willfully infringe upon our intellectual property rights, design around our protected technology, or develop their own competitive technologies that arguably fall outside of our intellectual property rights.
As a result, our stockholders may lose opportunities to dispose of their shares at favorable prices generally available in takeover attempts or that may be available under a merger proposal and the market price, voting, and other rights of the holders of common stock may also be affected.
As a result, our stockholders may lose opportunities to dispose of their shares at favorable prices generally available in takeover attempts or that may be available under a merger proposal and the market price, voting, and other rights of the holders of common stock may also be affected. 27 Our stock price may be volatile, and you could lose all or part of your investment.
The failure of these systems to operate as anticipated could disrupt our business and result in decreased revenue and increased overhead costs. In addition, we do not have complete redundancy for all of our systems and our disaster recovery planning cannot account for all eventualities.
The efficient operation of our business is dependent on information technology and communications systems. The failure of these systems to operate as anticipated could disrupt our business and result in decreased revenue and increased overhead costs. In addition, we do not have complete redundancy for all of our systems and our disaster recovery planning cannot account for all eventualities.
Our ability to implement a successful business plan with respect to drug discovery, drug development and clinical research services remains unproven and no assurance can be given that we will ever generate sufficient revenues to sustain our business. We have a limited operating history which makes it difficult to evaluate our performance.
Our ability to implement a successful business plan with respect to drug discovery, drug development and clinical research services remains unproven, and we may not ever generate sufficient revenues to sustain our business. We have a limited operating history which makes it difficult to evaluate our performance.
We cannot assure the shareholders’ that the indemnification granted by sellers of acquired companies will be sufficient in amount, scope, or duration to fully offset the possible liabilities associated with businesses or properties we assume upon consummation of an acquisition.
Also, the indemnification granted by sellers of acquired companies may not be sufficient in amount, scope, or duration to fully offset the possible liabilities associated with businesses or properties we assume upon consummation of an acquisition.
If we are sued for product liability or errors and omissions liability, we could face substantial liabilities that exceed our resources. The marketing, sale, and use of our molecular diagnostic tests could lead to product liability claims if someone were to allege that the molecular diagnostic test failed to perform as it was designed.
If we are sued for product liability or errors and omissions liability, we could face substantial liabilities that exceed our resources. The marketing, sale, and use of our products could lead to product liability claims. These claims could allege that the products failed to perform as they were designed.
If such financing or adequate funds from operations are not available, we would be forced to limit our business activities, which would have a material adverse effect on our results of operations and financial condition.
If such financing or adequate funds from operations are not available, we would be forced to limit our business activities and we could default on existing payment obligations, which would have a material adverse effect on our financial condition and results of operations, and may ultimately be required to cease our operations and liquidate our business.
If these suppliers can no longer provide us with the materials needed to perform our molecular diagnostic tests, if the materials do not meet required quality specifications, or if we cannot obtain acceptable substitute materials, an interruption in molecular diagnostic test processing could occur. Any such interruption may directly impact our revenue and cause us to incur higher costs.
If these suppliers can no longer provide us with the materials used in our business, if the materials do not meet required quality specifications, or if we cannot obtain acceptable substitute materials, an interruption in our products and services provided to customers could occur. Any such interruption may directly impact our revenue and cause us to incur higher costs.
In the event our common stock is delisted from The NASDAQ Capital Market and we are also unable to maintain listing on another alternate exchange, trading in our common stock could thereafter be conducted in FINRA’s OTC Bulletin Board or in the over-the-counter markets in the so-called pink sheets.
In the event our common stock is delisted from the Nasdaq Capital Market and we are also unable to maintain listing on another alternate exchange, trading in our common stock could thereafter be conducted through one or more over-the-counter markets.
Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code and may be subject to further limitation because of prior or future offerings of our stock or other transactions. 25 Sections 382 and 383 of the United States Internal Revenue Code of 1986, as amended (the “Code”) contain rules that limit the ability of a company that undergoes an ownership change, which is generally an increase in the ownership percentage of certain stockholders in the stock of a company by more than 50% over a three-year period, to utilize its net operating loss and tax credit carryforwards and certain built-in losses recognized in years after the ownership change.
Sections 382 and 383 of the United States Internal Revenue Code of 1986, as amended (the “Code”) contain rules that limit the ability of a company that undergoes an ownership change, which is generally an increase in the ownership percentage of certain stockholders in the stock of a company by more than 50% over a three-year period, to utilize its net operating loss and tax credit carryforwards and certain built-in losses recognized in years after the ownership change.
The exercise of outstanding warrants, and issuance of equity awards may have a dilutive effect on our stock, and negatively impact the price of our common stock. As of December 31, 2022, we had 36,328,731 warrants outstanding at a weighted average exercise price of $7.31 per share.
The exercise of outstanding warrants, and issuance of equity awards may have a dilutive effect on our stock, and negatively impact the price of our common stock. As of December 31, 2023, we had 1,806,589 warrants outstanding at a weighted average exercise price of $21.52 per share.
In such event, the liquidity of our common stock would likely be impaired, not only in the number of shares which could be bought and sold, but also through delays in the timing of the transactions, and there would likely be a reduction in our coverage by security analysts and the news media, thereby resulting in lower prices for our common stock than might otherwise prevail.
In such event, the liquidity of our common stock would likely be impaired, not only in the number of shares which could be bought and sold, but also through delays in the timing of the transactions, and there would likely be a reduction in our coverage by security analysts and the news media, thereby resulting in lower prices for our common stock than might otherwise prevail. 26 Limitations on director and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing a suit against a director.
We are able to grant stock options, restricted stock, restricted stock units, stock appreciation rights, bonus stock, and performance awards under our 2012 Equity Incentive Plan. Under the 2012 Stock Incentive Plan, 1,064.393 shares were issuable under outstanding incentive awards at December 31, 2022, and 2,894,413 shares remained available for issuance pursuant to future incentive grants.
We are able to grant stock options, restricted stock, restricted stock units, stock appreciation rights, bonus stock, and performance awards under our 2012 Stock Incentive Plan. Under the 2012 Stock Incentive Plan, 47,664 shares were issuable under outstanding incentive awards at December 31, 2023, and 94,878 shares remained available for issuance pursuant to future incentive grants.
General Risk Factors Our success is dependent on our ability to attract and retain technical personnel, sales and marketing personnel, and other skilled management. Our success depends to a significant degree on our ability to attract, retain, and motivate highly skilled and qualified personnel.
Our success is dependent on our ability to attract and retain technical personnel, sales and marketing personnel, and other skilled management. Our success depends to a significant degree on our ability to attract, retain, and motivate highly skilled and qualified personnel. Failure to attract and retain necessary technical, sales and marketing personnel, and skilled management could adversely affect our business.
Risks Related to the Securities Markets and Ownership of Our Common Stock Our certificate of incorporation, as amended, provides that, to the fullest extent permitted by law, the Court of Chancery of the State of Delaware will be the exclusive forum for certain legal actions between us and our stockholders, which could limit our stockholders ability to obtain a judicial forum viewed by the stockholders as more favorable for disputes with us or our directors, officers, or employees.
We cannot predict whether future healthcare initiatives will be implemented at the federal or state level, or how any future legislation or regulation may affect us. 25 Risk Factors Related to the Securities Markets and Ownership of Our Common Stock Our certificate of incorporation, as amended, provides that, to the fullest extent permitted by law, the Court of Chancery of the State of Delaware will be the exclusive forum for certain legal actions between us and our stockholders, which could limit our stockholders ability to obtain a judicial forum viewed by the stockholders as more favorable for disputes with us or our directors, officers, or employees.
Were we to lose one or more of these key individuals, we would be forced to expend significant time and money in the pursuit of a replacement, which could result in both a delay in the implementation of our business plan and the diversion of our limited working capital.
Were we to lose one or more members of our management team for any reason, we would be required to expend significant time and money to find a replacement, which could result in both a delay in the implementation of our business plan and the diversion of our limited working capital.
Violations of Federal or State regulations may incur investigation or enforcement action by the FDA, Department of Justice, State agencies, or other legal authorities, and may result in substantial civil, criminal, or other sanctions.
Possible violations of Federal or State regulations may spur investigations or enforcement actions by the FDA, Department of Justice, State agencies, or other legal authorities, and confirmed violations may result in substantial civil, criminal, or other fees, penalties or sanctions.
Our inability to retain those officers would impede our business plan and growth strategies, which would have a negative impact on our business and the value of an investment. Our success depends on the skills, experience, and performance of key members of our management team. We heavily depend on our management team: Raymond F.
We are dependent on a few key executive officers for our success. Our inability to retain those officers would impede our business plan and growth strategies, which would have a negative impact on our business, financial condition, and results of operations. Our success depends on the skills, experience, and performance of key members of our management team.
Companies may apply for or be awarded patents or have other intellectual property rights covering aspects of our technologies or businesses. Litigation may be necessary for us to enforce our patents and proprietary rights or to determine the scope, coverage, and validity of the proprietary rights of others.
Litigation may be necessary for us to enforce our patents and proprietary rights or to determine the scope, coverage, and validity of the proprietary rights of others.
Complying with these various laws could cause us to incur substantial costs or require us to change our business practices, systems, and compliance procedures in a manner adverse to our business.
If so, this could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. Complying with these various laws could cause us to incur substantial costs or require us to change our business practices, systems, and compliance procedures in a manner adverse to our business.
If these businesses are unsuccessful or require too great of a financial investment to be profitable, our business may fail. We rely on sole suppliers for some of the materials used in our molecular diagnostic tests, and we may not be able to find replacements or transition to alternative suppliers in a timely manner.
We rely on sole suppliers for some of the materials used in our business, and we may not be able to find replacements or transition to alternative suppliers in a timely manner. We rely on sole suppliers for certain materials used in our business.
Legislative proposals addressing the FDA’s oversight of LDTs have been introduced in previous Congresses, and we expect that new legislative proposals will be introduced from time‑to‑time. The likelihood that Congress will pass such legislation and the extent to which such legislation may affect the FDA’s plans to regulate certain LDTs as medical devices is difficult to predict at this time.
The likelihood that Congress will pass such legislation and the extent to which such legislation may affect the FDA’s plans to regulate certain LDTs as medical devices is difficult to predict at this time.
In addition, our ability to pay dividends on our common stock may be limited by state law. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize certain returns on their investment.
Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, and the availability of a liquid trading market in our shares as the only way to realize certain returns on their investment.
Unauthorized access, loss, or dissemination could disrupt our operations, including collecting, processing, and preparing company financial information, managing the administrative aspects of our business, and damaging our reputation, any of which could adversely affect our business. In addition, the interpretation and application of consumer, health-related, and data protection laws in the United States are often uncertain, contradictory, and in flux.
Unauthorized access, loss, or dissemination could disrupt our operations, including collecting, processing, and preparing company financial information, managing the administrative aspects of our business, and damaging our reputation, any of which could adversely affect our business.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. Our common stock could be delisted from The NASDAQ Capital Market, which delisting could hinder your ability to obtain accurate quotations on the price of our common stock or dispose of our common stock in the secondary market.
Our common stock could be delisted from the Nasdaq Capital Market, which delisting could hinder your ability to obtain accurate quotations on the price of our common stock or dispose of our common stock in the secondary market.
Any substantial sale, or cumulative sales, of our common stock pursuant to Rule 144 or pursuant to any resale prospectus may have a material adverse effect on the market price of our securities. We expect volatility in the price of our common stock, which may subject us to securities litigation.
Any substantial sale, or cumulative sales, of our common stock pursuant to Rule 144 or pursuant to any resale prospectus may have a material adverse effect on the market price of our securities. We may be unable to provide stock-based incentives to our employees without an increase in shares available for issuance.
The letter stated that we had 180 days, or until November 9, 2022, to regain compliance by maintaining a closing bid price of at least $1.00 for a minimum of 10 consecutive trading days. 23 On November 10, 2022, Nasdaq notified us that while the Company had not regained compliance with the Minimum Bid Price Requirement, it was eligible for an additional 180-day calendar period, or until May 8, 2023, to regain compliance.
The letter stated that we had 180 days, or until November 9, 2022, to regain compliance by maintaining a closing bid price of at least $1.00 for a minimum of 10 consecutive trading days. This deadline was subsequently extended by Nasdaq to May 8, 2023. On April 23, 2023, we effected a 20-for-1 reverse stock split to cure this deficiency.
To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we would be exposed to a greater risk of competition. If our intellectual property does not provide adequate coverage of our competitors’ products, our competitive position could be adversely affected, as could our overall business.
To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we would be exposed to a greater risk of competition.
If demand for our STREAMWAY System or molecular diagnostic tests is unexpectedly high or if we experience problems in scaling our operations, there is no assurance that there will not be supply interruptions or delays that could limit the growth of our revenue.
If demand for our STREAMWAY System or molecular diagnostic tests is unexpectedly high or if we experience problems in scaling our operations, there may be supply interruptions or delays that could limit the growth of our revenue. We have contracted with a manufacturing company that follows ISO compliance regulations of the FDA and that can manufacture products at high volumes.
In connection with developing our drug discovery solutions, we have committed and will continue to commit significant capital to investments in early-stage companies, all of which may be lost, and which may require us to raise significant additional capital, and our entering into new lines of business will result in significant diversion of management resources, all of which may result in failure of our business.
Our entering into new lines of business could result in significant diversion of management resources, all of which may result in failure of our business. We have committed significant capital and management resources to developing our drug discovery solutions and other new business areas, and we intend to continue to devote significant capital and management resources to new businesses.
Any change in legislation or regulations that governs the review and approval process relating to our current and future products could make it more difficult and costlier to obtain approval for new products, or to produce, market, and distribute existing products. 19 If the FDA begins to enforce regulation of our molecular diagnostic tests, we could incur substantial costs and delays associated with trying to obtain pre-market clearance or approval and costs associated with complying with post-market requirements.
Any change in legislation or regulations that governs the review and approval process relating to our current and future products could make it more difficult and costlier to obtain approval for new products, or to produce, market, and distribute existing products.
We may also acquire technologies or companies by issuing stock or other equity securities rather than, or in addition to, payment of cash, which may have the result of diluting our stockholders’ investments. Further, the energy and resources of our officers and personnel may be substantially diverted to new lines of business, which are unproven.
We may not be successful in raising sufficient capital, and the terms of any such financing may be dilutive to our stockholders. We may also acquire technologies or companies by issuing stock or other equity securities rather than, or in addition to, payment of cash, which may have the result of diluting our stockholders’ investments.
These factors include uncertainty as to whether we will be able to: 14 Succeed in uncertain markets; Respond effectively to competitive pressures; Successfully address intellectual property issues of others; Protect and expand our intellectual property rights; and Continue to develop and upgrade our products.
These factors include uncertainty as to whether we will be able to: Succeed in uncertain markets; Respond effectively to competitive pressures; Successfully address intellectual property issues of others; Protect and expand our intellectual property rights; and Continue to develop and upgrade our products. 16 In connection with developing our drug discovery solutions, we have committed significant capital to investments in early-stage companies, all of which may be lost, and our ability to continue to commit capital in other early-stage companies will require us to raise significant additional capital.
In addition, these breaches and other forms of inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above.
In addition, these breaches and other forms of inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above. 30 If our information technology and communications systems fail or we experience a significant interruption in our operations, our reputation, business, and results of operations could be materially and adversely affected.
New molecular diagnostic tests we may develop may be subject to new approvals by governmental bodies, and we may not be able to offer our new molecular diagnostic tests to patients in such jurisdictions until such approvals are received.
New molecular diagnostic tests we may develop may be subject to new approvals by governmental bodies, and we may not be able to offer our new molecular diagnostic tests to patients in such jurisdictions until such approvals are received. 23 Complying with numerous statutes and regulations pertaining to our molecular diagnostics business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
Additionally, in connection with the COVID-19 pandemic, many of our employees have the ability to work remotely, which may increase the risk of security breaches, loss of data, and other disruptions as a consequence of more employees accessing sensitive and critical information from remote locations. 27 If we are unable to prevent such security breaches or privacy violations or implement satisfactory remedial measures in connection with security incidents, we may suffer loss of reputation, financial loss, and civil or criminal fines or other penalties.
Additionally, many of our employees have the ability to work remotely, which may increase the risk of security breaches, loss of data, and other disruptions as a consequence of more employees accessing sensitive and critical information from remote locations.
Any litigation that may be necessary in the future could result in substantial costs and diversion of resources and could have a material adverse effect on our business, financial condition, and operating results. Risk Factors Relating to Regulation Our business is subject to intense governmental regulation and scrutiny, both in the U.S. and abroad.
Any litigation that may be necessary in the future could result in substantial costs and diversion of resources and could have a material adverse effect on our business, financial condition, and operating results. If we breach our license agreements it could have a material adverse effect on our commercialization efforts for our product candidates.
Of this amount, 2,300,000 shares have been designated as series B convertible preferred stock, of which 79,246 shares are outstanding. The remaining authorized shares are undesignated preferred stock.
Our board of directors ability to issue undesignated preferred stock and the existence of anti-takeover provisions may depress the value of our common stock. Our authorized capital includes 20 million shares of preferred stock. Of this amount, 2,300,000 shares have been designated as series B convertible preferred stock, of which 79,246 shares are outstanding.
We have committed significant capital and management resources to developing our drug discovery solutions and other new business areas, and we intend to continue to devote significant capital and management resources to new businesses. Therefore, we could invest significant capital in business enterprises with no certainty when or whether we will realize a return on these investments.
Therefore, we could invest significant capital in business enterprises with no certainty when or whether we will realize a return on these investments. Any investments using cash will deplete our capital resources, meaning we will be required to raise significant amounts of new capital.
In addition, our Pittsburgh laboratory is required to be licensed on a test-specific basis by certain other states.
Pennsylvania laws also require that we maintain a license and establish standards for the day-to-day operation of our clinical reference laboratory in Pittsburgh, Pennsylvania. In addition, our Pittsburgh laboratory is required to be licensed on a test-specific basis by certain other states.
There may be additional risks and claims made by third parties derived from an improper disclosure that are difficult to ascertain at this time. 22 We cannot predict whether future healthcare initiatives will be implemented at the federal or state level, or how any future legislation or regulation may affect us. The U.S.
There may be additional risks and claims made by third parties derived from an improper disclosure that are difficult to ascertain at this time.
The exercise of outstanding warrants, and issuance of equity awards may have a dilutive effect on our stock, and negatively impact the price of our common stock Acquisitions involve risks that could result in adverse changes to operating results, cash flows, and liquidity. 26 We may desire to make strategic acquisitions in the future.
The exercise of outstanding warrants, and issuance of equity awards may have a dilutive effect on our stock, and negatively impact the price of our common stock.
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. 20 We are subject to CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
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.
If we become subject to intellectual property actions, it could hinder our ability to deliver our products and services and our business could be negatively impacted. We could be subject to legal or regulatory actions alleging intellectual property infringement or similar claims against us.
If our intellectual property does not provide adequate coverage of our competitors’ products, our competitive position could be adversely affected, as could our overall business. 19 If we become subject to intellectual property actions, it could hinder our ability to deliver our products and services and our business could be negatively impacted.
In the past, plaintiffs have often initiated securities class action litigation against companies following periods of volatility in the market price of their securities. We may in the future be the target of similar litigation. Securities litigation could result in substantial costs and liabilities and could divert management’s attention and resources.
Further, in the past, following periods of volatility in the overall market and the market prices of particular companies’ securities, securities class action litigations have often been instituted against these companies. Litigation of this type, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.
We have contracted with a manufacturing company that follows ISO compliance regulations of the FDA and that can manufacture products at high volumes. However, if demand for our product is higher than anticipated, there is no assurance that we or our manufacturing partners will be able to produce the product in sufficiently higher quantity to satisfy demands.
However, if demand for our product is higher than anticipated, then we or our manufacturing partners may not be able to produce the product in sufficiently higher quantity to satisfy demand.
In assessing these risks, you should also refer to the other information contained in this Form 10-K, including our financial statements and related notes. Risk Factors Relating to Our Business Our limited operating history with respect to our drug discovery solutions makes evaluation of our business difficult.
In assessing these risks, you should also refer to the other information contained in this Form 10-K, including our financial statements and related notes. Risk Factors Related to Our Business There is substantial doubt about our ability to continue as a going concern. We will require significant additional financing to fund operating expenses and implement our business plan.
CLIA regulations mandate specific standards in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, and quality assurance. CLIA certification is also required in order for our business to be eligible to bill Federal and State healthcare programs, as well as many private third-party payors, for our molecular diagnostic tests.
CLIA certification is also required in order for our business to be eligible to bill Federal and State healthcare programs, as well as many private third-party payors, for our molecular diagnostic tests. To renew these certifications, we are subject to survey and inspection every two years. Moreover, CLIA inspectors may make random inspections of our clinical reference laboratories.
We can give no assurance that we would be able to find satisfactory replacements for these key individuals at all, or on terms that are not unduly expensive or burdensome to us. We may fail to realize the anticipated benefits of the zPREDICTA acquisition.
We may not be able to find satisfactory replacements for members of our management team at all, or on terms that are not unduly expensive or burdensome to us. Such loss of a key member or members of our management team without adequate replacements would have a negative impact on our business, financial condition, and results of operations.
These possibilities, to the extent available, may be on terms that result in significant dilution to our existing shareholders or that result in our existing shareholders losing part or all of their investment. Our business and operations have been and may continue to be materially and adversely affected by the COVID-19 pandemic.
These alternatives may include, but are not limited to, equity financing, issuing debt, entering into other financing arrangements, or monetizing operating businesses or assets. These possibilities, to the extent available, may be on terms that result in significant dilution to our existing stockholders or that result in our existing stockholders losing part or all of their investment.
The Company is monitoring and taking actions to mitigate potential risks of these shortages and delays which may impact the Company’s ability to obtain new contracts, the fulfillment of product demand and to meet its contract obligations.
We monitor and act as necessary to mitigate potential risks of shortages and delays that may impact our ability to obtain new contracts, fulfill product demands and meet our contract obligations. The extent to which business disruptions may impact our financial condition and results of operations remains uncertain and is dependent on numerous evolving factors.
Removed
Investments using cash will deplete our capital resources, meaning we will be required to raise significant amounts of new capital. There is no assurance that we will be successful in raising sufficient capital, and the terms of any such financing will be dilutive to our stockholders.
Added
Such financing, if available, may be dilutive. We have incurred significant and recurring losses from operations for the past several years and had an accumulated deficit of $167,761,883 as of December 31, 2023. We had cash and cash equivalents of $8,728,660 as of December 31, 2023 and need to raise significant additional capital to meet our operating needs.
Removed
We rely on sole suppliers for certain materials used to perform our molecular diagnostic tests. We also purchase reagents used in our molecular diagnostic tests from sole-source suppliers.
Added
Our short-term obligations as of December 31, 2023 were $3,951,031, consisting primarily of aggregate accounts payable and accrued expenses of $2,973,729 and operating lease obligations of $517,427.
Removed
We may require additional financing to fund operating expenses and fulfill our business plan. Such financing, if available, will be dilutive. We have not achieved profitability and anticipate that we will continue to incur net losses at least through the remainder of 2023.
Added
As of December 31, 2023, we also had a short-term note payable of $150,408 that bears interest at an annual percentage rate of 9.25% and long-term operating lease obligations of $2,188,979 with a weighted average remaining lease term of 3.99 years. We do not expect to generate sufficient operating revenue to sustain our operations in the near term.
Removed
We may need to raise additional capital to finance operating expenses, invest in our sales organization and new product development, compete in the international marketplace, and develop the strategic assets of our Helomics businesses, especially over the longer term.
Added
During the year ended December 31, 2023, we incurred negative cash flows from operations of $13,189,390.
Removed
We may attempt to raise these funds through equity or debt financing that may include public offerings, private placements, alternative offerings, or other means. Such additional financing would be dilutive to existing stockholders, and there is no assurance that such financing would be available upon terms acceptable to us or at all.
Added
Although we have attempted to improve our operating margin by bolstering revenues and curtailing expenses and continue to seek ways to generate revenue through business development activities, there is no guarantee that we will be able to improve our operating margin sufficiently or achieve profitability in the near term.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeITEM 2. PROPERTIES. Our corporate offices are located in Eagan, Minnesota. We lease 5,773 square feet at this location, of which 2,945 square feet is used for office space and 2,828 is used for manufacturing.
Biggest changeITEM 2. PROPERTIES. Our corporate offices are in Pittsburgh, Pennsylvania. We have leases for office and laboratory space that are effective through February 29, 2028. We lease office and laboratory space in Birmingham, Alabama. This lease is effective through August 31, 2025. We lease office and manufacturing space in Eagan, Minnesota. This lease is effective through May 31, 2025.
We expect that the current space will be adequate for our current office and laboratory needs. ITEM 3. LEGAL PROCEEDINGS. Not applicable. ITEM 4. MINE SAFETY DISCLOSURES. Not applicable. 28 PART II
We expect that the current space will be adequate for our current office and laboratory needs. 32 ITEM 3. LEGAL PROCEEDINGS. None. ITEM 4. MINE SAFETY DISCLOSURES. Not applicable. PART II
Removed
The lease as amended has a one-year term that ended January 31, 2022, and as of December 10, 2021 has a second amended six-month term until July 31, 2022. Management and the landlord have verbally agreed to further extensions as needed. The offices of our Helomics subsidiary are located in Pittsburgh, Pennsylvania.
Removed
We lease 20,835 square feet at this location, of which approximately 4,418 square feet are used for office space and 16,417 square feet is used for laboratory operations. The lease, as amended, has a two-year term ending February 28, 2023.
Removed
We entered into two new leases with the primary lease effective March 1, 2023, both of which have an approximate five-year term ending February 28, 2028. Soluble Biotech’s offices are located in Birmingham, Alabama. We lease approximately 5,274 square feet at this location. The lease is effective through August 25, 2025.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeWe have not paid, and do not expect to declare or pay, cash dividends on common stock in the foreseeable future. Securities Authorized for Issuance under Equity Compensation Plans The information required by this Item 5 regarding securities authorized for issuance under equity compensation plans is incorporated herein by reference to Item 12 below.
Biggest changeWe have not paid, nor do we expect to declare or pay, cash dividends on common stock in the foreseeable future. Securities Authorized for Issuance under Equity Compensation Plans The information required by this Item 5 regarding securities authorized for issuance under equity compensation plans is incorporated herein by reference to Item 12 below. ITEM 6. [RESERVED] Not Required.
Prior to February 2, 2018, our common stock was listed on The NASDAQ Capital Market under the symbol “SKLN”. Holders As of March 14, 2023, there were approximately 154 stockholders of record of our common stock. Dividend Policy We follow a policy of retaining earnings, if any, to finance the expansion of our business.
Prior to February 2, 2018, our common stock was listed on The NASDAQ Capital Market under the symbol “SKLN”. Holders As of March 18, 2024, there were approximately 155 stockholders of record of our common stock. Dividend Policy We follow a policy of retaining earnings, if any, to finance the expansion of our business.
Removed
Recent Sales of Unregistered Securities Information regarding sales of unregistered securities during the periods covered hereby has been included in previous reports on Form 8-K or 10-Q. For additional information on such sales, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources – Financing Transactions.” ITEM 6. SELECTED FINANCIAL DATA. Not Required.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeImportant factors that may cause actual results to differ from projections include: Our history of operating losses; Current negative operating cash flows; Our capital needs to accomplish our goals, and the adequacy of available funds, including our ability to access the capital markets, our ability to obtain additional equity funding from current or new stockholders to fund our business operations and/or future growth plans, and the dilutive effect that raising equity capital would have on the relative equity ownership of our existing investor Risks related to prior and future acquisitions, including the possibility of impairment of goodwill acquired and risks related to the benefits and costs of acquisition; Risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns; 29 Risk that we will be unable to protect our intellectual property or claims that we are infringing on others’ intellectual property; The impact of competition; Acquisition and maintenance of any necessary regulatory clearances applicable to applications of our technology; Inability to attract or retain qualified senior management personnel, including sales and marketing personnel; Risk that we never become profitable if our products and services are not accepted by potential customers; Possible impact of government regulation and scrutiny; Unexpected costs and operating deficits, and lower than expected sales and revenues, if any; Adverse results of any legal proceedings; The volatility of our operating results and financial condition, Management of growth; Risk that our business and operations will continue to be materially and adversely affected by the COVID-19 pandemic, which has resulted in delayed production and less efficiency; and has impacted on our sales efforts, accounts receivable, and terms demanded by suppliers; and may impact financing transactions; and Other specific risks that may be alluded to in this report.
Biggest changeImportant factors that may cause actual results to differ from projections include: Our ability to continue operating beyond twelve months without additional financing; Continued negative operating cash flows; Our capital needs to accomplish our goals, including any further financing, which may be highly dilutive and may include onerous terms; Risks related to recent and future acquisitions, including risks related to the benefits and costs of acquisition; 33 Risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns; Risks related to the initiation, formation, or success of our collaboration arrangements, commercialization activities and product sales levels by our collaboration partners and future payments that may come due to us under these arrangements, Risk that we will be unable to protect our intellectual property or claims that we are infringing on others’ intellectual property; The impact of competition; Acquisition and maintenance of any necessary regulatory clearances applicable to applications of our technology; Inability to attract or retain qualified senior management personnel, including sales and marketing personnel; Risk that we never become profitable if our products and services are not accepted by potential customers; Possible impact of government regulation and scrutiny; Unexpected costs and operating deficits, and lower than expected sales and revenues, if any; Adverse results of any legal proceedings; The volatility of our operating results and financial condition, Management of growth; Risk that our business and operations could be materially and adversely affected by disruptions caused by economic and geopolitical uncertainties as well as epidemics or pandemics; and Other specific risks that may be alluded to in this report.
From time to time during the three-year commitment period, provided that the closing conditions are satisfied, the Company may provide the investor with put notices to purchase a specified number of shares subject to certain limitations and conditions and at specified prices, which generally represent discounts to the market price of the common stock.
From time to time during the three-year commitment period, provided that the closing conditions were satisfied, the Company could provide the investor with put notices to purchase a specified number of shares subject to certain limitations and conditions and at specified prices, which generally represent discounts to the market price of the common stock.
In addition, the Company granted to the placement agent or its assigns warrants to purchase 7.5% of the shares sold to investors in the offering at an exercise price equal to 125% of the price of the shares in the transaction, or $0.75 per share, with a term of five years (the “Agent Warrants”).
In addition, the Company granted to the placement agent or its assigns warrants to purchase 7.5% of the shares sold to investors in the offering at an exercise price equal to 125% of the price of the shares in the transaction, or $15.00 per share, with a term of five years (the “Agent Warrants”).
The Company first has the option to assess qualitative factors to determine if it is more likely than not that the carrying value of a reporting unit exceeds its estimated fair value. The Company may also elect to skip the qualitative testing and proceed directly to the quantitative testing.
We first have the option to assess qualitative factors to determine if it is more likely than not that the carrying value of a reporting unit exceeds its estimated fair value. We may also elect to skip the qualitative testing and proceed directly to the quantitative testing.
For that reason we also use the Black-Scholes option-pricing model to value options and warrants granted to non-employees, which requires the input of significant assumptions including an estimate of the average period that investors or consultants will retain vested stock options and warrants before exercising them, the estimated volatility of our common stock price over the expected term, the number of options and warrants that will ultimately be forfeited before completing vesting requirements and the risk-free interest rate.
For that reason, we also use the Black-Scholes option-pricing model to value options and warrants granted to non-employees, which requires the input of significant assumptions including an estimate of the average period that investors or consultants will retain vested stock options and warrants before exercising them, the estimated volatility of our common stock price over the expected term, and the risk-free interest rate.
Events or changes in circumstances that indicate the carrying amount may not be recoverable include, but are not limited to, a significant change in the medical device marketplace and a significant adverse change in the business climate in which the Company operates.
Events or changes in circumstances that indicate the carrying amount may not be recoverable include, but are not limited to, a significant change in the medical device marketplace and a significant adverse change in the business climate in which we operate.
Actual results could differ materially and adversely from those anticipated in such forward-looking statements as a result of certain factors, including those set forth below and elsewhere in this report.
Actual results could differ materially and adversely from those anticipated in such forward-looking statements as a result of certain factors, including but not limited to those set forth below and elsewhere in this report.
Upon the terms and subject to the conditions in the purchase agreement, the investor is committed to purchase shares having an aggregate value of up to $15,000,000 of the Company’s common stock for a period of up to three years.
According to the terms and subject to the conditions in the purchase agreement, the investor was committed to purchase shares having an aggregate value of up to $15,000,000 of the Company’s common stock for a period of up to three years.
For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. 40 Recent Accounting Developments See “Note 1 - Summary of Significant Accounting Policies - Recently Adopted Accounting Standards” in Notes to Consolidated Financial Statements of this Annual Report on Form 10-K.
For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. 40 Recent Accounting Developments See “Recent Accounting Pronouncements” and “Recently Adopted Accounting Standards” under Note 1 - Summary of Significant Accounting Policies in Notes to Consolidated Financial Statements of this Annual Report on Form 10-K.
Goodwill is not amortized but is tested on an annual basis for impairment at the reporting unit level as of December 31, or whenever events or changes in circumstances indicate that the carrying amount may not be fully recoverable. 39 To determine whether goodwill is impaired, annually or more frequently if needed, the Company performs a multi-step impairment test.
Goodwill is tested on an annual basis for impairment at the reporting unit level as of December 31, or whenever events or changes in circumstances indicate that the carrying amount may not be fully recoverable. To determine whether goodwill is impaired, annually or more frequently if needed, we perform a multi-step impairment test.
We believe that these estimates and assumptions are reasonable under the circumstances and form the basis for our making judgments about the carrying values of our assets and liabilities that are not readily apparent from other sources. Actual results and outcomes could differ from our estimates primarily due to incorrect sales forecasting.
We believe that these estimates and assumptions are reasonable under the circumstances and form the basis for our making judgments about the carrying values of our assets and liabilities that are not readily apparent from other sources. Actual results and outcomes could differ from our estimates.
The Company issued to the investor 104,651 commitment shares at a fair market value of $450,000 for entering into the agreement.
The Company issued to the investor 5,233 commitment shares at a fair market value of $450,000 for entering into the agreement.
We base our estimates and assumptions on our historical experience and on various other information available to us at the time that these estimates and assumptions are made.
We evaluate our estimates and assumptions on an on-going basis. 38 We base our estimates and assumptions on our historical experience and on various other information available to us at the time that these estimates and assumptions are made.
Critical Accounting Policies and Estimates The discussion and analysis of our financial condition and results of operations are based upon our audited consolidated Financial Statements, which have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”).
The equity line expired on October 23, 2022. Critical Accounting Estimates The discussion and analysis of our financial condition and results of operations are based upon our audited consolidated Financial Statements, which have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”).
The Warrants have an exercise price equal to $0.70 per share, became exercisable six months from the date of issuance, and will expire five and one-half years from the date of issuance.
The Warrants have an exercise price equal to $14.00 per share, will become exercisable six months from the date of issuance, and will expire five and one-half years from the date of issuance.
We believe that the following discussion addresses our critical accounting policies and reflects those areas that require more significant judgments and use of estimates and assumptions in the preparation of our audited consolidated Financial Statements. Revenue Recognition. We recognize revenue in accordance with ASC 606, Revenue Recognition .
We believe that the following discussion addresses our critical accounting estimates and reflects those areas that require more significant judgments and use of estimates and assumptions in the preparation of our audited consolidated Financial Statements.
When performing quantitative testing, the Company first estimates the fair values of its reporting units using discounted cash flows. To determine fair values, the Company is required to make assumptions about a wide variety of internal and external factors.
When performing quantitative testing, we first estimate the fair values of our reporting units using discounted cash flows. To determine fair values, we are required to make assumptions about a wide variety of internal and external factors.
May 2022 Offerings On May 16, 2022, the Company, issued and sold to several institutional and accredited investors pursuant in a registered direct offering (the “First Offering”) an aggregate of 3,837,280 shares of its common stock, at a purchase price of $0.60 per share.
May 2022 Offerings On May 16, 2022, the Company issued and sold an aggregate of 191,864 shares of its common stock, at a purchase price of $12.00 per share to several institutional and accredited investors in a registered direct offering (the “First Offering”).
Under the Warrant Amendment, certain existing warrants to purchase up to 16,325,435 shares of common stock that were previously issued in 2020 and 2021 to those purchasers, with exercise prices ranging from $1.00 to $2.00 per share (the “Existing Warrants”), were amended to: (i) lower the exercise price of the Existing Warrants to $0.70 per share, (ii) provide that the Existing Warrants, as amended, would not be exercisable until six months following the closing date of the Second Offering, and (iii) extend the original expiration date of the Existing Warrants until five and one-half years following the close of the Second Offering.
Under the Warrant Amendment, the Company agreed to amend certain existing warrants to purchase up to 816,272 shares of common stock that were previously issued in 2020 and 2021 to those purchasers, with exercise prices ranging from $20.00 to $40.00 per share (the “Existing Warrants”), were amended to: (i) lower the exercise price of the Existing Warrants to $14.00 per share, (ii) provide that the Existing Warrants, as amended, will not be exercisable until six months following the closing date of the Second Offering, and (iii) extend the original expiration date of the Existing Warrants by five and one-half years following the close of the Second Offering.
Pursuant to the securities purchase agreement, in a concurrent private placement, the Company also issued to these purchasers unregistered warrants to purchase up to an aggregate of 3,837,280 shares of common stock (the “Warrants”).
Pursuant to the securities purchase agreement, the Company also agreed to issue to these purchasers unregistered warrants to purchase up to an aggregate of 191,864 shares of common stock (the “Warrants”) in a concurrent private placement.
See Note 8 Intangible Assets and Goodwill in our audited consolidated financial statements included in this annual report. I ncome Taxes. Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards.
See Note 4 Property and Equipment and Note 5 Intangible Assets to our audited consolidated financial statements included in this annual report on Form 10-K. Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards.
See “Liquidity and Capital Resources Liquidity and Plan of Financing” below. Our limited history of operations, especially in our suite of solutions for oncology drug development, and our change in the emphasis of our business, starting in 2017, makes prediction of future operating results difficult.
See “Liquidity and Capital Resources Liquidity and Plan of Financing; Going Concern” below. Our limited history of operations, especially in our drug discovery business, and our change in the emphasis of our business, starting in 2017, makes prediction of future operating results difficult.
We incurred net losses of $25,737,634 and $19,657,174 for the years ended December 31, 2022, and December 31, 2021, respectively. As of December 31, 2022, and December 31, 2021, we had an accumulated deficit of $153,777,916 and $128,040,282, respectively. We have never generated sufficient revenues to fund our capital requirements.
We incurred net losses of $13,983,967 and $25,737,634 for the years ended December 31, 2023, and December 31, 2022, respectively. As of December 31, 2023, and December 31, 2022, we had an accumulated deficit of $167,761,883 and $153,777,916, respectively. We have never generated sufficient revenues to fund our capital requirements.
Equity Line On October 24, 2019, the Company entered into an equity purchase agreement with an investor, providing for an equity financing facility.
The Agent Warrants become exercisable six months after issuance. Equity Line On October 24, 2019, the Company entered into an equity purchase agreement with an investor, providing for an equity financing facility.
We use the Black-Scholes option-pricing model which requires the input of significant assumptions including an estimate of the average period of time employees and directors will retain vested stock options before exercising them, the estimated volatility of our common stock price over the expected term, the number of options that will ultimately be forfeited before completing vesting requirements and the risk-free interest rate.
We estimate the fair value of stock-based payment awards on the date of grant using the Black-Scholes option-pricing model which requires the input of significant assumptions including an estimate of the average period of time employees and directors will retain vested stock options before exercising them, the estimated volatility of our common stock price over the expected term, and the risk-free interest rate.
In addition, in a concurrent registered direct offering (the “Second Offering”), on May 16, 2022, the Company entered into a securities purchase agreement with several institutional and accredited investors pursuant to which the Company issued and sold to several institutional and accredited investors pursuant an aggregate of 8,162,720 shares of its common stock, at a purchase price of $0.60 per share.
In addition, in a concurrent registered direct offering (the “Second Offering”), on May 16, 2022, the Company issued and sold to several institutional and accredited investors an aggregate of 408,136 shares of its common stock, at a purchase price of $12.00 per share.
Our future cash requirements and the adequacy of available funds depend on our ability to generate revenues from our Helomics and zPREDICTA segments; our ability to continue to sell our Skyline Medical products and to reach profitability in the Skyline Medical business, our ability to generate revenue from our Soluble reportable segment and the availability of future financing to fulfill our business plans.
Our future cash requirements and the adequacy of available funds depend on our ability to generate revenues from our oncology businesses located in Pittsburgh and Birmingham; our ability to continue to sell our Skyline Medical products and services and to reach profitability in all our businesses; and the availability of future financing to fulfill our business plans.
Our Soluble segment provides services using a self-contained, automated system that conducts high-throughput, self-interaction chromatography screens, using additives and excipients commonly included in protein formulations resulting in soluble and physically stable formulations for biologics. Our Skyline segment consists of the STREAMWAY System product sales.
In our second business area, we provide services and research using a proprietary self-contained and automated system that conducts high-throughput, self-interaction chromatography screens using additives and excipients commonly included in protein formulations resulting in soluble and physically stable formulations of biologics.
Other income included interest income and in the year ended December 31, 2022 gains associated with equipment abandoned in connection with a sublease and losses on asset disposals. The year ended December 31, 2021 included gains on settlement of outstanding payables during 2021. Other expense. We incurred other expenses of $5,275 in 2022 compared to $239,631 in 2021.
Other income primarily consists of interest income and, in the year ended December 31, 2022, gains associated with equipment abandoned in connection with a sublease and losses on asset disposals. The decrease in other income was primarily due to lower interest income. 36 Other expense. We incurred other expenses of $64,967 in 2023 compared to $5,275 in 2022.
Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all the deferred tax assets will not be realized.
Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit.
The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit.
We recognize compensation expense for these service-based equity-classified awards over their requisite service period and adjust for forfeitures as they occur. We also have certain awards which vest upon a combination of the satisfaction of service-based and performance-based conditions.
We recognize compensation expense for these service-based equity-classified awards over their requisite service period and adjust for forfeitures as they occur.
Off-Balance Sheet Transactions We have no off-balance sheet transactions. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. Not required.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. Not required.
We completed a fair value assessment which resulted in the impairment and allocated the impairment to the assets of each of the affected asset groups. During the year ended December 31, 2021, we incurred a loss on impairment on acquired software of $1,249,727 due to the decline in future projected cash flows.
We then allocated the impairment to the assets of the affected asset group. We recorded a loss on impairment of property and equipment of $185,469 during the year ended December 31, 2022. The impairment was primarily due to a decline in projected future cash flows. We completed a fair value assessment which resulted in an impairment.
We incurred a gain of $115,647 in 2022 compared to a gain of $164,902 in 2021, primarily related to the changes in fair market value on derivatives. Income Taxes.
We recorded a gain of $12,457 in 2023 compared to a gain of $115,647 in 2022, primarily related to the changes in fair market value on derivatives. Income Taxes. We incurred zero income tax expense in 2023 and 2022 due to losses in both years.
In connection with the May 2022 offerings, the Company agreed not to access the remaining balance for a period of one year after the May 18, 2023 closing date. The equity line expired on October 23, 2022.
During the year ended December 31, 2022, the Company issued 15,750 shares of its common stock valued at $236,009 pursuant to the equity line. In connection with the May 2022 offerings, the Company agreed not to access the remaining balance for a period of one year after the closing date, or May 18, 2022.
Since 2017, we have diversified our business by investing in ventures, including making significant loans and investments in early-stage companies. These activities led to the acquisition of Helomics in April 2019, the purchase of the assets of two businesses in 2020 and the acquisition of zPREDICTA in November 2021, each of which have accelerated our capital needs.
These activities led to the acquisition of Helomics Corporation in April 2019, two transactions to acquire the assets of three businesses in 2020, and the acquisition of zPREDICTA Inc. (“zPREDICTA”) in November 2021, each of which have accelerated our capital needs.
The value of the intangible assets of the Helomics operating segment following the impairment was $0 at December 31, 2021. See Note 8 to our audited consolidated financial statements included in this annual report. 32 Loss on impairment of tangible long-lived assets.
The value of the intangible assets of zPREDICTA following the impairment was $0 at December 31, 2022. zPREDICTA was merged with Predictive Oncology at the end of 2022 and is now reported as part of the Pittsburgh operating segment. See Note 5 Intangible Assets to our audited consolidated financial statements included in this annual report on Form 10-K.
To the extent the carrying amount of goodwill exceeds the implied goodwill, the difference is the amount of the goodwill impairment. The Company also completes a reconciliation between the implied equity valuation prepared and the Company’s market capitalization.
To the extent the carrying amount of goodwill exceeds the implied goodwill, the difference is the amount of the goodwill impairment. We also complete a reconciliation between the implied equity valuation prepared and our market capitalization. The majority of the inputs used in the discounted cash flow model are unobservable and thus are considered to be Level 3 inputs.
We have been on the NASDAQ Capital Market since 2015 and have had a volatile stock including reverse stock splits. The assumptions we use in calculating the fair value of stock-based payment awards represent our best estimates, which involve inherent uncertainties and the application of management's judgment.
The assumptions we use in calculating the fair value of stock-based payment awards represent our best estimates, which involve inherent uncertainties and the application of management's judgment. As a result, if factors change and we use different assumptions, our stock-based compensation expense could be materially different in the future.
The impairment recorded relates to the intangible assets of our zPREDICTA operating segment and is primarily due to the declines in projected future cash flows for the operating segment. The value of the intangible assets of the zPREDICTA operating segment following the impairment was $0 at December 31, 2022.
The impairment recorded related to the finite-lived intangible assets obtained with our acquisition of zPREDICTA in 2021 and was primarily due to declines in projected future cash flows.
During the year ended December 31, 2022, we incurred a loss on impairment of goodwill of $7,231,093 relating to the goodwill acquired in our 2021 zPREDICTA acquisition primarily related to the declines in our market capitalization. Our goodwill, for our zPREDICTA operating segment, following the impairment in 2022 was $0 with the cumulative losses on goodwill are $7,231,093.
During the year ended December 31, 2022, we determined that the goodwill was impaired primarily due to declines in our market capitalization and recorded an impairment loss of $7,231,093.
Through AI, Predictive Oncology uses a biobank of 150,000+ cancer tumor samples, categorized by patient type, against drug compounds to help the drug discovery process and increase the probability of success.
We use AI and a proprietary biobank of 150,000+ tumor samples, categorized by tumor type, to provide actionable insights about drug compounds to improve the drug discovery process and increase the probability of drug compound success. We offer a suite of solutions for oncology drug development from early discovery to clinical trials.
In accordance with ASC 350, Intangibles Goodwill and Other , goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of net assets acquired. Goodwill is an asset representing the future economic benefits arising from other assets acquired in a business combination.
Goodwill is an asset representing the future economic benefits arising from other assets acquired in a business combination. Goodwill is an indefinite-lived intangible asset and is not amortized.
Overview Predictive Oncology is a knowledge-driven company focused on applying AI to support the development of optimal cancer therapies, which can ultimately lead to more effective treatments and improved patient outcomes.
These cautionary statements qualify all forward-looking statements attributable to us or persons acting on our behalf. Overview We are a knowledge and science-driven company that applies artificial intelligence (“AI”) to support the discovery and development of optimal cancer therapies, which can ultimately lead to more effective treatments and improved patient outcomes.
Cash flows provided by financing activities in 2022 were primarily due from proceeds from the issuance of common stock and warrants in May 2022.
Cash provided by financing activities in 2023 was primarily related to proceeds from financing insurance premiums over the insured period with a short-term note payable while the cash provided in 2022 was primarily proceeds from the issuance of common stock and warrants.
Depending on how we choose to fund will affect numerous expense categories so the potential for underestimating those expenses is a viable concern. 36 Our significant accounting policies are described in “Note 1 Summary of Significant Accounting Policies,” in Notes to audited consolidated Financial Statements of this Annual Report on Form 10-K.
Our significant accounting policies are described in Note 1 Summary of Significant Accounting Policies in Notes to Consolidated Financial Statements of this Annual Report on Form 10-K.
We have funded our operations through a variety of debt and equity instruments. See “Liquidity and Capital Resources Liquidity and Plan of Financing” and “Liquidity and Capital Resources Financing Transactions” below.
See “Liquidity and Capital Resources Liquidity and Plan of Financing; Going Concern” and “Liquidity and Capital Resources Financing Transactions” below.
Please see Note 8 to our audited consolidated financial statements included in this annual report for further information. Other income. We earned other income of $185,646 in 2022 compared to $184,528 in 2021.
We then allocated the impairment to the assets of each of the affected asset groups. See Note 4 Property and Equipment to our audited consolidated financial statements included in this annual report on Form 10-K. Other income. We earned other income of $152,776 in 2023 compared to $185,646 in 2022.
Cash flows used in investing activities in 2021 were primarily related to the acquisition of our zPREDICTA subsidiary in the amount of $9,590,214 and $910,429 of cash outflows related to purchases of fixed assets. Net cash provided by financing activities was $6,715,405 in 2022 compared to net cash provided of $50,340,748 in 2021.
Cash used in investing activities decreased in 2023 primarily due to a decrease in the acquisition of property and equipment. Net cash provided by financing activities was $148,898 in 2023 compared to $6,715,405 in 2022.
Other expenses consisted primarily of interest expense and in addition in the year ended December 31, 2021 we also incurred expenses related to payment penalties and the amortization of original issue discounts. Gain on derivative instruments.
Other expenses primarily consist of interest expense and, in the year ended December 31, 2023, losses on a note receivable deemed uncollectible. The increase in other expenses was primarily due to writing off a note receivable deemed uncollectible. Gain on derivative instruments.
Results of Operations Comparison of Year Ended December 31, 2022 with Year Ended December 31, 2021 2022 2021 Difference Revenue $ 1,505,459 $ 1,420,680 $ 84,779 Cost of sales 505,107 487,024 (18,083 ) General and administrative expense 11,110,735 10,932,125 (178,610 ) Operations expense 3,798,425 2,698,565 (1,099,860 ) Sales and marketing expense 1,358,907 774,530 (584,377 ) 31 Revenue.
Results of Operations Comparison of Year Ended December 31, 2023, with Year Ended December 31, 2022 2023 2022 Difference Revenue $ 1,780,093 $ 1,505,459 $ 274,634 Cost of sales 634,796 505,107 (129,689 ) General and administrative expense 9,428,496 11,110,735 1,682,239 Operations expense 4,127,268 3,798,425 (328,843 ) Sales and marketing expense 1,510,861 1,358,907 (151,954 ) Revenue.
These increases were offset by approximately $627,000 lower costs for professional fees including consultants supporting our quality assurance efforts, investor relations and lower legal expenses. Operations expense. Operations expense in our current stage primarily consists of expenses related to product development, prototyping and testing including staff related expenses for individuals performing this work.
Additional decreases included lower amortization expense related to acquired intangible assets impaired in the prior year. These decreases were offset by higher professional fees including consultants supporting our management team and investor relations as well as other G&A expenses. Operations expense. Operations expenses primarily consist of expenses related to product development, prototyping and testing.
The increase in 2022 was primarily due to $578,000 in expenses related to the addition of headcount supporting our sales and marketing efforts as well as consulting expenses related to the overall marketing approach for the company. Loss on goodwill impairment.
The increase in 2023 was primarily due to approximately $209,000 higher staff-related expenses resulting from the addition of headcount supporting our sales and marketing efforts, offset by lower spend on other marketing activities. Loss on goodwill impairment. Upon closing our acquisition of zPREDICTA on November 24, 2021, we recorded related goodwill of $7,231,093.
We incurred a loss on impairment on certain tangible long-lived assets of $185,469 during the year ended December 31, 2022. The impairment was recorded as a result of our annual assessment and primarily due to the decline in projected future cash flows.
Loss on impairment of tangible long-lived assets. We recorded a loss on impairment of property and equipment of $162,905 during the year ended December 31, 2023. We prepared an undiscounted cash flow for our Birmingham asset group as of June 30, 2023, to evaluate long-lived assets, then completed a fair value assessment which resulted in the impairment.
Revenues are derived from studies conducted with biopharmaceutical and pharmaceutical companies. The specific methodology for revenue recognition is determined on a case-by-case basis according to the facts and circumstances applicable to a given contract.
The specific pattern of revenue recognition for CRO services is determined on a case-by-case basis according to the facts and circumstances applicable to a given contract. We evaluate each product or service promised in a contract to determine whether it represents a distinct performance obligation.
The gross profit margin was 66% in each of the years ended December 31, 2022 and 2021, respectively. General and Administrative expense . General and administrative (“G&A”) expense primarily consists of management salaries, professional fees, consulting fees, travel expense, administrative fees and general office expenses. G&A expense increased by $178,610 to $11,110,735 in 2022 from $10,932,125 in 2021.
General and administrative (“G&A”) expenses primarily consist of management salaries, professional fees, consulting fees, depreciation and amortization, office rents, and general office expenses. G&A expenses decreased by $1,682,239 to $9,428,496 in 2023 from $11,110,735 in 2022. The decrease was primarily due to decreases in staff-related expenses of approximately $1,980,000.
For market-based awards, we determine the grant-date fair value utilizing a Monte Carlo valuation model, which incorporates various assumptions including expected stock price volatility, expected term and risk-free interest rates. Changes in the assumptions can materially affect the estimate of fair value of stock-based compensation and, consequently, the related expense recognizes that.
In the case of options to employees, we estimated the life to be the legal term. 39 Changes in the assumptions can materially affect the estimate of fair value of stock-based compensation and, consequently, the related expense recognizes that. We have been traded on the NASDAQ Capital Market exchange since 2015 and have experienced significant volatility in our stock price.
In the Helomics acquisition, the Company recorded goodwill of $23,790,290. The goodwill was recorded to the Helomics segment which represents a single reporting unit. The cumulative losses on goodwill are $23,790,290 as of December 31, 2021. See Note 8 Intangible Assets and Goodwill in our audited consolidated financial statements included in this annual report.
Accordingly, goodwill related to zPREDICTA was $0 at both December 31, 2023, and December 31, 2022. zPREDICTA was merged with Predictive Oncology at the end of 2022 and is now reported as part of the Pittsburgh operating segment. See Note 5 Intangible Assets to our audited consolidated financial statements included in this annual report on Form 10-K.
Our goodwill, for the Helomics operating segment, following the impairment in 2021 was $0 with the cumulative losses on goodwill are $23,790,290. See Note 8 to our audited consolidated financial statements included in this annual report. Loss on intangible asset impairment. We incurred a loss on impairment of intangibles of $3,349,375 during the year ended December 31, 2022.
Loss on finite-lived intangible asset impairment. During the year ended December 31, 2023, we incurred no losses on impairment of finite-lived intangible assets. During the year ended December 31, 2022, we incurred a loss on impairment of finite-lived intangible assets of $3,349,375.
We recorded revenue of $1,505,459 in 2022, compared to $1,420,680 in 2021. Our Skyline division was responsible for the majority of the revenue, with zPREDICTA generating $352,379 and Soluble generating $82,301 in revenue in the year ended December 31, 2022. During the year ended December 31, 2021, revenue of $1,420,680 was primarily generated at Skyline Medical with Soluble generating $233,293.
We recorded revenue of $1,780,093 in 2023, compared to $1,505,459 in 2022. Revenues for the years ended December 31, 2023, and December 31, 2022, were primarily derived from our Eagan operating segment.
Liquidity and Capital Resources Cash Flows Net cash used in operating activities was $12,370,800 in 2022, compared with net cash used of $12,208,929 in 2021. Cash used in operating activities increased in 2022 primarily due to cash operating losses as well as outflows related to payments on accounts payables and payments for inventories and other liabilities.
Cash used in operating activities increased in 2023 primarily due to cash operating losses as well as changes in working capital including decreases in accrued expenses and contract liabilities, offset by an increase in accounts payable. Net cash used in investing activities was $302,371 in 2023, compared to $475,697 in 2022.
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These cautionary statements qualify all forward-looking statements attributable to us or persons acting on our behalf. Information regarding market and industry statistics contained in this report is included based on information available to us that we believe is accurate. It is generally based on academic and other publications that are not produced for purposes of securities offerings or economic analysis.
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Our mission is to change the landscape of oncology drug discovery and enable the development of more effective therapies for the treatment of cancer. By harnessing the power of machine learning and scientific rigor, we believe that we can improve the probability of success of advancing pharmaceutical and biological drug candidates with a higher degree of confidence.
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We have not reviewed or included data from all sources, and we cannot assure potential investors of the accuracy or completeness of the data included in this report.
Added
We operate in three business areas. In our first area, we provide optimized, high-confidence drug-response predictions through the application of AI using our proprietary biobank of tumor samples to enable a more informed selection of drug/tumor combinations and increase the probability of success during development.
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Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue, and market acceptance of products and services. We have no obligation to update forward-looking information to reflect actual results or changes in assumptions or other factors that could affect those statements.
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We also create and develop tumor-specific 3D cell culture models mimicking the physiological environment of human tissue enabling better-informed decision-making during development.
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The company offers a suite of solutions for oncology drug development from early discovery to clinical trials. 30 We operate in four primary business areas: first, the application of AI for optimized, high-confidence drug-response predictions within a large experimental space that enables a more informed selection of drug/tumor combinations to increase the probability of success during development; second, creation and development of tumor-specific 3D cell culture models driving accurate prediction of drug response with high correlation to clinical response; third, contract services and research focused on solubility improvements, stability studies, and protein production, and; fourth, production of the FDA-cleared STREAMWAY System for automated, direct-to-drain medical fluid disposal and associated products.
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Our third business area produces the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal.
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We have four reportable segments: Helomics, zPREDICTA, Soluble and Skyline. The Helomics segment provides services that include the application of AI, collaboration projects and clinical testing. Our zPREDICTA segment specializes in organ-specific disease models that provide 3D reconstruction of human tissues more accurately representing each disease state and mimicking drug response enabling accurate testing of anticancer agents.
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As of January 1, 2023, we changed our reportable segments to align with these business areas. 34 We have three reportable segments, which have been delineated by location and business area: ● Pittsburgh segment: provides services that include the application of AI using its proprietary biobank of 150,000+ tumor samples.
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Going forward, we have determined that we will focus our resources on applying AI to support the development of optimal cancer therapies, partnering with biopharma clients to help prioritize drugs for development and identify biomarker-informed indications. Our platform provides a more informed decision tool to select optimal drug/tumor combinations to increase the probability of success during drug development.
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Pittsburgh also creates proprietary 3D culture models used in drug development. ● Birmingham segment : provides contract services and research focused on solubility improvements, stability studies, and protein production. ● Eagan segment: produces the FDA-cleared STREAMWAY System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal. Capital Requirements Since inception, we have been unprofitable.
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As a result of this focused approach, we have consolidated our brand under Predictive Oncology name. Going forward, we will operate under the Predictive Oncology tradename with laboratory operations in Pittsburgh, Pennsylvania and Birmingham, Alabama. Capital Requirements Since inception, we have been unprofitable.
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We have funded our operations through a variety of debt and equity instruments. Since 2017, we have diversified our business by investing in ventures, including making significant loans and investments in early-stage companies.
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We sold 7 STREAMWAY System units in 2022 and 15 STREAMWAY System units in 2021. Cost of sales. Cost of sales was $505,107 and $487,024 in 2022 and 2021, respectively. The increase in cost of sales is primarily due to increased cost of disposables and costs associated with our repair and maintenance contracts.
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The Eagan operating segment contributed $1,135,101 and $1,063,493 for the years ended December 31, 2023, and December 31, 2022, respectively, while the Pittsburgh operating segment contributed $492,596 and $358,776, respectively. 35 Cost of sales. Cost of sales was $634,796 and $505,107 for the years ended December 31, 2023, and December 31, 2022, respectively.
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The increase was primarily due to increases in staff related expenses of approximately $354,000. Additional increases included higher costs for expenses for office space of approximately $162,000, expenses related to the assessment and risk mitigation efforts related to our cyber security and other minor operating expenses.
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Cost of sales increased primarily due to costs associated with Pittsburgh contracted services. The gross profit margin declined to 64% in 2023 from 66% in 2022. The decline in gross profit margin was primarily due to costs related to contracted services provided by our Pittsburgh operating segment. General and administrative expense .

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