Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 06, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-36790 | |
Entity Registrant Name | Predictive Oncology Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 33-1007393 | |
Entity Address, Address Line One | 91 43rd Street, Suite 110 | |
Entity Address, City or Town | Pittsburgh | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 15201 | |
City Area Code | 412 | |
Local Phone Number | 432-1500 | |
Title of 12(b) Security | Common stock, $0.01 par value | |
Trading Symbol | POAI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 4,063,081 | |
Entity Central Index Key | 0001446159 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Assets, Current [Abstract] | ||
Cash and cash equivalents | $ 11,915,048 | $ 22,071,523 |
Accounts receivable | 544,756 | 331,196 |
Inventories | 439,989 | 430,493 |
Prepaid expense and other assets | 620,692 | 526,801 |
Total current assets | 13,520,485 | 23,360,013 |
Property and equipment, net | 1,392,681 | 1,833,255 |
Intangibles, net | 259,320 | 253,865 |
Lease right-of-use assets | 2,870,286 | 211,893 |
Other long-term assets | 124,096 | 75,618 |
Total assets | 18,166,868 | 25,734,644 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Accounts payable | 1,168,226 | 943,452 |
Note payable | 260,220 | 0 |
Accrued expenses and other liabilities | 1,810,838 | 2,229,075 |
Derivative liability | 2,109 | 13,833 |
Contract liabilities | 374,957 | 602,073 |
Lease liability | 555,541 | 94,237 |
Total current liabilities | 4,171,891 | 3,882,670 |
Lease liability – net of current portion | 2,343,622 | 86,082 |
Total liabilities | 6,515,513 | 3,968,752 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Common stock, $.01 par value, 200,000,000 shares authorized, 4,033,293 and 3,938,160 shares outstanding as of September 30, 2023 and December 31, 2022, respectively | 40,333 | 39,382 |
Additional paid-in capital | 175,896,766 | 175,503,634 |
Accumulated deficit | (164,286,536) | (153,777,916) |
Total stockholders’ equity | 11,651,355 | 21,765,892 |
Total liabilities and stockholders’ equity | 18,166,868 | 25,734,644 |
Series B Convertible Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Series B Convertible Preferred Stock, $.01 par value, 2,300,000 shares authorized, 79,246 shares outstanding as of September 30, 2023 and December 31, 2022 | $ 792 | $ 792 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred Stock, Shares Authorized (in shares) | 20,000,000 | 20,000,000 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | $ 0.01 |
Common Stock, Shares Authorized (in shares) | 200,000,000 | 200,000,000 |
Common Stock, Shares, Outstanding (in shares) | 4,033,293 | 3,938,160 |
Series B Convertible Preferred Stock [Member] | ||
Preferred Stock, Shares Authorized (in shares) | 2,300,000 | 2,300,000 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred Stock, Shares Outstanding (in shares) | 79,246 | 79,246 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Net Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue | $ 715,056 | $ 455,827 | $ 1,445,061 | $ 1,141,986 |
Cost of goods sold | 106,940 | 108,151 | 386,840 | 351,669 |
Gross profit | 608,116 | 347,676 | 1,058,221 | 790,317 |
General and administrative expense | 2,583,574 | 3,287,918 | 7,624,085 | 8,063,265 |
Operations expense | 842,579 | 857,130 | 2,714,139 | 2,657,314 |
Sales and marketing expense | 336,043 | 333,377 | 1,135,383 | 908,867 |
Loss on goodwill impairment | 0 | 0 | 0 | 7,231,093 |
Loss on impairment of property and equipment | 0 | 0 | 162,905 | 0 |
Total operating loss | (3,154,080) | (4,130,749) | (10,578,291) | (18,070,222) |
Other income | 47,838 | 63,047 | 118,618 | 146,524 |
Other expense | (60,671) | (2,001) | (60,671) | (5,207) |
Gain on derivative instruments | 3,463 | 10,219 | 11,724 | 107,381 |
Net loss | $ (3,163,450) | $ (4,059,484) | $ (10,508,620) | $ (17,821,524) |
Net loss attributable to common shareholders per common shares-basic and diluted (in dollars per share) | $ (0.78) | $ (1.04) | $ (2.63) | $ (4.95) |
Weighted average shared used in computation – basic and diluted (in shares) | 4,031,356 | 3,919,203 | 3,998,887 | 3,602,515 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Series B Convertible Preferred Stock [Member] Preferred Stock [Member] | Series F Preferred Stock [Member] Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 79,246 | 3,280,750 | ||||
Balance at Dec. 31, 2021 | $ 792 | $ 32,808 | $ 168,272,366 | $ (128,040,282) | $ 40,265,684 | |
Shares issued to consultant & other (in shares) | 0 | 8,595 | ||||
Shares issued to consultant & other | $ 0 | $ 86 | 162,036 | 0 | 162,122 | |
Vesting expense | 0 | 0 | 36,518 | 0 | 36,518 | |
Net loss | 0 | 0 | 0 | (3,370,715) | (3,370,715) | |
Vesting expense, net of forfeitures | $ 0 | $ 0 | (36,518) | 0 | (36,518) | |
Shares issued pursuant to equity line (in shares) | 0 | 6,000 | ||||
Shares issued pursuant to equity line | $ 0 | $ 60 | 86,825 | 0 | 86,885 | |
Balance (in shares) at Mar. 31, 2022 | 79,246 | 3,295,345 | ||||
Balance at Mar. 31, 2022 | $ 792 | $ 32,954 | 168,557,745 | (131,410,997) | 37,180,494 | |
Balance (in shares) at Dec. 31, 2021 | 79,246 | 3,280,750 | ||||
Balance at Dec. 31, 2021 | $ 792 | $ 32,808 | 168,272,366 | (128,040,282) | 40,265,684 | |
Net loss | (17,821,524) | |||||
Balance (in shares) at Sep. 30, 2022 | 79,246 | 3,920,397 | ||||
Balance at Sep. 30, 2022 | $ 792 | $ 39,206 | 175,414,685 | (145,861,805) | 29,592,878 | |
Balance (in shares) at Mar. 31, 2022 | 79,246 | 3,295,345 | ||||
Balance at Mar. 31, 2022 | $ 792 | $ 32,954 | 168,557,745 | (131,410,997) | 37,180,494 | |
Shares issued to consultant & other (in shares) | 0 | 2,684 | ||||
Shares issued to consultant & other | $ 0 | $ 27 | 50,643 | 0 | 50,670 | |
Vesting expense | 0 | 0 | 39,383 | 0 | 39,383 | |
Net loss | 0 | 0 | 0 | (10,391,324) | (10,391,324) | |
Vesting expense, net of forfeitures | $ 0 | $ 0 | (39,383) | 0 | (39,383) | |
Shares issued pursuant to equity line (in shares) | 0 | 9,750 | ||||
Shares issued pursuant to equity line | $ 0 | $ 98 | 149,026 | 0 | 149,124 | |
Issuance of shares and warrants pursuant to May 2022 Private Offering (in shares) | 0 | 600,000 | ||||
Issuance of shares and warrants pursuant to May 2022 Private Offering | $ 0 | $ 6,000 | 6,501,050 | 0 | 6,507,050 | |
Balance (in shares) at Jun. 30, 2022 | 79,246 | 3,907,779 | ||||
Balance at Jun. 30, 2022 | $ 792 | $ 39,079 | 175,297,847 | (141,802,321) | 33,535,397 | |
Shares issued to consultant & other (in shares) | 0 | 11,461 | ||||
Shares issued to consultant & other | $ 0 | $ 115 | 93,885 | 0 | 94,000 | |
Net loss | 0 | 0 | 0 | (4,059,484) | (4,059,484) | |
Vesting expense, net of forfeitures | $ 0 | $ 12 | 22,953 | 0 | 22,965 | |
Balance (in shares) at Sep. 30, 2022 | 79,246 | 3,920,397 | ||||
Balance at Sep. 30, 2022 | $ 792 | $ 39,206 | 175,414,685 | (145,861,805) | 29,592,878 | |
Balance (in shares) at Dec. 31, 2022 | 79,246 | 0 | 3,938,160 | |||
Balance at Dec. 31, 2022 | $ 792 | $ 0 | $ 39,382 | 175,503,634 | (153,777,916) | 21,765,892 |
Shares issued to consultant & other (in shares) | 0 | 0 | 31,833 | |||
Shares issued to consultant & other | $ 0 | $ 0 | $ 318 | 200,690 | 0 | 201,008 |
Vesting expense | $ 0 | $ 0 | $ 0 | 9,287 | 0 | 9,287 |
Series F Preferred Stock dividend (in shares) | 0 | 79,404 | 0 | |||
Series F Preferred Stock dividend | $ 0 | $ 794 | $ 0 | 794 | 0 | 0 |
Series F Preferred Stock dividend | 0 | (794) | 0 | (794) | 0 | 0 |
Net loss | 0 | 0 | 0 | 0 | (3,421,802) | (3,421,802) |
Vesting expense, net of forfeitures | $ 0 | $ 0 | $ 0 | (9,287) | 0 | (9,287) |
Balance (in shares) at Mar. 31, 2023 | 79,246 | 79,404 | 3,969,993 | |||
Balance at Mar. 31, 2023 | $ 792 | $ 794 | $ 39,700 | 175,712,817 | (157,199,718) | 18,554,385 |
Balance (in shares) at Dec. 31, 2022 | 79,246 | 0 | 3,938,160 | |||
Balance at Dec. 31, 2022 | $ 792 | $ 0 | $ 39,382 | 175,503,634 | (153,777,916) | 21,765,892 |
Net loss | (10,508,620) | |||||
Balance (in shares) at Sep. 30, 2023 | 79,246 | 0 | 4,033,293 | |||
Balance at Sep. 30, 2023 | $ 792 | $ 0 | $ 40,333 | 175,896,766 | (164,286,536) | 11,651,355 |
Balance (in shares) at Mar. 31, 2023 | 79,246 | 79,404 | 3,969,993 | |||
Balance at Mar. 31, 2023 | $ 792 | $ 794 | $ 39,700 | 175,712,817 | (157,199,718) | 18,554,385 |
Shares issued to consultant & other (in shares) | 0 | 0 | 10,965 | |||
Shares issued to consultant & other | $ 0 | $ 0 | $ 110 | 68,058 | 0 | 68,168 |
Vesting expense | 0 | 0 | 0 | 5,872 | 0 | 5,872 |
Net loss | $ 0 | $ 0 | $ 0 | 0 | (3,923,368) | (3,923,368) |
Shares issued in connection with reverse stock split (in shares) | 0 | 0 | 25,343 | |||
Shares issued in connection with reverse stock split | $ 0 | $ 0 | $ 253 | (253) | 0 | 0 |
Series F Preferred Stock redemption (in shares) | 0 | (79,404) | 0 | |||
Series F Preferred Stock redemption | $ 0 | $ (794) | $ 0 | 794 | 0 | 0 |
Vesting expense, net of forfeitures | $ 0 | $ 0 | $ 0 | (5,872) | 0 | (5,872) |
Balance (in shares) at Jun. 30, 2023 | 79,246 | 0 | 4,006,301 | |||
Balance at Jun. 30, 2023 | $ 792 | $ 0 | $ 40,063 | 175,787,288 | (161,123,086) | 14,705,057 |
Shares issued to consultant & other (in shares) | 0 | 0 | 25,835 | |||
Shares issued to consultant & other | $ 0 | $ 0 | $ 258 | 125,299 | 0 | 125,557 |
Vesting expense | 0 | 0 | 0 | 14,300 | 14,300 | |
Net loss | 0 | 0 | 0 | 0 | (3,163,450) | (3,163,450) |
Vesting expense, net of forfeitures | $ 0 | $ 0 | $ 0 | (14,300) | (14,300) | |
Shares issued to management for vesting of restricted stock units, net of repurchase to cover withholding tax (in shares) | 0 | 0 | 1,157 | |||
Shares issued to management for vesting of restricted stock units, net of repurchase to cover withholding tax | $ 0 | $ 0 | $ 12 | (1,521) | 0 | (1,509) |
Balance (in shares) at Sep. 30, 2023 | 79,246 | 0 | 4,033,293 | |||
Balance at Sep. 30, 2023 | $ 792 | $ 0 | $ 40,333 | $ 175,896,766 | $ (164,286,536) | $ 11,651,355 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flow from operating activities: | ||
Net loss | $ (10,508,620) | $ (17,821,524) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 580,976 | 980,381 |
Vesting expense | 859 | 102,894 |
Common stock issued for consulting and other | 204,839 | 306,792 |
Gain on valuation of equity-linked instruments and derivative liability | (11,724) | (107,381) |
Loss on goodwill impairment | 0 | 7,231,093 |
Loss on impairment of property and equipment | 162,905 | 0 |
Loss on property and equipment disposal | 903 | 1,700 |
Changes in assets and liabilities: | ||
Accounts receivable | (213,560) | 29,488 |
Inventories | (9,496) | (106,038) |
Prepaid expense and other assets | (142,369) | (39,928) |
Accounts payable | 224,774 | (104,503) |
Accrued expenses | (169,401) | 476,035 |
Contract liabilities | (227,116) | (64,889) |
Other long-term liabilities | 0 | (19,932) |
Net cash used in operating activities: | (10,107,030) | (9,135,812) |
Cash flow from investing activities: | ||
Purchase of property and equipment | (283,648) | (361,916) |
Acquisition of intangibles | (26,018) | (50,180) |
Net cash used in investing activities | (309,666) | (412,096) |
Cash flow from financing activities: | ||
Proceeds from issuance of common stock and warrants, net | 0 | 6,507,050 |
Proceeds from issuance of common stock pursuant to equity line | 0 | 236,009 |
Repurchase of common stock upon vesting of restricted stock units | 0 | 4,028 |
Proceeds from note payable | 364,721 | 0 |
Repayment of note payable | (104,500) | 0 |
Net cash provided by financing activities | 260,221 | 6,739,031 |
Net increase (decrease) in cash and cash equivalents | (10,156,475) | (2,808,877) |
Cash and cash equivalents at beginning of period | 22,071,523 | 28,202,615 |
Cash and cash equivalents at end of period | 11,915,048 | 25,393,738 |
Supplemental disclosure for cash flow information: | ||
Cash payments for interest | 9,608 | 3,754 |
Non-cash transactions: | ||
Right-of-use assets obtained in exchange for lease liabilities | 2,997,181 | 0 |
Series F Preferred Stock dividend | 794 | 0 |
Common stock issued in connection with reverse stock split | 189,896 | 0 |
Redemption of Series F Preferred Stock | (794) | 0 |
Restricted Stock Units (RSUs) [Member] | ||
Non-cash transactions: | ||
Common stock issued in connection with reverse stock split | 4,934 | 0 |
Reverse Stock Split [Member] | ||
Non-cash transactions: | ||
Common stock issued in connection with reverse stock split | $ 253 | $ 0 |
Note 1 - Summary of Significant
Note 1 - Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Operations and Going Concern Predictive Oncology Inc. (“Predictive Oncology”) is a knowledge-driven company focused on applying artificial intelligence (“AI”) to support the development of optimal cancer therapies, which can ultimately lead to more effective treatments and improved patient outcomes. Through AI, Predictive Oncology uses its proprietary 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 successful drug development. The company offers a suite of solutions for oncology drug development from early discovery to clinical trials. The Company operates in three primary business areas: first, along the drug discovery continuum (i) 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 and (ii) the creation and development of tumor-specific 3D cell culture models; second, contract services and research focused on solubility improvements, stability studies, and protein production, and; third, production of the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System for automated fluid waste management, direct-to-drain medical fluid disposal and associated products. The Company has determined that it will focus its 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. Its platform provides a more informed decision tool to select optimal drug/tumor combinations to increase the probability of success during drug development. As a result of this focused approach, the Company has consolidated its brand under the Predictive Oncology name. Going forward, the Company will operate under the Predictive Oncology tradename with laboratory operations in Pittsburgh, Pennsylvania and Birmingham, Alabama. As of January 1, 2023, the Company has changed its reportable segments because of this focused approach. The Company has three Note 12 Segments. The Company has incurred significant and recurring losses from operations for the past several years and had an accumulated deficit of $164,286,536 as of September 30, 2023. The Company had cash and cash equivalents of $11,915,048 as of September 30, 2023 and needs to raise significant additional capital to meet its operating needs. The Company’s short-term obligations as of September 30, 2023 were $4,171,891, consisting primarily of aggregate accounts payable and accrued expenses of $2,979,064 and operating lease obligations of $555,541. As of September 30, 2023, the Company also had a short-term note payable of $260,220 that bears interest at an annual percentage rate of 9.25% and long-term operating lease obligations of $2,343,622 with a weighted average remaining lease term of 4.23 years. The Company does not expect to generate sufficient operating revenue to sustain its operations in the near term. Year-to-date, the Company incurred negative cash flows from operations of $10,107,030. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company is evaluating alternatives to obtain the required additional funding to maintain future operations. These alternatives may include, but are not limited to, equity financing, issuing debt, entering into other financing arrangements, or monetizing operating businesses or assets. Despite these potential sources of funding, the Company may be unable to access financing or obtain additional liquidity when needed or under acceptable terms, if at all. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the financial statements are issued. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business, and do not include any adjustments that might result from the outcome of this uncertainty. Reverse Stock Split On April 19, 2023, the Company completed a one-for- twenty Interim Financial Statements The Company has prepared the condensed consolidated financial statements and related unaudited financial information in the footnotes in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim condensed consolidated financial statements. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These interim condensed consolidated financial statements reflect all adjustments consisting of normal recurring accruals, which in the opinion of management, are necessary to present fairly the Company’s position, the results of its operations, and its cash flows for the interim periods. These interim condensed consolidated financial statements reflect all intercompany eliminations. These interim condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the notes thereto contained in the Annual Report on Form 10-K filed with the SEC on March 21, 2023. The nature of the Company’s business is such that the results of any interim period may not be indicative of the results to be expected for the entire year. Accounting Policies and Estimates The preparation of condensed consolidated financial statements in conformity with U.S. 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 condensed consolidated financial statements and during the reporting period. Actual results could materially differ from those estimates. Reclassifications Certain reclassifications have been made to the prior year’s condensed consolidated financial statements to conform to the current year presentation. The reclassifications had no effect on previously reported results of operations, cash flows or stockholders’ equity. 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 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. 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 status of individual accounts. Amounts recorded in accounts receivable on the condensed consolidated balance sheet include amounts billed and currently due from customers. The amounts due are stated at their net estimated realizable value. An allowance is maintained to provide for the estimated amount of receivables that will not be collected. The Company determines the allowance based on historical experience as well as external business factors expected to impact collectability such as economic factors. The Company reviews customers’ credit history before extending unsecured credit and establishes an allowance 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 are generally considered past due. 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 accounts receivable balance was $0 as of both September 30, 2023 and December 31, 2022. Fair Value Measurements As outlined in Accounting Standards Codification (“ASC”) 820, Fair Value Measurement 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. 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. The fair value of the Company’s derivative liabilities were determined based on Level 3 inputs. The Company generally uses the Black Scholes method for determining the fair value of warrants classified as liabilities on a recurring basis. 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 2 Fair Value Measurements Note 8 Derivatives Inventories Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is computed using the straight-line method over the estimated useful lives of the respective assets. Estimated useful asset life by classification is as follows: Years Computers, software, and office equipment 3 - 10 Leasehold improvements (1) 2 Manufacturing tooling 3 - 7 Laboratory equipment 4 - 10 Demo equipment 3 (1) Leasehold improvements are amortized over the shorter of the useful life or the remaining lease term. Upon retirement or sale of property and equipment, the cost and related accumulated depreciation or amortization are removed from the condensed consolidated balance sheet and the resulting gain or loss is reflected in operations. Maintenance and repairs are charged to operations expense as incurred. Long-lived Assets Finite-lived intangible assets consist of patents and trademarks, licensing fees, developed technology, and customer relationships, and are amortized over their estimated useful life. Accumulated amortization is included in intangibles, net in the accompanying condensed consolidated balance sheets. The Company reviews finite-lived identifiable intangible assets for impairment in accordance with ASC 360, Property, Plant and Equipment Goodwill In accordance with ASC 350, Intangibles Goodwill and Other To determine whether goodwill is impaired, annually or more frequently if needed, the Company performs a multi-step impairment test. 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. 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. 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. Comparative market multiples are used to corroborate the results of the discounted cash flow test. These assumptions require significant judgement. Pursuant to ASU 2017-04, Simplifying the Test for Goodwill Impairment Note 5 Intangible Assets Leases At inception of a contract, a determination is made whether an arrangement meets the definition of a lease. A contract contains a lease if there is an identified asset, and the Company has the right to control the asset. Operating leases are recorded as right-of-use (“ROU”) assets with corresponding current and noncurrent operating lease liabilities on our condensed consolidated balance sheets. Financing leases are included within fixed assets with corresponding current within other current liabilities and noncurrent within other long-term liabilities on our condensed consolidated balance sheets. ROU assets represent our right to use an underlying asset for the duration of the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Recognition on the commencement date is based on the present value of lease payments over the lease term using an incremental borrowing rate. Leases with a term of 12 months or less at the commencement date are not recognized on the condensed consolidated balance sheet and are expensed as incurred. The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component for all asset classes. Leases are accounted for at a portfolio level when similar in nature with identical or nearly identical provisions and similar effective dates and lease terms. Collaboration Arrangements The Company enters into collaboration arrangements with oncology drug development partners, under which the Company utilizes its active learning technology, proprietary biobank, and know-how to provide predictive models of tumor responses to various drug compounds and treatments of partners. Consideration under these contracts may include an upfront payment, development and regulatory milestones and other contingent payments, expense reimbursements, royalties based on net sales of approved drugs, and commercial sales milestone payments. The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements Revenue from Contracts with Customers Revenue Recognition The Company recognizes revenue when it satisfies a performance obligation by transferring control of the promised goods or services to its customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. Sales taxes are imposed on the Company’s sales to nonexempt customers. The Company collects the taxes from the customers and remits the entire amounts to the governmental authorities. Sales taxes are excluded from revenue and expenses. Revenue from Product Sales The Company has medical device revenue consisting of sales of the STREAMWAY System ( i.e. i.e. Product sales for medical devices consist of a single performance obligation that the Company satisfies at a point in time. The Company recognizes product revenue when the following events have occurred: (1) the Company has transferred physical possession of the products, (2) the Company has a present right to payment, (3) the customer has legal title to the products, and (4) the customer bears significant risks and rewards of ownership of the products. Based on the shipping terms specified in the sales agreements and purchase orders, these criteria are generally met when the products are shipped from the Company’s facilities (“FOB origin,” which is the Company’s standard shipping terms). As a result, the Company determined that the customer could direct the use of and obtain substantially all of the benefits from, the products at the time the products are shipped. The Company may, at its discretion, negotiate different shipping terms with customers which may affect the timing of revenue recognition. The Company’s standard payment terms for its customers are generally 30 to 60 days after the Company transfers control of the product to its customer. The Company allows returns of defective disposable merchandise if the customer requests a return merchandise authorization from the Company. Customers may also purchase a maintenance plan for the medical devices from the Company, which requires the Company to service the STREAMWAY System for a period of one year. The maintenance plan is considered a separate performance obligation from the product sale, is charged separately from the product sale, and is recognized over time (ratably over the one-year period) as maintenance services are provided. A time-elapsed output method is used to measure progress because the Company transfers control evenly by providing a stand-ready service. The Company has determined that this method provides a faithful depiction of the transfer of services to its customers. All amounts billed to a customer in a sales transaction for medical devices related to shipping and handling, if any, represent revenues earned for the goods provided, and these amounts have been included in revenue. Costs related to such shipping and handling billing are classified as cost of goods sold. This revenue stream is reported under the Eagan reportable segment. Revenue from Clinical Testing Clinic diagnostic testing is comprised of our Tumor Drug Response Testing (“ChemoFx”) and Genomic Profiling (“BioSpeciFx”) 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. Revenues are recognized when control of the promised goods or services is transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. The estimated uncollectible amounts are generally considered implicit price concessions that are a reduction in revenue. Pittsburgh’s payments terms vary by the agreements reached with insurance carriers and Medicare. The Company’s performance obligations are satisfied at one point in time when test reports are delivered. For service revenues, the Company estimates the transaction price which is the amount of consideration it expects to be entitled to receive in exchange for providing services based on its historical collection experience using a portfolio approach as a practical expedient to account for patient contracts as collective groups rather than individually. The Company monitors its estimates of transaction price to depict conditions that exist at each reporting date. If the Company subsequently determines that it will collect more consideration than it originally estimated for a contract with a patient, it will account for the change as an increase to the estimate of the transaction price, provided that such downward adjustment does not result in a significant reversal of cumulative revenue recognized. The Company recognizes revenue from these patients when contracts, as defined in ASC 606, Revenue from Contracts with Customers Contract Research Organization ( CRO ) and AI-Driven Business Contract revenues are generally 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 Company uses an input method that recognizes revenue based on the Company’s efforts to satisfy the performance obligation relative to the total expected inputs to the satisfaction of that performance obligation. For contracts with multiple performance obligations, the Company allocates the contract’s transaction price to each performance obligation based on the standalone-selling price of each distinct good or service in the contract. Advance payments received in excess of revenues recognized are classified as deferred revenue until such time as the revenue recognition criteria have been met. Payment terms are net 30 from the invoice date, which is sent to the customer as the Company satisfies the performance obligation relative to the total expected inputs to the satisfaction of that performance obligation. This revenue stream is reported under the Birmingham and Pittsburgh segments. Royalty Revenue The Company has a collaboration arrangement that includes sales-based royalties, under which our collaboration partners are obligated to pay a royalty that is based on the net sales of their approved drugs. The Company recognizes royalty revenue when the underlying sales occur based on its best estimate of sales of the drugs. To date, the Company has not recognized revenues related to royalties earned under collaboration arrangements. Variable Consideration The Company records revenue from distributors and direct end customers in an amount that reflects the transaction price it expects to be entitled to after transferring control of those goods or services. The Company’s current contracts do not contain any features that create variability in the amount or timing of revenue to be earned. Warranty The Company generally provides one-year warranties against defects in materials and workmanship on product sales and will either repair the products or provide replacements at no charge to customers. As they are considered assurance-type warranties, the Company does not account for them as separate performance obligations. Warranty reserve requirements are based on a specific assessment of the products sold with warranties where a customer asserts a claim for warranty or a product defect. Contract Balances The Company records a receivable when it has an unconditional right to receive consideration after the performance obligations are satisfied. Accounts receivable totaled $544,756 and $331,196 as of September 30, 2023 and December 31, 2022, respectively. As of December 31, 2021, accounts receivable totaled $354,196. The Company’s contract liabilities related primarily to 3D services and maintenance plans were $374,957 and $602,073 as of September 30, 2023 and December 31, 2022, respectively. The Company recognized revenue of $227,116 during the nine-months ended September 30, 2023 that was included in contract liabilities as of December 31, 2022. As of December 31, 2021, contract liabilities totaled $186,951. Practical Expedients The Company has elected the practical expedient not to determine whether contracts with customers contain significant financing components as contracts are generally for less than one year, as well as the practical expedient to recognize shipping and handling costs at point of sale. Valuation and Accounting for Stock Options and Warrants The Company determines the grant date fair value of options and warrants using a Black-Scholes option valuation model based upon assumptions regarding risk-free interest rate, expected dividend rate, volatility, and estimated term. The fair value of each option grant is estimated on the grant date using the Black-Scholes option valuation model with the following assumptions: For the nine months ended September 30, 2023 2022 Stock Options Expected dividend yield 0.0% 0.0% Expected stock price volatility 90.8% – 98.2% 86.5% – 92.2% Risk-free interest rate 3.38% – 3.95% 1.83% – 3.43% Expected life (years) 10 10 Warrants Expected dividend yield 0.0% 0.0% Expected stock price volatility 0% 92.2% Risk-free interest rate 0% 2.96% – 2.97% Expected life (years) 0 5 – 5.5 On January 1, 2023, the Company adopted a sequencing policy under ASC 815-40-35 (“ASC 815”) that will apply if reclassification of contracts from equity to liabilities is necessary. If the Company is unable to demonstrate it has sufficient authorized shares, shares will be allocated based on the earliest issuance date of potentially dilutive financial instruments, with the earliest financial instruments receiving the first allocation of shares. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees are not subject to the sequencing policy. Research and Development Research and development costs are charged to operations as incurred. Research and development costs were $20,671 and $15,150 for the three months ended September 30, 2023 and 2022, respectively. Research and development costs were $88,843 and $116,763 for the nine months ended September 30, 2023 and 2022, respectively. Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes There is no The Company reviews income tax positions expected to be taken in income tax returns to determine if there are any income tax uncertainties. The Company recognizes tax benefits from uncertain tax positions only if it is more likely than not that the tax positions will be sustained on examination by taxing authorities, based on technical merits of the positions. The Company has identified no Under Internal Revenue Code Section 382, certain stock transactions which significantly change ownership could limit the amount of net operating carryforwards that may be utilized on an annual basis to offset taxable income in future periods. The Company has not yet performed an analysis of the annual net operating loss carryforwards and limitations that are available to be used against taxable income. Consequently, the limitation, if any, could result in the expiration of the Company’s loss carryforwards before they can be utilized. The Company has not analyzed net operating loss carryforwards under Section 382 to date. As a result of the acquisition of Helomics Corporation (“Helomics”) in 2019, there may be significant limitations to the net operating loss. In addition, the current net operating loss carryforwards might be further limited by future issuances of our common stock. Tax years after 2002 remain open to examination by federal and state tax authorities due to unexpired net operating loss carryforwards. Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash. The Company places its cash with financial institutions and, by policy, generally limits the amount of credit exposure to any one financial institution. As of September 30, 2023, the Company had $34,853 of credit risk for cash amounts held in a single institution that are in excess of amounts insured by the Federal Deposit Insurance Corporation. Risks and Uncertainties The Company is subject to risks common to companies in the medical device and biopharmaceutical industries, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with regulations of the Food and Drug Administration, Clinical Laboratory Improvement Amendments, and other governmental agencies. The Company is also subject to general economic and geopolitical uncertainties caused by inflation, rising interest rates, supply chain disruptions, tight labor markets, wage inflation, pricing volatility for certain goods and services, banking and financial sector disruptions, instability and volatility in the global markets, disruptions from COVID-19, and geopolitical conflict. The impacts of economic and other global events could have a material adverse effect on our business, results of operations, liquidity or financial condition and heighten or exacerbate risks described in our Annual Report on Form 10-K filed with the SEC on March 21, 2023. Recent Accounting Pronouncements 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. Recently Adopted Accounting Standards 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. 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. The Company adopted the provisions of ASU 2016-13 on January 1, 2023; the adoption did not have a material impact on our consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, “Debt – Debt with Conversion and Other Options and Derivatives and Hedging – Contracts in Entity’s Own Equity” (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. The new guidance also modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. As a smaller reporting company pursuant to Rule 12b 2 1934, In September 2022, the FASB issued ASU 2022-04, “Liabilities – Supplier Finance Programs” (“ASU 2022-04”). ASU 2022-04 was issued to enhance the transparency of supplier finance programs used by an entity in connection with the purchase of goods and services. The standard requires entities that use supplier finance programs to disclose the key terms, including a description of payment terms, the confirmed amount outstanding under the program at the end of each reporting period, a description of where those obligations are presented on the balance sheet, and an annual rollforward, including the amount of obligations confirmed and the amount paid during the period. The guidance does not affect the recognition, measurement, or financial statement presentation of obligations covered by supplier finance programs. ASU 2022-04 is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, except for the required rollforward information, which is effective for fiscal years beginning after December 15, 2023. The Company adopted ASU 2022-04 on January 1, 2023 and its adoption did not have a material impact on the Company’s financial statements. |
Note 2 - Fair Value Measurement
Note 2 - Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | NOTE 2 FAIR VALUE MEASUREMENTS The following table summarizes the Company’s fair value hierarchy for its liabilities measured at fair value on a recurring basis: September 30, 2023 Fair Value Level 1 Level 2 Level 3 Liabilities: Derivatives $ 2,109 $ - $ - $ 2,109 December 31, 2022 Fair Value Level 1 Level 2 Level 3 Liabilities: Derivatives $ 13,833 $ - $ - $ 13,833 |
Note 3 - Inventories
Note 3 - Inventories | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | NOTE 3 INVENTORIES Inventory balances are as follows: As of September 30, 2023 As of December 31, 2022 Finished goods $ 242,949 $ 290,616 Raw materials 190,346 133,183 Work-In-Process 6,694 6,694 Total $ 439,989 $ 430,493 |
Note 4 - Property and Equipment
Note 4 - Property and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | NOTE 4 PROPERTY AND EQUIPMENT The Company’s property and equipment consist of the following: As of September 30, 2023 As of December 31, 2022 Computers, software, and office equipment $ 496,382 $ 463,292 Leasehold improvements 506,162 535,527 Laboratory equipment 3,661,891 3,559,362 Manufacturing tooling 133,285 121,120 Demo equipment 31,554 31,554 Total 4,829,274 4,710,855 Less: Accumulated depreciation (3,436,593 ) (2,877,600 ) Total Property and Equipment, Net $ 1,392,681 $ 1,833,255 Due to changes in its future projected cash flows, the Company prepared an undiscounted cash flow for its Birmingham asset group as of June 30, 2023 360 and determined the carrying amount of the asset group exceeded its estimated undiscounted future cash flows. The Company determined the fair value of the Birmingham asset group using replacement cost and market approaches Depreciation expense, recorded within general and administrative expenses and operations expenses, was $156,124 and $227,135 for the three months ended September 30, 2023 and 2022, respectively, and $560,413 and $669,686 during the nine months ended September 30, 2023 and 2022, respectively. |
Note 5 - Intangible Assets
Note 5 - Intangible Assets | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Intangible Assets Disclosure [Text Block] | NOTE 5 INTANGIBLE ASSETS Finite-lived Intangible Assets The components of intangible assets were as follows: As of September 30, 2023 As of December 31, 2022 Gross Carrying Costs Accumulated Amortization Net Carrying Amount Gross Carrying Costs Accumulated Amortization Impairment Net Carrying Amount Patents & Trademarks $ 535,096 $ (275,776 ) $ 259,320 $ 509,141 $ (255,276 ) $ - $ 253,865 Developed Technology - - - 3,500,000 (386,459 ) (3,113,541 ) - Customer Relationships - - - 200,000 (22,083 ) (177,917 ) - Tradename - - - 80,000 (22,083 ) (57,917 ) - Total $ 535,096 $ (275,776 ) $ 259,320 $ 4,289,141 $ (685,901 ) $ (3,349,375 ) $ 253,865 Amortization expense, recorded within general and administrative expenses, was $6,863 and $103,805 during the three months ended September 30, 2023 and 2022, respectively, and $20,563 and $310,695 during the nine months ended September 30, 2023 and 2022, respectively. The following table outlines the estimated future amortization expense related to intangible assets held as of September 30, 2023: Year ending December 31, Expense Remainder of 2023 $ 6,863 2024 27,451 2025 27,451 2026 27,451 2027 27,451 Thereafter 142,653 Total $ 259,320 The Company recognized no Goodwill As of September 30, 2022, the Company concluded that the goodwill acquired in connection with the acquisition of zPREDICTA Inc., the Company’s former wholly owned subsidiary, was fully impaired and recognized an impairment loss on goodwill of $7,231,093 during the nine months then ended. As of September 30, 2023, the cumulative impairment of goodwill recorded was $7,231,093. The goodwill acquired by the Company in connection with the acquisition of Helomics was zero |
Note 6 - Stockholders' Equity,
Note 6 - Stockholders' Equity, Stock Options and Warrants | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | NOTE 6 STOCKHOLDERS EQUITY, STOCK OPTIONS AND WARRANTS Series F Preferred Stock Dividend and Reverse Stock Split On March 16, 2023, the Board of Directors of the Company authorized the issuance of 80,000 shares of Series F Preferred Stock, par value $0.01 per share. On March 16, 2023, the Board of Directors of the Company declared a dividend of one On April 19, 2023, the Company completed a one-for- twenty Redemption of Series F Preferred Stock On April 17, 2023, the Company convened a special meeting of stockholders, which was adjourned due to the lack of a quorum and reconvened on April 19, 2023 (the “Special Meeting”), at which the Company’s stockholders approved a proposal to amend the Company’s certificate of incorporation to effect a reverse stock split of the Company’s common stock at a ratio in the range of 1-for-2 to 1-for-25, with such ratio to be determined by the Company’s Board of Directors (the “Reverse Split Proposal”). All shares of Series F Preferred Stock that were not present in person or by proxy at the Special Meeting as of immediately prior to the opening of the polls (the “Initial Redemption Time”) were automatically redeemed (the “Initial Redemption”). All outstanding shares of Series F Preferred Stock that were not redeemed pursuant to the Initial Redemption were redeemed automatically upon the approval by the Company’s stockholders of the Reverse Split Proposal (the “Subsequent Redemption” and, together with the Initial Redemption, the “Redemption”). Both the Initial Redemption and the Subsequent Redemption occurred on April 19, 2023. As a result, no Equity Incentive Plan The Company has an equity incentive plan, which allows issuance of incentive and non-qualified stock options to employees, directors, and consultants of the Company, where permitted under the plan. The exercise price for each stock option is determined by the Board of Directors. Vesting requirements are determined by the Board of Directors when granted and currently range from immediate to three three ten The following summarizes transactions for stock options and warrants for the periods indicated: Stock Options Warrants Number of Shares Average Exercise Price Number of Shares Average Exercise Price Outstanding at December 31, 2021 53,144 $ 96.60 1,584,995 $ 33.20 Issued 1,599 8.40 1,053,136 14.00 Forfeited (2,013 ) 17.60 - - Expired (3,677 ) 208.40 (5,422 ) 329.60 Cancelled - - (816,272 ) 30.20 Outstanding at December 31, 2022 49,053 $ 91.69 1,816,437 $ 22.60 Issued 1,075 5.45 - - Forfeited (49 ) 6.18 - - Expired (1,854 ) 121.24 (9,417 ) 217.64 Outstanding at September 30, 2023 48,225 $ 83.58 1,807,020 $ 21.58 Stock-based compensation expense, net of forfeitures, recognized for the three months ended September 30, 2023 and September 30, 2022 was $(14,300) and $26,993, respectively. Stock-based compensation expense recognized for the nine months ended September 30, 2023 and September 30, 2022 was $859 and $102,894, respectively. The Company has $2,833 of unrecognized compensation expense related to unvested stock options that is expected to be recognized over the next 19 months. At September 30, 2023, there were no restricted stock units (“RSUs”) outstanding under the plan and the Company has no unrecognized compensation expense related to unvested RSUs. |
Note 7 - Collaborative Agreemen
Note 7 - Collaborative Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | NOTE 7 COLLABORATIVE AGREEMENT Collaborative Agreement with Cancer Research Horizons On March 16, 2023, the Company entered into a Collaboration Agreement (the “CRH Agreement”) with Cancer Research Horizons (“CRH”), pursuant to which the Company will use its PEDAL technology to evaluate CRH pre-clinical drug inhibitors of Glutaminase to determine which cancer types and patient populations are most likely to respond to treatment with these compounds (the “Project”). Under the CRH Agreement, both parties will retain rights to their respective background intellectual property. Rights to reports, findings, supporting data, and materials (“Project Intellectual Property”) that are generated by the Company pursuant to its performance under the CRH Agreement vest exclusively in CRH. Each party funds its own participation in the Project. Costs incurred to participate in the CRH Agreement are recorded in Operations Expense in the Company’s Statement of Net Loss. Pursuant to the CRH Agreement, the Company shall receive a percentage of net revenue, as defined in the agreement, received by CRH for the commercialization of the CRH Candidates and any CRH Derivatives. The percentage of net revenue varies depending on the stage of development. As of September 30, 2023, the Company has not |
Note 8 - Derivatives
Note 8 - Derivatives | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Derivative Instruments and Hedging Activities Disclosure [Text Block] | NOTE 8 DERIVATIVES Certain warrants issued to placement agents were determined to be a derivative liability due to certain features of the warrants which could, in certain circumstances, result in the holder receiving the Black Scholes value of the outstanding warrants in the same type of consideration as the common stockholders. As a result, in those circumstances, the amount of consideration would differ from that provided to holders of common stock, therefore, the warrants were classified as a liability. The fair value of the placement agent warrants issued in connection with the March 2020 private placement was determined to be $293 and $3,355 as of September 30, 2023 and December 31, 2022, respectively. The Company recorded gains on the change in fair value of the placement agent warrants of $743 and $3,308 during the three months ended September 30, 2023 and September 30, 2022, respectively, and $3,062 and $35,474 during the nine months ended September 30, 2023 and September 30, 2022, respectively. The placement agent warrants expire in March 2025. The fair value of the placement agent warrants issued in connection with the May 2020 offering of securities was determined to be $576 and $4,479 as of September 30, 2023 and December 31, 2022, respectively. The Company recorded gains on the change in fair value of the placement agent warrants of $1,133 and $3,370 during the three months ended September 30, 2023 and September 30, 2022, respectively, and $3,903 and $35,421 during the nine months ended September 30, 2023 and September 30, 2022, respectively. The placement agent warrants expire in May 2025. The placement agent warrants issued in connection with the June 2020 warrant exercise and issuance had a fair value of $1,240 and $5,999 as of September 30, 2023 and December 31, 2022, respectively. The Company recorded gains on the change in fair value of the placement agent warrants of $1,587 and $3,541 during the three months ended September 30, 2023 and September 30, 2022, respectively, and $4,759 and $36,486 during the nine months ended September 30, 2023 and September 30, 2022, respectively. The placement agent warrants expire in June 2025. The table below discloses changes in value of the Company’s embedded derivative liabilities discussed above. Derivative liability balance at December 31, 2021 $ 129,480 Gain recognized to revalue derivative instrument at fair value (1,908 ) Derivative liability balance at March 31, 2022 $ 127,572 Gain recognized to revalue derivative instrument at fair value (95,254 ) Derivative liability balance at June 30, 2022 $ 32,318 Gain recognized to revalue derivative instrument at fair value (10,219 ) Derivative liability balance at September 30, 2022 $ 22,099 Derivative liability balance at December 31, 2022 $ 13,833 Gain recognized to revalue derivative instrument at fair value (953 ) Derivative liability balance at March 31, 2023 $ 12,880 Gain recognized to revalue derivative instrument at fair value (7,308 ) Derivative liability balance at June 30, 2023 $ 5,572 Gain recognized to revalue derivative instrument at fair value (3,463 ) Derivative liability balance at September 30, 2023 $ 2,109 |
Note 9 - Loss Per Share
Note 9 - Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | NOTE 9 LOSS PER SHARE The following table presents the shares used in the basic and diluted loss per common share computations: Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to common stockholders: basic and diluted calculation $ (3,163,450 ) $ (4,059,485 ) $ (10,508,620 ) $ (17,821,524 ) Denominator: Weighted average common shares outstanding - basic 4,031,356 3,919,203 3,998,887 3,602,515 Effect of diluted stock options, warrants, and preferred stock (1) - - - - Weighted average common shares outstanding - diluted 4,031,356 3,919,203 3,998,887 3,602,515 Loss per common share - basic and diluted $ (0.78 ) $ (1.04 ) $ (2.63 ) $ (4.95 ) (1) The following is a summary of the number of underlying shares outstanding at the end of the respective periods that have been excluded from the diluted calculations because the effect on loss per common share would have been anti-dilutive: Three and Nine Months Ended September 30, 2023 2022 Options 48,225 51,082 Restricted Stock Units - 24,167 Warrants 1,807,020 1,819,927 Series B Convertible Preferred Stock 16 16 There were 79,246 shares of Series B Convertible Preferred Stock outstanding as of September 30, 2023 and September 30, 2022. In total, the 79,246 shares of Series B Convertible Preferred Stock were convertible to 16 shares of common stock as of September 30, 2023 and September 30, 2022 due to the cumulative effect of reverse stock splits. |
Note 10 - Leases
Note 10 - Leases | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | NOTE 10 LEASES The Company’s corporate offices and other offices are located in Pittsburgh, Pennsylvania. Upon expiration of previous leases for office space and laboratory operations, the Company entered into two new leases for office space and laboratory operations on January 4, 2023. The leases each have an approximate five-year The Company has an office in Eagan, Minnesota, which is used for office space and manufacturing. Since July 31, 2022, the lease was month-to-month tenancy. On June 1, 2023, the lease was amended for two The Company has an additional office in Birmingham, Alabama, which is used for office space, warehousing and laboratory operations. The lease is effective through August , 2025. Lease expense, recorded within general and administrative expenses, was $230,390 and $183,924 for the three months ended September 30, 2023 and September 30, 2022, respectively, and $665,252 and $536,156 for the nine months ended September 30, 2023 and September 30, 2022, respectively. The following table summarizes other information related to the Company’s operating leases: September 30, 2023 Weighted average remaining lease term – operating leases in years 4.23 Weighted average discount rate – operating leases 12 % The Company’s operating lease obligations as of September 30, 2023 are as follows: Remainder of 2023 $ 209,506 2024 887,424 2025 857,622 2026 803,724 2027 827,909 Thereafter 139,022 Total lease payments 3,725,207 Less: interest (826,044 ) Present value of lease liabilities $ 2,899,163 |
Note 11 - Note Payable
Note 11 - Note Payable | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | NOTE 11 NOTE PAYABLE In June 2023, the Company purchased director and officer insurance policies with a policy period ending June 2024. In July 2023, the Company financed $364,721 of its total premium by entering into a note payable with a finance provider that requires ten |
Note 12 - Segments
Note 12 - Segments | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Segment Reporting Disclosure [Text Block] | NOTE 12 SEGMENTS The Company has determined that it will focus its 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. Its platform provides an informed decision tool to select optimal drug/tumor combinations to increase the probability of success during drug development. As a result of this focused approach, the Company has consolidated its brand under the Predictive Oncology name. Going forward, the Company will operate under the Predictive Oncology tradename with laboratory operations in Pittsburgh, Pennsylvania and Birmingham, Alabama. As of January 1, 2023, the Company changed its reportable segments because of this focused approach. The Company has retrospectively revised the reported segment information for all periods presented for consistency. The Company has three The Company has determined its operating segments in accordance with ASC 280 – Segment Reporting See discussion of revenue recognition in Note 1 Summary of Significant Accounting Policies Revenue Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Pittsburgh $ 417,096 $ 172,637 $ 441,567 $ 266,642 Eagan 259,530 253,751 866,535 809,875 Birmingham 38,430 29,439 136,959 64,580 Corporate - - - 889 Total $ 715,056 $ 455,827 $ 1,445,061 $ 1,141,986 Segment Loss Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Pittsburgh $ (674,952 ) $ (1,076,508 ) $ (3,428,644 ) $ (10,891,767 ) Eagan (189,031 ) (109,408 ) (756,115 ) (259,444 ) Birmingham (415,083 ) (407,622 ) (1,483,222 ) (1,206,550 ) Corporate (1,884,384 ) (2,465,946 ) (4,840,639 ) (5,463,763 ) Total $ (3,163,450 ) $ (4,059,484 ) $ (10,508,620 ) $ (17,821,524 ) Assets As of As of September 30, December 31, 2023 2022 Pittsburgh $ 3,422,462 $ 1,055,228 Eagan 1,336,101 946,394 Birmingham 1,116,990 1,353,434 Corporate 12,291,315 22,379,588 Total $ 18,166,868 $ 25,734,644 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Nature Of Operations and Going Concern Policy [Policy Text Block] | Nature of Operations and Going Concern Predictive Oncology Inc. (“Predictive Oncology”) is a knowledge-driven company focused on applying artificial intelligence (“AI”) to support the development of optimal cancer therapies, which can ultimately lead to more effective treatments and improved patient outcomes. Through AI, Predictive Oncology uses its proprietary 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 successful drug development. The company offers a suite of solutions for oncology drug development from early discovery to clinical trials. The Company operates in three primary business areas: first, along the drug discovery continuum (i) 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 and (ii) the creation and development of tumor-specific 3D cell culture models; second, contract services and research focused on solubility improvements, stability studies, and protein production, and; third, production of the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System for automated fluid waste management, direct-to-drain medical fluid disposal and associated products. The Company has determined that it will focus its 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. Its platform provides a more informed decision tool to select optimal drug/tumor combinations to increase the probability of success during drug development. As a result of this focused approach, the Company has consolidated its brand under the Predictive Oncology name. Going forward, the Company will operate under the Predictive Oncology tradename with laboratory operations in Pittsburgh, Pennsylvania and Birmingham, Alabama. As of January 1, 2023, the Company has changed its reportable segments because of this focused approach. The Company has three Note 12 Segments. The Company has incurred significant and recurring losses from operations for the past several years and had an accumulated deficit of $164,286,536 as of September 30, 2023. The Company had cash and cash equivalents of $11,915,048 as of September 30, 2023 and needs to raise significant additional capital to meet its operating needs. The Company’s short-term obligations as of September 30, 2023 were $4,171,891, consisting primarily of aggregate accounts payable and accrued expenses of $2,979,064 and operating lease obligations of $555,541. As of September 30, 2023, the Company also had a short-term note payable of $260,220 that bears interest at an annual percentage rate of 9.25% and long-term operating lease obligations of $2,343,622 with a weighted average remaining lease term of 4.23 years. The Company does not expect to generate sufficient operating revenue to sustain its operations in the near term. Year-to-date, the Company incurred negative cash flows from operations of $10,107,030. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company is evaluating alternatives to obtain the required additional funding to maintain future operations. These alternatives may include, but are not limited to, equity financing, issuing debt, entering into other financing arrangements, or monetizing operating businesses or assets. Despite these potential sources of funding, the Company may be unable to access financing or obtain additional liquidity when needed or under acceptable terms, if at all. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the financial statements are issued. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business, and do not include any adjustments that might result from the outcome of this uncertainty. |
Stockholders' Equity, Policy [Policy Text Block] | Reverse Stock Split On April 19, 2023, the Company completed a one-for- twenty |
Basis of Accounting, Policy [Policy Text Block] | Interim Financial Statements The Company has prepared the condensed consolidated financial statements and related unaudited financial information in the footnotes in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim condensed consolidated financial statements. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These interim condensed consolidated financial statements reflect all adjustments consisting of normal recurring accruals, which in the opinion of management, are necessary to present fairly the Company’s position, the results of its operations, and its cash flows for the interim periods. These interim condensed consolidated financial statements reflect all intercompany eliminations. These interim condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the notes thereto contained in the Annual Report on Form 10-K filed with the SEC on March 21, 2023. The nature of the Company’s business is such that the results of any interim period may not be indicative of the results to be expected for the entire year. |
Use of Estimates, Policy [Policy Text Block] | Accounting Policies and Estimates The preparation of condensed consolidated financial statements in conformity with U.S. 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 condensed consolidated financial statements and during the reporting period. Actual results could materially differ from those estimates. |
Reclassification, Comparability Adjustment [Policy Text Block] | Reclassifications Certain reclassifications have been made to the prior year’s condensed consolidated financial statements to conform to the current year presentation. The reclassifications had no effect on previously reported results of operations, cash flows or stockholders’ equity. |
Cash and Cash Equivalents, Policy [Policy Text Block] | 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 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. |
Receivable [Policy Text Block] | 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 status of individual accounts. Amounts recorded in accounts receivable on the condensed consolidated balance sheet include amounts billed and currently due from customers. The amounts due are stated at their net estimated realizable value. An allowance is maintained to provide for the estimated amount of receivables that will not be collected. The Company determines the allowance based on historical experience as well as external business factors expected to impact collectability such as economic factors. The Company reviews customers’ credit history before extending unsecured credit and establishes an allowance 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 are generally considered past due. 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 accounts receivable balance was $0 as of both September 30, 2023 and December 31, 2022. |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value Measurements As outlined in Accounting Standards Codification (“ASC”) 820, Fair Value Measurement 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. 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. The fair value of the Company’s derivative liabilities were determined based on Level 3 inputs. The Company generally uses the Black Scholes method for determining the fair value of warrants classified as liabilities on a recurring basis. 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 2 Fair Value Measurements Note 8 Derivatives |
Inventory, Policy [Policy Text Block] | Inventories Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is computed using the straight-line method over the estimated useful lives of the respective assets. Estimated useful asset life by classification is as follows: Years Computers, software, and office equipment 3 - 10 Leasehold improvements (1) 2 Manufacturing tooling 3 - 7 Laboratory equipment 4 - 10 Demo equipment 3 (1) Leasehold improvements are amortized over the shorter of the useful life or the remaining lease term. Upon retirement or sale of property and equipment, the cost and related accumulated depreciation or amortization are removed from the condensed consolidated balance sheet and the resulting gain or loss is reflected in operations. Maintenance and repairs are charged to operations expense as incurred. |
Goodwill and Intangible Assets, Intangible Assets, Policy [Policy Text Block] | Long-lived Assets Finite-lived intangible assets consist of patents and trademarks, licensing fees, developed technology, and customer relationships, and are amortized over their estimated useful life. Accumulated amortization is included in intangibles, net in the accompanying condensed consolidated balance sheets. The Company reviews finite-lived identifiable intangible assets for impairment in accordance with ASC 360, Property, Plant and Equipment |
Goodwill and Intangible Assets, Goodwill, Policy [Policy Text Block] | Goodwill In accordance with ASC 350, Intangibles Goodwill and Other To determine whether goodwill is impaired, annually or more frequently if needed, the Company performs a multi-step impairment test. 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. 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. 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. Comparative market multiples are used to corroborate the results of the discounted cash flow test. These assumptions require significant judgement. Pursuant to ASU 2017-04, Simplifying the Test for Goodwill Impairment Note 5 Intangible Assets |
Lessee, Leases [Policy Text Block] | Leases At inception of a contract, a determination is made whether an arrangement meets the definition of a lease. A contract contains a lease if there is an identified asset, and the Company has the right to control the asset. Operating leases are recorded as right-of-use (“ROU”) assets with corresponding current and noncurrent operating lease liabilities on our condensed consolidated balance sheets. Financing leases are included within fixed assets with corresponding current within other current liabilities and noncurrent within other long-term liabilities on our condensed consolidated balance sheets. ROU assets represent our right to use an underlying asset for the duration of the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Recognition on the commencement date is based on the present value of lease payments over the lease term using an incremental borrowing rate. Leases with a term of 12 months or less at the commencement date are not recognized on the condensed consolidated balance sheet and are expensed as incurred. The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component for all asset classes. Leases are accounted for at a portfolio level when similar in nature with identical or nearly identical provisions and similar effective dates and lease terms. |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Collaboration Arrangements The Company enters into collaboration arrangements with oncology drug development partners, under which the Company utilizes its active learning technology, proprietary biobank, and know-how to provide predictive models of tumor responses to various drug compounds and treatments of partners. Consideration under these contracts may include an upfront payment, development and regulatory milestones and other contingent payments, expense reimbursements, royalties based on net sales of approved drugs, and commercial sales milestone payments. The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements Revenue from Contracts with Customers |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition The Company recognizes revenue when it satisfies a performance obligation by transferring control of the promised goods or services to its customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. Sales taxes are imposed on the Company’s sales to nonexempt customers. The Company collects the taxes from the customers and remits the entire amounts to the governmental authorities. Sales taxes are excluded from revenue and expenses. Revenue from Product Sales The Company has medical device revenue consisting of sales of the STREAMWAY System ( i.e. i.e. Product sales for medical devices consist of a single performance obligation that the Company satisfies at a point in time. The Company recognizes product revenue when the following events have occurred: (1) the Company has transferred physical possession of the products, (2) the Company has a present right to payment, (3) the customer has legal title to the products, and (4) the customer bears significant risks and rewards of ownership of the products. Based on the shipping terms specified in the sales agreements and purchase orders, these criteria are generally met when the products are shipped from the Company’s facilities (“FOB origin,” which is the Company’s standard shipping terms). As a result, the Company determined that the customer could direct the use of and obtain substantially all of the benefits from, the products at the time the products are shipped. The Company may, at its discretion, negotiate different shipping terms with customers which may affect the timing of revenue recognition. The Company’s standard payment terms for its customers are generally 30 to 60 days after the Company transfers control of the product to its customer. The Company allows returns of defective disposable merchandise if the customer requests a return merchandise authorization from the Company. Customers may also purchase a maintenance plan for the medical devices from the Company, which requires the Company to service the STREAMWAY System for a period of one year. The maintenance plan is considered a separate performance obligation from the product sale, is charged separately from the product sale, and is recognized over time (ratably over the one-year period) as maintenance services are provided. A time-elapsed output method is used to measure progress because the Company transfers control evenly by providing a stand-ready service. The Company has determined that this method provides a faithful depiction of the transfer of services to its customers. All amounts billed to a customer in a sales transaction for medical devices related to shipping and handling, if any, represent revenues earned for the goods provided, and these amounts have been included in revenue. Costs related to such shipping and handling billing are classified as cost of goods sold. This revenue stream is reported under the Eagan reportable segment. Revenue from Clinical Testing Clinic diagnostic testing is comprised of our Tumor Drug Response Testing (“ChemoFx”) and Genomic Profiling (“BioSpeciFx”) 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. Revenues are recognized when control of the promised goods or services is transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods or services. The estimated uncollectible amounts are generally considered implicit price concessions that are a reduction in revenue. Pittsburgh’s payments terms vary by the agreements reached with insurance carriers and Medicare. The Company’s performance obligations are satisfied at one point in time when test reports are delivered. For service revenues, the Company estimates the transaction price which is the amount of consideration it expects to be entitled to receive in exchange for providing services based on its historical collection experience using a portfolio approach as a practical expedient to account for patient contracts as collective groups rather than individually. The Company monitors its estimates of transaction price to depict conditions that exist at each reporting date. If the Company subsequently determines that it will collect more consideration than it originally estimated for a contract with a patient, it will account for the change as an increase to the estimate of the transaction price, provided that such downward adjustment does not result in a significant reversal of cumulative revenue recognized. The Company recognizes revenue from these patients when contracts, as defined in ASC 606, Revenue from Contracts with Customers Contract Research Organization ( CRO ) and AI-Driven Business Contract revenues are generally 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 Company uses an input method that recognizes revenue based on the Company’s efforts to satisfy the performance obligation relative to the total expected inputs to the satisfaction of that performance obligation. For contracts with multiple performance obligations, the Company allocates the contract’s transaction price to each performance obligation based on the standalone-selling price of each distinct good or service in the contract. Advance payments received in excess of revenues recognized are classified as deferred revenue until such time as the revenue recognition criteria have been met. Payment terms are net 30 from the invoice date, which is sent to the customer as the Company satisfies the performance obligation relative to the total expected inputs to the satisfaction of that performance obligation. This revenue stream is reported under the Birmingham and Pittsburgh segments. Royalty Revenue The Company has a collaboration arrangement that includes sales-based royalties, under which our collaboration partners are obligated to pay a royalty that is based on the net sales of their approved drugs. The Company recognizes royalty revenue when the underlying sales occur based on its best estimate of sales of the drugs. To date, the Company has not recognized revenues related to royalties earned under collaboration arrangements. Variable Consideration The Company records revenue from distributors and direct end customers in an amount that reflects the transaction price it expects to be entitled to after transferring control of those goods or services. The Company’s current contracts do not contain any features that create variability in the amount or timing of revenue to be earned. Warranty The Company generally provides one-year warranties against defects in materials and workmanship on product sales and will either repair the products or provide replacements at no charge to customers. As they are considered assurance-type warranties, the Company does not account for them as separate performance obligations. Warranty reserve requirements are based on a specific assessment of the products sold with warranties where a customer asserts a claim for warranty or a product defect. Contract Balances The Company records a receivable when it has an unconditional right to receive consideration after the performance obligations are satisfied. Accounts receivable totaled $544,756 and $331,196 as of September 30, 2023 and December 31, 2022, respectively. As of December 31, 2021, accounts receivable totaled $354,196. The Company’s contract liabilities related primarily to 3D services and maintenance plans were $374,957 and $602,073 as of September 30, 2023 and December 31, 2022, respectively. The Company recognized revenue of $227,116 during the nine-months ended September 30, 2023 that was included in contract liabilities as of December 31, 2022. As of December 31, 2021, contract liabilities totaled $186,951. Practical Expedients The Company has elected the practical expedient not to determine whether contracts with customers contain significant financing components as contracts are generally for less than one year, as well as the practical expedient to recognize shipping and handling costs at point of sale. |
Valuation and Accounting for Stock Options and Warrants, Policy [Policy Text Block] | Valuation and Accounting for Stock Options and Warrants The Company determines the grant date fair value of options and warrants using a Black-Scholes option valuation model based upon assumptions regarding risk-free interest rate, expected dividend rate, volatility, and estimated term. The fair value of each option grant is estimated on the grant date using the Black-Scholes option valuation model with the following assumptions: For the nine months ended September 30, 2023 2022 Stock Options Expected dividend yield 0.0% 0.0% Expected stock price volatility 90.8% – 98.2% 86.5% – 92.2% Risk-free interest rate 3.38% – 3.95% 1.83% – 3.43% Expected life (years) 10 10 Warrants Expected dividend yield 0.0% 0.0% Expected stock price volatility 0% 92.2% Risk-free interest rate 0% 2.96% – 2.97% Expected life (years) 0 5 – 5.5 On January 1, 2023, the Company adopted a sequencing policy under ASC 815-40-35 (“ASC 815”) that will apply if reclassification of contracts from equity to liabilities is necessary. If the Company is unable to demonstrate it has sufficient authorized shares, shares will be allocated based on the earliest issuance date of potentially dilutive financial instruments, with the earliest financial instruments receiving the first allocation of shares. Pursuant to ASC 815, issuance of stock-based awards to the Company’s employees are not subject to the sequencing policy. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Research and development costs are charged to operations as incurred. Research and development costs were $20,671 and $15,150 for the three months ended September 30, 2023 and 2022, respectively. Research and development costs were $88,843 and $116,763 for the nine months ended September 30, 2023 and 2022, respectively. |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes There is no The Company reviews income tax positions expected to be taken in income tax returns to determine if there are any income tax uncertainties. The Company recognizes tax benefits from uncertain tax positions only if it is more likely than not that the tax positions will be sustained on examination by taxing authorities, based on technical merits of the positions. The Company has identified no Under Internal Revenue Code Section 382, certain stock transactions which significantly change ownership could limit the amount of net operating carryforwards that may be utilized on an annual basis to offset taxable income in future periods. The Company has not yet performed an analysis of the annual net operating loss carryforwards and limitations that are available to be used against taxable income. Consequently, the limitation, if any, could result in the expiration of the Company’s loss carryforwards before they can be utilized. The Company has not analyzed net operating loss carryforwards under Section 382 to date. As a result of the acquisition of Helomics Corporation (“Helomics”) in 2019, there may be significant limitations to the net operating loss. In addition, the current net operating loss carryforwards might be further limited by future issuances of our common stock. Tax years after 2002 remain open to examination by federal and state tax authorities due to unexpired net operating loss carryforwards. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash. The Company places its cash with financial institutions and, by policy, generally limits the amount of credit exposure to any one financial institution. As of September 30, 2023, the Company had $34,853 of credit risk for cash amounts held in a single institution that are in excess of amounts insured by the Federal Deposit Insurance Corporation. |
Risks and Uncertainties Policy [Policy Text Block] | Risks and Uncertainties The Company is subject to risks common to companies in the medical device and biopharmaceutical industries, including, but not limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with regulations of the Food and Drug Administration, Clinical Laboratory Improvement Amendments, and other governmental agencies. The Company is also subject to general economic and geopolitical uncertainties caused by inflation, rising interest rates, supply chain disruptions, tight labor markets, wage inflation, pricing volatility for certain goods and services, banking and financial sector disruptions, instability and volatility in the global markets, disruptions from COVID-19, and geopolitical conflict. The impacts of economic and other global events could have a material adverse effect on our business, results of operations, liquidity or financial condition and heighten or exacerbate risks described in our Annual Report on Form 10-K filed with the SEC on March 21, 2023. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements 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. Recently Adopted Accounting Standards 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. 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. The Company adopted the provisions of ASU 2016-13 on January 1, 2023; the adoption did not have a material impact on our consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, “Debt – Debt with Conversion and Other Options and Derivatives and Hedging – Contracts in Entity’s Own Equity” (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. The new guidance also modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. As a smaller reporting company pursuant to Rule 12b 2 1934, In September 2022, the FASB issued ASU 2022-04, “Liabilities – Supplier Finance Programs” (“ASU 2022-04”). ASU 2022-04 was issued to enhance the transparency of supplier finance programs used by an entity in connection with the purchase of goods and services. The standard requires entities that use supplier finance programs to disclose the key terms, including a description of payment terms, the confirmed amount outstanding under the program at the end of each reporting period, a description of where those obligations are presented on the balance sheet, and an annual rollforward, including the amount of obligations confirmed and the amount paid during the period. The guidance does not affect the recognition, measurement, or financial statement presentation of obligations covered by supplier finance programs. ASU 2022-04 is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, except for the required rollforward information, which is effective for fiscal years beginning after December 15, 2023. The Company adopted ASU 2022-04 on January 1, 2023 and its adoption did not have a material impact on the Company’s financial statements. |
Note 1 - Summary of Significa_2
Note 1 - Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Property Plant and Equipment Useful Life [Table Text Block] | Years Computers, software, and office equipment 3 - 10 Leasehold improvements (1) 2 Manufacturing tooling 3 - 7 Laboratory equipment 4 - 10 Demo equipment 3 |
Fair Value Measurement Inputs and Valuation Techniques [Table Text Block] | For the nine months ended September 30, 2023 2022 Stock Options Expected dividend yield 0.0% 0.0% Expected stock price volatility 90.8% – 98.2% 86.5% – 92.2% Risk-free interest rate 3.38% – 3.95% 1.83% – 3.43% Expected life (years) 10 10 Warrants Expected dividend yield 0.0% 0.0% Expected stock price volatility 0% 92.2% Risk-free interest rate 0% 2.96% – 2.97% Expected life (years) 0 5 – 5.5 |
Note 2 - Fair Value Measureme_2
Note 2 - Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | September 30, 2023 Fair Value Level 1 Level 2 Level 3 Liabilities: Derivatives $ 2,109 $ - $ - $ 2,109 December 31, 2022 Fair Value Level 1 Level 2 Level 3 Liabilities: Derivatives $ 13,833 $ - $ - $ 13,833 |
Note 3 - Inventories (Tables)
Note 3 - Inventories (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | As of September 30, 2023 As of December 31, 2022 Finished goods $ 242,949 $ 290,616 Raw materials 190,346 133,183 Work-In-Process 6,694 6,694 Total $ 439,989 $ 430,493 |
Note 4 - Property and Equipme_2
Note 4 - Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | As of September 30, 2023 As of December 31, 2022 Computers, software, and office equipment $ 496,382 $ 463,292 Leasehold improvements 506,162 535,527 Laboratory equipment 3,661,891 3,559,362 Manufacturing tooling 133,285 121,120 Demo equipment 31,554 31,554 Total 4,829,274 4,710,855 Less: Accumulated depreciation (3,436,593 ) (2,877,600 ) Total Property and Equipment, Net $ 1,392,681 $ 1,833,255 |
Note 5 - Intangible Assets (Tab
Note 5 - Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Finite-Lived Intangible Assets [Table Text Block] | As of September 30, 2023 As of December 31, 2022 Gross Carrying Costs Accumulated Amortization Net Carrying Amount Gross Carrying Costs Accumulated Amortization Impairment Net Carrying Amount Patents & Trademarks $ 535,096 $ (275,776 ) $ 259,320 $ 509,141 $ (255,276 ) $ - $ 253,865 Developed Technology - - - 3,500,000 (386,459 ) (3,113,541 ) - Customer Relationships - - - 200,000 (22,083 ) (177,917 ) - Tradename - - - 80,000 (22,083 ) (57,917 ) - Total $ 535,096 $ (275,776 ) $ 259,320 $ 4,289,141 $ (685,901 ) $ (3,349,375 ) $ 253,865 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] | Year ending December 31, Expense Remainder of 2023 $ 6,863 2024 27,451 2025 27,451 2026 27,451 2027 27,451 Thereafter 142,653 Total $ 259,320 |
Note 6 - Stockholders' Equity_2
Note 6 - Stockholders' Equity, Stock Options and Warrants (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Share-Based Payment Arrangement, Activity [Table Text Block] | Stock Options Warrants Number of Shares Average Exercise Price Number of Shares Average Exercise Price Outstanding at December 31, 2021 53,144 $ 96.60 1,584,995 $ 33.20 Issued 1,599 8.40 1,053,136 14.00 Forfeited (2,013 ) 17.60 - - Expired (3,677 ) 208.40 (5,422 ) 329.60 Cancelled - - (816,272 ) 30.20 Outstanding at December 31, 2022 49,053 $ 91.69 1,816,437 $ 22.60 Issued 1,075 5.45 - - Forfeited (49 ) 6.18 - - Expired (1,854 ) 121.24 (9,417 ) 217.64 Outstanding at September 30, 2023 48,225 $ 83.58 1,807,020 $ 21.58 |
Note 8 - Derivatives (Tables)
Note 8 - Derivatives (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Derivative Liabilities at Fair Value [Table Text Block] | Derivative liability balance at December 31, 2021 $ 129,480 Gain recognized to revalue derivative instrument at fair value (1,908 ) Derivative liability balance at March 31, 2022 $ 127,572 Gain recognized to revalue derivative instrument at fair value (95,254 ) Derivative liability balance at June 30, 2022 $ 32,318 Gain recognized to revalue derivative instrument at fair value (10,219 ) Derivative liability balance at September 30, 2022 $ 22,099 Derivative liability balance at December 31, 2022 $ 13,833 Gain recognized to revalue derivative instrument at fair value (953 ) Derivative liability balance at March 31, 2023 $ 12,880 Gain recognized to revalue derivative instrument at fair value (7,308 ) Derivative liability balance at June 30, 2023 $ 5,572 Gain recognized to revalue derivative instrument at fair value (3,463 ) Derivative liability balance at September 30, 2023 $ 2,109 |
Note 9 - Loss Per Share (Tables
Note 9 - Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to common stockholders: basic and diluted calculation $ (3,163,450 ) $ (4,059,485 ) $ (10,508,620 ) $ (17,821,524 ) Denominator: Weighted average common shares outstanding - basic 4,031,356 3,919,203 3,998,887 3,602,515 Effect of diluted stock options, warrants, and preferred stock (1) - - - - Weighted average common shares outstanding - diluted 4,031,356 3,919,203 3,998,887 3,602,515 Loss per common share - basic and diluted $ (0.78 ) $ (1.04 ) $ (2.63 ) $ (4.95 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three and Nine Months Ended September 30, 2023 2022 Options 48,225 51,082 Restricted Stock Units - 24,167 Warrants 1,807,020 1,819,927 Series B Convertible Preferred Stock 16 16 |
Note 10 - Leases (Tables)
Note 10 - Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Lease, Cost [Table Text Block] | September 30, 2023 Weighted average remaining lease term – operating leases in years 4.23 Weighted average discount rate – operating leases 12 % |
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block] | Remainder of 2023 $ 209,506 2024 887,424 2025 857,622 2026 803,724 2027 827,909 Thereafter 139,022 Total lease payments 3,725,207 Less: interest (826,044 ) Present value of lease liabilities $ 2,899,163 |
Note 12 - Segments (Tables)
Note 12 - Segments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Segment Reporting Information, by Segment [Table Text Block] | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Pittsburgh $ 417,096 $ 172,637 $ 441,567 $ 266,642 Eagan 259,530 253,751 866,535 809,875 Birmingham 38,430 29,439 136,959 64,580 Corporate - - - 889 Total $ 715,056 $ 455,827 $ 1,445,061 $ 1,141,986 Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Pittsburgh $ (674,952 ) $ (1,076,508 ) $ (3,428,644 ) $ (10,891,767 ) Eagan (189,031 ) (109,408 ) (756,115 ) (259,444 ) Birmingham (415,083 ) (407,622 ) (1,483,222 ) (1,206,550 ) Corporate (1,884,384 ) (2,465,946 ) (4,840,639 ) (5,463,763 ) Total $ (3,163,450 ) $ (4,059,484 ) $ (10,508,620 ) $ (17,821,524 ) As of As of September 30, December 31, 2023 2022 Pittsburgh $ 3,422,462 $ 1,055,228 Eagan 1,336,101 946,394 Birmingham 1,116,990 1,353,434 Corporate 12,291,315 22,379,588 Total $ 18,166,868 $ 25,734,644 |
Note 1 - Summary of Significa_3
Note 1 - Summary of Significant Accounting Policies (Details Textual) | 3 Months Ended | 9 Months Ended | |||||
Apr. 19, 2023 | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Number of Tumor Samples | 150,000 | 150,000 | |||||
Number of Operating Segments | 3 | ||||||
Retained Earnings (Accumulated Deficit) | $ 164,286,536 | $ 164,286,536 | $ 153,777,916 | ||||
Cash and Cash Equivalents, at Carrying Value | 11,915,048 | 11,915,048 | 22,071,523 | ||||
Liabilities, Current | 4,171,891 | 4,171,891 | 3,882,670 | ||||
Accounts Payable and Accrued Liabilities, Current | 2,979,064 | 2,979,064 | |||||
Operating Lease, Liability, Current | 555,541 | 555,541 | 94,237 | ||||
Notes Payable, Current | $ 260,220 | $ 260,220 | 0 | ||||
Short-Term Debt, Percentage Bearing Fixed Interest Rate | 9.25% | 9.25% | |||||
Operating Lease, Liability, Noncurrent | $ 2,343,622 | $ 2,343,622 | 86,082 | ||||
Operating Lease, Weighted Average Remaining Lease Term (Year) | 4 years 2 months 23 days | 4 years 2 months 23 days | |||||
Net Cash Provided by (Used in) Operating Activities | $ 10,107,030 | $ 9,135,812 | |||||
Accounts Receivable, Allowance for Credit Loss, Current | $ 0 | 0 | 0 | ||||
Accounts Receivable, after Allowance for Credit Loss | 544,756 | 544,756 | 331,196 | $ 354,196 | |||
Contract with Customer, Liability | 374,957 | 374,957 | $ 602,073 | $ 186,951 | |||
Contract liabilities | (227,116) | (64,889) | |||||
Research and Development Expense | 20,671 | $ 15,150 | 88,843 | $ 116,763 | |||
Income Tax Expense (Benefit) | 0 | ||||||
Unrecognized Tax Benefits | 0 | 0 | |||||
Cash, Uninsured Amount | $ 34,853 | $ 34,853 | |||||
Reverse Stock Split [Member] | |||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 20 |
Note 1 - Summary of Significa_4
Note 1 - Summary of Significant Accounting Policies - Schedule of Property, Plant and Equipment, Useful Life (Details) | Sep. 30, 2023 | |
Office Equipment [Member] | Minimum [Member] | ||
Computers, software, and office equipment (Year) | 3 years | |
Office Equipment [Member] | Maximum [Member] | ||
Computers, software, and office equipment (Year) | 10 years | |
Leasehold Improvements [Member] | ||
Computers, software, and office equipment (Year) | 2 years | [1] |
Manufacturing Tooling [Member] | Minimum [Member] | ||
Computers, software, and office equipment (Year) | 3 years | |
Manufacturing Tooling [Member] | Maximum [Member] | ||
Computers, software, and office equipment (Year) | 7 years | |
Laboratory Equipment [Member] | Minimum [Member] | ||
Computers, software, and office equipment (Year) | 4 years | |
Laboratory Equipment [Member] | Maximum [Member] | ||
Computers, software, and office equipment (Year) | 10 years | |
Demo Equipment [Member] | ||
Computers, software, and office equipment (Year) | 3 years | |
[1]Leasehold improvements are amortized over the shorter of the useful life or the remaining lease term. |
note 1 - Summary of Significa_5
note 1 - Summary of Significant Accounting Policies - Valuation Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Expected dividend yield | 0% | 0% |
Expected life (years) (Year) | 10 years | 10 years |
Measurement Input, Expected Dividend Rate [Member] | ||
Measurement input | 0 | 0 |
Measurement Input, Price Volatility [Member] | ||
Measurement input | 0 | 0.922 |
Measurement Input, Risk Free Interest Rate [Member] | ||
Measurement input | 0 | |
Measurement Input, Expected Term [Member] | ||
Measurement input | 0 | |
Minimum [Member] | ||
Expected stock price volatility | 90.80% | 86.50% |
Risk-free interest rate | 3.38% | 1.83% |
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Measurement input | 0.0296 | |
Minimum [Member] | Measurement Input, Expected Term [Member] | ||
Measurement input | 5 | |
Maximum [Member] | ||
Expected stock price volatility | 9,820% | 9,220% |
Risk-free interest rate | 3.95% | 3.43% |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Measurement input | 0.0297 | |
Maximum [Member] | Measurement Input, Expected Term [Member] | ||
Measurement input | 5.5 |
Note 2 - Fair Value Measureme_3
Note 2 - Fair Value Measurements - Fair Value of Assets and Liabilities on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Derivatives | $ 2,109 | $ 13,833 |
Fair Value, Inputs, Level 1 [Member] | ||
Derivatives | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Derivatives | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Derivatives | $ 2,109 | $ 13,833 |
Note 3 - Inventories - Schedule
Note 3 - Inventories - Schedule of Inventory (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Finished goods | $ 242,949 | $ 290,616 |
Raw materials | 190,346 | 133,183 |
Work-In-Process | 6,694 | 6,694 |
Total | $ 439,989 | $ 430,493 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Depreciation, Total | $ 156,124 | $ 227,135 | $ 560,413 | $ 669,686 |
Property, Plant and Equipment [Member] | Birmingham Operating Segment [Member] | ||||
Asset Impairment Charges | $ 162,905 |
Note 4 - Property and Equipme_4
Note 4 - Property and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant, and Equipment Gross | $ 4,829,274 | $ 4,710,855 |
Less: Accumulated depreciation | (3,436,593) | (2,877,600) |
Total Property and Equipment, Net | 1,392,681 | 1,833,255 |
Office Equipment [Member] | ||
Property, Plant, and Equipment Gross | 496,382 | 463,292 |
Leasehold Improvements [Member] | ||
Property, Plant, and Equipment Gross | 506,162 | 535,527 |
Laboratory Equipment [Member] | ||
Property, Plant, and Equipment Gross | 3,661,891 | 3,559,362 |
Manufacturing Tooling [Member] | ||
Property, Plant, and Equipment Gross | 133,285 | 121,120 |
Demo Equipment [Member] | ||
Property, Plant, and Equipment Gross | $ 31,554 | $ 31,554 |
Note 5 - Intangible Assets (Det
Note 5 - Intangible Assets (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Amortization of Intangible Assets | $ 6,863 | $ 103,805 | $ 20,563 | $ 310,695 | |
Impairment of Intangible Assets (Excluding Goodwill) | 0 | 0 | 0 | 0 | |
Goodwill, Impairment Loss | 0 | 0 | 0 | 7,231,093 | |
zPREDICTA [Member] | |||||
Goodwill, Impairment Loss | 7,231,093 | 7,231,093 | |||
Goodwill, Gross | $ 7,231,093 | $ 7,231,093 | |||
Helomics Holding Corp. [Member] | |||||
Goodwill | 0 | 0 | $ 0 | ||
Goodwill, Impaired, Accumulated Impairment Loss | $ 23,790,290 | $ 23,790,290 |
Note 5 - Intangible Assets - Co
Note 5 - Intangible Assets - Components of Intangible Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Sep. 30, 2023 | |
Gross Carrying Costs | $ 4,289,141 | $ 535,096 |
Accumulated Amortization | (685,901) | (275,776) |
Net Carrying Amount | 253,865 | 259,320 |
Impairment, finite | (3,349,375) | |
Patents and Trademarks [Member] | ||
Gross Carrying Costs | 509,141 | 535,096 |
Accumulated Amortization | (255,276) | (275,776) |
Net Carrying Amount | 253,865 | 259,320 |
Impairment, finite | 0 | |
Developed Technology Rights [Member] | ||
Gross Carrying Costs | 3,500,000 | 0 |
Accumulated Amortization | (386,459) | 0 |
Net Carrying Amount | 0 | 0 |
Impairment, finite | (3,113,541) | |
Customer Relationships [Member] | ||
Gross Carrying Costs | 200,000 | 0 |
Accumulated Amortization | (22,083) | 0 |
Net Carrying Amount | 0 | 0 |
Impairment, finite | (177,917) | |
Trade Names 1 [Member] | ||
Gross Carrying Costs | 80,000 | 0 |
Accumulated Amortization | (22,083) | 0 |
Net Carrying Amount | 0 | $ 0 |
Impairment, finite | $ (57,917) |
Note 5 - Intangible Assets - Es
Note 5 - Intangible Assets - Estimated Future Amortization Expense (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Remainder of 2023 | $ 6,863 | |
Finite-Lived Intangible Asset, Expected Amortization, Year One | 27,451 | |
Finite-Lived Intangible Asset, Expected Amortization, Year Two | 27,451 | |
Finite-Lived Intangible Asset, Expected Amortization, Year Three | 27,451 | |
Finite-Lived Intangible Asset, Expected Amortization, Year Four | 27,451 | |
Thereafter | 142,653 | |
Total | $ 259,320 | $ 253,865 |
Note 6 - Stockholders' Equity_3
Note 6 - Stockholders' Equity, Stock Options and Warrants (Details Textual) | 3 Months Ended | 9 Months Ended | |||||
Apr. 19, 2023 shares | Mar. 16, 2023 $ / shares shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 shares | |
Preferred Stock, Shares Authorized | 20,000,000 | 20,000,000 | 20,000,000 | ||||
Common Stock, Shares Authorized | 200,000,000 | 200,000,000 | 200,000,000 | 200,000,000 | |||
Share-Based Payment Arrangement, Expense | $ | $ 14,300 | $ 26,993 | $ 859 | $ 102,894 | |||
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ | $ 2,833 | $ 2,833 | |||||
Share-Based Payment Arrangement, Option [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 3 years | ||||||
Minimum [Member] | Share-Based Payment Arrangement, Option [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 3 years | ||||||
Maximum [Member] | Share-Based Payment Arrangement, Option [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 10 years | ||||||
Reverse Stock Split [Member] | |||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 20 | ||||||
Reverse Stock Split [Member] | Minimum [Member] | |||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 2 | ||||||
Reverse Stock Split [Member] | Maximum [Member] | |||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 25 | ||||||
Series F Preferred Stock [Member] | |||||||
Preferred Stock, Shares Authorized | 80,000 | ||||||
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.01 | ||||||
Preferred Stock Dividends, Shares Per Share | 0.001 | ||||||
Dividends Payable, Date of Record | Mar. 27, 2023 | ||||||
Preferred Stock, Shares Issued | 79,404 | ||||||
Preferred Stock, Voting Rights Per Share | 1,000,000 | ||||||
Preferred Stock, Shares Outstanding (in shares) | 0 |
Note 6 - Stockholders' Equity_4
Note 6 - Stockholders' Equity, Stock Options and Warrants - Summary of Transactions for Stock Options and Warrants (Details) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Number of Shares Outstanding (in shares) | 1,816,437 | 1,584,995 |
Average Exercise Price Outstanding (in dollars per share) | $ 22.60 | $ 33.20 |
Number of Shares Issued (in shares) | 0 | 1,053,136 |
Average Exercise Price Issued (in dollars per share) | $ 0 | $ 14 |
Number of Shares Forfeited (in shares) | 0 | 0 |
Expired, warrants (in shares) | (9,417) | (5,422) |
Average Exercise Price Expired (in dollars per share) | $ 217.64 | $ 329.60 |
Cancelled, warrants (in shares) | 816,272 | |
Cancelled, warrants, average exercise price (in dollars per share) | $ 30.20 | |
Number of Shares Outstanding (in shares) | 1,807,020 | 1,816,437 |
Average Exercise Price Outstanding (in dollars per share) | $ 21.58 | $ 22.60 |
Share-Based Payment Arrangement, Option [Member] | ||
Number of Shares Outstanding (in shares) | 49,053 | 53,144 |
Average Exercise Price Outstanding (in dollars per share) | $ 91.69 | $ 96.60 |
Number of Shares Issued (in shares) | 1,075 | 1,599 |
Average Exercise Price Issued (in dollars per share) | $ 5.45 | $ 8.40 |
Number of Shares Forfeited (in shares) | (49) | (2,013) |
Average Exercise Price Forfeited (in dollars per share) | $ 6.18 | $ 17.60 |
Expired, options (in shares) | (1,854) | (3,677) |
Expired, options, average exercise price (in dollars per share) | $ 121.24 | $ 208.40 |
Cancelled, options (in shares) | 0 | |
Cancelled, options, average exercise price (in dollars per share) | $ 0 | |
Number of Shares Outstanding (in shares) | 48,225 | 49,053 |
Average Exercise Price Outstanding (in dollars per share) | $ 83.58 | $ 91.69 |
Note 7 - Collaborative Agreem_2
Note 7 - Collaborative Agreements (Details Textual) $ in Thousands | 3 Months Ended |
Sep. 30, 2023 USD ($) | |
Cancer Research Horizons [Member] | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement [Member] | |
Revenue from Collaborative Arrangement, Excluding Revenue from Contract with Customer | $ 0 |
Note 8 - Derivatives (Details T
Note 8 - Derivatives (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Agent Warrants In Connection With March 2020 Private Placement [Member] | |||||
Derivative Liability, Total | $ 293 | $ 293 | $ 3,355 | ||
Derivative, Gain (Loss) on Derivative, Net, Total | 743 | $ 3,308 | 3,062 | $ 35,474 | |
Agent Warrants Issued in Connection with May 2020 Offering [Member] | |||||
Derivative Liability, Total | 576 | 576 | 4,479 | ||
Derivative, Gain (Loss) on Derivative, Net, Total | 1,133 | 3,370 | 3,903 | 35,421 | |
Agent Warrants In Connection With June 2020 Warrant [Member] | |||||
Derivative Liability, Total | 1,240 | 1,240 | $ 5,999 | ||
Derivative, Gain (Loss) on Derivative, Net, Total | $ 1,587 | $ 3,541 | $ 4,759 | $ 36,486 |
Note 8 - Derivatives - Change i
Note 8 - Derivatives - Change in Fair Value of Derivative Liabilities 2 (Details) - USD ($) | 3 Months Ended | |||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | |
Derivative liability balance | $ 5,572 | $ 12,880 | $ 13,833 | $ 32,318 | $ 127,572 | $ 129,480 |
Gain recognized to revalue derivative instrument at fair value | (3,463) | (7,308) | (953) | (10,219) | (95,254) | (1,908) |
Derivative liability balance | $ 2,109 | $ 5,572 | $ 12,880 | $ 22,099 | $ 32,318 | $ 127,572 |
Note 9 - Loss Per Share (Detail
Note 9 - Loss Per Share (Details Textual) - Series B Convertible Preferred Stock [Member] - shares | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 |
Preferred Stock, Shares Outstanding (in shares) | 79,246 | 79,246 | 79,246 |
Preferred Stock, Convertible, Shares Issuable | 16 | 16 |
Note 9 - Loss Per Share - Share
Note 9 - Loss Per Share - Shares Used in Basic and Diluted Loss Per Common Share Computations (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Net loss attributable to common stockholders: basic and diluted calculation | $ (3,163,450) | $ (4,059,485) | $ (10,508,620) | $ (17,821,524) |
Weighted average shared used in computation – basic and diluted (in shares) | 4,031,356 | 3,919,203 | 3,998,887 | 3,602,515 |
Effect of diluted stock options, warrants, and preferred stock (1) (in shares) | 0 | 0 | 0 | 0 |
Weighted average common shares outstanding - diluted (in shares) | 4,031,356 | 3,919,203 | 3,998,887 | 3,602,515 |
Net loss attributable to common shareholders per common shares-basic and diluted (in dollars per share) | $ (0.78) | $ (1.04) | $ (2.63) | $ (4.95) |
Note 9 - Loss Per Share - Antid
Note 9 - Loss Per Share - Antidilutive Securities Excluded from the Diluted Calculations (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities (in shares) (in shares) | 48,225 | 51,082 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities (in shares) (in shares) | 0 | 24,167 |
Warrant [Member] | ||
Antidilutive Securities (in shares) (in shares) | 1,807,020 | 1,819,927 |
Series B Convertible Preferred Stock [Member] | ||
Antidilutive Securities (in shares) (in shares) | 16 | 16 |
Note 10 - Leases (Details Textu
Note 10 - Leases (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Jun. 01, 2023 | Jan. 04, 2023 | Dec. 31, 2022 | |
Operating Lease, Right-of-Use Asset | $ 2,870,286 | $ 2,870,286 | $ 2,922,365 | $ 211,893 | |||
Operating Lease, Expense | $ 230,390 | $ 183,924 | $ 665,252 | $ 536,156 | |||
Helomics' Offices [Member] | |||||||
Lessee, Operating Lease, Lease Not yet Commenced, Term of Contract | 5 years | ||||||
Eagan, Minnesota Office [Member] | |||||||
Operating Lease, Right-of-Use Asset | $ 74,816 | ||||||
Lessee, Operating Lease, Remaining Lease Term | 2 years |
Note 10 - Leases - Lease Inform
Note 10 - Leases - Lease Information (Details) | Sep. 30, 2023 |
Weighted average remaining lease term – operating leases in years (Year) | 4 years 2 months 23 days |
Weighted average discount rate – operating leases | 12% |
Note 10 - Leases - Rent Obligat
Note 10 - Leases - Rent Obligation (Details) | Sep. 30, 2023 USD ($) |
Remainder of 2023 | $ 209,506 |
Lessee, Operating Lease, Liability, to be Paid, Year One | 887,424 |
Lessee, Operating Lease, Liability, to be Paid, Year Two | 857,622 |
Lessee, Operating Lease, Liability, to be Paid, Year Three | 803,724 |
Lessee, Operating Lease, Liability, to be Paid, Year Four | 827,909 |
Thereafter | 139,022 |
Total lease payments | 3,725,207 |
Less: interest | (826,044) |
Present value of lease liabilities | $ 2,899,163 |
Note 11 - Note Payable (Details
Note 11 - Note Payable (Details Textual) - Insurance Policy Financing [Member] | 1 Months Ended |
Jul. 31, 2023 USD ($) | |
Debt Instrument, Face Amount | $ 364,721 |
Debt Instrument, Number of Monthly Installment | 10 |
Debt Instrument, Interest Rate, Stated Percentage | 9.25% |
Notes Payable | $ 260,220 |
Note 12 - Segments (Details Tex
Note 12 - Segments (Details Textual) | 9 Months Ended |
Sep. 30, 2023 | |
Number of Operating Segments | 3 |
Number of Tumor Samples | 150,000 |
Note 12 - Segments - Segments (
Note 12 - Segments - Segments (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Revenue | $ 715,056 | $ 455,827 | $ 1,445,061 | $ 1,141,986 | |||||
Net loss | (3,163,450) | $ (3,923,368) | $ (3,421,802) | (4,059,484) | $ (10,391,324) | $ (3,370,715) | (10,508,620) | (17,821,524) | |
Assets | 18,166,868 | 18,166,868 | $ 25,734,644 | ||||||
Operating Segments [Member] | Pittsburgh [Member] | |||||||||
Revenue | 417,096 | 172,637 | 441,567 | 266,642 | |||||
Net loss | (674,952) | (1,076,508) | (3,428,644) | (10,891,767) | |||||
Assets | 3,422,462 | 3,422,462 | 1,055,228 | ||||||
Operating Segments [Member] | Eagan [Member] | |||||||||
Revenue | 259,530 | 253,751 | 866,535 | 809,875 | |||||
Net loss | (189,031) | (109,408) | (756,115) | (259,444) | |||||
Assets | 1,336,101 | 1,336,101 | 946,394 | ||||||
Operating Segments [Member] | Birmingham [Member] | |||||||||
Revenue | 38,430 | 29,439 | 136,959 | 64,580 | |||||
Net loss | (415,083) | (407,622) | (1,483,222) | (1,206,550) | |||||
Assets | 1,116,990 | 1,116,990 | 1,353,434 | ||||||
Corporate, Non-Segment [Member] | |||||||||
Revenue | 0 | 0 | 0 | 889 | |||||
Net loss | (1,884,384) | $ (2,465,946) | (4,840,639) | $ (5,463,763) | |||||
Assets | $ 12,291,315 | $ 12,291,315 | $ 22,379,588 |