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Predictive Oncology Inc

For the period ended Sep 30, 2024. Filed Nov 12, 2024.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2024 · Filed Nov 12, 2024

AGPU$7.50+11.4%Stored close · as of Nov 9, 2026

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NOTE 1–** SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES**

Nature of Operations

Predictive Oncology Inc. (“Predictive Oncology” or the “Company”) 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.

Predictive Oncology’s mission is to change the landscape of oncology drug discovery and enable the development of more effective therapies for the treatment of cancer. By harnessing the power of machine learning and scientific rigor, the Company believes that it can improve the probability of success of advancing pharmaceutical and biological drug candidates with a higher degree of confidence.

During the third quarter of 2024, the Company’s former Birmingham operating segment, which provided contract services and research focused on solubility improvements, stability studies and protein production, met the criteria to be reported as discontinued operations. As a result, the Company operates in two business areas. In its first area, the Company provides optimized, high-confidence drug-response predictions through the application of AI using its proprietary biobank of tumor samples to enable a more informed selection of drug/tumor combinations and increase the probability of success during drug development. The Company also creates and develops tumor-specific 3D cell culture models mimicking the physiological environment of human tissue enabling better-informed decision-making during development. In its second business area, the Company produces the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal.

As a result of the decision to discontinue its former Birmingham operating segment, the Company hastwo reportable segments, which have been delineated by location and business area, as further described inNote 13–* Segments*:

●Pittsburgh segment: provides services that include the application of AI using its proprietary biobank of 150,000+ tumor samples. Pittsburgh also creates proprietary 3D culture models used in drug development.
●Eagan segment: produces the FDA-cleared STREAMWAY System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal.

Going Concern

These condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.

The Company has incurred significant and recurring losses from operations for the past several years and, as of September 30, 2024, had an accumulated deficit of $178,256,677. The Company had cash and cash equivalents of $3,078,955 as of September 30, 2024, and needs to raise significant additional capital to meet its operating needs. The Company had short-term obligations of $3,816,766 and long-term operating lease obligations of $1,704,453 as of September 30, 2024. The Company does not expect to generate sufficient operating revenue to sustain its operations in the near term. During the nine months ended September 30, 2024, the Company incurred negative cash flows from continuing operating activities of $8,913,589. Although the Company has attempted to improve its cash flows from continuing operating activities by bolstering revenues and continues to seek ways to generate revenue through business development activities, there is no guarantee that the Company will be able to improve its cash flows from continuing operating activities sufficiently or achieve profitability in the near term. As a result of these conditions, substantial doubt exists about the Company’s ability to continue as a going concern within one year after the date these condensed consolidated financial statements are issued.

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. These possibilities, to the extent available, may be on terms that result in significant dilution to the Company’s existing stockholders or that result in the Company’s existing stockholders losing part or all of their investment. 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. If such financing or adequate funds from operations are not available, the Company would be forced to limit its business activities and the Company could default on existing payment obligations, which would have a material adverse effect on its financial condition and results of operations, and the Company may ultimately be required to cease its operations and liquidate its business. The Company’s condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include any adjustment relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.

Basis of Presentation

The Company has prepared the condensed consolidated financial statements and related unaudited financial information in the notes 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 adjustments, 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 28, 2024. 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.

NASDAQ Notice of Non-Compliance

On September 19, 2024, the Company received a letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the bid price for the Company’s common stock had closed below $1.00 per share for 30 consecutive business days, and that the Company is therefore not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The notification has no immediate effect on the listing of the Company’s common stock and the Company has a period of 180 calendar days, or until March 18, 2025, to regain compliance with the Minimum Bid Price Requirement. In the event the Company does not regain compliance with the Minimum Bid Price Requirement by March 18, 2025, the Company may be eligible for additional time pursuant to the Company meeting certain further Nasdaq requirements.

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. Estimates are used in the following areas, among others: variable consideration associated with revenue recognition, stock-based compensation expense, fair value of long-lived assets for impairment analyses, the valuation allowance included in the deferred income tax calculation, accrued expenses, and fair value of derivative liabilities.

Note 1 to the annual consolidated financial statements contained in the Annual Report on Form 10-K filed with the SEC on March 28, 2024, describes the significant accounting policies and estimates used in preparation of the consolidated financial statements. There have been no material changes in the Company’s significant accounting policies during the nine months ended September 30, 2024.

Principles of Consolidation

The Company had two wholly owned subsidiaries, Helomics Corporation and Skyline Medical, Inc. (“Skyline Medical”), as of September 30, 2024, and December 31, 2023, and for the three and nine months ended September 30, 2024, and 2023. The condensed consolidated financial statements include the accounts of the Company and these wholly owned subsidiaries after elimination of intercompany transactions and balances as of September 30, 2024, and December 31, 2023, and for the three and nine months ended September 30, 2024, and 2023.

Discontinued Operations

During the quarter ended September 30, 2024, the Company disposed of its former Birmingham operating segment. Disposal groups that meet the discontinued operations criteria provided in the Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) 205-20-45 are classified as discontinued operations. Assets and liabilities of discontinued operations are presented separately in the Company’s condensed consolidated balance sheets and results of discontinued operations are reported as a separate component of net loss in the Company’s condensed consolidated statements of net loss for all periods presented, resulting in changes to the presentation of certain prior period amounts. Results of discontinued operations are excluded from segment results for all periods presented. Cash flows from discontinued operations are also reported separately in the Company’s condensed consolidated statements of cash flows.

Refer toNote 2–* Discontinued Operations* for additional discussion of discontinued operations. All other notes to these condensed consolidated financial statements present the results of continuing operations and exclude amounts related to discontinued operations for all periods presented.]

Concentration of Credit Risk

Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents and accounts receivable. The Company maintains its cash and cash equivalent balances with high quality financial institutions and, consequently, the Company believes that such funds are subject to minimal credit risk. The Company is exposed to credit risk in the event of default by the financial institutions to the extent amounts recorded on the condensed consolidated balance sheets are in excess of insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds.

As of September 30, 2024, accounts receivable fromtwo customers represented 25% and 16% of the Company’s total accounts receivable, respectively. As of December 31, 2023, accounts receivable from asingle customer represented 16% of the Company’s total accounts receivable.

Recent Accounting Pronouncements

The Company considers the applicability and impact of all Accounting Standards Updates (“ASUs”) issued by 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.

In November 2023, the FASB issued ASU 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU updates reportable segment disclosures by expanding the frequency and extent of segment disclosures. This ASU is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The ASU requires the retrospective adoption method. Management is currently evaluating this ASU to determine its impact on the Company’s disclosures.

In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires more detailed income tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. Management is currently evaluating this ASU to determine its impact on the Company’s disclosures.

In November 2024, the FASB issued ASU 2024-03,Income Statement–* Reporting Comprehensive Income*–* Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses*. This ASU requires more detailed disclosures related to certain costs and expenses. The guidance requires entities to disclose amounts of certain expense categories included in expense captions presented on the face of the income statement, including purchases of inventory, employee compensation, depreciation, and intangible asset amortization. This ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods beginning after December 15, 2027, with early adoption permitted. The disclosure requirements may be applied either prospectively or retrospectively. Management is currently evaluating this ASU to determine its impact on the Company’s disclosures.

NOTE 2–** DISCONTINUED OPERATIONS**

On July 25, 2024, the Company’s Board of Directors approved a plan to implement a strategic cost savings initiative, primarily related to the Company’s Birmingham laboratory. In August 2024, the Company explored options for the leased Birmingham laboratory and office space, including potential sublease arrangements.

In September, the Company transferred certain pieces of computer hardware with alternative use to the Pittsburgh laboratory, while the rest of the laboratory equipment and inventories from the Birmingham laboratory were marketed for sale and the related product and service lines were discontinued. The Company executed a sales agreement for all remaining laboratory equipment and inventories from the Birmingham laboratory and all items were removed from the laboratory premises as of September 30, 2024. As of September 30, 2024, the Company vacated and ceased use of the Birmingham laboratory and office space. The Company’s lease continues through August 2025.

The Company concluded that, in aggregate, the disposal of these assets comprising the former Birmingham operating segment met the criteria for discontinued operations presentation in the third quarter of 2024. As a result, the former Birmingham operating segment has been reclassified to discontinued operations in these condensed consolidated financial statements for all periods presented.

The following table presents a reconciliation of the carrying amounts of the major classes of assets and liabilities to the current assets and liabilities of discontinued operations as presented in the Company’s condensed consolidated balance sheets:

September 30, 2024December 31, 2023
Assets:
Accounts receivable58,75956,056
Inventories-13,571
Prepaid expense and other assets18,9679,622
Total current assets of discontinued operations77,72679,249
Property and equipment, net-742,696
Intangibles, net-11,118
Lease right-of-use assets-130,264
Other long-term assets-18,587
Total assets of discontinued operations$77,726$981,914
Liabilities:
Accounts payable$12,556$7,964
Accrued expenses and other liabilities116,11894,345
Lease liability78,97072,530
Total current liabilities of discontinued operations207,644174,839
Lease liability – net of current portion-58,002
Total liabilities$207,644$232,841

The following table provides details about the major classes of line items constituting the loss from discontinued operations presented in the Company’s condensed consolidated statements of net loss:

Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Revenue$968$38,430$32,790$136,959
Cost of sales1,5039,0723,29519,379
Gross profit (loss) from discontinued operations(535)29,35829,495117,580
Operating expenses:
General and administrative expense291,944238,953804,098800,760
Operations expense55,671203,883495,741614,165
Sales and marketing expense-1,6051,98022,972
Loss on impairment of property and equipment---162,905
Total operating expenses347,615444,4411,301,8191,600,802
Total operating (loss) from discontinued operations(348,150)(415,083)(1,272,324)(1,483,222)
Loss on disposal of discontinued operations(463,127)-(463,127)-
Net (loss) from discontinued operations$(811,277)$(415,083)$(1,735,451)$(1,483,222)

The loss on disposal of discontinued operations represents the loss on impairment of assets sold, including laboratory equipment and inventories, and impairment of other non-current assets.

NOTE 3–** COLLABORATIVE ARRANGEMENTS AND CONTRACTS WITH CUSTOMERS**

Collaboration 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 used its PEDAL technology to evaluate CRH pre-clinical drug inhibitors of Glutaminase to determine which cancer types and patient populations were most likely to respond to treatment with those compounds (the “Project”). Under the CRH Agreement, both parties retained rights to their respective background intellectual property. Rights to reports, findings, supporting data, and materials (“Project Intellectual Property”) that were generated by the Company pursuant to its performance under the CRH Agreement vested exclusively in CRH. Each party funded its own participation in the Project. Costs incurred to participate in the CRH Agreement were recorded in Cost of sales in the Company’s Consolidated Statement of Net Loss for the year ended December 31, 2023.

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 (each as defined in the CRH Agreement). The percentage of net revenue varies depending on the stage of development. The revenue sharing fees represent variable consideration, which is measured using the expected value method under ASC 606,Revenue from Contracts with Customers based on the actual net revenues earned by CRH under Relevant Transfer Agreements (as defined in the CRH Agreement) relating to the CRH Candidates and CRH Derivatives. Due to the uncertainty associated with the timing and amount of revenue sharing fees, the Company concluded that the revenue sharing fees should be fully constrained until such time that Relevant Transfer Agreements have been entered and net revenues have been earned. These estimates will be reassessed at each reporting period. During the nine months ended September 30, 2024, and 2023, the Company recognizedno revenue under the CRH Agreement.

Contracts with Customers and Contract Balances

The Company records a receivable when it has an unconditional right to receive consideration after the performance obligations are satisfied. As of September 30, 2024, and December 31, 2023, accounts receivable totaled $463,834 and $277,641, respectively. The allowance for accounts receivable balance was $0 as of both September 30, 2024, and December 31, 2023.

During the three months ended September 30, 2024, revenues fromtwo customers were 28% and 22% of the Company’s total revenue, respectively. During the three months ended September 30, 2023, revenues from asingle customer were 62% of the Company’s total revenue. During the nine months ended September 30, 2024, revenues from asingle customer were 33% of the Company’s total revenue. During the nine months ended September 30, 2023, revenues from asingle customer were 34% of the Company’s total revenue.

Advance payments received in excess of revenues recognized are classified as contract liabilities until such time as the revenue recognition criteria have been met. The Company’s contract liabilities, related primarily to development of 3D models and STREAMWAY maintenance plans, were $267,439 and $307,958 as of September 30, 2024, and December 31, 2023, respectively. During the three and nine months ended September 30, 2024, the Company recognized revenue of $7,643 and $68,188, respectively, related primarily to deposits for development of 3D models and STREAMWAY maintenance plans that were included in contract liabilities as of December 31, 2023. The Company’s contract liabilities as of September 30, 2024, primarily represent its remaining performance obligations. The Company’s long-term contract liabilities are reported in Other long-term liabilities in the condensed consolidated balance sheets.

NOTE 4–** FAIR VALUE MEASUREMENTS**

The following table summarizes the Company’s fair value hierarchy for its assets and liabilities measured at fair value on a recurring basis:

September 30, 2024 · Fair Value · Level 1 · Level 2 · Level 3
Assets:
Money market funds$2,350,000$2,350,000$-$-
Liabilities:
Derivatives$1$-$-$1
December 31, 2023 · Fair Value · Level 1 · Level 2 · Level 3
Liabilities:
Derivatives$1,376$-$-$1,376

NOTE 5–** INVENTORIES**

Inventory balances were as follows:

As of September 30, 2024As of December 31, 2023
Raw materials$309,030$227,110
Work-in-process15,000-
Finished goods180,350253,693
Total$504,380$480,803

NOTE 6–** PROPERTY AND EQUIPMENT**

The Company’s property and equipment, net consisted of the following:

As of September 30, 2024As of December 31, 2023
Computers, software, and office equipment$459,641$467,716
Leasehold improvements306,961306,961
Laboratory equipment1,692,2311,696,430
Warehouse and manufacturing equipment139,763133,285
Demo equipment31,55431,554
Total2,630,1502,635,946
Less: Accumulated depreciation(2,227,241)(2,144,732)
Total Property and equipment, net$402,909$491,214

Depreciation expense, recorded within general and administrative expenses of continuing operations, was $33,175 and $36,083 for the three months ended September 30, 2024, and 2023, respectively, and $102,153 and $187,060 during the nine months ended September 30, 2024, and 2023, respectively.

No impairment charges related to property and equipment held and used in continuing operations were incurred during the nine months ended September 30, 2024, and 2023.

NOTE 7–** INTANGIBLE ASSETS**

The Company’s intangibles, net consisted of the following:

As of September 30, 2024As of December 31, 2023
Gross Carrying CostsAccumulated AmortizationNet Carrying AmountGross Carrying CostsAccumulated AmortizationNet Carrying Amount
Patents & Trademarks$521,621$(300,148)$221,473$521,621$(280,282)$241,339

Finite-lived intangible assets are amortized over their estimated useful lives. Amortization expense, recorded within general and administrative expenses of continuing operations, was $6,621 and $6,622 during the three months ended September 30, 2024, and 2023, respectively, and $19,866 and $19,841 during the nine months ended September 30, 2024, and 2023, respectively. Accumulated amortization is included in Intangibles, net in the condensed consolidated balance sheets.

The following table outlines the estimated future amortization expense related to intangible assets held as of September 30, 2024:

Year Ending December 31,Expense
Remainder of 2024$6,622
202526,489
202626,489
202726,489
202826,489
Thereafter108,895
Total$221,473

The Company reviews finite-lived intangible assets for impairment in accordance with ASC 360,Property, Plant, and Equipment whenever events or changes in circumstances indicate the carrying amount may not be recoverable. Events or changes in circumstances that indicate the carrying amount may not be recoverable include, but are not limited to, a significant change in the medical device marketplace and a significant adverse change in the business climate in which the Company operates. No impairment charges related to finite-lived intangible assets held and used in continuing operations were incurred during the nine months ended September 30, 2024, and 2023.

NOTE 8–** LEASES**

The Company’s corporate offices and other offices are located in Pittsburgh, Pennsylvania. The leases are effective through February 29, 2028.

The Company also has an office in Eagan, Minnesota, which is used for office space and manufacturing. This lease is effective through May 31, 2025.

Lease expense under operating lease arrangements, recorded within general and administrative expenses of continuing operations, was $206,760 and $214,813 for the three months ended September 30, 2024, and 2023, respectively, and $620,403 and $604,329 for the nine months ended September 30, 2024, and 2023, respectively.

The following table summarizes other information related to the Company’s operating leases used in continuing operations:

September 30, 2024September 30, 2023
Weighted average remaining lease term – operating leases in years3.384.36
Weighted average discount rate – operating leases13%13%

The Company’s operating lease obligations as of September 30, 2024, which include expected lease extensions that are reasonably certain of renewal, were as follows:

Remainder of 2024$137,597
2025798,262
2026803,724
2027827,909
2028139,022
Total lease payments2,706,514
Less: interest(505,273)
Present value of lease liabilities$2,201,241

NOTE 9–** 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 requiredten monthly installment payments through April 2024. The note was secured by a first priority lien on the financed policies. The short-term note bore interest at an annual percentage rate of 9.25% over the life of the note. As of December 31, 2023, the outstanding balance of the note was $150,408 including interest. As of June 30, 2024, there wasno outstanding balance on the note.

In June 2024, the Company purchased director and officer insurance policies with a policy period ending June 2025 and financed $275,098 of its total premium by entering into a note payable with a finance provider that requiredten monthly installment payments through April 2025. The note was secured by a first priority lien on the financed policies. The short-term note bore interest at an annual percentage rate of 8.00% over the life of the note. As of September 30, 2024, the outstanding balance of the note was $195,776 including interest.

NOTE 10–** DERIVATIVES**

Certain warrants issued to placement agents in 2020 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 fair 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 $0 and $135 as of September 30, 2024, and December 31, 2023, respectively. The Company recorded no gain or loss on the change in fair value of the placement agent warrants during the three months ended September 30, 2024. The Company recorded a gain on the change in fair value of the placement agent warrants of $743 during the three months ended September 30, 2023, and gains of $135 and $3,062 during the nine months ended September 30, 2024, and 2023, 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 $0 and $333 as of September 30, 2024, and December 31, 2023, respectively. The Company recorded no gain or loss on the change in fair value of the placement agent warrants during the three months ended September 30, 2024. The Company recorded a gain on the change in fair value of the placement agent warrants of $1,133 during the three months ended September 30, 2023, and gains of $333 and $3,903 during the nine months ended September 30, 2024, and 2023, 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 and $908 as of September 30, 2024, and December 31, 2023, respectively. The Company recorded gains on the change in fair value of the placement agent warrants of $7 and $1,587 during the three months ended September 30, 2024, and 2023, respectively, and $907 and $4,759 during the nine months ended September 30, 2024, and 2023, 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 as of December 31, 2022$13,833
(Gain) recognized to revalue derivative instrument at fair value(953)
Derivative liability balance as of March 31, 2023$12,880
(Gain) recognized to revalue derivative instrument at fair value(7,308)
Derivative liability balance as of June 30, 2023$5,572
(Gain) recognized to revalue derivative instrument at fair value(3,463)
Derivative liability balance as of September 30, 2023$2,109
Derivative liability balance as of December 31, 2023$1,376
(Gain) recognized to revalue derivative instrument at fair value(1,009)
Derivative liability balance as of March 31, 2024$367
(Gain) recognized to revalue derivative instrument at fair value(359)
Derivative liability balance as of June 30, 2024$8
(Gain) recognized to revalue derivative instrument at fair value(7)
Derivative liability balance as of September 30, 2024$1

NOTE 11–** 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 ofone one-thousandth of a share of Series F Preferred Stock, par value $0.01 per share, for each outstanding share of the Company’s common stock held on record as of March 27, 2023.79,404 shares of Series F Preferred Stock were issued pursuant to the stock dividend. Each share of Series F Preferred Stock entitled the holder thereof to 1,000,000 votes per share to vote together with the outstanding shares of common stock of the Company as a single class to adopt an amendment to the Company’s Certificate of Incorporation to affect a reverse stock split.

On April 19, 2023, the Company completed a one-for-twenty reverse stock split that was effective for trading purposes on April 24, 2023. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. The number of authorized shares of common stock under the Company’s certificate of incorporation, as amended, remained unchanged at 200,000,000 shares. All numbers of shares and per-share amounts in this report have been adjusted to reflect the reverse split. Proportionate reductions were made to the number of shares of common stock reserved for future issuance under our 2012 Equity Incentive Plan and the number of shares of common stock that may be issued upon exercise or vesting of outstanding equity incentive awards and warrants, and proportionate increases were made to the exercise price or share-based performance criteria, if any, applicable to such awards and warrants.

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 shares of Series F Preferred Stock remain outstanding.

At The Market Offering

On May 3, 2024, the Company entered into an ATM Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), to sell shares of the Company’s common stock, par value $0.01 per share (the “Shares”), having an aggregate sales price of up to $3,696,000, from time to time, through an “at the market offering” program pursuant to which Wainwright acted as sales agent. Subject to the terms and conditions of the Sales Agreement, Wainwright was permitted to sell the Shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. Under the Sales Agreement, Wainwright was entitled to compensation for its services of 3.0% of the gross sales price of all shares sold through Wainwright under the Sales Agreement. As of June 30, 2024, the Company sold 1,607,100 shares of common stock at an average price of approximately $2.30 per share, resulting in aggregate gross proceeds of approximately $3,696,000. No further shares are available to be sold under the Sales Agreement.

Warrant Inducement Transaction

On July 25, 2024, the Company entered into definitive agreements with certain of its existing warrant holders for the exercise of warrants to purchase an aggregate of 958,117 shares of its common stock having a current exercise price of $14.00 originally issued in February 2021, June 2021 and May 2022, at a reduced exercise price of $1.32 per share. The gross proceeds to the Company from the exercise of the existing warrants were approximately $1,265,000, prior to deducting placement agent fees and transaction expenses payable by the Company. The reduction of the exercise price represented a modification to the existing warrants, which was recognized as an equity issuance cost of $594,033 charged against the proceeds of the offering.

In consideration for the immediate cash exercise of the warrants, the Company concurrently issued to the warrant holders new unregistered Series A warrants to purchase up to 958,117 shares of common stock (the “Series A Warrants”) and new Series B warrants to purchase up to 958,117 shares of common stock (the “Series B Warrants”). The Series A Warrants and the Series B Warrants have an exercise price of $1.07 per share and are exercisable immediately upon issuance. The Series A Warrants have a term equal tofive years from the date of issuance, and the Series B Warrants have a term equal to 18 months from the date of issuance.

The transactions described above closed on July 26, 2024. Wainwright acted as the exclusive placement agent for the above-mentioned transactions. The Company paid Wainwright as consideration (i) an aggregate cash fee equal to 7.0% of the gross proceeds from the exercise of the existing warrants, (ii) a management fee equal to 1.0% of the aggregate gross proceeds from the exercise of the existing warrants, (iii) $35,000 for expenses, and (iv) $15,950 for clearing fees. Additionally, the Company issued to Wainwright (or its designees) as compensation, warrants to purchase up to 67,068 shares of common stock of the Company (equal to 7.0% of the aggregate number of existing warrants exercised in the offering) (the “Placement Agent Warrants”). The Placement Agent Warrants have a term offive years from the closing of the offering and an exercise price of $1.65 per share.

Equity Incentive Plan

The Company’s Amended and Restated 2012 Stock Incentive Plan (the “2012 Plan”) allows for the issuance of incentive and non-qualified stock options, stock appreciation rights, stock awards, restricted stock, restricted stock units (“RSUs”) and performance awards to employees, directors, and consultants of the Company, where permitted under the plan. The exercise price for each stock option is determined by the market price on the date of issuance. Vesting requirements are determined by the Board of Directors when granted and currently range from immediate to three years. Options outstanding under this plan have a contractual life of ten years.

ASC 718,Compensation–* Stock Compensation*(“ASC 718”), requires that a company that issues equity as compensation record compensation expense that corresponds to the estimated cost of those equity grants. ASC 718 requires companies to estimate the fair value of stock-based payment awards on the date of grant using an option-pricing model or other acceptable means.

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 stock option grant was estimated on the grant date using the Black-Scholes option valuation model with the following assumptions:

Nine Months Ended September 30,
20242023
Stock Options
Expected dividend yield-0.0%
Expected stock price volatility-90.8% – 91.6%
Risk-free interest rate-3.38% – 3.72%
Expected life-10 years
Warrants
Expected dividend yield0.0%-
Expected stock price volatility97.3%-
Risk-free interest rate4.06% – 4.58%-
Expected life1.5 – 5 years-

Stock Options and Warrants Granted by the Company

The following summarizes transactions for stock options and warrants for the period indicated:

Stock OptionsWarrants
Number of SharesAverage Exercise PriceNumber of SharesAverage Exercise Price
Outstanding as of December 31, 202347,664$82.231,806,589$21.52
Issued--1,983,3021.09
Forfeited(309)5.04--
Expired(2,164)3.03(81,346)37.90
Exercised--(958,117)1.32
Outstanding as of September 30, 202445,191$86.552,750,428$8.92

Stock-based compensation expense, net of forfeitures, recognized for the three months ended September 30, 2024, and 2023, was $88 and $(14,336), respectively. Stock-based compensation expense, net of forfeitures, recognized for the nine months ended September 30, 2024, and 2023, was $1,103 and $10, respectively. Stock-based compensation expense is recorded within each of the captions comprising Operating expenses from continuing operations. The Company has $16 of unrecognized compensation expense related to unvested stock options that is expected to be recognized over the next 4 months.

NOTE 12–** LOSS PER SHARE**

The following table presents the shares used in the basic and diluted loss per common share computations:

Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Numerator:
Net (loss) from continuing operations$(2,283,413)$(2,748,367)$(8,759,343)$(9,025,398)
Net (loss) from discontinued operations(811,277)(415,083)(1,735,451)(1,483,222)
Net (loss) attributable to common stockholders$(3,094,690)$(3,163,450)$(10,494,794)$(10,508,620)
Denominator:
Weighted average common shares outstanding - basic6,396,2214,031,3565,046,2273,998,887
Effect of diluted stock options, warrants, and preferred stock (1)----
Weighted average common shares outstanding - diluted6,396,2214,031,3565,046,2273,998,887
Net (loss) from continuing operations attributable to common stockholders per common share – basic and diluted(0.36)(0.68)(1.74)(2.26)
Net (loss) from discontinued operations attributable to common stockholders per common share – basic and diluted(0.13)(0.10)(0.34)(0.37)
(Loss) per common share - basic and diluted$(0.48)$(0.78)$(2.08)$(2.63)
(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,
20242023
Options45,19148,225
Warrants2,750,4281,807,020
Preferred stock: Series B1616

NOTE 13–** SEGMENTS**

The Company has determined its operating segments in accordance with ASC 280,Segment Reporting. Factors used to determine the Company’s reportable segments include the availability of separate financial statements, the existence of locally based leadership across geographic regions, the economic factors affecting each segment, and the evaluation of operating results at the segment level. The Chief Operating Decision Maker (“CODM”) allocates the Company’s resources for each of the operating segments and evaluates their relative performance. Each operating segment listed below has separate financial statements and locally based leadership that are evaluated based on the results of their respective segments. It should be noted that the operating segments below have different products and services. The financial information is consolidated and evaluated regularly by the CODM in assessing performance and allocating resources.

The Company hastwo reportable segments, which have been delineated by location and business area:

●Pittsburgh segment: provides services that include the application of AI using its proprietary biobank of 150,000+ tumor samples. Pittsburgh also creates proprietary 3D culture models used in drug development.
●Eagan segment: produces the FDA-cleared STREAMWAY System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal.

As described in Note 2, the Company’s former Birmingham operating segment met the criteria to be reported as discontinued operations during the third quarter of 2024. As such, the former Birmingham segment is excluded from the tables below, which only reflect continuing operations for all periods presented.

All revenues are earned from external customers.

The tables below summarize the Company’s segment reporting as of September 30, 2024, and December 31, 2023, and for the three and nine months ended September 30, 2024, and 2023.

Pittsburgh · Eagan · Corporate · Total
Revenue$3,907$341,779$-$345,686
Depreciation and amortization(30,766)(7,348)(1,682)(39,796)
Segment loss$(1,053,373)$(153,533)$(1,076,507)$(2,283,413)
Pittsburgh · Eagan · Corporate · Total
Revenue$76,020$936,212$-$1,012,232
Depreciation and amortization(94,272)(22,395)(5,352)(122,019)
Segment loss$(3,260,416)$(608,689)$(4,890,238)$(8,759,343)
PittsburghEaganCorporateTotal
Assets$2,797,545$1,270,451$3,352,512$7,420,508
Pittsburgh · Eagan · Corporate · Total
Revenue$417,096$259,530$-$676,626
Depreciation and amortization(31,946)(8,909)(1,851)(42,706)
Segment loss$(674,952)$(189,031)$(1,884,384)$(2,748,367)
Pittsburgh · Eagan · Corporate · Total
Revenue$441,567$866,535$-$1,308,102
Depreciation and amortization(175,713)(25,660)(5,528)(206,901)
Segment loss$(3,428,644)$(756,115)$(4,840,639)$(9,025,398)
PittsburghEaganCorporateTotal
Assets$3,263,270$1,390,031$8,782,034$13,435,335
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.