Predictive Oncology Inc
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
View on SEC.govAbout this filing
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
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-13.
0001171843-24-004757
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001171843-24-006292
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 45 previous paragraphs and 50 current paragraphs.
18 unchanged; 25 reworded; 7 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 22 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
In July 2024, our Board of Directors approved a plan to implement a strategic cost savings initiative, primarily related to the Company’s Birmingham laboratory. After extensive consideration, we decided that transferring the laboratory equipment and related product/service lines from Birmingham to Pittsburgh would not be a strategic and effective use of Company resources. In aggregate, the disposal of the assets comprising the former Birmingham operating segment resulted in a strategic shift that had a major effect on our operations and financial results.
Current report
As a result of the strategic cost savings initiative, historical results of the former Birmingham operating segment have been reflected as discontinued operations in our condensed consolidated financial statements for all historical periods presented in the statements of net loss. Assets and liabilities associated with the former Birmingham operating segment are classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations, including results from discontinued operations, are provided in Note 2 to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
Current report
The results presented below, and the following discussion, are based on and relate to our continuing operations.
Current report
Net cash used in discontinued operations was $861,576 and $1,293,359 for the nine months ended September 30, 2024, and 2023, respectively. Net cash used in operating activities of discontinued operations was $893,576 and $1,046,745 for the nine months ended September 30, 2024, and 2023, respectively. This change primarily relates to changes in working capital. Net cash provided by investing activities of discontinued operations was $32,000 for the nine months ended September 30, 2024, while net cash used in investing activities of discontinued operations was $246,614 for the nine months ended September 30, 2023.
Current report
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.
Current report
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 to five years from the date of issuance, and the Series B Warrants have a term equal to 18 months from the date of issuance.
Current report
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 of five years from the closing of the offering and an exercise price of $1.65 per share.
Removed paragraphs (2)
Previous report
On July 25, 2024, our board of directors approved a plan to implement a strategic cost savings initiative, primarily related to the consolidation of the operations of our Birmingham laboratory into our Pittsburgh laboratory. We began implementing the cost savings initiative in August 2024 and continue to review its progress and effectiveness, including the impact of the changes on our operating segments as described immediately above. In particular, we anticipate that our three segments will be reduced to two in future reporting periods with the closure of our Birmingham laboratory. The initiative is expected to reduce the Company’s run rate for cash used in operating activities by approximately 20% annually when fully implemented in Q4 2024.
Previous report
Loss on impairment of property and equipment. We recorded no losses on impairment of property and equipment during the three and six months ended June 30, 2024. We recorded a loss on impairment of property and equipment of $162,905 during the three and six months ended June 30, 2023. We prepared an undiscounted cash flow for our Birmingham asset group as of June 30, 2023, to evaluate long-lived assets, then completed a fair value assessment which resulted in the impairment and allocated the impairment to the assets of the affected asset group. Please seeNote 5–* Property and Equipment* to our unaudited condensed consolidated financial statements for further information.
Reworded paragraphs (25)
Previous wording
We operate in three business areas. In our first area, we provide optimized, high-confidence drug-response predictions through the application of AI using our proprietary biobank of tumor samples to enable a more informed selection of drug/tumor combinations and increase the probability of success during development. We also create and develop tumor-specific 3D cell culture models mimicking the physiological environment of human tissue enabling better-informed decision-making during development. In our second business area, we provide services and research using a proprietary self-contained and automated system that conducts high-throughput, self-interaction chromatography screens using additives and excipients commonly included in protein formulations resulting in soluble and physically stable formulations of biologics. Our third business area produces the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System and associated products for automated medical fluid waste management and patient-to-drain medical fluid disposal.
Current wording
During the third quarter of 2024, our former Birmingham operating segment met the criteria under US GAAP to be reported as discontinued operations. As a result, we operate in two business areas. In our first area, we provide optimized, high-confidence drug-response predictions through the application of AI using our proprietary biobank of tumor samples to enable a more informed selection of drug/tumor combinations and increase the probability of success during development. We also create and develop tumor-specific 3D cell culture models mimicking the physiological environment of human tissue enabling better-informed decision-making during development. In our second business area, we produce 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.
Previous wording
We have three reportable segments, which have been delineated by location and business area:
Current wording
As a result of the decision to discontinue our former Birmingham operating segment, we have two reportable segments, which have been delineated by location and business area:
Previous wording
Since inception, we have been unprofitable. We incurred net losses of $7,400,104 and $7,345,170 for the six months ended June 30, 2024, and 2023, respectively. As of June 30, 2024, and December 31, 2023, we had an accumulated deficit of $175,161,987 and $167,761,883, respectively.
Current wording
Since inception, we have been unprofitable. We incurred net losses of $10,494,794 and $10,508,620 for the nine months ended September 30, 2024, and 2023, respectively. As of September 30, 2024, and December 31, 2023, we had an accumulated deficit of $178,256,677 and $167,761,883, respectively.
Previous wording
Our future cash requirements and the adequacy of available funds depend on our ability to generate revenues from our oncology businesses located in Pittsburgh and Birmingham; our ability to continue to sell our Skyline Medical products and services and to reach profitability in all our businesses; and the availability of future financing to fulfill our business plans. See “Liquidity and Capital Resources – Liquidity and Plan of Financing; Going Concern” below.
Current wording
Our future cash requirements and the adequacy of available funds depend on our ability to generate revenues from our oncology business located in Pittsburgh; our ability to continue to sell our Skyline Medical products and services and to reach profitability in all our businesses; and the availability of future financing to fulfill our business plans. See “Liquidity and Capital Resources – Liquidity and Plan of Financing; Going Concern” below.
Previous wording
Comparison of three and six months ended June 30, 2024, and 2023
Current wording
Comparison of three and nine months ended September 30, 2024, and 2023
Previous wording
Revenue. We recorded revenue of $278,722 and $490,110 in the three months ended June 30, 2024, and 2023, respectively. Revenue in the three months ended June 30, 2024, and 2023, was primarily derived from the Eagan operating segment. The decrease in revenue from the comparative period was primarily due to a change in sales mix with decreased sales of STREAMWAY systems in the three months ended June 30, 2024.
Current wording
Revenue. We recorded revenue of $345,686 and $676,626 in the three months ended September 30, 2024, and 2023, respectively. Revenue in the three months ended September 30, 2024, was primarily derived from the Eagan operating segment, while revenue in the three months ended September 30, 2023, was primarily derived from the Pittsburgh operating segment. The decrease in revenue from the comparative period was primarily due to decreased sales of tumor-specific 3D cell culture models from the Pittsburgh operating segment, offset by increased sales of STREAMWAY systems during the third quarter of 2024 from the Eagan operating segment.
Previous wording
We recorded revenue of $698,368 and $730,005 in the six months ended June 30, 2024, and 2023, respectively. Revenue in the six months ended June 30, 2024, was primarily derived from the Eagan operating segment. The decrease in revenue from the comparative period was primarily due to a change in sales mix with decreased sales related to biologics in our Birmingham operating segment during the six months ended June 30, 2024.
Current wording
We recorded revenue of $1,012,232 and $1,308,102 in the nine months ended September 30, 2024, and 2023, respectively. Revenue in the nine months ended September 30, 2024, and 2023, was primarily derived from the Eagan operating segment. The decrease in revenue from the comparative nine-month period was also primarily due to decreased sales of tumor-specific 3D cell culture models in 2024 from the Pittsburgh operating segment, offset by increased sales of STREAMWAY systems during 2024 from the Eagan operating segment.
Previous wording
Cost of sales. Cost of sales was $152,968 and $159,761 in the three months ended June 30, 2024, and 2023, respectively. The gross profit margin was approximately 45% and 67% in the three months ended June 30, 2024, and 2023, respectively. The decline in gross profit margin for the three months ended June 30, 2024, was primarily due to increased labor costs and a change in sales mix with decreased sales of STREAMWAY systems.
Current wording
Cost of sales. Cost of sales was $196,919 and $97,868 in the three months ended September 30, 2024, and 2023, respectively. The gross profit margin was approximately 43% and 86% in the three months ended September 30, 2024, and 2023, respectively. The decline in gross profit margin for the three months ended September 30, 2024, was primarily due to increased labor costs and a change in sales mix with decreased sales of 3D models with higher margins than STREAMWAY systems.
Previous wording
Cost of sales was $340,383 and $279,900 in the six months ended June 30, 2024, and 2023, respectively. The gross profit margin was approximately 51% and 62% in the six months ended June 30, 2024, and 2023, respectively. The decline in gross profit margin for the six months ended June 30, 2024, was primarily due to increased labor costs.
Current wording
Cost of sales was $535,511 and $367,461 in the nine months ended September 30, 2024, and 2023, respectively. The gross profit margin was approximately 47% and 72% in the nine months ended September 30, 2024, and 2023, respectively. The decline in gross profit margin for the nine months ended September 30, 2024, was also primarily due to increased labor costs and the change in sales mix with decreased sales of 3D models with higher margins than STREAMWAY systems.
Previous wording
General and administrative expense. General and administrative (“G&A”) expense primarily consists of management salaries, professional fees, consulting fees, administrative fees, and general office expenses. G&A expense decreased by $567,338 to $2,137,189 in the three months ended June 30, 2024, compared to $2,704,527 in the comparable period in 2023. The decrease was primarily due to decreased employee compensation and decreased investor relations costs, offset by increased consultant fees.
Current wording
General and administrative expense. General and administrative (“G&A”) expense primarily consists of management salaries, professional fees, consulting fees, administrative fees, and general office expenses. G&A expense decreased by $761,949 to $1,582,671 in the three months ended September 30, 2024, compared to $2,344,620 in the comparable period in 2023. The decrease was primarily due to decreased employee compensation related to lower headcount related expenses and severance for former employees.
Previous wording
G&A expense decreased by $276,246 to $4,764,265 in the six months ended June 30, 2024, compared to $5,040,511 in the comparable period in 2023. The decrease was primarily due to decreased employee compensation and decreased investor relations costs, offset by increased audit fees and consultant fees.
Current wording
G&A expense decreased by $988,541 to $5,834,783 in the nine months ended September 30, 2024, compared to $6,823,324 in the comparable period in 2023. The decrease was primarily due to decreased employee compensation due to lower headcount and decreased investor relations costs, offset by increased audit fees and consultant fees.
Previous wording
Operations expense. Operations expense primarily consists of expenses related to product development and prototyping and testing. Operations expense decreased by $99,651 to $893,391 in the three months ended June 30, 2024 compared to $993,042 in the comparable period in 2023. The decrease was primarily due to decreased cloud computing expenses related to our Pittsburgh operating segment.
Current wording
Operations expense. Operations expense primarily consists of expenses related to product development and prototyping and testing. Operations expense decreased by $5,274 to $633,422 in the three months ended September 30, 2024 compared to $638,696 in the comparable period in 2023. The minor decrease was primarily due to decreased cloud computing expenses resulting from cost saving efforts, offset by increased costs associated with our Pittsburgh laboratory including supplies and maintenance.
Previous wording
Operations expense increased by $124,024 to $1,995,584 in the six months ended June 30, 2024, compared to $1,871,560 in the comparable period in 2023. The increase was primarily due to higher employee compensation.
Current wording
Operations expense increased by $88,962 to $2,188,936 in the nine months ended September 30, 2024, compared to $2,099,974 in the comparable period in 2023. The increase was primarily due to higher employee compensation, offset by lower cloud computing expenses and recruiting fees.
Previous wording
Sales and marketing expense. Sales and marketing expenses consist of expenses required to market and sell our products including staff-related expenses for individuals performing this work. Sales and marketing expense decreased by $144,682 to $284,421 in the three months ended June 30, 2024, compared to $429,103 in the comparable period in 2023. The decrease was primarily due to lower employee compensation including sales commissions.
Current wording
Sales and marketing expense. Sales and marketing expenses consist of expenses required to market and sell our products including staff-related expenses for individuals performing this work. Sales and marketing expense decreased by $87,789 to $246,650 in the three months ended September 30, 2024, compared to $334,439 in the comparable period in 2023. The decrease was primarily due to lower employee compensation including sales commissions.
Previous wording
Sales and marketing expense increased by $224,815 to $1,024,155 in the six months ended June 30, 2024, compared to $799,340 in the comparable period in 2023. The increase was primarily due to severance related to a former executive.
Current wording
Sales and marketing expense increased by $156,412 to $1,268,824 in the nine months ended September 30, 2024, compared to $1,112,412 in the comparable period in 2023. The increase was primarily due to severance related to a former executive, offset by lower other employee compensation costs related to lower headcount and sales commissions.
Previous wording
Other income. We earned other income of $9,461 during the three months ended June 30, 2024, compared to $28,552 in the comparable period in 2023. We earned other income of $28,118 during the six months ended June 30, 2024, compared to $70,780 in the comparable period in 2023. Other income in all periods primarily consisted of interest income.
Current wording
Other income. We earned other income of $36,378 during the three months ended September 30, 2024, compared to $47,838 in the comparable period in 2023. We earned other income of $64,497 during the nine months ended September 30, 2024, compared to $118,618 in the comparable period in 2023. Other income in all periods primarily consisted of interest income on cash and cash equivalents.
Previous wording
Other expense. We incurred other expense of $1,834 during the three months ended June 30, 2024, compared to no other expense in the comparable period in 2023. We incurred other expense of $3,571 during the six months ended June 30, 2024, compared to no other expense in the comparable period in 2023. Other expense in 2024 consisted primarily of interest expense.
Current wording
Other expense. We incurred other expense of $5,822 during the three months ended September 30, 2024, compared to $60,671 in the comparable period in 2023. We incurred other expense of $9,393 during the nine months ended September 30, 2024, compared to $60,671 in the comparable period in 2023. Other expense in 2024 consisted primarily of interest expense, while other expense in 2023 was primarily due to the write off of a note receivable deemed uncollectible.
Previous wording
Gain on derivative instruments. We recorded a gain of $359 in the three months ended June 30, 2024, compared to $7,308 in the comparable period in 2023. We recorded a gain of $1,368 in the six months ended June 30, 2024, compared to $8,261 in the comparable period in 2023. These gains related to the change in fair value of the derivative.
Current wording
Gain on derivative instruments. We recorded a gain of $7 in the three months ended September 30, 2024, compared to $3,463 in the comparable period in 2023. We recorded a gain of $1,375 in the nine months ended September 30, 2024, compared to $11,724 in the comparable period in 2023. These gains related to the change in fair value of the derivative instruments.
Previous wording
Net cash used in operating activities was $6,634,072 and $7,002,033 for the six months ended June 30, 2024, and 2023, respectively. Cash used in operating activities decreased in the 2024 period primarily because of changes in working capital.
Current wording
Net cash used in operating activities of continuing operations was $8,913,589 and $9,060,285 for the nine months ended September 30, 2024, and 2023, respectively. Cash used in operating activities decreased in the 2024 period primarily because of changes in working capital.
Previous wording
Net cash used in investing activities was $9,510 and $305,745 for the six months ended June 30, 2024, and 2023, respectively. Cash used in investing activities decreased in the 2024 period primarily due to a decrease in fixed asset purchases during the six months ended June 30, 2024, as compared to the same period in 2023.
Current wording
Net cash used in investing activities of continuing operations was $9,510 and $63,052 for the nine months ended September 30, 2024, and 2023, respectively. Cash used in investing activities decreased in the 2024 period primarily due to a decrease in fixed asset purchases during the nine months ended September 30, 2024, as compared to the same period in 2023.
Previous wording
Net cash provided by financing activities was $3,246,692 and $0 for the six months ended June 30, 2024, and 2023, respectively. The cash provided in the six months ended June 30, 2024, was primarily due to proceeds from the issuance of common stock pursuant to the ATM offering completed in May 2024.
Current wording
Net cash provided by financing activities of continuing operations was $4,134,970 and $260,221 for the nine months ended September 30, 2024, and 2023, respectively. The cash provided in the nine months ended September 30, 2024, was primarily due to proceeds from the issuance of common stock pursuant to the ATM offering completed in May 2024 and proceeds from the exercise of warrants into common stock pursuant to the Warrant Inducement Transaction in July 2024.
Previous wording
We have incurred significant and recurring losses from operations for the past several years and, as of June 30, 2024, had an accumulated deficit of $175,161,987. We had cash and cash equivalents of $5,331,770 as of June 30, 2024, and need to raise significant additional capital to meet our operating needs. We had short-term obligations of $4,618,511 and long-term operating lease obligations of $1,860,983 as of June 30, 2024. We do not expect to generate sufficient operating revenue to sustain our operations in the near term. During the six months ended June 30, 2024, we incurred negative cash flows from operations of $6,634,072. Although we have attempted to improve our cash flows from operations by bolstering revenues and continue to seek ways to generate revenue through business development activities, there is no guarantee that we will be able to improve our cash flows from operations sufficiently or achieve profitability in the near term. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern within one year after the date our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q are issued.
Current wording
We have 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. We had cash and cash equivalents of $3,078,955 as of September 30, 2024, and need to raise significant additional capital to meet our operating needs. We had short-term obligations of $3,816,766 and long-term operating lease obligations of $1,704,453 as of September 30, 2024. We do not expect to generate sufficient operating revenue to sustain our operations in the near term. During the nine months ended September 30, 2024, we incurred negative cash flows from continuing operating activities of $8,913,589. Although we have attempted to improve our cash flows from continuing operating activities by bolstering revenues and continue to seek ways to generate revenue through business development activities, there is no guarantee that we will be able to improve our cash flows from continuing operating activities sufficiently or achieve profitability in the near term. As a result of these conditions, substantial doubt exists about our ability to continue as a going concern within one year after the date our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q are issued.
Previous wording
We are 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 our existing stockholders or that result in our existing stockholders losing part or all of their investment. Despite these potential sources of funding, we 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, we would be forced to limit our business activities and we could default on existing payment obligations, which would have a material adverse effect on our financial condition and results of operations, and may ultimately be required to cease our operations and liquidate our business. Our condensed consolidated financial statements as of and for the three and six months ended June 30, 2024, included in this Quarterly Report on Form 10-Q, have been prepared assuming we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
We are 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 our existing stockholders or that result in our existing stockholders losing part or all of their investment. Despite these potential sources of funding, we 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, we would be forced to limit our business activities and we could default on existing payment obligations, which would have a material adverse effect on our financial condition and results of operations, and may ultimately be required to cease our operations and liquidate our business. Our condensed consolidated financial statements as of and for the three and nine months ended September 30, 2024, included in this Quarterly Report on Form 10-Q, have been prepared assuming we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
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 will act as sales agent. Subject to the terms and conditions of the Sales Agreement, Wainwright is 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. The Sales Agreement provides that Wainwright will be 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 has 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.
Current wording
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.
Previous wording
There were no financing transactions during the six months ended June 30, 2023.
Current wording
There were no financing transactions during the nine months ended September 30, 2023.