Washington, D.C. 20549

Form 8-K


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): November 16, 2020  

Predictive Oncology Inc.
(Exact Name of Registrant as Specified in Charter)

(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)


2915 Commers Drive, Suite 900, Eagan, Minnesota 55121
(Address of Principal Executive Offices) (Zip Code)

(651) 389-4800
(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 [   ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 [   ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 [   ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 [   ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [   ]


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]


Securities registered pursuant to Section 12(b) of the Act:


Title of each classTrading symbol(s)Name of each exchange on which registered
Common stock, $0.01 par valuePOAINasdaq Capital Market



Item 2.02. Results of Operations and Financial Condition.

(a)Not applicable.
(b)Not applicable.
(c)Not applicable.

Item 9.01. Financial Statements and Exhibits.

99.1   Press Release dated November 16, 2020


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 Predictive Oncology Inc.
Date: November 16, 2020By: /s/ Bob Myers        
  Bob Myers
  Chief Financial Officer



Predictive Oncology Reports Third Quarter 2020 Financial Results, Provides Business Update

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI), a knowledge-driven company focused on applying artificial intelligence (“AI”) to personalized medicine and drug discovery, today reported financial results for the quarter ended September 30, 2020 and provided a business update.

Business Highlights

“During the third quarter, we continued our work of laying a foundation for our precision medicine business,” commented Dr. Carl Schwartz, Predictive Oncology CEO. “We are making steady progress in our Helomics division with the launch of a restructured clinical test offering to clinicians for ovarian cancer. Our project with UPMC-Magee Womens Hospital, analyzing the genomic and drug response profiles of women with ovarian cancer to build predictive models’ terms of therapy response, is close to completion. We are also in discussions with several pharmaceutical companies about partnerships that will monetize our efforts.

“At our Soluble Biotech division, which provides optimized FDA-approved formulations for vaccines, antibodies and other protein therapeutics faster and at a lower cost basis to its customers, we signed our first contract with a pharmaceutical company for protein expression and solubility studies,” continued Dr. Schwartz. “Importantly, this win validates our investment in state-of-the-art lab equipment and expanded facilities. We are working judiciously to secure additional contracts with other biotechnology and pharmaceutical companies.”

Dr. Schwartz continued, “In our TumorGenesis division, we introduced our Ovarian Cell Line Media at the BIO-Europe Digital Conference where numerous researchers learned from us how they can isolate and successfully culture ovarian cancer cells that previously could not be cultured. Cornell University (Weill) Medical School and TumorGenesis are collaborating to help identify the best culture media for the studying of mutations that increase the risk of ovarian, breast and other types of cancers.

“The Skyline Medical division continues to be self-sustaining, from an operating cash perspective, as sales of new waste fluid management systems and recurring sales of disposables to support those systems more than cover the operating expenses and capital needs of this segment of our business,” noted Dr. Schwartz. “Importantly, sustaining and even modestly growing this division provides us with cash we need as we accelerate the precision medicine components of our business. During the third quarter, we sold 15 STREAMWAY® Systems, including eight to a large university hospital organization in the state of Virginia.

“Our operating cash improved over the first nine months of 2020 as a result of an improvement in operating expenses, if the non-cash expense for goodwill impairment is excluded, continued new sales of our STREAMWAY Systems, which provide an annuity-like revenue stream from ongoing sales of disposables, and proceeds from equity offerings, indicating investor confidence in our emerging precision medicine business,” concluded Dr. Schwartz. “Concurrently, we are taking the necessary steps to manage our balance sheet, including reducing our accounts payable and reducing our derivative liability by amending a settlement provision for certain outstanding warrants.

“Management continues to focus the majority of its resources on the Company’s primary mission of applying artificial intelligence to precision medicine and to drug discovery. Our approach and the mediums used to replace rats and mice in preliminary cancer studies are working in three of our operating subsidiaries, Helomics, TumorGenesis and Soluble Biotech.”

Third Quarter 2020 Financial Results

Revenues of $0.5 million were level with the third quarter of last year, primarily driven through the sale of Predictive Oncology’s proprietary STREAMWAY product line, of which 15 and 19 units were sold in the three months ended September 30, 2020 and 2019, respectively.

Gross margin was 64% in the third quarter of 2020 compared with 60% in the 2019 period. The increase in gross margin was driven by lower manufacturing costs. General & administrative expenses declined 15% to $2.2 million in the third quarter of 2020, primarily as a result of a decrease in penalties related to short-term notes issued in 2019, lower audit fees and share-based compensation expenses. This was partially offset by increases in salary and related expenses, investor relations costs and depreciation. Operations expenses slightly decreased in the third quarter of 2020 primarily due to lower costs related to staff, including share-based compensation.

Operating loss was $5.6 million in the third quarter of 2020 compared with $3.4 million in the 2019 period. General and administrative, operations and sales and marketing expenses were lower across all categories; a non-cash goodwill impairment charge of $3.0 million drove the 2020 operating loss above the 2019 third quarter period.

Net loss attributable to common shareholders was $6.9 million, or $(0.46) per diluted share in the third quarter of 2020, compared with a loss of $4.1 million, or $(1.31) per diluted share for the 2019 period. The loss in the third quarter of 2020 includes other expense of $2.1 million. This includes higher net interest expense, payment penalties, amortization of original issue discounts and a loss on debt extinguishment related to the Company’s notes payable. Additionally, a $0.6 million non-cash deemed dividend (to account for a warrant exercise price adjustment for warrants issued in June 2020) was recognized. These were partially offset by a non-cash gain of $1.4 million related to the revaluation of equity method investments.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Skyline, Helomics and Soluble Biotech), which contain four subsidiaries: Helomics, TumorGenesis, Skyline Medical and Soluble Biotech.

Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. TumorGenesis Inc. specializes in media that help cancer cells grow and retain their DNA/RNA and proteomic signatures, providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. Skyline Medical markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. Soluble Biotech is a provider of soluble and stable formulations for proteins including vaccines, antibodies, large and small proteins and protein complexes.

Forward-Looking Statements

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “would,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading “Risk Factors” in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:

Hayden IR
James Carbonara

-- Tables Follow


  September 30, 2020 December 31, 2019
  (unaudited) (audited)
Current Assets:      
Cash $2,474,312  $150,831 
Accounts Receivable  508,265   297,055 
Inventories  205,908   190,156 
Prepaid Expense and Other Assets  269,282   160,222 
Total Current Assets  3,457,767   798,264 
Fixed Assets, net  3,755,464   1,507,799 
Intangibles, net  3,464,327   3,649,412 
Lease Right-of-Use Assets  1,790,130   729,745 
Goodwill  12,693,290   15,690,290 
Total Assets $25,160,978   $22,375,510 
Current Liabilities:      
Accounts Payable $1,628,944  $3,155,641 
Notes Payable – Net of Discounts of $495,100 and $350,426  5,751,876   4,795,800 
Accrued Expenses  2,530,385   2,371,633 
Derivative Liability  1,052,494   50,989 
Deferred Revenue  66,123   40,384 
Lease Liability  577,505   459,481 
Total Current Liabilities  11,607,327   10,873,928 
Lease Liability – Net of current portion  1,221,806   270,264 
Other long-term liabilities  95,079   - 
Total Liabilities  12,924,212   11,144,192 
Stockholders’ Equity:      
Preferred Stock, 20,000,000 authorized inclusive of designated below      
Series B Convertible Preferred Stock, $.01 par value, 2,300,000 shares authorized, 79,246 and 79,246 shares outstanding  792   792 
Series D Convertible Preferred Stock, $.01 par value, 3,500,000 shares authorized, 0 and 3,500,000 outstanding  -   35,000 
Series E Convertible Preferred Stock, $.01 par value, 350 shares authorized, 0 and 258 outstanding  -   3 
Common Stock, $.01 par value, 100,000,000 shares authorized, 16,593,283 and 4,056,652 outstanding  165,932   40,567 
Additional paid-in capital  108,983,174   93,653,667 
Accumulated Deficit  (96,913,132)  (82,498,711)
Total Stockholders' Equity  12,236,766   11,231,318 
Total Liabilities and Stockholders' Equity $25,160,978  $22,375,510 


 Three Months Ended
September 30,
 Nine Months Ended
September 30, 

 2020 2019 2020 2019
Revenue$480,757  $522,696  $958,484  $1,064,088 
Cost of goods sold 175,206   208,096   353,124   400,202 
Gross margin 305,551   314,600   605,360   663,886 
General and administrative expense 2,226,634   2,616,991   8,266,927   7,425,305 
Operations expense 568,766   707,414   1,638,635   2,445,238 
Sales and marketing expense 121,514   434,955   518,938   1,674,200 
Loss on goodwill impairment 2,997,000   -   2,997,000   - 
Total operating loss (5,608,363)  (3,444,760)  ( 12,816,140)  (10,880,857)
Gain on revaluation of cash advances to Helomics -   -   -   1,222,244 
Other income 44,926   15,084   97,894   65,293 
Other expense (2,147,057)  (894,811)  (3,993,969)  (2,052,522)
Gain (loss) on derivative instruments 1,402,768   315,975   1,007,794   84,627 
Gain on notes receivables associated with asset purchase -
Loss on equity method investment -   -   -   439,637 
Gain on revaluation of equity method in investment -   -   -   6,164,260 
Net (loss)$(6,307,726) $(4,008,512) $(14,414,421) $(5,836,592)
Deemed dividend 554,287   125,801   554,287   146,199 
Net income (loss) attributable to common shareholders per common shares-basic and diluted$(6,862,013) $(4,134,313) $(14,968,708) $(5,982,791)
Gain (loss) per common share basic and diluted$(0.46) $(1.31) $(1.51) $(2.32)
Weighted average shared used in computation – basic and diluted 15,026,789   3,146,609   9,935,738   2,581,014