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): August 13, 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.

On August 13, 2020, Predictive Oncology Inc. issued a press release attached hereto as Exhibit 99.1 announcing its financial results for the quarter ended June 30, 2020.

Item 9.01. Financial Statements and Exhibits.

(a) Not applicable.

(b) Not applicable.

(c) Not applicable.

(d) Exhibits

Exhibit No.   Description
99.1 Press Release dated August 13, 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: August 13, 2020By: /s/ Bob Myers        
  Bob Myers
  Chief Financial Officer



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

Increases Readiness for Commercialization with Expanded Portfolio of Solutions for Precision Medicine

NEW YORK, Aug. 13, 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 June 30, 2020 and provided a business update.

Financial and Business Highlights of Q2 and Recent Developments

“During the second quarter we reached a major milestone in our journey towards full commercialization with the first sale of our novel ovarian cancer cell media to a top-rated medical university in New England,” commented Dr. Carl Schwartz, Predictive Oncology CEO. "This sale serves as a solid proof point of our mission and is a significant achievement towards improving healthcare outcomes for cancer patients. Our unique media significantly expands the number of ovarian cancer cell types that can be studied representing nearly 95% of all ovarian cancers, many of which have never been cultured before now, and reduces waste in cancer research.”

“Our acquisitions of Soluble Therapeutics and BioDtech position us with next level capabilities that we believe will materially advance our progress towards developing new targeted therapies in collaborations with pharmaceutical companies and enable meaningful expansion of revenue opportunities,” added Dr. Schwartz. “Soluble Therapeutics assets will help us to provide the best formulation with the highest concentration and the most stable solution for protein and peptide-based drugs while the acquisition of BioDtech gives us governance over its testing solution for unmasking endotoxins. Together, we believe these acquisitions will substantially advance the discipline of precision medicine and accelerate our pursuit of monetizing our full portfolio of assets.”

Dr. Schwartz continued, “We also completed our acquisition of QM in early 2020, bringing its proven, machine learning platform, CoRE, into our portfolio of assets in our Helomics business and equipping us with a framework for an end-to-end solution for precision medicine. We are encouraged by the emerging opportunities this opens for us to further revolutionize AI-driven predictive modeling that can be used to accelerate the development of personalized patient treatments.”   

“Our Helomics business continues to make solid progress with our CancerQuest 2020 initiative and our collaboration with UPMC Magee Hospital to build AI-driven predictive models for the treatment of ovarian cancer,” added Dr. Schwartz. “Thus far, we have received outcome data, completed the second phase of sequencing and have begun the process to build our AI-model. We are on track to complete the study and have our first AI-driven model in accordance with our workplans, despite a later start date that was triggered by a delay in funding resulting from the COVID-19 pandemic. We expect to have our first AI-driven model completed in the second half of 2020. Just as important, we have been ramping up our commercial outreach activities with large pharma companies to build a pipeline of targeted opportunities ahead of model completion.”

Dr. Schwartz concluded, “We further bolstered our liquidity position with approximately $4.6 million in gross proceeds from a registered direct offering of common stock, the exercise of warrants and the issuance of additional warrants. Although we still have significant short-term debt obligations, the equity offerings demonstrate investor confidence, extend our cash runway and provide working capital to continue our pursuit of developing commercially viable solutions for large pharma. From a governance perspective, we refreshed our board operations with the appointment of three new independent directors, who collectively have extensive industry, financial and business development experience and a rich network of industry contacts that we believe will be extremely advantageous as we execute the next steps in our business plan.”

Second Quarter 2020 Financial Results

Revenues were $183,000 compared with $286,000 for the second quarter of 2019. Revenues in both years were primarily driven through the sale of Predictive Oncology’s proprietary STREAMWAY units, of which 1 unit and 7 units were sold in the three months ended June 30, 2020 and 2019, respectively.

Gross margin was 53% in the second quarter of 2020 compared with 59% in the 2019 period. The decrease was due to higher costs on lower revenue in the current period compared to the prior year period. General & administrative expenses decreased 3% to $3.2 million in the second quarter of 2020 as a result of lower costs related to share-based compensation. Operations expenses decreased to $521,000, compared with $1.3 million in the second quarter of 2019.

Net loss was $3.6 million, inclusive of other income of $1.3 million related to the revaluation of equity method investments and gains on elimination of notes outstanding, and interest and dividend income, compared with net income of $1.5 million for the second quarter of 2019. The second quarter of 2020 includes a gain on the revaluation of cash advances to Helomics of $1.2 million and a gain of $6.2 million on a revaluation of equity method investment. 


Management continues to focus its resources on the Helomics and TumorGenesis divisions and the Company’s primary mission of applying artificial intelligence to precision medicine, drug discovery and the mediums used to replace rats and mice in preliminary cancer studies. Management reaffirms that it is focusing the majority of its resources on maximizing opportunities within the Company’s precision medicine business.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Domestic, International and other), which contain four subsidiaries; Helomics, TumorGenesis, Skyline Medical and Skyline Europe. 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. Helomics’ CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy. In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor™, patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary bioinformatics platform to provide a tailored solution to its clients’ specific needs. Predictive Oncology’s TumorGenesis subsidiary is developing a new rapid approach to growing tumors in the laboratory, which essentially “fools” cancer cells into thinking they are still growing inside a patient. Its proprietary Oncology Discovery Technology Platform kits will assist researchers and clinicians to identify which cancer cells bind to specific biomarkers. Once the biomarkers are identified they can be used in TumorGenesis’ Oncology Capture Technology Platforms which isolate and help categorize an individual patient’s heterogeneous tumor samples to enable the development of patient specific treatment options. Helomics and TumorGenesis are focused on ovarian cancer. Predictive Oncology’s Skyline Medical division 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. The company has achieved sales in five of the seven continents through both direct sales and distributor partners. For more information, please visit www.Predictive-Oncology.com.

Forward-Looking Statements

Portions of the narrative set for this document that are not statements of historical or current facts are forward-looking statements, in particular, the commercial outlook provided above. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors.

These factors include, in addition to those mentioned elsewhere herein:

Investor Relations Contact:

Hayden IR
James Carbonara

-- Tables Follow –


 June 30, 2020 December 31, 2019
 (unaudited) (audited)
Current Assets:      
Cash and Cash Equivalents$3,394,078  $150,831 
Accounts Receivable 272,493   297,055 
Inventories 235,368   190,156 
Prepaid Expense and Other Assets 426,704   160,222 
Total Current Assets 4,328,643   798,264 
Fixed Assets, net 2,409,721   1,507,799 
Intangibles, net 3,539,597   3,649,412 
Lease Right-of-Use Assets 1,528,150   729,745 
Goodwill 15,690,290   15,690,290 
Total Assets$27,496,401   22,375,510 
Current Liabilities:      
Accounts Payable$2,449,046  $3,155,641 
Notes Payable – Net of Discounts of $282,099 and $350,426 4,412,377   4,795,800 
Accrued Expenses 2,649,160   2,371,633 
Derivative Liability 4,629,570   50,989 
Deferred Revenue 38,582   40,384 
Lease Liability 473,043   459,481 
Total Current Liabilities 14,651,778   10,873,928 
Lease Liability – Net of current portion 1,055,107   270,264 
Other long-term liabilities 98,358   - 
Total Liabilities 15,805,243   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, 13,190,787 and 4,056,652 outstanding 131,908   40,567 
Additional paid-in capital 102,163,864   93,653,667 
Accumulated Deficit (90,605,406)  (82,498,711)
Total Stockholders' Equity 11,691,158   11,231,318 
Total Liabilities and Stockholders' Equity$27,496,401  $   22,375,510 



 Three Months Ended      Six Months Ended
 June 30,   
 June 30, 
  2020   2019   2020   2019 
Revenue$182,784  $286,151  $477,727  $541,392 
Cost of goods sold 85,261   118,390   177,918   192,106 
Gross margin 97,523   167,761   299,809   349,286 
General and administrative expense 3,211,817   3,310,368   6,040,293   4,808,314 
Operations expense 521,116   1,271,258   1,069,869   1,737,824 
Sales and marketing expense 133,015   685,029   397,424   1,239,245 
Total operating loss (3,768,425)  (5,098,894)  (7,207,777)  (7,436,097)
Gain on revaluation of cash advances to Helomics          -   1,222,244                               -                  1,222,244 
Other income 52,965   (3,223)  52,968   50,209 
Other expense (729,837)  (607,343)  (1,846,912)  (1,157,711)
Gain (loss) on derivative instruments (422,081)  (211,940)  (394,974)  (231,348)
Gain on notes receivables associated with asset purchase                1,290,000                                -                  1,290,000                                - 
Loss on equity method investment -   -   -   439,637 
Gain on revaluation of equity method in investment                                -   6,164,260                                 -                  6,164,260 
Net income (loss)$(3,577,378) $1,465,104  $(8,106,695) $(1,828,080)
Deemed dividend on Series E Convertible Preferred Stock                                -      20,398                                  -                       20,398 
Net income (loss) attributable to common shareholders per common shares-basic and diluted$(3,577,378) $            1,444,706  $        (8,106,695) $          (1,848,478)
Gain (loss) per common share basic$  (0.36) $  0.49  $  (1.10) $ (0.81)
Gain (loss) per common share diluted   (0.36)    0.24     (1.10)    (0.81)
Weighted average shared used in computation - basic 9,838,152       2,960,937                              7,362,240               2,274,754 
Weighted average shared used in computation - diluted 9,838,152    6,007,078   7,362,240   2,274,754