As filed with the Securities and Exchange Commission on December 8, 2017Registration No. 333-                

Registration No. 333-___________

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549As filed with the Securities and Exchange Commission on April 6, 2020

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-3

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

________________________________

 

Skyline MedicalPredictive Oncology Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

33-1007393
(State or jurisdiction

(I.R.S. Employer
of incorporation or organization)

33-1007393

(IRS Employer

Identification No.)

2915 Commers Drive, Suite 900
Eagan, Minnesota 55121

(651) 389-4800

(Address, including zip code, and telephone number, including
area code, of registrant’s principal executive offices)

 

2915 Commers Drive, Suite 900

Eagan, Minnesota 55121

(651) 389-4800

(Address and telephone number of registrant’s principal executive offices and principal place of business)

Bob Myers

Chief Financial Officer

Predictive Oncology Inc.

2915 Commers Drive, Suite 900

Eagan, Minnesota 55121

(651) 389-4800

(Name, address including zip code, and telephone number
including area code, of agent for
service)

Copies

Copy to:

Martin R. Rosenbaum, Esq.

Maslon LLP

3300 Wells Fargo Center

90 South 7th Street Suite 3300

Minneapolis, Minnesota 55402

Telephone: (612) 672-8200

Facsimile: (612) 642-8326672-8397

Approximate date of commencement of proposed sale to the public:From time to time on or after the effective date of this Registration Statement.

 

If the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.¨

 

If any of the securities being registered on this formForm are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box:þ

 

If this formForm is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.o

 

If this formForm is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.¨

 

If this formForm is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commissionfiled pursuant to Rule 462(e)462(d) under the Securities Act, check the following box.¨box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

If this formForm is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitionthe definitions of  “large accelerated filer,” “accelerated filer,” “smaller reporting company,”company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer¨Accelerated filer¨
Non-accelerated filer ☒Smaller reporting company ☒

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 7(a)(2)(B) of Securities Act. ☐

CALCULATION OF REGISTRATION FEE

Title of Each Class of
Securities to be Registered
Amount to be
Registered(1)
Proposed Maximum
Offering Price Per
Security (1)(2)
Proposed
Maximum Aggregate
Offering Price
Amount of
Registration Fee
(2)
Common stock, $0.01 par
value per share

5,889,561

$1.4375

$8,466,243.94

$1,098.92

(1)Pursuant to Rule 416 under the Securities Act of 1933, as amended, this registration statement shall be deemed to cover additional securities of the same class as the securities covered by this registration statement issued or issuable prior to completion of the distribution of the securities covered by this registration statement as a result of a split of, or a stock dividend on, the registered securities.
  
Non-accelerated filer¨Smaller reporting companyþ
(Do not check if a smaller reporting company)
Emerging growth company¨

CALCULATION OF REGISTRATION FEE

Title of each class of

securities to be registered

Amount to be
registered(1)

Proposed maximum

offering price

per share(2)

Proposed maximum

aggregate

offering price(2)

Amount of

registration fee

Common stock, par value $0.01 per share1,857,179$1.235$2,293,616$285.56

(1)There is also being registered hereunder an indeterminate number of additional shares of common stock as shall be issuable pursuant to Rule 416 to prevent dilution resulting from stock splits, stock dividends or similar transactions.

(2)Estimated solely for the purpose of calculatingcomputing the registration fee in accordance withfee. Pursuant to Rule 457 of457(c) under the Securities Act based upon a $1.235of 1933, as amended, the proposed maximum offering price per share is based on the average of the high and low sale prices of the registrant’s common stock on the Nasdaq Capital Market on December 7, 2017.April 1, 2020.

 

 

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 

 

 

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The information in this prospectus is not complete and may be changed. The selling stockholderWe may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any statejurisdiction where the offer solicitation or sale is not permitted.

 

Subject to completion, dated December __, 2017PRELIMINARY PROSPECTUS, SUBJECT TO COMPLETION - DATED APRIL 6, 2020

 

PROSPECTUS

 

SKYLINE MEDICALPREDICTIVE ONCOLOGY INC.

 

1,857,1795,889,561 Shares of

Common Stock

 

This prospectus relates to the proposedoffer and resale or other disposition from time to time of up to 1,857,1795,889,561 shares of Skyline Medical Inc.our common stock, $0.01 par value $0.01 per share, by the selling stockholder identifiedstockholders as listed in this prospectus. Of these shares, up to 1,250,269 are shares of common stock that may be issued upon conversion of our Series C Convertible Preferred Stock held by the selling stockholder and 606,910 are shares issuable uponstockholders table on page 15 (the “Selling Stockholders”).  

For more information about the exerciseSelling Stockholders, please see the section of warrants held by the selling stockholder. We are not sellingthis prospectus entitled “Selling Stockholders” beginning on page 14.

The Selling Stockholders may sell any shares of common stockoffered under this prospectus and will not receive any of the proceeds from the sale or other disposition of common stock by the selling stockholder.

The selling stockholder or its pledgees, assignees or successors-in-interest may offer and sell or otherwise dispose of the shares of common stock described in this prospectus from time to time through public or private transactions at fixed prices, prevailing market prices at prices related to prevailing marketthe time of sale, at varying prices or at privately negotiated prices. The selling stockholder will bear all commissions and discounts, if any, attributable

One or more of the Selling Stockholders may be deemed to be “underwriters” within the salesmeaning of shares. We will bear all other costs, expenses and feesthe Securities Act of 1933, as amended (the “Securities Act”), in connection with the registrationresale of our common stock, and any broker-dealers or agents that are involved in such resales may be deemed to be “underwriters” within the meaning of the shares. SeeSecurities Act in connection therewith. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. For more information, please see the section of this prospectus titled “Plan of Distribution” beginning on page 8 for more information about how17.

We will not receive any proceeds from the selling stockholder may sell or disposeresale of their shares of common stock.stock by the Selling Stockholders. We will, however, receive the proceeds of any cash exercises of warrants.

 

Our common stock is listed on the Nasdaq Capital Market under the symbol “SKLN.“POAI.” On December 7, 2017,April 1, 2020, the last reported per share price of our common stock on the Nasdaq Capital Market was $1.24$1.40 per share.

 

Investing in our common stock involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks that we have described beginning on page 610 of this prospectus under the caption "Risk Factors"“Risk Factors” and in the documents incorporated by reference into this prospectus.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

The date of this prospectus is , 2017.____________, 20__. 

 

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Table of Contents

 

 Page
About this Prospectus1
About This Prospectus Summaryi3
Prospectus SummaryRisk Factors110
Risk Factors6
Cautionary Note Regarding Forward-LookingForward Looking Statements611
Use of Proceeds612
Selling StockholderDescription of Capital Stock712
Selling Stockholder14
Plan of Distribution816
Legal Matters1016
Experts1017
Where You Can Find More Information1017
Incorporation of Certain InformationDocuments by Reference10
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ABOUT THIS PROSPECTUS

 

This prospectus is part of a registration statement that we have filed with the Securities and Exchange Commission (the “SEC”) pursuant to which the selling stockholderSelling Stockholders named herein may, from time to time, offer and sell or otherwise dispose of the securities covered by this prospectus. You should not assume that the information contained in this prospectus is accurate on any date subsequent to the date set forth on the front cover of this prospectus or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or securities are sold or otherwise disposed of on a later date. It is important for you to read and consider all information contained in this prospectus, including the Information Incorporated by Reference herein, in making your investment decision. You should also read and consider the information in the documents to which we have referred you under the captions “Where You Can Find More Information” and “Incorporation of Information by Reference” in this prospectus.

 

Neither we nor the selling stockholder hasSelling Stockholders have authorized any dealer, salesman or other person to give any information or to make any representation other than those contained or incorporated by reference in this prospectus. You should not rely upon any information or representation not contained or incorporated by reference in this prospectus. This prospectus does not constitute an offer to sell or the solicitation of an offer to buy any of our securities other than the securities covered hereby, nor does this prospectus constitute an offer to sell or the solicitation of an offer to buy any securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about, and to observe, any restrictions as to the offering and the distribution of this prospectus applicable to those jurisdictions.

 

We further note that the representations, warranties and covenants made in any agreement that is filed as an exhibit to any document that is incorporated by reference in the prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

 

Unless the context otherwise requires, references in this prospectus to “Skyline,“Predictive,” the “Company,” “we,” “us,” and “our” refer to Skyline MedicalPredictive Oncology Inc.

 

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You should rely only on the information contained or incorporated by reference, as applicable, in this prospectus, any prospectus supplement, or other offering materials related to an offering of securities described in this prospectus. We have not authorized anyone to provide you with different or additional information. If anyone provides you with different or additional information, you should not rely on it.

You should not assume that the information contained or incorporated by reference, as applicable, in this prospectus, any prospectus supplement, or other offering materials related to an offering of securities described in this prospectus is accurate as of any date other than the date of that document. Neither the delivery of this prospectus, any prospectus supplement or other offering materials related to an offering of securities described in this prospectus, nor any distribution of securities pursuant to this prospectus, any such prospectus supplement, or other offering materials shall, under any circumstances, create any implication that there has been no change in the information set forth or incorporated by reference, as applicable, in this prospectus, any such prospectus supplement or other offering materials since the date of each such document. Our business, financial condition, results of operations and prospects may have changed since those dates.

This prospectus does not constitute, and any prospectus supplement or other offering materials related to an offering of securities described in this prospectus will not constitute, an offer to sell, or a solicitation of an offer to purchase, the offered securities in any jurisdiction to or from any person to whom or from whom it is unlawful to make such offer or solicitation in such jurisdiction.

 

 

 

Prospectus SUMMARY

 

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PROSPECTUS SUMMARY

The following is a summary of what we believe to be the most important aspects of our business and the offering of our securities under this prospectus. We urge you to read this entire prospectus, including the more detailed financial statements, notes to the financial statements and other information incorporated by reference from our other filings with the SEC. Each of the risk factors could adversely affect our business, operating results and financial condition, as well as adversely affect the value of an investment in our securities.

The Company

We operate in two primary business areas: first, application of artificial intelligence (“AI”) in our precision medicine business, to provide AI-driven predictive models of tumor drug response to improve clinical outcomes for patients and to assist pharmaceutical, diagnostic, and biotech industries in the development of new personalized drugs and diagnostics; and second, production of the United States Food and Drug Administration (“FDA”)-cleared STREAMWAY® System for automated, direct-to-drain medical fluid disposal and associated products.

We have three operating segments: domestic, international, and Helomics. Domestic and international consist of the STREAMWAY System product sales. The Helomics segment consists of clinical testing and contract research. Our TumorGenesis subsidiary is included within corporate. Going forward, we have determined that we will focus our resources on the Helomics segment and our primary mission of applying AI to precision medicine and drug discovery.

Precision Medicine Business

 

Our Companyprecision medicine business, conducted in our Helomics division, is committed to improving the effectiveness of cancer therapy using our proprietary, multi-omic tumor profiling platform, one-of-a-kind database of historical tumor data, and the power of AI to build predictive models of tumor drug response.

Helomics’ mission is to improve clinical outcomes for patients by partnering with pharmaceutical, diagnostic, and academic organizations to bring innovative clinical products and technologies to the marketplace. In addition to our proprietary patient-derived (“PDx”) tumor profiling platform for oncology, Helomics offers: 1) data and AI driven contract research organization (“CRO”) services for clinical and translational research that leverage PDx tumor models, 2) a wide range of multi-omics assays (genomics, proteomics, and biochemical), and 3) AI driven predictive models to drive the discovery of targeted therapies.

Contract Research Organization (CRO) and AI-Driven Business

We believe leveraging our unique, historical database of the drug responses of over 149,000 patient tumors to build AI and data-driven multi-omic predictive models of tumor drug response and outcome will provide actionable insights critical to both new drug development and individualizing patient treatment. Our large historical database of tumors and related data, plus our ability to obtain the associated patient outcome data is a significant competitive advantage. Cancer treatments require at least 5 years of testing to provide sufficient information on progression-free survival rates. While competitors must wait for this data, we can leverage it today. These AI-driven predictive models, coupled with the PDx platform will create a unique service to drive revenue generating projects with pharma, diagnostic and biotech companies in areas such as biomarker discovery, drug screening, drug repurposing, and clinical trials. The AI-driven models will, once validated, also provide clinical decision support to help oncologists individualize treatment.

Our CRO/AI business is committed to improving the process of targeted therapy discovery. Our proprietary, TruTumor multi-omic PDx profiling and AI platform coupled to our vast multi-omic database of biochemical and clinical information on patients with cancer, uses deep learning to understand the association between the mutational profile of a patient’s tumor and the drug response profile of the tumor that is grown in the lab. This approach is used to build an AI-driven predictive model that offers actionable insights of which mutations in the tumor are associated with drugs to which the tumor is sensitive and which will lead to the optimal outcome for the patient.

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Our CRO services business applies these AI-driven predictive models coupled with our unique proprietary TruTumor PDx model to address a range of needs from discovery through clinical and translational research, to clinical trials and diagnostic development and validation as noted below:

Research

Biomarker discovery

Drug discovery

Drug-repurposing

Development

Patient enrichment & selection for trials

Clinical trial optimization

Adaptive trials

Clinical Decision Support

Patient stratification

Treatment selection

We believe this market segment has significant growth potential and we believe we are differentiated from traditional CRO’s and other precision medicine and AI companies through these unique assets:

•       clinically validated PDx platform;

•       database of over 149,000 tumor cases;

•       experienced AI team and AI platform;

•       ability to access outcome data going back over ten years for over 120,000 of the tumor cases in our database.

Industry and Market Background and Analysis – Precision Medicine Business

Precision medicine is an emerging approach for disease treatment and prevention that considers individual variability in genes, disease, environment, and lifestyle for each case to develop effective therapies. This approach allows doctors and researchers to predict more accurately which treatment, dose, and therapeutic regimen could provide the best possible outcome. The global precision medicine market is estimated to reach $141.7 billion by 2026, up from $43.6 billion in 2016. This growth is supported by the industry’s investment in precision medicine, with leading biopharmaceutical companies doubling their investments in the technology over the last five years, with the potential to increase by an additional 33% over the next five years (Source: BIS Research’s Global Precision Medicine Market to Reach $141.70 Billion by 2026, December 2017).

Precision medicine, precisely targeting drugs based on the genomic profile of the patient, has become the aspiration for cancer therapy. Over the past several decades, researchers have identified molecular patterns that are useful in defining the prognosis of a given cancer, determining the appropriate treatments, and designing targeted treatments to address specific molecular alterations. The objective of precision oncology is to develop treatments tailored to the genetic changes in each person’s cancer, intended to improve the effectiveness of the therapeutic regimen and minimize the treatment’s effects on healthy cells. However, for a majority of patients the reality is that while many mutations in the patient’s tumor can be identified most are not actionable with current protocols. As a result, the impact of targeted therapies is low, and uptake in clinical practice is inconsistent.

There is now a growing realization that genomics alone will not be enough to achieve the promise of personalized therapeutics, especially for cancer. A multi-omic approach (e.g. assessing the genome, transcriptome, epigenome, proteome, responseome, and microbiome) provides researchers and clinicians the comprehensive information necessary for new drug development and individualized therapy. Comparatively, the multi-omic approach provides a three-dimensional, 360-degree view of the cancer, while genomics alone is just a flat, one-dimensional view. However, multi-omic data is difficult to access quickly as it is both costly and time consuming to initiate prospective data collection, and few comprehensive, multi-omic datasets exist, especially specific to cancer.

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Clinical Testing

Via our Helomics subsidiary, we offer a group of clinically relevant, cancer-related tumor profiling and biomarker tests for gynecological cancers that determine how likely the patient is to respond to various types of chemotherapy and which therapies might be indicated by relevant tumor biomarkers.

Clinical testing is comprised of ChemoFx and BioSpeciFx tests. The ChemoFx test determines how a patient’s tumor specimen responds to a panel of various chemotherapy drugs, while the BioSpeciFx test evaluates the expression of a specific genes, or biomarkers, in the patient’s tumor. Our proprietary TruTumor™ PDx tumor platform provides us with the ability to work with actual live tumor cells to study the unique biology of the patient’s tumor in order to understand how the patient responds to treatment.

Testing involves obtaining tumor tissue during biopsy or surgery which is then sent to our Clinical Laboratory Improvement Amendments (“CLIA”) certified laboratory using a special collection kit. Two samples of the tumor tissue are obtained, fixed and live. The fixed tumor tissue is tested for a panel of biomarkers using a combination of Immunohistochemistry and Quantitative Polymerase Chain Reactions. The live tumor tissue is grown in the lab and used to test the drug response of the tumor to a panel of standard-of-care drugs. When testing is complete a report is provided back to the clinician with recommended therapies based on the drug response and biomarker profiles. Helomics integrates the drug response with other genomic and molecular data and compares it with historical data in our database to generate a roadmap that provides additional context to help the oncologist personalize patient treatment.

Business Strategy for Precision Medicine Business

We are a data and AI-driven discovery services company that provides AI-driven predictive models of tumor drug response to improve clinical outcomes for patients by leveraging our two primary unique assets:

A clinically validated PDx tumor profiling platform, TruTumor, that can generate drug response profiles and other multi-omic data. Over $200 million has been invested in this platform and was clinically validated in ovarian cancer.

Data on the drug response profiles of over 149,000 tumors across 137 cancer types tested using the PDx platform in over 10+ years of clinical testing. We call this database TumorSpace™.

Over 38,000 of the more than 149,000 clinically validated cases in our TumortSpace™ database are specific to ovarian cancer. The data in TumorSpace is highly differentiated, having both drug response data, biomarkers and access to historical outcome data from those patient samples. We intend to generate additional data (genomics and transcriptomics) from these tumor samples to deliver a multi-omic approach to the pharmaceutical industry.

Through our Helomics subsidiary, we will utilize both this historical data and the PDx platform to build AI-driven predictive models of tumor drug response and outcome through our CancerQuest 2020 (“CCQ2020”) initiative. Once validated, we will commercialize these AI-driven predictive models in revenue generating service projects with pharmaceutical, biotech, and diagnostic companies.

A key part of our commercialization strategy for the CCQ2020 initiative is the understanding that our AI-driven models of tumor drug response serves a key unmet need of pharmaceutical, diagnostic, and biotech industries for actionable multi-omic insights on cancer. In collaboration with these companies, using the predictive models, we will accelerate the search for more individualized and effective cancer treatments, through revenue generating projects in biomarker discovery, drug screening, drug repurposing, and clinical trials.

Our commercial strategy has identified a portfolio of revenue generating project types that leverage the predictive models, our AI expertise, PDx tumor profiling, and CLIA laboratory to provide custom solutions utilizing our full array of assets and expertise.

The CCQ2020 initiative will focus initially on ovarian cancer, which is where we have the most expertise, samples, data, and access to outcomes. However, we intend to expand the initiative to include cancers of the lung, breast, colon, and prostate, and will actively seek partners to assist in that effort.

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Within the clinical sector, we will utilize these predictive models (once validated) for new clinical decision support tools for individualizing therapy for patients with cancer. These clinical decision support tools are a longer revenue horizon than the research projects with pharmaceutical companies but, importantly, will provide a steady stream of additional data generation to refine the predictive models for both clinical and research applications.

 

Skyline Medical produces a fully automated, patented, FDA-cleared waste fluid disposal system that– The STREAMWAY System

Sold through our subsidiary, Skyline Medical, Inc (“Skyline Medical”), the STREAMWAY System virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods that require hand carrying and emptying filled fluid canisters present both an exposure risk and potential liability. Skyline Medical'sMedical’s STREAMWAY System fully automates the collection, measurement, and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers; 2) improve compliance with OSHAthe Occupational Safety and Health Administration (“OSHA”) and other regulatory agency safety guidelines; 3) improve efficiency in the operating room and radiology and endoscopy departments, thereby leading to greater profitability; and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills each year in the U.S.  SinceUnited States.

In December 2019, we announced that we had received indications of interest from several parties for the possible acquisition of our inceptionSkyline Medical division, and we reaffirmed that we are focusing our resources on our precision medicine business. We continue to operate the Skyline Medical business with a focus on maximizing our strategic opportunities with respect to this division.

Industry and Market Background and Analysis - Infectious and Bio-hazardous Waste Management

There has long been recognition of the collective potential for ill effects to healthcare workers from exposure to infectious/bio-hazardous materials. Federal and state regulatory agencies have issued mandatory guidelines for the control of such materials, and in 2002, we have invested significant resources into product development.  We believeparticular, bloodborne pathogens. OSHA’s Bloodborne Pathogens Standard (29 CFR 1910.1030) requires employers to adopt engineering and work practice controls that our success depends upon convertingwould eliminate or minimize employee exposure from hazards associated with bloodborne pathogens. In 2001, in response to the traditional processNeedlestick Safety and Prevention Act, OSHA revised the Bloodborne Pathogens Standard. The revised standard clarifies and emphasizes the need for employers to select safer needle devices and to involve employees in identifying and choosing these devices. The revised standard also calls for the use of “automated controls” as it pertains to the minimization of healthcare exposure to bloodborne pathogens.

Most surgical procedures produce potentially infectious materials that must be disposed with the lowest possible risk of cross-contamination to healthcare workers. Current standards of care allow for these fluids to be retained in canisters and located in the operating room where they can be monitored throughout the surgical procedure. Once the procedure is complete these canisters and their contents are disposed using a variety of methods, all of which include manual handling and result in a heightened risk to healthcare workers for exposure to their contents. Canisters are the most prevalent means of collecting and disposing of infectious fluids in hospitals today. Traditional, non-powered canisters and related suction and fluid disposable products are exempt and do not require FDA clearance.

We believe that our virtually hands free direct-to-drain technology (1) significantly reduces the risk of healthcare worker exposure to these infectious fluids by replacing canisters, (2) further reduces the risk of worker exposure when compared to powered canister technology that requires transport to and from the operating roomsroom, (3) reduces the cost per procedure for handling these fluids, and (4) enhances the surgical team’s ability to collect data to accurately assess the patient’s status during and after procedures. In addition to the traditional canister method of waste fluid disposal, several other powered medical facilitiesdevices have been developed that address some of the deficiencies described above. Most of these competing products continue to utilize some variation on the existing canister technology, and while not directly addressing the canister, most have been successful in eliminating the need for an expensive gel and its associated handling and disposal costs. Our existing competitors with products already on the market have a clear competitive advantage over us in terms of brand recognition and market exposure. In addition, many of our wall-mounted Fluid Management System (“SYSTEM”)competitors have extensive marketing and development budgets that could overpower an emerging growth company like ours.

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We expect the hospital surgery market to continue to increase due to population growth, the aging of the population, and expansion of surgical procedures to new areas (for example, use of ourthe endoscope) which requires more fluid management and new medical technology.

STREAMWAY System Product Sales

Our domestic and international segments consist primarily of sales of the STREAMWAY System, as well as sales of the proprietary cleaning fluid and bifurcated filter.filters for use with the STREAMWAY System. We manufacture an environmentally conscious system for the collection and disposal of infectious fluids resulting from surgical and other medical procedures. We have been granted patents for the STREAMWAY System in the United States, Canada, and Europe. We distribute our products to medical facilities where bodily and irrigation fluids produced during medical procedures must be contained, measured, documented, and disposed. Our products minimize the exposure potential to the healthcare workers who handle such fluids. In addition to simplifying the handling of these fluids, our goal is to create products that dramatically reduce staff exposure without significant changes to established operative procedures, historically a major industry stumbling block to innovation and product introduction.

 

Products.The STREAMWAY SYSTEM suctionsSystem is a wall-mounted fully automated system that disposes of an unlimited amount of suction fluid providing uninterrupted performance for physicians while virtually eliminating healthcare workers’ exposure to potentially infectious fluids collected during surgical waste fluid from theand other patient using standard surgical tubing. The waste fluid passes through our proprietary disposable filters and into our device.procedures. The STREAMWAY SYSTEM maintains continuous suction to the procedural field at all times. A simple, easy to use Human Interface Display screen guides the user through the simple set up process, ensuring that a safe vacuum level is identified and set by the user for each procedure and additionally guides them through the cleaning process.

In contrast to competitive products, the wall-mounted SYSTEM does not take up any operating room floor space and it does not require the use of any external canisters or handling by operating room personnel. It does require a dedicated system in each operating room where it is to be used. The SYSTEM is the only known direct-to-drain system that is wall-mounted and designed to collect, measure and dispose of, surgical waste. Other systems on the market are portable, meaning that they are rolled to the bedside for the surgical case and then rolled to a cleaning area, after the surgery is complete, and use canisters, which still require processing or require a secondary device (such as a docking station)System also provides an innovative way to dispose of ascites and pleural fluid with no evac bottles, suction canisters, transport, or risk of exposure. We also manufacture and sell two disposable products required for the fluid inoperation of the sanitary sewerSTREAMWAY System: a bifurcated dual port procedure filter with tissue trap and a single use bottle of cleaning solution. Both items are utilized on a single procedure basis and must be discarded after it has been collected. They are essentially powered canisters.

use. The SYSTEM may be installed on or in the wall during new construction or renovation or installed in a current operating room by connecting the device to the hospital’s existing sanitary sewer drain and wall suction systems. With new construction or renovation, the system will be placed in the wall and the incremental costs are minimal, limited to connectors to the hospital drain and suction systems (which systems are already required in an operating room), the construction of a frame to hold the SYSTEM in position, and minimal labor.

The SkylineSTREAMWAY disposables are a critical component of our business model. The disposables consist of a proprietary, pre-measured amount of cleaning solution in a plastic bottle that attaches to the SYSTEM. The disposables also include a 2-port bifurcated single use in-line filter. The proprietary cleaning solution, placed in the specially designed holder, is attached and recommended to be used following each surgical procedure. Due to the nature of the fluids and particles removed during surgical procedures, the SYSTEM is recommended to be cleaned following each use. The disposables have the “razor blade business model” characteristic with an ongoing stream of revenue for every SYSTEM unit installed, andRecurring revenues from the sale of the disposables are expected to be significantly higher over time than the revenues from the initial sale of the unit. Our disposable, bifurcated filter is designed specifically for use only on our SYSTEM. The filter is used only once per procedure followed by immediate disposal. Our operation instructions and warranty require that a Skyline filter is used for every procedure. We have exclusive distribution rights to the disposable fluid and facilitate the use of only our fluid for cleaning following procedures by incorporating a special container to connect the fluid to the connector on the SYSTEM. We will also tie the fluid usage, which we will keep track of with the SYSTEM software, to the product warranty.

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Marketing and Sales Distribution.We currently have a Vice President of Sales, one in house sales person and five regional sales managers to sell the STREAMWAY SYSTEM. We have signed two independent contractors, and will continue to sign more, to further represent the Company across the country and in Canada in the fourth quarter and fiscal 2018. We have been issued our Medical Device Establishment License permitting the Company to sell the STREAMWAY SYSTEM and disposables across the 13 provinces of Canada. In March 2017, the Company completed its first sale of a STREAMWAY SYSTEM to a customer in Ontario. In June 2017, we received notice that our STREAMWAY SYSTEM has met all requirements and can now be affixed with the CE mark and marketed in 32 European countries. We have signed a contract with a special consultant to hire distributors throughout Europe and Canada to sell the STREAMWAY SYSTEM. During the fourth quarter, we have executed contracts with three international distributors. Quadromed, is a Canadian distributor who will represent us throughout the entire Canadian country over the next two years, with annual automatic renewals. MediBridge Sarl, is a Swiss distributor representing us in Switzerland entirely over the next two years, with annual automatic renewals. Device Technologies Australia PTY LTD, is an Australian distributor representing us throughout Australia, New Zealand, Fiji and the Pacific Islands over the next five years with annual automatic renewals.solution.

 

We have also reached a short-term exclusive agreement with Alliant Healthcare, a major provider ofsell our medical device products directly to the federal government. Alliant Healthcare is a CVE verified SDVOSB (Service-Disabled Veteran-Owned Small Business). The agreement is for ninety days (July 1 – September 30, 2017), with an optional ninety-day renewal term (October 1 – December 31, 2017, the government’s first fiscal quarter) upon agreement of both parties. We have signed a three-year contract with Alliant effective November 1, 2017 ending October 31, 2020, with annual automatic renewals thereafter.

Corporate Strategy. Our strategy is focused on expansion within our core producthospitals and market segments, while utilizing a progressive approach to manufacturing and marketing to ensure maximum flexibility and profitability.

Our strategy is to:

·         Develop a complete line of wall-mounted fluid evacuation systems for use in hospital operating rooms, radiological rooms and free standing surgery centers as well as clinics and physicians’ offices.

·         Provide products that greatly reduce healthcare worker and patient exposure to harmful materials present in infectious fluids and that contribute to an adverse working environment.

·         Provide a hybridother medical facilities using employed sales force utilizing direct salespersons, manufacturing representatives, independent contractors and distributors.

 

·         ContinueOur subsidiary, TumorGenesis, is pursuing a new rapid approach to utilize operating room consultants, builders and architects as referrals to hospitals and day surgery centers.

Our strategies may also include:

·         Partnering with leading GOP’s (Group Purchasing Organizations) to gain access to the majority of hospital systemsgrowing tumors in the United States.

·         Employing a lean operating structure, while utilizinglaboratory, which essentially “fools” the latest trends and technologies in manufacturing and marketing, to achieve both market share growth and projected profitability.

·         Providing a leasing program and/or “pay per use” program as alternatives to purchasing.

·         Providing service contracts to establish an additional revenue stream.

·         Utilizingcancer cells into thinking they are still growing inside the manufacturing experience of our management team to develop sources of supply and manufacturing to reduce costs while still obtaining excellent quality. While cost is not a major consideration in the roll-out of leading edge products, we believe that being a low-cost provider will be important long term.

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·         Offering an innovative warranty program that is contingent on the exclusive use of our disposables to enhance the success of our after-market disposable products.

Strategic Relationships and Transactions. The Company is seeking to broaden its business and from time to time considers acquisitions of companies and strategic partnerships and investments.

On August 9, 2017, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Skyline Cyto Acquisition, Inc. and CytoBioscience, Inc. (“CytoBioscience”). CytoBioscience creates and manufactures devices used in human cell research focused on new therapeutic drug development and has a well-known scientific and technical staff, collaborative partnerships with leading pharmaceutical companies and strategic alliances with key groups and academic institutions. The Merger Agreement contemplated a reverse triangular merger with CytoBioscience becoming a wholly owned operating subsidiary of the Company (the “Merger”). In November 2017, the Company and CytoBioscience announced that they terminated the Merger Agreement to focus on structuring a proposed joint venture to market CytoBioscience’s personalized research services 

In November 2017, the Companypatient. We have also announced a proposed joint venture with Helomics Corporation, a precision diagnostic company and integrated clinical contract research organization, to use the Helomics D-CHIP™ platform to develop new approaches for personalized cancer diagnosis and care. This partnership between the two companies is expected to provide Skyline with opportunities to generate revenues from additional markets. Skyline Medical will own 51% of the joint venture, with Helomics owning the remaining 49%.

In November 2017, the Company, Helomics Corporation and GLG Pharma a company developing precision medicines that target the Signal Transducer and Activator of Transcription factor 3 (“p-STAT3 and STAT3”) pathway, jointly announced a strategic partnership among these three companies, focused on using their combined technologies to bring personalized medicines and testing to ovarian and breast cancer patients, especially those who present with ascites fluid (over one-third of patients). The partnership brings GLG’s new Cell Capture, Culture and Screening system to help isolate samples of ascites fluids from patients that may contain cancer stem cells, cancer cells and other cells together with the Skyline-Helomics. The partnership will build on Skyline’s STREAMWAY System to add a collection system for ascites fluids based on GLG’s Capture, Culture and Screening system, that pathologists can then process and send to Helomics for further evaluation in using Helomics’ ChemoFx® diagnostic platform. Together with a combination of STAT3 inhibitors from GLG, the partnership is expected to create new revenue streams to be shared between the Skyline-Helomics venture and GLG.

Financial Condition and Results of Operations.Since inception, we have been unprofitable. We incurred net losses of approximately $1.0 million and $4.9 million for the three and nine months ended September 30, 2017, and $1.1 million and $5.8 million for the three and nine months ended September 30, 2016, respectively. As of September 30, 2017, and September 30, 2016, we had an accumulated deficit of approximately $51.9 million and $47.0 million, respectively.

We received approval from the FDA in April 2009 to commence sales and marketing activities of the STREAMWAY SYSTEM and shipped the first system in 2009. However, there was no significant revenue prior to 2011, primarily due to lack of funds to build and ship the product. In the first quarter of 2014, the Company commenced sales of an updated version of the STREAMWAY SYSTEM, which provides several enhancements to the existing product line including a more intuitive and easier to navigate control screen, data storage capabilities, and additional inlet ports on the filters, among other improvements. This updated version utilizes improved technology, including the capability for continuous flow and continuous suctioning, as covered by our provisional patent application filed in 2013 and our non-provisional patent application filed in January 2014. We have sold one hundred three STREAMWAY units to date.

We expect the revenue for STREAMWAY SYSTEM units to increase significantly at such time as significantly more hospitals approve the use of the units for their applications and place orders for billable units. We also expect an increase in trial-based units. Trial basis units are either installed in or hung on the hospital room wall. The unit is connected to the hospital plumbing and sewer systems, as well as, the hospital vacuum system. The unit remains on the customer site for 2 – 4 weeks, as contracted, at no cost to the customer. However, the customer does purchase the disposable products (cleaning fluid and filters) necessary to effectively operate the units. Once the trial period has expired, the unit is either returned to the Company or purchased by the customer. If purchased, at that time, the Company invoices the customer based upon a contracted price negotiated prior to the trial.

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Ability to Continue as a Going Concern

 

We have suffered recurring losses from operations, and we have a stockholders’ deficit.significant debt repayment obligations that are due within the current year. Although we have been able to fund our current working capital requirements, principally through debt and equity financing, there is no assurance that we will be able to do so in the future. As a result of our capital needs for operations and debt repayment, we need to raise significant capital, and there is no assurance that we will be successful in raising sufficient capital. These factors raise substantial doubt about our ability to continue as a going concern. As a result of the above factors, our independent registered public accounting firmmanagement has indicated in their audit opinion, contained in our financial statements included in this prospectus that they have serioussubstantial doubts about our ability to continue as a going concern.

 

Description of the Private PlacementCorporate Information

 

On November 28, 2017, we entered into a securities purchase agreement (the “Securities Purchase Agreement”)We were originally incorporated on April 23, 2002 and related documentation with the selling stockholder, governing an offering by the Company of a newly created series of preferred stock designated as “Series C Convertible Preferred Stock” (the “Series C Stock”). The closing of the offering also occurredreincorporated in Delaware in 2013. We changed our name from Skyline Medical, Inc. to Precision Therapeutics, Inc. on November 28, 2017 (the “Closing Date”). PursuantFebruary 1, 2018 and to the Securities Purchase Agreement, the selling stockholder purchased 1,213,819 shares of Series C Stock (the “Series C Shares”) at a purchase price of $1.071 per Series C Share, together with a warrant (the “Warrant”) to purchase up to 606,910 shares of common stock. The Warrant has an exercise price of $1.26 per share, subject to adjustment, has a five and one-half year term and is exercisable commencing six months following the date of issuance. The Warrant contains “blocker” provisions restricting the holders’ ability to exercise if the issuance of shares upon exercise would result in the holder beneficially owning in excess of 4.99% or 9.99% of our common stock. Total gross proceeds to us from the offering were $1.3 million, before deducting offering expenses. The rights, preferences, powers, restrictions and limitations of the Series C Stock are set forth in in the Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (the “Certificate of Designation”), which has been incorporated by reference as an exhibit to the registration statement of which this prospectus is a part. See “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.”

Pursuant to the Securities Purchase Agreement, and subject to certain exceptions, we agreed that we will not issue any equity security or any equity-linked or related security for a period of 45 days from the date that the Registration Statement (as defined below) is declared effective, and we have agreed not to enter into Variable Rate transactions (as such term is defined in the Securities Purchase Agreement) for a period of 12 months from the date that the Registration Statement is declared effective. In addition, we granted the selling stockholder the right to participate in up to one-third of the aggregate offering amount of a future series D preferred stock or similar round of Company financing. Further, as long as the selling stockholder holds outstanding Series C Shares with a stated value of at least $250,000, we have agreed not to issue debt securities or any shares of preferred stock that are senior to or pari passu with the Series C Stock without the consent of the holders of a majority of the outstanding Series C Shares, except for issuances pursuant to acquisitions, joint ventures, license arrangements, leasing arrangements and other similar transactions.

In connection with the Offering and pursuant to a registration rights agreement (the “Registration Rights Agreement”), the Company has agreed to file a “resale” registration statement (the “Registration Statement”) covering all of the shares of common stock issuable upon conversion of the Series C Shares (the “Conversion Shares”) and upon exercise of the Warrant (the “Warrant Shares”) by the 15th calendar day after the Closing Date (the “Filing Deadline”) and cause the Registration Statement to be declared effective by the earlier of the 45th calendar day after the Closing Date and the 5th business day after we are notified by the SEC that the Registration Statement will not be reviewed or will not be subject to further review (the “Effectiveness Deadline”). The registration statement of which this prospectus is a part is that Registration Statement.

If (i) we fail to file the Registration StatementPredictive Oncology, Inc. on or before the Filing Deadline (a “Filing Failure”) or cause the Registration Statement to be declared effective on or before the Effectiveness Deadline (an “Effectiveness Failure”), (ii) we fail to maintain the effectiveness of the Registration Statement (a “Maintenance Failure”), or (iii) a Registration Statement covering the resale of the Conversion Shares and Warrant Shares is not effective and we fail to file current public information with the SEC that permits resales of such securities without restriction under Rule 144, then we be required to pay the holder of such securities an amount in cash or stock, for each month (or portion of a month) in which such delay shall occur, equal to one-and-one-half percent (1.5%) of the Investor’s total committed purchase price for Series C Shares pursuant to the Securities Purchase Agreement until the applicable failure has been cured or, if earlier, until the Conversion Shares and Warrant Shares are sold or are otherwise can be sold pursuant to Rule 144 without any restrictions. Notwithstanding the foregoing, we will not be required to make more than six (6) payments (each in an amount equal to one-and-one-half percent (1.5%) of the selling stockholder’s total committed purchase price for Series C Shares) as a result of a Filing Failure, an Effectiveness Failure or a Maintenance Failure.

June 13, 2019.

 

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The foregoing descriptions of each of the Securities Purchase Agreement, the Warrant and the Registration Rights Agreement are not complete and are qualified in their entirety by reference to the Securities Purchase Agreement, the Warrant and the Registration Rights Agreement, each of which has been incorporated by reference as an exhibit to the registration statement of which this prospectus is a part. See “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.”

Corporate Information

 

Our address is 2915 Commers Drive, Suite 900, Eagan, Minnesota 55121. Our telephone number is (651) 389-4800, and our website address is www.skylinemedical.com. Our website address is www.skylinemedical.com.www.predictive-oncology.com. The information contained on, or that can be accessed through, our website is not part of this prospectus.

Description of the Private Placements

Securities Purchase Agreement and Registration Rights Agreement

On March 15, 2020, Predictive Oncology Inc. (the “Company”) entered the Securities Purchase Agreement (the Purchase Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”) and Sabby Volatility Warrant Master Fund, Ltd. (“Sabby”). On March 19, 2020, the Company closed on the sale of its common stock and warrants to Armistice and Sabby. The Company sold and issued (i) 260,000 shares of common stock, at a sale price of $2.121 per share; (ii) prefunded warrants (the “Prefunded Warrants”) to acquire 1,390,166 shares of common stock, sold at $2.12 per share and exercisable at an exercise price of $0.001 per share; (iii) Series A warrants (the “Series A Warrants”) to acquire 1,650,166 shares of Common Stock at $1.88 per share, exercisable immediately and terminating five and one-half years after the date of issuance; and (iv) Series B warrants (the “Series B Warrants”) to acquire 1,650,166 shares of Common Stock at $1.88 per share, exercisable immediately and terminating two years after the date of issuance. The Prefunded Warrants, the Series A Warrants and the Series B Warrants are referred to collectively herein as the “Warrants”.

Net proceeds from the sale of the Offering Shares and Prefunded Warrants was approximately $3,185,000 after deducting the placement agent fees and estimated offering expenses payable by the Company. The Company agreed to use the net proceeds from the offering for general corporate purposes and not for (a) for the satisfaction of any portion of the Company’s debt (other than payment of trade payables in the ordinary course of the Company’s business and prior practices), (b) for the redemption of any Common Stock or Common Stock equivalents, (c) for the settlement of any outstanding litigation or (d) in violation of the Foreign Corrupt Practices Act of 1977, as amended, or Office of Foreign Assets Control of the U.S. Treasury Department regulations.

In connection with the offering, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which, among other things, the Company agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) one or more registration statements, to register for resale the Offering Shares sold in the offering and the shares of Common Stock underlying the Warrants.

The securities issued in the offering have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and until so registered the securities may not be offered or sold absent registration or availability of an applicable exemption from registration.

The Company agreed that from March 13, 2020 until 90 days after the initial registration statement required by the Registration Rights Agreement is declared effective by the SEC, neither the Company nor any of its subsidiaries will issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock equivalents. Notwithstanding the foregoing, if, at any time following 30 days after the effective date of such registration statement, the last closing sale price for the Common Stock on the Nasdaq Capital Market is at least $6.30 (subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the Common Stock that occur after the date of the Purchase Agreement) for three consecutive trading days, then these issuance restrictions shall have no further force and effect.

On March 15, 2020, the Company also entered into a letter agreement (the “Placement Agreement”) with H.C. Wainwright & Co, LLC (the “Placement Agent”), pursuant to which the Placement Agent agreed to serve as placement agent for the offering. The Company has agreed to pay the Placement Agent an aggregate fee equal to 7.5% of the aggregate gross proceeds received by the Company in the offering. The Company will also issue the Placement Agent warrants to purchase shares of Common Stock equal to 7.5% of the number of the shares issuable in the offering, pay the Placement Agent a management fee equal to 1% of the aggregate gross aggregate gross proceeds received by the Company in the offering, and reimburse the Placement Agent for $25,000 in non-accountable expenses and up to $40,000 in legal and other out-of-pocket expenses.

The Purchase Agreement and the Placement Agreement contain customary representations, warranties and covenants by the Company, customary conditions to closing, indemnification obligations of the Company and the Investors, including for liabilities under the Securities Act, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Purchase Agreement and the Placement Agreement were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

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Securities Purchase Agreement with Oasis Capital, LLC

On February 5, 2020 (the “Effective Date”), Predictive Oncology Inc. (the "Company") entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Oasis Capital, LLC (“Oasis”) pursuant to which the Company issued a convertible promissory note to Oasis (the “Note”) in the principal amount of up to $1,450,000 in exchange for a cash investment of $1,200,000. $240,000 of the Note’s principal represents an original issue discount (“OID”) and the remaining $10,000 represents a credit for the Oasis’ transaction expenses. Under a Security Agreement entered into by the Company and Oasis on the Effective Date (the “Security Agreement”), the Company granted to Oasis a security interest in the Company’s assets to secure repayment of the Note. The principal amount of the Note accrues interest at a rate of 8% per annum (with six months of interest guaranteed). Unless previously converted (as discussed below), the Note will mature and become due and payable on the six month anniversary of the Effective Date. The Company will incur a 20% repayment charge in connection with any repayment of principal under the Note. Subject to certain limitations, the outstanding principal amount of the Note and interest thereon are convertible at the election of Oasis into shares of the Company’s common stock at a conversion price equal to $2.589.

Advances under the Note will be made in three tranches. The principal amount of the first tranche, which was advanced on the Effective Date, was $490,000 (including a $400,000 cash advance, a pro rata ($80,000) OID and the $10,000 transaction expense credit). The second and third tranches, each with principal amounts of $480,000 (including a $400,000 cash advance and a pro rata ($80,000) OID), will be advanced 30 and 60 days after the Effective Date, respectively.

The Company issued to Oasis five-year warrants (“Warrants”) to purchase 94,631 shares of the Company’s common stock at the closing of the first tranche, and will issue Warrants to purchase 92,700 shares at the closing of each of the second and third tranches. The Warrants are exercisable beginning on the sixth month anniversary of the issuance date at an exercise price equal $2.992 per share. As additional consideration for the investment, the Company issued 46,875 shares of its common stock (the “Inducement Shares”) to the Investor at the closing of the first tranche. The Investor will have piggyback registration rights with respect to the Inducement Shares and the shares issuable upon conversion of the Note.

Third Amendment to and Extension of Promissory Note.

On March 19, 2020, Predictive Oncology Inc. (the “Company”) entered into a third amendment to the Amended and Restated Senior Secured Promissory Note dated September 28, 2018 and amended and restated as of February 7, 2019 issued to L2 Capital, LLC (as amended by that certain First Amendment dated September 27, 2019 and that certain Second Amendment dated December 12, 2019, the “L2 Note”). Under the third amendment, the maturity date of the L2 Note was extended from March 28, 2020 to June 28, 2020.

First Amendment to and Extension of Promissory Note.

On March 19, 2020, the Company entered into an amendment to the Senior Secured Promissory Note dated September 27, 2019 issued to Oasis Capital, LLC (the “Oasis Note”). Under the amendment, the maturity date of the Oasis Note was extended from March 27, 2020 to June 27, 2020. In exchange for such extension, the outstanding principal amount of the Oasis Note was increased by $300,000, such that, as of the effective date of the amendment, the outstanding principal amount owed under the Oasis Note was $980,833.33. Under the amendment, through March 26, 2020, the holder waived its rights under the Oasis Note to have the Oasis Note repaid from the proceeds of any financing consummated by the Company. In exchange for such waiver, the Company issued 30,000 shares of common stock (the “Waiver Shares”) to the holder.

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Risk Factors

 

Our business is subject to numerous risks. For a discussion of the risks you should consider before purchasing shares of our common stock, see “Risk Factors” on page 610 of this prospectus.

 

The Offering

 

This prospectus relates to the proposed resale or other disposition from time to time of up to 1,857,1795,889,561 shares of ourPredictive Oncology Inc. (“Predictive”) common stock, $0.01 par value per share, which includes 336,875 shares of common stock which up to 1,250,269 arehave been issued; 4,970,529 shares of common stock that may be issued upon exercise of warrants, and 582,157 shares of common stock that may be issued upon conversion of our Series C Convertible Preferred Stocka convertible promissory note held by the selling stockholder and 606,910 are shares issuable upon the exercise of warrants held by the selling stockholder, or its pledgees, assignees or successors-in-interest.Selling Stockholders identified in this prospectus. See “Selling Stockholder”Stockholders” and “Plan of Distribution.”

 

The selling stockholderSelling Stockholders may offer to sell the shares being offered in this prospectus at fixed prices, at prevailing market prices at the time of sale, at varying prices or at negotiated prices. Our common stock is listed on the Nasdaq Capital Market under the symbol “SKLN.“POAI.

 

We have agreed to register the offer and sale of the common stock to satisfy registration rights we have granted to the selling stockholder.Selling Stockholders. We will not receive any of the proceeds from the sale of shares of our common stock in this offering. The Selling Stockholders will receive all of the securities byproceeds from this offering. We will, however, receive the selling stockholder.proceeds of any cash exercises of the warrants.

 

 

RISK FACTORS

 

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RISK FACTORS

PleaseAn investment in our securities involves a number of risks. Before deciding to invest in our securities, you should carefully consider the risk factorsrisks described below and discussed under the section captioned “Risk Factors” contained in our periodic reports filed withAnnual Report on Form 10-K for the SEC,year ended December 31, 2019, which areis incorporated by reference in this prospectus. Before making an investment decision, you should carefully consider these risks as well as otherprospectus, the information we include or incorporate by reference in this prospectus. Additional risks and uncertainties not presently known to us or that we deem currently immaterial may also impair our business operations or adversely affect our results of operations or financial condition.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains, and the documents incorporated by reference herein, and in any prospectus supplement heretoor free writing prospectus that we have authorized for use in connection with an offering. If any of these risks actually occurs, our business, financial condition, results of operations or cash flow could be harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment. The risks described in the documents referenced above are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may contain,also affect our business.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements made in this prospectus are “forward-looking statements” that indicate certain risks and uncertainties related to the Company, many of which are beyond the Company’s control. The Company’s actual results could differ materially and adversely from those anticipated in such forward-looking statements within the meaningas a result of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),certain factors, including those set forth below and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).   These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Specificelsewhere in this report. Important factors that mightmay cause actual results to differ from our expectations or may affect the value of the common stock, include, but are not limited to those discussed in this prospectus under the caption “Risk Factors” above as well as the risk factors contained in our filings with the SEC that are incorporated by reference in this prospectus.projections include:

We may not be able to continue operating without additional financing;
Current negative operating cash flows;
The terms of any further financing, which may be highly dilutive and may include onerous terms;
Risks related to the 2019 merger with Helomics including; 1) significant goodwill could result in further impairment; 2) possible failure to realize anticipated benefits of the merger; 3) costs associated with the merger may be higher than expected; 4) the merger may result in the disruption of our existing businesses; and 5) distraction of management and diversion of resources;
Risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns;
Risks related to the transaction with Quantitative Medicine including: 1) completion of the transaction; 2) possible failure to realize anticipated benefits of the merger; 3) costs associated with the merger may be higher than expected; 4) the merger may result in the disruption of our existing businesses; and 5) distraction of management and diversion of resources;
Risk that we will be unable to complete the transaction with InventaBioTech;
Risk that we will be unable to protect our intellectual property or claims that we are infringing on others’ intellectual property;
The impact of competition;
Acquisition and maintenance of any necessary regulatory clearances applicable to applications of our technology;
Inability to attract or retain qualified senior management personnel, including sales and marketing personnel;
Risk that we never become profitable if our product is not accepted by potential customers;
Possible impact of government regulation and scrutiny;

 

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,”“may”, “will”, “should”, “could”, “would”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “projects”, “predicts”, “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

Further, any We discuss many of these risks in greater detail under the heading “Risk Factors” beginning on page 6 of this prospectus and in our SEC filings. Also, these forward-looking statement speaksstatements represent our estimates and assumptions only as of the date of the document containing the applicable statement.

You should read this prospectus, the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we have authorized for use in connection with this offering completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in the foregoing documents by these cautionary statements.

Information regarding market and industry statistics contained in this prospectus is included based on whichinformation available to the Company that it believes is made,accurate. It is generally based on academic and we undertakeother publications that are not produced for purposes of securities offerings or economic analysis. The Company has not reviewed or included data from all sources, and the Company cannot assure potential investors of the accuracy or completeness of the data included in this prospectus. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue and market acceptance of products and services. The Company has no obligation to update any forward-looking statement or statementsinformation to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially fromor changes in assumptions or other factors that could affect those contained in any forward-looking statements.

  

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USE OF PROCEEDS

 

We will not receive any of the proceeds from the sale of the shares of our common stock by the Selling Stockholders. However, we will receive proceeds from the exercise, if any, of the Warrants issued to the Selling Stockholders pursuant to the Securities Purchase Agreement. We will use these proceeds for general corporate and working capital purposes, or for other purposes that our board of directors, in its good faith, deems to be in the best interest of our Company. We have agreed to bear the expenses relating to the registration of the offer and resale by the Selling Stockholders of the shares being offered hereby.   

DESCRIPTION OF CAPITAL STOCK

The following description summarizes the material terms of our capital stock. This summary is, however, subject to the provisions of our certificate of incorporation and bylaws. For greater detail about our capital stock, please refer to our certificate of incorporation and bylaws.

General

Our authorized capital stock consists of 100,000,000 shares of Common Stock, and 50,000,000 shares of preferred stock, $0.01 par value per share (“Preferred Stock”). Out of the Preferred Stock, as of December 31, 2019, (i) 300,000 shares have been designated Series B Convertible Preferred Stock, of which 79,246 shares were outstanding, (ii) 3,500,000 shares have been designated Series D Convertible Preferred Stock, of which 3,500,000 shares were shares outstanding, and (iii) 350 shares have been designated Series E Convertible Preferred Stock, of which 258 shares were outstanding.

The outstanding shares of our Common Stock and Preferred Stock are fully paid and nonassessable.

The Series B Convertible Preferred Stock is convertible into Common Stock at the option of its holders on a 1:1 basis, subject to a 4.99% beneficial ownership blocker. The Series D Convertible Preferred Stock converts on a 1:10 basis on April 4, 2020, subject to a 4.99% beneficial ownership blocker. Each share of Series E Convertible Preferred Stock is convertible at the option of its holder into 0.056857% of the shares of Common Stock issued and outstanding immediately prior to giving effect to such conversion, subject to a 19.99% beneficial ownership blocker, and on June 13, 2020, the Company may at its option convert all outstanding shares of Series E Convertible Preferred Stock into shares of Common Stock.

Our Board of Directors is authorized, subject to any limitations prescribed by law, to provide for the issuance of the shares of Preferred Stock in series and, by filing a certificate pursuant to the applicable law of the State of Delaware, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and any qualifications, limitations or restrictions thereon. The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the outstanding shares of Common Stock without a vote of the holders of the Preferred Stock, or of any series thereof, unless a vote of any such holders is required pursuant to the certificate or certificates establishing the series of Preferred Stock.

Common Stock

As of March 30, 2020, we had 5,847,718 shares of common stock outstanding held by approximately 165 stockholders of record.

12

Voting Rights. The holders of our Common Stock are entitled to one vote for each outstanding share of Common Stock owned by that shareholder on every matter properly submitted to the shareholders for their vote. Shareholders are not entitled to vote cumulatively for the election of directors.

Dividend Rights. Subject to the dividend rights of the holders of any outstanding series of preferred stock, holders of our Common Stock are entitled to receive ratably such dividends and other distributions of cash or any other right or property as may be declared by our Board of Directors out of our assets or funds legally available for such dividends or distributions.

Liquidation Rights. In the event of any voluntary or involuntary liquidation, dissolution or winding up of our affairs, holders of our Common Stock would be entitled to share ratably in our assets that are legally available for distribution to shareholders after payment of liabilities and after the satisfaction of any liquidation preference owed to the holders of any Preferred Stock.

Conversion, Redemption and Preemptive Rights. Holders of our Common Stock have no conversion, redemption, preemptive, subscription or similar rights.

Anti-Takeover Provisions

Bylaws. Certain provisions of our Bylaws could have anti-takeover effects. These provisions are intended to enhance the likelihood of continuity and stability in the composition of our corporate policies formulated by our Board of Directors. In addition, these provisions also are intended to ensure that our Board of Directors will have sufficient time to act in what our Board of Directors believes to be in the best interests of our Company and our shareholders. Nevertheless, these provisions could delay or frustrate the removal of incumbent directors or the assumption of control of us by the holder of a large block of Common Stock, and could also discourage or make more difficult a merger, tender offer, or proxy contest, even if such event would be favorable to the interest of our shareholders. These provisions are summarized below.

Advance Notice Provisions for Raising Business or Nominating Directors. Sections 2.09 and 2.10 of our Bylaws contain advance-notice provisions relating to the ability of shareholders to raise business at a shareholder meeting and make nominations for directors to serve on our Board of Directors. These advance-notice provisions generally require shareholders to raise business within a specified period of time prior to a meeting in order for the business to be properly brought before the meeting.

Number of Directors and Vacancies. Our Bylaws provide that the exact number of directors shall be determined from time to time solely by resolution adopted by the affirmative vote of a majority of the entire Board of Directors. The Board of Directors is divided into three classes, as nearly equal in number as possible, designated: Class I, Class II and Class III (each, a “Class”). In the case of any increase or decrease, from time to time, in the number of directors, the number of directors in each class shall be apportioned as nearly equal as possible. Except as otherwise provided in the Certificate of Incorporation, each director serves for a term ending on the date of the third annual meeting of the Company’s stockholders following the annual meeting at which such director was elected; provided, that the term of each director shall continue until the election and qualification of a successor and be subject to such director’s earlier death, resignation or removal. Vacancies on the Board of Directors resulting from death, resignation, removal or otherwise and newly created directorships resulting from any increase in the number of directors may be filled solely by a majority of the directors then in office (although less than a quorum) or by the sole remaining director.

Delaware Law. We are subject to Section 203 of the Delaware General Corporation Law. This provision generally prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date the stockholder became an interested stockholder, unless:

prior to such date, the board of directors approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding those shares owned by persons who are directors and also officers and by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
on or subsequent to such date, the business combination is approved by the board of directors and authorized at an annual meeting or special meeting of stockholders and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder.

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Section 203 defines a business combination to include:

any merger or consolidation involving the corporation and the interested stockholder;
any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;
subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or
the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

In general, Section 203 defines an “interested stockholder” as any entity or person beneficially owning 15% or more of the outstanding voting stock of a corporation, or an affiliate or associate of the corporation and was the owner of 15% or more of the outstanding voting stock of a corporation at any time within three years prior to the time of determination of interested stockholder status; and any entity or person affiliated with or controlling or controlled by such entity or person.

These statutory provisions could delay or frustrate the removal of incumbent directors or a change in control of our company. They could also discourage, impede, or prevent a merger, tender offer, or proxy contest, even if such event would be favorable to the interests of stockholders. In addition, note that while Delaware law permits companies to opt out of its business combination statute, our Certificate of Incorporation does not include this opt-out provision.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is Corporate Stock Transfer, Inc.

Listing

The shares of our common stock are listed on The Nasdaq Capital Market under the symbol “POAI.” On April 1, 2020, the last reported sale price per share for our common stock as reported by The Nasdaq Capital Market was $1.40.

SELLING STOCKHOLDERS

This prospectus covers the resale by the Selling Stockholders or its permitted transferees of up to 5,889,561 shares that have been or may be issued by us to the Selling Stockholders under the arrangements and agreements described in “Prospectus Summary – Description of the Private Placements.” The Selling Stockholders have not had any position or office, or other material relationship with us or any of our affiliates over the past three years. The following table sets forth certain information regarding the beneficial ownership of shares of common stock by the Selling Stockholders as of March 30, 2020 and the number of shares of our common stock inbeing offered pursuant to this offering. The selling stockholder will receive all of the proceeds from this offering.

6

SELLING STOCKHOLDERprospectus.

 

The shares of common stock being offered bytable below (i) lists the selling stockholder are those issuable to the selling stockholder upon conversion of our Series C Convertible Preferred Stock and those issuable upon the exercise of warrants. For additional information regarding the issuances of our Series C Convertible Preferred Stock and warrants to the selling stockholder, and the relationship between the selling stockholder and us, see “Prospectus Summary—Description of the Private Placement” above. We are registering the shares of common stock in order to permit the selling stockholder to offer the shares for resale from time to time.

The following table sets forth:

the selling stockholderSelling Stockholders and other information regarding the beneficial ownership of the shares ofour common stock by the sellingSelling stockholder;

the number of shares of common stock beneficially owned (ii) have been prepared based upon information furnished to us by the selling stockholderstockholder; and (iii) to our knowledge, is accurate as of December 7, 2017, assuming the conversiondate of the Series C Convertible Preferred Stock held by the selling stockholder on that date and the exercise of warrants held by the selling stockholder on that date, without regard to any limitations on exercises prior to the sale of the shares covered by this prospectus;

the number of shares that may be offered by the selling stockholder pursuant to this prospectus;

the number of shares to be beneficially owned by the selling stockholder and its affiliates following the sale of any shares covered by this prospectus; and

the percentage of our issued and outstanding common stock to be beneficially owned by the selling stockholder and its affiliates following the sale of all shares covered by this prospectus.

The selling stockholderSelling Stockholders may sell all, some or none of their shares in this offering. See “PlanThe Selling Stockholders identified in the table below may have sold, transferred or otherwise disposed of Distribution.”some or all of its shares since the date of this prospectus in transactions exempt from or not subject to the registration requirements of the Securities Act. Information concerning the Selling Stockholders may change from time to time and, if necessary, we will amend or supplement this prospectus accordingly and as required.

 

Selling Stockholder

Shares

Beneficially

Owned Before

Offering (1)

Total Shares
Offered 
By Selling
Stockholder

Shares

Beneficially

Owned After

Offering (1) (2)

Percentage of

Beneficial

Ownership

After

Offering (1) (2)

Esousa Holdings, LLC(3)1,213,819(4)1,857,179(5)0*14

_______________

*       Less than 1%

  Shares beneficially   Number of shares to be
beneficially
owned and percentage of
beneficial
ownership after the offering(1)(2)
Name of selling
stockholder
 owned as of the date 
of this prospectus(1)
 Number of shares 
being offered
 Number of
shares
 Percentage of
class (3)
Armistice Capital Master Fund  2,828,856(4)  2,828,856(4)  0   0%
Sabby Volatility Warrant Master Fund, Ltd.  2,121,642(5)  2,121,642(5)  0   0%
Oasis Capital, LLC  1,091,532(6)  939,063(7)  152,469(8)  2.54%

 

(1)

Beneficial ownership is determined in accordance with SEC rules beneficial ownershipand generally includes any shares as to which the stockholder has sole or shared voting power or investment power with respect to shares of common stock. Shares of common stock subject to options and also any shares which the stockholder has the right to acquirewarrants currently exercisable, or exercisable within 60 days, are counted as outstanding for computing the percentage of the date hereof, whether throughperson holding such options or warrants but are not counted as outstanding for computing the percentage of any other person. Substantially all of the warrants and convertible securities included in the table are subject to restrictions that prevent exercise to the extent that after the exercise the holder or conversionits affiliates would beneficially own in excess of any4.99% of the Company’s outstanding stock.

(2)

The amount and percentage of shares of our common stock option, convertible security, warrant or other right. The indication herein that shares arewill be beneficially owned is not an admission onby the partSelling Stockholders after completion of the stockholderoffering assume that he, she or it is a direct or indirect beneficial owner of those shares.

(2)Assumes sales ofthey will sell all shares of our common stock being offered underpursuant to this prospectus.

(3)Based on 5,847,718 shares of our common stock issued and outstanding as of March 30, 2020. All shares of our common stock being offered pursuant to this prospectus by a Selling Stockholder are counted as outstanding for computing the selling stockholder.percentage beneficial ownership of such Selling Stockholder.

(3)
(4)Rachel GlicksmanIncludes 260,000 shares owned directly by Armistice Capital Master Fund Ltd. (“Armistice”) and 2,568,856 shares issuable upon exercise of warrants. Such warrants are subject to restrictions that prevent exercise to the extent that after the exercise the holder or its affiliates would beneficially own in excess of 4.99% of the Company’s outstanding stock. Steven Boyd has shared voting and investment control over shares owned by Armistice.
(5)

Includes 2,121,642 shares issuable upon exercise of warrants. Such warrants are subject to restrictions that prevent exercise to the extent that after the exercise the holder or its affiliates would beneficially own in excess of 4.99% of the Company’s outstanding stock. Sabby Management, LLC serves as the investment manager of Sabby Volatility Warrant Master Fund, Ltd. (“SVWMF”). Hal Mintz is the Managing Membermanager of Esousa Holdings,Sabby Management, LLC and may be deemed to be a beneficial ownerhas voting and investment control of the securities held by the selling stockholder. Rachel GlicksmanSVWMF. Each of Sabby Management, LLC and Hal Mintz disclaims beneficial ownership over the securities beneficially owned by SVWMF except to the extent of such securities.

their respective pecuniary interest therein.

 

(4)(6)Includes 1,213,81985,733 shares owned directly, up to 280,031 shares issuable upon exercise of our common stock issuablewarrants and up to 582,167 shares upon conversion of 1,213,819a convertible promissory note.  Adam Long has sole voting and investment control over shares owned by Oasis Capital, LLC.
(7)Includes 76,875 shares owned directly, up to 280,031 shares issuable upon exercise of our Series C Convertible Preferred Stock held by the selling stockholder. Each share of Series C Convertible Preferred Stock is convertible into one share of common stock, subjectwarrants and up to conversion rate adjustments in the event the closing bid price of our common stock on the day prior to the effective date of this Registration Statement is lower than $1.26. However, the number of582,157 shares of common stock issuable upon conversion of Series C Convertible Preferred Stock helda convertible promissory note. Adam Long has sole voting and investment control over shares owned by the selling stockholder may not exceed 1,250,269. The calculationOasis Capital, LLC.
(8)Includes 8,858 shares owned directly and up to 143,611 shares issuable upon exercise of beneficial ownership in this table does not take into account any such conversion rate adjustment. Thewarrants.  Adam Long has sole voting and investment control over shares of Series C Convertible Preferred Stock and the warrant heldowned by the selling stockholder contain “blocker” provisions that limits the holder’s ability convert such shares and exercise the warrant to the extent that such conversion or exercise would cause its beneficial ownership in the Company to exceed either 4.99% or 9.99% of the Company’s then outstanding shares. The calculation of beneficial ownership in this table does not take into account the effect of such “blocker” provisions.Oasis Capital, LLC.

 

715

(5)Includes up to 1,857,179 shares of our common stock, of which up to 1,250,269 are shares of common stock that may be issued upon conversion of our Series C Convertible Preferred Stock held by the selling stockholder and 606,910 are shares issuable upon the exercise of warrants held by the selling stockholder.

 

PLAN OF DISTRIBUTION

 

We are registering the shares of common stock issuable to the selling stockholder upon conversion of our Series C Convertible Preferred Stock held by the selling stockholder and exerciseThe Selling Stockholders or exchange of warrants held by the selling stockholder to permit the resale of these shares of common stock by the holders of the common stock, the Series C Convertible Preferred Stock and warrantstheir permitted transferees may, from time to time, aftersell any or all of shares of our common stock covered hereby on the date of this prospectus. We will not receiveNasdaq stock market, or any of the proceeds from the sale by the selling stockholder ofother stock exchange, market or trading facility on which the shares of common stock. We will bear all fees and expenses incident to our obligation to register the shares of common stock.

are traded or in private transactions. The selling stockholderSelling Stockholders may sell all or a portion of the shares of common stock held by them andbeing offered hereby from timepursuant to time directly or through one or more underwriters, broker-dealers or agents. If the shares of common stock are sold through underwriters or broker-dealers, the selling stockholder will be responsible for underwriting discounts or commissions or agent’s commissions. The shares of common stock may be sold in one or more transactionsthis prospectus at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices. These salesThe Selling Stockholders may be effected in transactions, which may involve crosses or block transactions, pursuant touse any one or more of the following methods:methods when selling securities:

 

on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;
in the over-the-counter market;
in transactions otherwise than on these exchanges or systems or in the over-the-counter market;
through the writing or settlement of options, whether such options are listed on an options exchange or otherwise;
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
an exchange distribution in accordance with the rules of the applicable exchange;
privately negotiated transactions;
short sales made after the date the Registration Statement is declared effective by the SEC;
broker-dealers may agree with a selling securityholder to sell a specified number of such shares at a stipulated price per share;
a combination of any such methods of sale; and
any other method permitted pursuant to applicable law.
on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;
in the over-the-counter market;
in transactions otherwise than on these exchanges or systems or in the over-the-counter market;
through the writing or settlement of options, whether such options are listed on an options exchange or otherwise;
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
an exchange distribution in accordance with the rules of the applicable exchange;
privately negotiated transactions;

 

The selling stockholderSelling Stockholders may also sell shares of common stocksecurities under Rule 144 promulgated under the Securities Act, of 1933, as amended, if available, rather than under this prospectus. In addition,

Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, provided such amounts are in compliance with FINRA Rule 2121. Discounts, concessions, commissions and similar selling stockholder may transferexpenses, if any, that can be attributed to the sharessale of common stock will be paid by other means not described in this prospectus. If the selling stockholder effects such transactions by selling shares of common stock to Selling Stockholders and/or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling stockholder or commissions from purchasers of the shares of common stock for whom they may act as agent or to whom they may sell as principal (which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactions involved). The selling stockholder may also loan or pledge shares of common stock to broker-dealers that in turn may sell such shares.purchasers.

8

 

The selling stockholderSelling Stockholders may pledge or grant a security interest in some or all ofbe deemed to be underwriters within the Series C Preferred Shares, warrants or shares of common stock owned by it and, if the selling stockholder defaults in the performance of its secured obligations, the pledgees or secured parties may offer and sell the shares of common stock from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provisionmeaning of the Securities Act amending, if necessary, the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholder also may transfer and donate the shares of common stock in other circumstances in which case the pledgees, assignees or successors-in-interest will be the selling beneficial owners for purposes of this prospectus.

To the extent required by the Securities Act and the rules and regulations thereunder, the selling stockholder and any broker-dealer participatingbroker-dealers or agents that are involved in the distribution ofselling the shares of common stock may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any commission paid, or any discounts or concessions allowed to, any such broker-dealerprofit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. AtBecause the time a particular offeringSelling Stockholders may be deemed to be underwriters within the meaning of the shares of common stock is made, aSecurities Act, they may be subject to the prospectus supplement, if required, will be distributed, which will set forth the aggregate amount of shares of common stock being offered and the termsdelivery requirements of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation from the selling stockholder and any discounts, commissions or concessions allowed or re-allowed or paid to broker-dealers.Securities Act.

 

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale of securities laws of some states,may not simultaneously engage in market making activities with respect to the shares of common stock may be soldfor the applicable restricted period, as defined in such states only through registered or licensed brokers or dealers.Regulation M, prior to the commencement of the distribution. In addition, in some states the shares of common stock may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

There can be no assurance that the selling stockholder will sell any or all of the shares of common stock registered pursuant to the registration statement, of which this prospectus forms a part.

The selling stockholder and any other person participating in such distributionSelling Stockholders will be subject to applicable provisions of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, including without limitation, to the extent applicable, Regulation M, of the Exchange Act, which may limit the timing of purchases and sales of anysecurities of the shares of common stock by the selling stockholder andSelling Stockholders or any other participating person. ToWe will make copies of this prospectus available to the extent applicable, Regulation M may also restrict the ability of any person engaged in the distributionselling security holders and have informed them of the sharesneed to deliver a copy of common stockthis prospectus to engage in market-making activities with respecteach purchaser at or prior to the shares of common stock. Alltime of the foregoing may affect the marketability of the shares of common stock and the ability of any person or entity to engage in market-making activities with respect to the shares of common stock.sale.

 

We will pay all expenses of the registration of the shares of common stock pursuant to the registration rights agreement, estimated to be $40,000 in total, including, without limitation, SEC filing fees and expenses of compliance with state securities or “blue sky” laws; provided, however, the selling stockholder will pay all underwriting discounts and selling commissions, if any. We will indemnify the selling stockholder against liabilities, including some liabilities under the Securities Act in accordance with the registration rights agreements or the selling stockholder will be entitled to contribution. We may be indemnified by the selling stockholder against civil liabilities, including liabilities under the Securities Act that may arise from any written information furnished to us by the selling stockholder specifically for use in this prospectus, in accordance with the related registration rights agreements or we may be entitled to contribution.

Once sold under the registration statement, of which this prospectus forms a part, the shares of common stock will be freely tradable in the hands of persons other than our affiliates.

9

LEGAL MATTERS

 

The validity of the common stockany securities offered from time to time by this prospectus and any related prospectus supplement will be passed upon by Maslon LLP, Minneapolis, Minnesota.

 

16

EXPERTS

The financial statements incorporated in this prospectus by reference from the Company's Annual Report on Form 10-K for the year ended December 31, 2019 have been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their report, which is incorporated herein by reference. Such financial statements have been so incorporated in reliance upon the report of such firm given upon their authority as experts in accounting and auditing.

 

The financial statements of Helomics Holding Corporation for the Company as of December 31, 2016 and 2015 and for each of the two years in the periodfiscal year ended December 31, 20162018, as restated, incorporated by reference in this prospectus and the registration statement have been so incorporated in reliance on the reportsreport of Olsen ThielenSchneider Downs & Co., Ltd, an independentInc., certified public accountants registered public accounting firm, incorporated hereinwith the Public Company Accounting Oversight Board, as auditor for Helomics Holding Corporation prior to the acquisition by reference, given on the authority of said firm as experts in auditing and accounting.Company.

 

WHERE YOU CAN FIND MORE INFORMATION

 

We are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and file annual, quarterly and current reports, proxy statements and other information with the SEC. You may readWe have filed with the SEC a registration statement on Form S-3 under the Securities Act with respect to the securities we are offering under this prospectus. This prospectus does not contain all of the information set forth in the registration statement and copy these reports,the exhibits to the registration statement. For further information with respect to us and the securities we are offering under this prospectus, we refer you to the registration statement and the exhibits and schedules filed as a part of the registration statement. Reports filed with the SEC pursuant to the Exchange Act, including proxy statements, annual and quarterly reports, and other informationreports filed by the Company can be inspected and copied at the SEC's public reference facilities maintained by the SEC at the Headquarters Office, 100 F Street N.E., Room 1580, Washington, D.C. 20549. YouThe reader may obtain information on the operation of the public reference room by calling the SEC at 1-800-SEC-0330. The reader can request copies of these documents upon payment of a duplicating fee by writing to the SEC and paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public reference facilities. SECSEC. Our filings are also available aton the SEC's webSEC’s internet site at http://www.sec.gov.

This prospectus is only part of a registration statement and the Company’s website at www.predictive-oncology.com. Information on Form S-3 that we have filed with the SEC under the Securities Act and therefore omits certain information contained in the registration statement. We have also filed exhibits and schedules with the registration statement that are excluded from this prospectus, and you should refer to the applicable exhibitany Company website, any subsection, page, or schedule for a complete descriptionother subdivision of any statement referringCompany website, or any website linked to by content on any contract or other document. You may inspect a copy of the registration statement, including the exhibits and schedules, without charge, at the public reference room or obtain a copy from the SEC upon payment of the fees prescribed by the SEC.

We also maintain a website at www.skylinemedical.com, through which you can access our SEC filings. The information set forth on, or accessible from, ourCompany website, is not part of this prospectus and you should not rely on that information unless that information is also in this prospectus or incorporated by reference in this prospectus.

 

INCORPORATION OF CERTAIN INFORMATIONDOCUMENTS BY REFERENCE

 

The SEC allows us to “incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The documents incorporated by reference into this prospectus contain important information that you should read about us. The following documents are incorporated by reference into this prospectus:

We are allowed to incorporate by reference information contained in documents that we file with them. Incorporation by reference allows us tothe SEC. This means that we can disclose important information to you by referring you to those other documents. Thedocuments and that the information in this prospectus is not complete and you should read the information incorporated by reference for more detail. We incorporate by reference in two ways. First, we list certain documents that we have already filed with the SEC. The information in these documents is an importantconsidered part of this prospectus, andprospectus. Second, the information in documents that we file later within the SECfuture will automatically update and supersede this information. This prospectus omits certainthe current information contained in, the registration statement, as permitted by the SEC. You should refer to the registration statement and any prospectus supplement filed hereafter, including the exhibits, for further information about us and the securities we may offer pursuant to this prospectus. Statements in this prospectus regarding the provisions of certain documents filed with, or incorporated by reference in, this prospectus.

We incorporate by reference the registration statement are not necessarily completedocuments listed below and each statement is qualified in all respects by that reference. Copies of allany future filings we will make with the SEC under Section 13(a), 13(c), 14 or any part15(d) of the registration statement, includingExchange Act (other than information furnished in Current Reports on Form 8-K filed under Item 2.02 or 7.01 of such form unless such form expressly provides to the documents incorporated by reference or the exhibits, may be obtained upon payment of the prescribed rates at the offices of the SEC listed above in “Where You Can Find More Information.” The documents we are incorporating by reference are:contrary): 

 

ourOur Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 15, 2017;2019;

 

our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2017, June 30, 2017 and September 30, 2017, filed on May 15, 2017, August 14, 2017 and November 14, 2017, respectively;

10

our Current Reports on Form 8-K filed on (i)March 23, 2020, March 16, 2020, February 21, 2020, February 7, 2020, February 4, 2020, January 19, 2017, (ii)28, 2020, January 27, 2017, (iii)24, 2020, and January 31, 2017, (iv) February 22, 2017, (v) June 22, 2017, (vi) August 2, 2017, (vii) August 10, 2017, (viii) August 11, 2017, (ix) August 15, 2017, (x) September 12, 2017, (xi) November 9, 2017, (xii) November 24, 2017, and (xiii) November 29, 2019; and6, 2020.

 

The description of ourthe Company’s common stock under the captionfiled as Exhibit 4.29 “Description of Securities – Common Stock” in Amendment No. 1Registrant’s Securities” to our registration statementthe Company’s Annual Report on Form S-4 filed10-K on March 25, 2016.April 1, 2020.

 

We also incorporate by reference any future filings (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, including those made after the date of the initial filing of the registration statement of which this prospectus is a part and prior to effectiveness of such registration statement, until we file a post-effective amendment that indicates the termination of the offering of the securities made by this prospectus and will become a part of this prospectus from the respective dates that such documents are filed with the SEC. Any statement contained herein or in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes hereof or of the related prospectus supplement to the extent that a statement contained herein or in any other subsequently filed document which is also incorporated or deemed to be incorporated herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.

17

 

We will provide to each person, including any beneficial owner, to whom a prospectus is delivered, a copy of any or all of the information that has been incorporated by reference in this prospectus but not delivered with this prospectus. You may request a copy of this information at no cost, by writing or telephoning us at the following address or telephone number:

 

Skyline MedicalPredictive Oncology Inc.

Attention: Corporate Secretary


2915 Commers Drive, Suite 900


Eagan, Minnesota 55121

(651) 389-4800

 

You should rely only on information contained in, or incorporated by reference into, this prospectus and any prospectus supplement. We have not authorized anyone to provide you with information different from that contained in this prospectus or incorporated by reference in this prospectus. We are not making offers to sell the securities in any jurisdiction in which such an offer or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make such offer or solicitation.

 

 

 

 

 

 

 

 

1118

 

PREDICTIVE ONCOLOGY INC.

5,889,561 Shares

Common Stock

______________________

PROSPECTUS

______________________

__________________, 2020

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 14.Other Expenses of Issuance and Distribution.

Item 14. Other Expenses Of Issuance And Distribution.

 

The following table sets forth the feescosts and expenses, other than underwriting compensation, payable by the registrant in connection with the registrationsale of securities hereunder.common stock being registered. All amounts are estimates except for the SEC registration fee and the Nasdaq listing fee.

 

SEC Registration Fee $285.56 
Legal Fees and Expenses $20,000.00 
Accounting Fees and Expenses $10,000.00 
Miscellaneous $9,714.44 
     
Total $40,000.00 

Securities and Exchange Commission registration fee $1,098.92 
NASDAQ listing fee $10,000.00 
Printing and engraving expenses $5,000.00 
Legal fees and expenses $25,000.00 
Accounting fees and expenses $10,000.00 
Miscellaneous $3,901.08 
Total $55,000.00 
Item 15.Indemnification of Directors and Officers.

Item 15. Indemnification of Directors and Officers.

 

We are a Delaware corporation and certain provisions of the Delaware Statutes and our bylaws provide for indemnification of our officers and directors against liabilities that they may incur in such capacities. A summary of the circumstances in which indemnification is provided is discussed below, but this description is qualified in its entirety by reference to our bylaws and to the statutory provisions.

 

Section 145 of the Delaware General Corporation Law provides for, under certain circumstances, the indemnification of our officers, directors, employees and agents against liabilities that they may incur in such capacities. A summary of the circumstances in which such indemnification provided for is contained herein, but that description is qualified in its entirety by reference to the relevant Section of the Delaware General Corporation Law.

 

In general, the statute provides that any director, officer, employee or agent of a corporation may be indemnified against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement, actually and reasonably incurred in a proceeding (including any civil, criminal, administrative or investigative proceeding) to which the individual was a party by reason of such status. Such indemnity may be provided if the indemnified person’s actions resulting in the liabilities: (i) were taken in good faith; (ii) were reasonably believed to have been in or not opposed to our best interest; and (iii) with respect to any criminal action, such person had no reasonable cause to believe the actions were unlawful. Unless ordered by a court, indemnification generally may be awarded only after a determination of independent members of the Board of Directors or a committee thereof, by independent legal counsel or by vote of the stockholders that the applicable standard of conduct was met by the individual to be indemnified.

 

The statutory provisions further provide that to the extent a director, officer, employee or agent is wholly successful on the merits or otherwise in defense of any proceeding to which he was a party, he is entitled to receive indemnification against expenses, including attorneys’ fees, actually and reasonably incurred in connection with the proceeding.

 

Indemnification in connection with a proceeding by or in the right of the Company in which the director, officer, employee or agent is successful is permitted only with respect to expenses, including attorneys’ fees actually and reasonably incurred in connection with the defense. In such actions, the person to be indemnified must have acted in good faith, in a manner believed to have been in our best interest and must not have been adjudged liable to us unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of liability, in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expense which the Court of Chancery or such other court shall deem proper. Indemnification is otherwise prohibited in connection with a proceeding brought on behalf of the Company in which a director is adjudged liable to us, or in connection with any proceeding charging improper personal benefit to the director in which the director is adjudged liable for receipt of an improper personal benefit.

 

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Delaware law authorizes us to reimburse or pay reasonable expenses incurred by a director, officer, employee or agent in connection with a proceeding in advance of a final disposition of the matter. Such advances of expenses are permitted if the person furnishes to us a written agreement to repay such advances if it is determined that he is not entitled to be indemnified by us.

 

The statutory section cited above further specifies that any provisions for indemnification of or advances for expenses does not exclude other rights under our certificate of incorporation, corporate bylaws, resolutions of our stockholders or disinterested directors, or otherwise. These indemnification provisions continue for a person who has ceased to be a director, officer, employee or agent of the corporation and inure to the benefit of the heirs, executors and administrators of such persons.

 

The statutory provision cited above also grants the power to the Company to purchase and maintain insurance policies that protect any director, officer, employee or agent against any liability asserted against or incurred by him in such capacity arising out of his status as such. Such policies may provide for indemnification whether or not the corporation would otherwise have the power to provide for it.

 

Article 8 of our certificate of incorporation provides that we shall indemnify our directors and officers to the fullest extent permitted by the Delaware General Corporation Law.

 

We have purchased directors’ and officers’ liability insurance in order to limit the exposure to liability for indemnification of directors and officers, including liabilities under the Securities Act of 1933.

 

Insofar as indemnification for liabilities arising under the Securities Act may be permitted for our directors, officers, and controlling persons pursuant to the foregoing provisions or otherwise, we have been advised that in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

Item 16.Exhibits.

Item 16. Exhibits.

See “Exhibit Index” below, which follows the signature pages to this registration statement.

Item 17. Undertakings.

 

The exhibits to this registration statement are listed in the Exhibit Index to this registration statement, which Exhibit Index isundersigned registrant hereby incorporated by reference.undertakes:

 

Item 17.Undertakings.(a)(1)To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(i)to include any prospectus required by section 10(a)(3) of the Securities Act of 1933;

(a)  The undersigned Registrant hereby undertakes:

(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(i)      To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

(ii)     To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

(ii)to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, an increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;

 

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 II-2(iii)to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement.

 
(2)That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3)To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(iii)    To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

(4)That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser:

(i)Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(ii)Each prospectus required to be filed pursuant to Rule 424(b)(2), 424(b)(5), or 424(b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), 415(a)(1)(vii), or 415(a)(1)(x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

provided, however, that the undertakings set forth in paragraphs (1)(i), (1)(ii) and (1)(iii) above do not apply if the registration statement is on Form S-3 or Form F-3 and the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement or is contained in a form of prospectus filed pursuant to Rule 424(b) that is a part of the registration statement.

(5)That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 (2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

(B) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

(5) That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

(i)Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

II-3

 II-3(ii)Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

 

(iii) (iii)The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

(iv)Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

(b)The undersigned registrant hereby further undertakes that, for the purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(c)The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(d)Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

(e)For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
(f)For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(g)If and when applicable, the Registrant hereby further undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed by the Securities and Exchange Commission under Section 305(b)(2) of the Trust Indenture Act.

 

II-4

(iv) Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

(6) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant's annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan's annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initialbona fide offering thereof.

(7) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication of such issue.

 

II-4

SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Minneapolis,Eagan, State of Minnesota, on December 8, 2017.April 6, 2020.

 

 SKYLINE MEDICAL

PREDICTIVE ONCOLOGY INC.

  
 By:/s/ Bob Myers
 Bob Myers
 Bob Myers, Chief Financial Officer

 

POWER OF ATTORNEY

 

Each person whose signature to this registration statement appears below hereby constitutes and appoints Carl Schwartz and Bob Myers, signing singlyand each of them, as his or her true and lawful attorney-in-factattorneys-in-fact and agent,agents, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign on his behalf individuallyany and in the capacity stated below and to perform any acts necessary to be done in order to file all amendments (including post-effective amendments) to this registration statement, and any and all instruments oradditional registration statements pursuant to Rule 462(b) of the Securities Act of 1933, as amended, and to file the same, with all exhibits thereto, and other documents filed as part of or in connection therewith, with this registration statementthe Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or the amendments theretocould do in person, hereby ratifying and each of the undersigned does hereby ratify and confirmconfirming all that said attorney-in-fact and agent or his substitutes shallor substitute, may lawfully do or cause to be done by virtue hereof. The undersigned also grants to said attorney-in-fact, full power and authority to do and perform any and all acts necessary or incidental to the performance and execution of the powers herein expressly granted. This Power of Attorney shall remain in effect until revoked in writing by the undersigned.

 

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed below by the following persons in the capacities and on the dates indicated:

  

NameSignature TitleDate
    
/s/ Carl Schwartz Chief Executive Officer (principal executive December 8, 2017
Carl Schwartz officer) and Director 
April 6, 2020
/s/ Bob Myers Carl Schwartz Chief Financial Officer (principal financial and December 8, 2017
Bob Myers accounting officer)
/s/ J. Melville Engle DirectorDecember 8, 2017
J. Melville Engle   
    
/s/ Richard L. Gabriel Bob Myers DirectorChief Financial Officer (principal financial and accounting officer)December 8, 2017April 6, 2020
Richard L. GabrielBob Myers   
    
/s/ Timothy A. Krochuk J. Melville Engle DirectorDecember 8, 2017April 6, 2020
Timothy A. KrochukJ. Melville Engle   
    
/s/ Thomas J. McGoldrick  Richard L. Gabriel DirectorDecember 8, 2017April 6, 2020
Thomas J. McGoldrickRichard L. Gabriel   
    
/s/ Pamela S. PriorDirectorApril 6, 2020
Pamela S. Prior
/s/ Daniel E. HandleyDirectorApril 6, 2020
Daniel E. Handley
/s/ Andrew P. Reding DirectorDecember 8, 2017April 6, 2020
Andrew P. Reding   
/s/ Gerald VardzelDirectorApril 6, 2020
Gerald Vardzel

 

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EXHIBIT INDEX

 

Exhibit No.

Number

 Description
   
3.11.1 

Amended and Restated Letter Agreement dated March 15, 2020 by and between the Company and H.C. Wainwright & Co., LLC (46)Exhibit 1.1

2.1Amended and Restated Agreement and Plan of Merger dated October 22, 2018 (18)Exhibit 2.1
3.1Certificate of Incorporation (incorporated by reference to (1)Exhibit 3.1 to the Current report on Form 8-K filed December 19, 2013)
3.2 
3.2Certificate of Amendment to Certificate of Incorporation to effect reverse stock split and reduction in authorized share capital filed with the Delaware Secretary of State on October 20, 2014 (incorporated by reference to (6)Exhibit 3.1 to the Current Report on Form 8-K filed on October 24, 2014)3.2
3.3 
3.3Certificate of Amendment to Certificate of Incorporation regarding increase in share capital, filed with the Delaware Secretary of State on July 24, 2015 (incorporated by reference to Appendix A to our Information Statement on Schedule 14C filed on June 30, 2015)(7)Exhibit 3.3
3.4 
3.4Certificate of Amendment to Certificate of Incorporation to increase authorized share capital, filed with the Delaware Secretary of State on September 16, 2016 (incorporated by reference to (11)Exhibit 3.1 to the Current Report on Form 8-K filed on September 16, 2016)3.4
3.5 
3.5Certificate of Amendment to Certificate of Incorporation to effect reverse stock split and reduction in authorized share capital, fled with the Delaware Secretary of State on October 26, 2016 (incorporation by reference to (12)Exhibit 3.7 to the Current Report on Form 8-K filed on October 27, 2016)3.5
3.6 
3.6Certificate of Amendment to Certificate of Incorporation regarding increase in share capital, filed with the Delaware Secretary of State on January 26, 2017 (incorporation by reference(13)Exhibit 3.6
3.7Certificate of Amendment to Exhibit 3.1Certificate of Incorporation to effect reverse stock split, filed with the Current Report on Form 8-K filedDelaware Secretary of State on January 27, 2017)2, 2018 (21)Exhibit 3.7
3.7 
3.8Certificate of Amendment to Certificate of Incorporation to effect name change, filed with the Delaware Secretary of State on February 1, 2018 (8)Exhibit 3.8
3.9Certificate of Amendment to Certificate of Incorporation to increase authorized share capital and establish a classified Board of Directors (23)Exhibit 3.9
3.10Second Amended and Restated Bylaws as of June 10, 2019 (34)Exhibit 3.10
3.11Form of Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to (9)Exhibit 3.6 to the Registration Statement on Form S-1 (File No. 333-198962) filed on August 20, 2015)3.11
3.8 
3.12

Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to (20)Exhibit 3.1 to the Current Report on Form 8-K filed on November 29, 2017)3.12

3.93.13 

Certificate of Amendment to Certificate of Incorporation dated March 22, 2019 (24)Exhibit 3.13

3.14Certificate of Designation Of Preferences, Rights And Limitations of Series D Convertible Preferred Stock (48)Exhibit 3.14

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3.15

Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock Effective June 13, 2019 (35)Exhibit 3.15

3.16

Certificate of Amendment of Certificate of Incorporation (34)Exhibit 3.16

3.17

Certificate of Amendment of Certificate of Incorporation (41)Exhibit 3.17

4.1Form of specimen certificate evidencing shares of Series B Convertible Preferred Stock (10)Exhibit 4.1
4.2Form of New Warrant Agency Agreement by and between Skyline Medical Inc. and Form of Warrant Certificate for Series B Warrant (14)Exhibit 4.2
4.3Form of Series B Warrant Certificate (included as part of Exhibit 4.2) (14)Exhibit 4.3
4.4Form of Series C Warrant (15)Exhibit 4.4
4.5Form of Unit Purchase Option (15)Exhibit 4.5
4.6Form of Series D Warrant Agency Agreement by and between Skyline Medical Inc. and Corporate Stock Transfer, Inc. and Form of Series D Warrant Certificate (16)Exhibit 4.6
4.7Form of Series D Warrant Certificate (included as part of Exhibit 4.6) (16)Exhibit 4.78
4.8

Form of Amendment to Warrant (8)Exhibit 4.8

4.9Investor Warrant (20)Exhibit 4.9
4.10Series E Warrant Agency Agreement by and between Skyline Medical Inc. and Corporate Stock Transfer, Inc. dated January 9, 2018 (22)Exhibit 4.10
4.11Form of Series E Warrant Certificate (22)Exhibit 4.11
4.12Common Stock Purchase Warrant issued to L2 Capital, LLC dated September 28, 2018 (23)Exhibit 4.12
4.13Common Stock Purchase Warrant issued to Peak One Opportunity Fund, LP dated September 28, 2018 (23)Exhibit 4.13
4.14Second Amended and Restated Bylaws (incorporated by referenceCommon Stock Purchase Warrant issued to Carl Schwartz dated February 6, 2019 (25)Exhibit 3.1 to the Current Report on Form 8-K filed January 27, 2016)4.14
4.1 Form of Investor Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed on November 29, 2017)
5.1*4.15 Form of Warrant (Initial Issue Date: March 1, 2019) (26)Exhibit 4.15
4.16Form of Unit Purchase Option (26)Exhibit 4.16
4.17Common Stock Purchase Warrant issued to Carl Schwartz dated November 30, 2018 (27)Exhibit 4.17
4.18

Amended and Restated Common Stock Purchase Warrant issued to Carl Schwartz dated January 8, 2019 (28)Exhibit 4.18

4.19

Form of Common Stock Purchase Warrant issued March 29, 2019 (31)Exhibit 4.19

4.20

Form of Unit Purchase Option for the Purchase of Units (31)Exhibit 4.20

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4.21

Common Stock Purchase Warrant Issued to Oasis Capital, LLC dated September 27, 2019 (37)Exhibit 4.21

4.22

Form of Specimen Common Stock Certificate (38)Exhibit 4.22

4.23

Form of Common Stock Purchase Warrant Issued on or about October 1, 2019 (39)Exhibit 4.23

4.24

Common Stock Purchase Warrant issued to Oasis Capital, LLC dated February 5, 2020 (45)Exhibit 4.24

4.25

Form of Series A Warrant (46)Exhibit 4.25

4.26

Form of Series B Warrant (46)Exhibit 4.26

4.27

Form of Prefunded Warrant (46)Exhibit 4.27

4.28

Form of Prefunded Common Stock Purchase Warrant (47)Exhibit 4.28

4.29

Description of Registrant’s Securities (48)Exhibit 4.29

4.30**

Common Stock Purchase Warrant issued to Oasis Capital, LLC dated March 6, 2020

4.31**

Common Stock Purchase Warrant issued to Oasis Capital, LLC dated April 5, 2020
5.1**Opinion of Maslon LLP as to the validity of the securities being registered
10.1 
10.1

Securities Purchase Agreement by and between the Issuer and Oasis Capital, LLC dated November 28, 2017 (incorporated by reference to September 27, 2019 (37)Exhibit 10.1 to the Current Report on Form 8-K filed on November 29, 2017)

10.2 

Senior Secured Promissory Note Issued to Oasis Capital, LLC dated September 27, 2019 (37)Exhibit 10.2

10.3

Security Agreement by and between the Issuer and Oasis Capital, LLC dated September 27, 2019 (37)Exhibit 10.3

10.4

Equity Purchase Agreement by and between the Issuer and Oasis Capital, LLC dated October 24, 2019 (40)Exhibit 10.4

10.5

Registration Rights Agreement by and between the Issuer and Oasis Capital, LLC dated November 28, 2017 (incorporated by reference to October 24, 2019 (40)Exhibit 10.2 to the Current Report on Form 8-K filed on November 29, 2017)10.5

23.1*10.6 

Promissory Note Issued to Oasis Capital, LLC dated November 26, 2019 (43)Exhibit 10.6

10.7

Securities Purchase Agreement by and between the Issuer and Oasis Capital, LLC dated February 5, 2020 (45)Exhibit 10.7

10.8

Senior Secured Promissory Note Issued to Oasis Capital, LLC dated February 5, 2020 (45)Exhibit 10.8

10.9

Security Agreement by and between the Issuer and Oasis Capital, LLC dated February 5, 2020 (45)Exhibit 10.9

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10.10Securities Purchase Agreement by and among the Company and the Investors dated March 15, 2020 (46)Exhibit 10.10
10.11

Registration Rights Agreement by and among the Company and the Investors dated March 15, 2020 (46)Exhibit 10.11

10.12

Amendment #3 to the Amended and Restated Senior Secured Promissory Note Originally Issued on September 28, 2018 (47)Exhibit 10.12

10.13Amendment #1 to the Senior Secured Promissory Note Originally Issued on September 27, 2019 (47)Exhibit 10.13

23.1**Consent of Olsen ThielenDeloitte & Touche LLP
23.2**Consent of Schneider Downs & Co., Ltd.Inc.
23.2* 
23.3**Consent of Maslon LLP (included as part of Exhibit 5.1)
24.1* 
24.1**Power of Attorney (included on signature page hereto)page)

 

** Filed herewith

(1)

Filed on December 19, 2013 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(2) - (5)   RESERVED
(6)Filed on October 24, 2014 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(7)Filed on June 30, 2015 as an appendix to our Information Statement on Schedule 14C and incorporated herein by reference.
(8)Filed on February 6, 2018 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(9)Filed on August 20, 2015 as an exhibit to our Registration Statement on Form S-1 (File No. 333-198962) and incorporated herein by reference.
(10)Filed on August 10, 2015 as an exhibit to our Registration Statement on Form S-1 (File No. 333-198962) and incorporated herein by reference.
(11)Filed on September 16, 2016 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(12)Filed on October 27, 2016 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(13)Filed on January 27, 2017 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

II-9

(14)Filed on March 25, 2016 as an exhibit to our Registration Statement on Form S-4 (File No. 333-210398) and incorporated herein by reference.
(15)Filed on November 30, 2016 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(16)Filed on January 10, 2017 as an exhibit to our Registration Statement on Form S-1 (File No. 333-215005) and incorporated herein by reference.
(17)RESERVED
(18)

Filed on October 30, 2018 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(19)RESERVED
(20)Filed on November 29, 2017 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(21)Filed on January 2, 2018 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(22)Filed on January 10, 2018 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(23)Filed on October 4, 2018 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(24)Filed on March 22, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(25)Filed on February 12, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(26)Filed on March 1, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(27)Filed on December 7, 2018 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(28)Filed on January 14, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(29)RESERVED
(30)

RESERVED

(31)

Filed on April 2, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(32)

RESERVED

(33)RESERVED

II-10

(34)

Filed on June 13, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(35)

Filed on June 19, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(36)

RESERVED

(37)

Filed on September 30, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(38)

Filed on October 3, 2019 as an exhibit to our Registration Statement on Form S-3 (File No. 333-234073) and incorporated herein by reference

(39)

Filed on October 10, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(40)

Filed on October 25, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(41)

Filed on October 28, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(42)

RESERVED

(43)

Filed on December 19, 2019 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(44)

RESERVED

(45)

Filed on February 7, 2020 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(46)

Filed on March 16, 2020 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(47)

Filed on March 23, 2020 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference

(48)Filed on April 1, 2020 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference

 

 

II-11