Registration No. 333-___________
As
filed with the Securities and Exchange Commission on September 30,
2022
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
________________________________
Predictive Oncology Inc.
(Exact name of registrant as specified in its charter)
Delaware |
3842 |
33-1007393 |
(State or jurisdiction |
(Primary Standard Industrial |
(I.R.S. Employer |
of incorporation or organization) |
Classification Code Number) |
Identification No.) |
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 and telephone number of agent for service)
|
Copy to:
Martin R. Rosenbaum, Esq.
Maslon LLP
3300 Wells Fargo Center
90
South 7th Street
Minneapolis, Minnesota 55402
Telephone: (612) 672-8200
Facsimile: (612) 672-8397
|
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 any of the securities
being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box: ☒
If this Form 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.
☐
If this Form 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 Form is a
post-effective amendment filed pursuant to Rule 462(d) 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. ☐
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 the definitions of “large accelerated
filer,” “accelerated filer,” “smaller reporting 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. ☐
________________________________
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.
The
information in this prospectus is not complete and may be changed.
The selling stockholders 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 is not soliciting an offer to buy these
securities in any jurisdiction where the offer or sale is not
permitted.
SUBJECT TO COMPLETION - DATED September 30, 2022
PRELIMINARY PROSPECTUS

PREDICTIVE ONCOLOGY INC.
4,737,280 Shares
Common Stock
This prospectus relates
to the offer and resale from time to time by the selling
stockholders named in this prospectus of up to an aggregate of
4,737,280 shares of our common stock, par value $0.01 per share.
These shares consist of (i) 3,837,280 shares of common stock
issuable upon the exercise of common stock purchase warrants that
were initially issued in a private placement to certain
institutional and accredited investors and (ii) 900,000 shares of
common stock issuable upon the exercise of placement agent warrants
that were initially issued to certain designees of H.C. Wainwright
& Co., LLC (“Wainwright”), as part of Wainwright’s compensation
for serving as our exclusive placement agent in connection with the
private placement and two concurrent registered direct offerings
completed on May 18, 2022.
Our registration of the
securities covered by this prospectus does not mean that the
selling stockholders will offer or sell any of the shares of common
stock. The selling stockholders may sell or otherwise dispose of
the shares of common stock publicly or through private transactions
at prevailing market prices or at negotiated prices. We provide
more information about how the selling stockholders may sell their
shares in the section entitled “Plan of Distribution.”
One or more of the
selling stockholders may be deemed to be “underwriters” within the
meaning of the Securities Act of 1933, as amended (the “Securities
Act”), in connection with the resale of our common stock. We will
bear all costs, expenses and fees in connection with the
registration of the shares. The selling stockholders will bear all
commissions and discounts, if any, attributable to their respective
sales of the shares.
We will not receive any
proceeds from the sale of shares of common stock by the selling
stockholders. We will, however, receive the proceeds from any
exercise of the warrants for cash.
Our common stock is listed on the Nasdaq Capital Market under the
symbol “POAI.” On September 29, 2022, the last reported per share
price of our common stock on the Nasdaq Capital Market was $0.3641
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 11 of this
prospectus under the caption “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
,
2022.
Table of Contents
|
Page |
About
this Prospectus |
1 |
Industry and Market Data |
1 |
The
Company |
2 |
Offering Summary |
10 |
Risk
Factors |
11 |
Cautionary Note Regarding Forward Looking
Statements |
11 |
Use of Proceeds |
12 |
Description of Capital Stock |
12 |
Selling Stockholders |
15 |
Plan
of Distribution |
17 |
Legal
Matters |
18 |
Experts |
18 |
Where
You Can Find More Information |
18 |
Incorporation of Certain Documents by
Reference |
18 |
ABOUT THIS PROSPECTUS
We
urge you to read carefully this prospectus, together with the
information incorporated herein by reference as described under
“Incorporation of Certain Documents by Reference” before buying any
of the securities offered.
This prospectus is part of a registration statement that we have
filed with the Securities and Exchange Commission (the “SEC”) under
which the selling stockholders named herein may, from time to time,
offer and sell or otherwise dispose of the securities covered by
this prospectus.
A
prospectus supplement may add, update or change information
included in this prospectus. You should read both this prospectus
and any applicable prospectus supplement together with additional
information described below under the heading “Where You Can Find
Additional Information.”
You should rely only on the information contained or incorporated
by reference in this prospectus and any applicable prospectus
supplement. Neither we nor the selling stockholders have authorized
anyone to provide you with different information, and if anyone
provides, or has provided you, with different or inconsistent
information, you should not rely on it. We and the selling
stockholders take no responsibility for, and can provide no
assurance as to the reliability of, any other information that
others may give you. This prospectus is an offer to sell only the
securities offered hereby and only under circumstances and in
jurisdictions where it is lawful to do so. This prospectus is not
an offer to sell securities, and it is not soliciting an offer to
buy securities, in any jurisdiction where the offer or sale is not
permitted. You should assume that the information appearing in this
prospectus, any prospectus supplement or in the documents
incorporated by reference herein is accurate only as of the date of
the document containing the information, regardless of the time of
delivery of this prospectus or any applicable prospectus supplement
or any sale of a security. Our business, financial condition,
results of operations and prospects may have changed since those
dates.
For investors outside of the United States, neither we nor the
selling stockholders have done anything that would permit this
offering or possession or distribution of this prospectus in any
jurisdiction where action for that purpose is required, other than
in the United States. You are required to inform yourselves about,
and to observe any restrictions relating to, this offering and the
distribution of this prospectus outside of the United States.
INDUSTRY AND MARKET DATA
This prospectus and the
information incorporated by reference herein contain market and
industry statistics that are based on various sources that we
believe is accurate. It is generally based on academic and other
publications that are not produced for purposes of securities
offerings or economic analysis. We believe the data contained in
these reports or publications to be reliable as of the date of this
prospectus, but there can be no assurance as to the accuracy or
completeness of such information. We have not independently
verified the market and industry data obtained from these sources.
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
This summary contains
basic information about us. You should carefully read the entire
prospectus and the documents we incorporate by reference herein.
Some of the statements contained in this prospectus and the
documents incorporated by reference herein, including statements
under this summary and “Risk Factors”, are forward-looking
statements and may involve a number of risks and uncertainties. We
note that our actual results and future events may differ
significantly based upon a number of factors. You should not put
undue reliance on the these forward-looking statements. References
to “we,” “our,” “us,” the “Company,” or “Predictive” refer to
Predictive Oncology Inc., a Delaware corporation.
Business
Overview
We operate in four
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; second, tumor-specific 3D cell
culture models driving accurate prediction of clinical outcomes;
third, contract services and research focused on solubility
improvements, stability studies, and protein production, and;
fourth, 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 four reportable
segments: Helomics®, zPREDICTA®, SolubleTM and Skyline®.
The Helomics segment includes clinical testing and contract
research services that include the application of AI. Our zPREDICTA
segment specializes in organ-specific disease models that provide
3D reconstruction of human tissues accurately representing each
disease state and mimicking drug response enabling accurate testing
of anticancer agents. Our Soluble segment provides services using a
self-contained, automated system that conducts high-throughput,
self-interaction chromatography screens, using additives and
excipients commonly included in protein formulations resulting in
soluble and physically stable formulations for biologics. Our
Skyline segment consists of the STREAMWAY System product sales, and
our TumorGenesis® subsidiary (Research and Development) is included
within corporate. Going forward, we have determined that we will
focus our resources on the Helomics and zPREDICTA segments and our
primary mission statements to accelerate patient-centric drug
discovery to improve patient outcomes in cancer treatment,
harnessing the power of AI, and to develop tumor-specific 3D cell
culture models that provide accurate 3D reconstruction of human
tissues representing each cancer disease state.
On November 24, 2021, we
acquired zPREDICTA, Inc. (“zPREDICTA”) in a merger transaction, and
at that time we identified zPREDICTA as a reportable segment.
zPREDICTA’s business, which involves integration of organ-specific
cellular and extracellular elements into 3D culture models for in
vitro cancer drug testing, represents a unique segment in the
Predictive offerings.
Precision Medicine
Business
Our precision 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.
Our Patient-centric Drug Discovery using Active Learning asset
(“PeDAL”™) is a unique technology that combines our proprietary,
clinically validated patient tumor cell line assay (“TruTumor”™), a
vast knowledgebase of proprietary and public data together
(“TumorSpace”™) with active learning - the active learning allowing
the efficient exploration of compound drug responses against a
large diverse patient “space”. PeDAL offers researchers the
opportunity to efficiently and cost-effectively bring patient
diversity much earlier in the drug discovery process. PeDAL works
by iterative cycles of active-learning powered Learn-Predict-Test
to guide the testing of patient-specific compound responses using
the TruTumor assay and patient cell lines to build a comprehensive
predictive model of patient responses to compounds. This predictive
model can then be used to rank compounds by the fraction of
patients of certain profiles that respond as well as the set of
compounds that provide the best coverage across patients. PeDAL
will be used in fee-for-service projects with pharmaceutical
companies.
Contract Research
Organization (“CRO”) and AI-Driven Business
We believe leveraging our
unique, historical database of the drug responses of over 150,000
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. Through the course of over 15 years of clinical
testing of the responses of patient tumors to drugs, Helomics has
amassed a huge proprietary knowledgebase of 150,000 patient cases.
This data has been rigorously de-identified and aggregated to build
a unique, proprietary model of tumor drug response that we call
TumorSpace. The TumorSpace model and its data provide a
priori knowledge for the machine learning approaches we employ
as part of the PeDAL approach.
TumorSpace model provides
a significant competitive advantage to our business offerings.
PeDAL's unique patient and tumor-centric AI-driven approach can
rapidly and cost-effectively screen hundreds of compounds in
thousands of tumor cell lines, and gain valuable information about
off-target effects and deliver:
|
· |
A ranked list of drug candidates by responsiveness |
|
· |
Sets of drug candidates that provide maximum patient
coverage |
|
· |
Biomarker profiles of patients that respond to specific drug
candidates |
PeDAL also can deliver
drug candidates targeted at a specific patient profile as early as
the hit-to-lead stage of discovery, significantly increasing the
chance of clinical success, leading to a dramatic improvement in
both the success, time, and cost of your oncology discovery
programs. The AI-driven models will, once validated, also provide
clinical decision support to help oncologists individualize
treatment.
Our CRO/AI business
leverages our core competence in profiling the drug response of
patient tumors. Our large knowledgebase of tumor drug response and
other data, together with proven AI, has created a unique
capability for oncology drug discovery that allows for the highly
efficient screening of drug responses from thousands of diverse,
well-characterized patient primary tumor cell lines. This novel
disruptive patient-centric approach is ideally suited to the early
part of drug discovery (especially hit-to-lead, lead optimization,
and pre-clinical), resulting in better prioritization of compounds
and better coverage of patient diversity. This will dramatically
improve the chances of successfully translating discoveries,
resulting in lowered costs, shortened timelines, and most
importantly enhanced “speed-to-patient” for new therapies.
Our CRO services business
applies PeDAL 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 TruTumor platform; |
|
· |
TumorSpace model of over 150,000 tumor cases; |
|
· |
Experienced AI team and AI/Core® 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.
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 this 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, due to a lack of research regarding which
mutations in a tumor confer a sensitivity to a particular drug. 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. Our Helomics
TumorSpace database addresses this need.
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 Tumor Drug Response Testing (formerly ChemoFx) and
Genomic Profiling (formerly BioSpeciFx) tests. The Tumor Drug
Response Testing determines how a patient’s tumor specimen responds
to a panel of various chemotherapy drugs, while the Genomic
Profiling evaluates the expression of specific genes, or
biomarkers, in the patient’s tumor. Our proprietary TruTumor 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. Tumor Drug
Response Testing is a fresh tissue platform that uses the patient’s
own live tumor cells to help physicians identify effective
treatment options for each gynecologic cancer patient.
Genomic Profiling offers
a select group of clinically relevant protein expression and
genetic mutation tests associated with drug response and disease
prognosis. Physicians can select biomarkers for testing from
carefully chosen panels of relevant tests, intuitively organized by
cancer pathway and tumor type. Results for these tests are
presented in a clear, easy to understand format, including
summaries of the clinical relevance of each marker.
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:
|
· |
TruTumor - a clinically validated tumor-profiling platform 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. |
|
· |
TumorSpace model contains data on the drug response profiles
across 131 cancer types over 10+ years of clinical testing. |
Over 38,000 of the more
than 150,000 clinically validated cases in our TumorSpace 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
TumorSpace platform to build AI-driven predictive models of tumor
drug response and outcome. 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 is the understanding that our AI-driven
models of tumor drug response serve 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, PeDAL tumor
profiling, and CLIA laboratory to provide custom solutions
utilizing our full array of assets and expertise.
The Cancer Quest 2020
initiative focused 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.
We completed our
Discovery 21 campaign, the proof of concept for PeDAL, which
incorporates CoRE™, our active machine learning program, with tumor
profile data and human tumor samples, to efficiently determine the
most effective drug treatment for a specific cancer type. With each
iteration of PeDAL, the program learns, predicts, and then directs
the most informative wet lab experimentation, while building the
predictive model.
Discovery 21 demonstrated
that a predictive model was built in an efficient manner using
PeDAL and that the model revealed drug response patterns that
provide insight into the treatment of ovarian cancer. This was
followed by a validation round, with results demonstrating the
accuracy of the model that predicted drug response. Within the
clinical sector, we will be able to 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 fee-for-service
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.
zPREDICTA
zPREDICTA develops
tumor-specific in vitro models for oncology drug discovery and
research by biopharmaceutical companies and other clients and
partners. zPREDICTA’s 3D product models accelerate the drug
development process for its clients and partners by leveraging the
expertise in carcinogenesis, metastasis and the tumor
microenvironment. It develops complex in vitro models that
recapitulate the physiological environment of human tissue.
From target discovery and
lead optimization to preclinical evaluation of efficacy and
toxicity, the objective is to develop the tools necessary to
accurately identify compounds that will have the highest
probability of improving human health. Product offerings include
preclinical testing services based on our proprietary models
directly to clients in the biopharmaceutical industry.
zPREDICTA has expertise
in creating human, disease-specific tissue microenvironments for
testing drug efficacy and safety. Unlike other platforms, the
patented 3D models utilize proprietary organ-specific extracellular
matrix formulations that match the in vivo milieu of the organ of
interest. These models reconstruct both cellular and extracellular
compartments of each tissue, which is especially essential for
testing of immuno-oncology agents.
zPREDICTA technology
demonstrates high clinical relevance, enabling its pharma clients
to manage pipeline attrition more efficiently by identifying drugs
that are effective in patients, from the hundreds, and often
thousands, of compounds in development. The tumor-specific models
are used by a number of biopharmaceutical companies to evaluate the
efficacy and toxicity of their therapeutic pipelines. Our models
replicate the extracellular matrix (“ECM”) of individual organs and
disease-specific soluble microenvironment mimicking the biology of
human disease, and as such, demonstrate high correlation with
clinical response.
The zPREDICTA 3D
tumor-specific models incorporate tissue-specific extracellular
matrices and tumor-specific medium supplements allowing for a true
reconstruction of tumor microenvironment. Our approach is
compatible with multiple classes of immuno-oncology agents from
naked antibodies and antibody-drug conjugates, to bi- and
tri-specific compounds, and CAR-T cells. The organ-specific disease
models provide 3D reconstruction of human tissues accurately
representing each disease state and mimicking drug response.
Our platform incorporates
both cellular and extracellular elements of tissue microenvironment
in an organ- and disease-specific manner.
Extracellular
components |
Cell-cell
interactions |
·
extracellular matrix |
·
tumor-tumor interactions |
·
soluble factors (cytokines,
etc.) |
·
tumor-stroma interactions |
Our platform is designed
to evaluate drug candidates and drug combinations within the native
microenvironment of human tissues. Our technology is a
patient-derived 3D culture platform that recreates the complex
human organ microenvironment thereby preserving the critical
interactions between a tumor and its surroundings. Our platform
supports long-term survival and proliferation of malignant and
non-malignant cellular components of tissues. This includes tumor
cells, stroma, and immune components. Anticancer cancer compounds
tested in our models exhibit high correlation with clinical
response when comparing treatment outcomes in the clinic with
cellular behavior in response to the therapeutic regimen. Our
organ-specific technology is compatible with multiple drug classes,
including small molecules, antibodies, antibody-drug conjugates,
immunomodulatory agents, CAR-T cells, etc. Our platform is fully
customizable to the tumor and tissue of interest. It is compatible
with multiple cell types, drug classes, and downstream analysis
methods.
Applications include
providing efficacy screening of anticancer compounds, evaluation of
mechanisms of drug resistance, identification of new drug
combinations, rescue of failed drug candidates, assessment of
off-target toxicity, target discovery and biomarker discovery.
Soluble
Biotech
Our subsidiary, Soluble
Biotech Inc. (“Soluble”), focuses on contract services and research
for biopharmaceutical company clients and academic collaborators,
focused on solubility improvements, stability studies, and protein
production. Specifically, Soluble provides optimized FDA-approved
formulations for vaccines, antibodies, and other protein
therapeutics in a faster and lower cost basis to its customers. In
addition, Soluble enables protein degradation studies, which is a
new and, based on current projections, potentially substantial line
of business for the Company.
The primary assets of
Soluble are our automated High Throughput Self-Interaction
Chromatography (HSC™). HSC is a self-contained, automated system
that conducts high-throughput, self-interaction chromatography
screens on excipients previously approved by the FDA for protein
formulations. Our technology measures second virial coefficient
(B22 value) of protein-protein interactions to identify excipients
that promote protein solubility in solutions. The data generated
from HSC screens are analyzed by a proprietary predictive algorithm
to identify the optimal combination(s) of buffers, pH, and
excipients, resulting in increased solubility and physical
stability of proteins. Several of our clients have seen ten-fold
and hundred-fold increases in their protein’s solubility while
maintaining physical stability. For biopharmaceutical clients this
means faster development times and quicker progression of molecules
into the clinic. For academic collaborators, this means further
progression of biochemical & biology studies necessary to
advance fundamental research in areas of unmet medical need.
In addition, Soluble
provides comprehensive protein stability analysis. Analysis via
time-dependent shelf-life studies and forced degradation studies
designed to quickly determine which of the previously FDA approved
additives that will improve the solubility and stability of
proteins in solutions. Services include pre-formulation
development, stability assessment, and biophysical characterization
which evaluate variables including pH, temperature, humidity,
light, oxidizing agents, and mechanical stress to determine the
most promising additives, formulation of B22 values and
confirmation on conformation stability. We provide clients with a
list of the most promising additives from a set of over 40
different additives that can increase the solubility and stability
of protein formulations.
Soluble also offers
protein solubility kits that allow rapid identification of soluble
formulations. We provide four different kits to fulfill customer
solubility requirements. The kits are in 96-well format and provide
the tools and methods to compare relative solubility across 88
common formulations (with 8 controls). Soluble kits utilize a
simple mix and spin protocol that quickly evaluates aggregation
behavior as a function of pH, salt, and additives costing
significantly less than if manually determined. In addition, we
provide innovative technologies for bacterial detection and removal
in therapeutic proteins that continue to be a significant issue in
the pharmaceutical field.
In addition, Soluble
supplies proprietary technologies for bacterial endotoxin detection
and removal. Endotoxin is an inherent byproduct of bacterial
expression of therapeutic proteins. However, therapeutic proteins
are required to have extremely low endotoxin levels. Soluble
provides a product to remove endotoxin that works through multiple
molecular interactions for efficient removal over a wide range of
buffer conditions with minimal product loss. The detection of
endotoxin can also be adversely affected by the protein therapeutic
itself. To address this, Soluble provides sample treatment kits to
minimize detection interference while using standard detection
assays.
Skyline Medical – 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’s STREAMWAY System fully automates the collection,
measurement, and disposal of waste fluids and is designed to: (i)
reduce overhead costs to hospitals and surgical centers; (ii)
improve compliance with the Occupational Safety and Health
Administration (“OSHA”) and other regulatory agency safety
guidelines; (iii) improve efficiency in the operating room and
radiology and endoscopy departments, thereby leading to greater
profitability; and (iv) provide greater environmental stewardship
by helping to eliminate the approximately 50 million potentially
disease-infected canisters that go into landfills each year in the
United States. We continue to operate the Skyline Medical business
by continually improving our strategic opportunities, while
focusing our resources on our precision medicine business.
Industry and Market
Background and Analysis - Infectious and Biohazardous Waste
Management
There has long been
recognition of the collective potential for ill effects to
healthcare workers from exposure to infectious/biohazardous
materials. Federal and state regulatory agencies have issued
mandatory guidelines for the control of such materials, and in
particular, bloodborne pathogens. OSHA’s Bloodborne Pathogens
Standard (29 CFR 1910.1030) requires employers to adopt engineering
and work practice controls that would eliminate or minimize
employee exposure from hazards associated with bloodborne
pathogens. In 2001, in response to the Needlestick 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 room, (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 devices 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 competitors have extensive marketing and development budgets
that could overpower an emerging growth company like ours.
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 the endoscope) which requires
more fluid management and new medical technology.
STREAMWAY System
Product Sales
Our Skyline Medical
division consists primarily of sales of the STREAMWAY System, as
well as sales of the proprietary cleaning fluid and 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.
The STREAMWAY System 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 and
other patient procedures. We also manufacture and sell two
disposable products required for the operation of the STREAMWAY
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
use. The STREAMWAY disposables are a critical component of our
business model. Recurring 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. We have exclusive distribution
rights to the disposable solution.
TumorGenesis
Our subsidiary
TumorGenesisis is our research and development arm for Helomics and
zPREDICTA. TumorGenesis also specializes in media that help cancer
cells grow outside the patient’s body and retain their DNA/RNA and
proteomic signatures. With this tool, researchers are able to
expand and study cancer cell types inherent in blood tumors and
organ systems of all mammals, including humans.
May 2022 Concurrent
Registered Direct Offerings and Private Placement
On May 18, 2022, we
completed a registered direct offering in which we issued and sold
an aggregate of 3,837,280 shares of our common stock, at a purchase
price of $0.60 per share (“First Offering”). In addition, in a
concurrent private placement (“Private Placement”), we sold to the
same investors unregistered warrants to purchase up to an aggregate
of 3,837,280 shares of our common stock at an exercise price of
$0.70 per share (the “May 2022 Warrants”). The May 2022 Warrants
will become exercisable on November 18, 2022 and will expire on
November 18, 2027.
On May 18, 2022, we also
completed a concurrent registered direct offering in which we
issued and sold an aggregate of 8,162,720 shares of our common
stock, at a purchase price of $0.60 per share (“Second Offering”).
In connection with the Second Offering, we entered into a warrant
amendment agreement (the “Warrant Amendment Agreement”) with each
of the purchasers in the Second Offering. Under the Warrant
Amendment Agreement, we agreed to amend certain existing warrants
to purchase up to 16,325,435 shares of common stock that were
previously issued in 2020 and 2021 to the purchasers in the Second
Offering, with exercise prices ranging from $1.00 to $2.00 per
share (the “Existing Warrants”), as follows: (i) lower the exercise
price of the Existing Warrants to $0.70 per share, (ii) provide
that the Existing Warrants, as amended, will not be exercisable
until six months following the closing date of the Second Offering,
and (iii) extend the original expiration date of the Existing
Warrant by five and one-half years following the close of the
Second Offering. We refer to the First Offering, Second Offering
and the Private Placement collectively as the “May 2022
Offerings”.
We received aggregate net
proceeds of approximately $6.5 million, after deducting placement
agent fees and other offering expenses payable by us, from the
First Offering and Second Offering.
Wainwright served as our
exclusive placement agent in connection with the May 2022
Offerings. We paid Wainwright a cash fee equal to 7.5% of the
aggregate gross proceeds from the sale of the shares in the First
Offering and Second Offering; a management fee equal to 1.0% of the
aggregate gross proceeds from the sale of the shares in the First
Offering and Second Offering; $65,000 for non-accountable expenses;
and $15,950 for clearing fees. In addition, we issued to designees
of Wainwright as compensation warrants to purchase up to an
aggregate of 900,000 shares of our common stock (the “Placement
Agent Warrants”), equal to 7.5% of the aggregate number shares of
our common stock sold in the First Offering and Second Offering.
The Placement Agent Warrants have an exercise price equal to $0.75
per share, which is 125% of the offering price per share in the
First Offering and Second Offering, will become exercisable on
November 18, 2022 and will expire on May 16, 2027. We refer to the
May 2022 Warrants and the Placement Agent Warrants collectively as
the “Warrants.”
Corporate
Information
We were originally
incorporated on April 23, 2002 and reincorporated in Delaware in
2013. We changed our name from Skyline Medical, Inc. to Precision
Therapeutics, Inc. on February 1, 2018 and to Predictive Oncology
Inc. on June 13, 2019.
Our address is 2915
Commers Drive, Suite 900, Eagan, Minnesota 55121. Our telephone
number is (651) 389-4800, and our website address is
www.predictive-oncology.com. The information contained on, or that
can be accessed through, our website is not part of this
prospectus.
OFFERING SUMMARY
Common stock that may be offered by selling stockholders |
|
4,737,280 shares, which are comprised of (i) 3,837,280 shares of
common stock issuable upon the exercise of the May 2022 Warrants,
and (ii) 900,000 shares of stock issuable upon the exercise of the
Placement Agent Warrants. |
|
|
|
Use of proceeds |
|
The selling stockholders will receive all of the net proceeds from
the sale of the shares offered pursuant to this prospectus. We will
not receive any of the proceeds from these sales. However, we will
receive proceeds from the exercise of the Warrants if exercised for
cash.
|
|
|
|
Plan of Distribution |
|
The selling stockholders may sell or otherwise dispose the
shares of our common stock covered by this prospectus in a
number of different ways and at varying prices. For further
information, see “Plan of Distribution” beginning on page 17. |
|
|
|
Risk Factors |
|
You should read the “Risk Factors” section of this prospectus and
the other information contained or incorporated by reference in
this prospectus for a discussion of factors to consider carefully
before deciding to invest in shares of our common stock. |
RISK FACTORS
An investment in our
securities involves a number of risks. Before deciding to invest in
our securities, in addition to the risks and uncertainties
discussed below under “Cautionary Note Regarding Forward-Looking
Statements,” you should carefully consider the specific risks
described under the section captioned “Risk Factors” in our most
recent Annual Report on Form 10-K, as updated by our subsequent
quarterly and other reports we file with the SEC. If any of these
risks actually occur, our business, financial condition, results of
operations or cash flow could be materially 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 and
uncertainties described in the documents referenced above are not
the only ones that we face. Additional risks and uncertainties not
presently known to us or that we currently believe to be immaterial
may become material and adversely affect our business.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the
documents incorporated by reference may contain “forward-looking
statements” within the meaning of Section 27A of the Securities Act
and Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), We have based these forward-looking
statements on our current expectations and beliefs about future
developments or events and their potential effects on us.
Forward-looking statements generally relate to future events or our
future financial or operating performance. 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”, “potential” and
similar expressions intended to identify forward-looking
statements. These forward-looking statements are subject to known
and unknown risks, uncertainties and assumptions about us that may
cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. Important factors that may cause such differences
include:
· |
Our history of operating losses; |
|
|
· |
Current negative operating cash flows; |
|
|
· |
Our capital needs to accomplish our goals, and the adequacy of
available funds, including our ability to access the capital
markets, our ability to obtain additional equity funding from
current or new stockholders to fund our business operations and/or
future growth plans, and the dilutive effect that raising equity
capital would have on the relative equity ownership of our existing
investors; |
|
|
· |
Risks related to recent and future acquisitions, including the
possibility of further impairment of goodwill and risks related to
the benefits and costs of acquisition; |
· |
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; |
|
|
· |
Risk related to the protection of our intellectual property or
any future legal claims relating to 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; |
|
|
· |
Unexpected costs and operating deficits, and lower than
expected sales and revenues, if any; |
|
|
· |
Adverse results of any legal proceedings; |
|
|
· |
The volatility of our operating results and financial
condition; |
|
|
· |
Management of growth; |
|
|
· |
Risk that our business and operations will continue to be
materially and adversely affected by the COVID-19 pandemic, which
has impacted on a significant supplier; has resulted in delayed
production and less efficiency; and has impacted on our sales
efforts, accounts receivable, and terms demanded by suppliers; and
may impact financing transactions; |
|
|
●
|
Our ability to maintain
effective control over financial reporting; and
|
|
|
● |
Other specific risks that may be alluded to in
this prospectus. |
We discuss many of these
and other risks and uncertainties in greater detail under the
heading “Risk Factors” in our most recent Annual Report on Form
10-K, as updated in our subsequent Quarterly Reports on Form 10-Q.
Given these risks and uncertainties, you should not place undue
reliance on these forward-looking statements. We undertake no
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as may be required under applicable securities laws.
You should read this
prospectus, as well as the documents incorporated by reference into
this prospectus, completely and with the understanding that our
actual future results, performance and achievements may be
materially different from what we expect. We qualify all of the
forward-looking statements in the foregoing documents by these
cautionary statements.
USE OF PROCEEDS
We will not receive any
proceeds from the sale of shares of our common stock by the selling
stockholders identified in this prospectus. However, we will
receive proceeds from the exercise of the Warrants for cash. We
expect to use these proceeds for working capital purposes. We will
have broad discretion over the use of proceeds from the exercise of
the Warrants. There is no assurance that the holders of the
Warrants will elect to exercise any or all of such Warrants. The
Warrants contain a “cashless exercise” feature that allows the
holders to exercise any of such Warrants without making a cash
payment to us if there is not an effective registration statement
covering the resale of the shares issuable upon exercise of such
Warrants.
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 200,000,000 shares of common stock, and
20,000,000 shares of preferred stock, $0.01 par value per share. As
of September 20, 2022, there were 78,388,875 shares of common stock
outstanding and 79,246 shares of Series B Convertible Preferred
Stock outstanding. All of the outstanding shares of our capital
stock are fully paid and nonassessable.
Common Stock
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.
Preferred 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.
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.
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. |
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 Equiniti.
Listing
The shares of our common
stock are listed on The Nasdaq Capital Market under the symbol
“POAI.”
SELLING STOCKHOLDERS
The selling stockholders
acquired the Warrants from us in a private offering in connection
with the completion of the First Offering and Second Offering on
May 18, 2022, pursuant to an exemption from the registration
requirements under Section 4(a)(2) of the Securities Act and Rule
506 of Regulation D promulgated thereunder. We agreed to file a
registration statement with the SEC for the purposes of registering
for resale from time to time the shares of common stock that may be
issued upon exercise of the May 2022 Warrants and Placement Agent
Warrants. For additional information regarding the issuances of the
Warrants, see “The Company - May 2022 Concurrent Direct Offerings
and Private Placement.”
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, except
as described in the table below.
The table below lists the
selling stockholders and other information regarding the ownership
of the shares of common stock offered hereby by the selling
stockholders. The second column lists the number of shares of
common stock owned by each selling stockholder as of September 20,
2022, assuming exercise of the May 2022 Warrants or Placement Agent
Warrants held by such selling stockholder on that date without
regard to any limitations on exercises. The third column lists the
shares of common stock being offered by this prospectus by the
selling stockholders. The fourth column assumes the sale of all of
the shares offered by the selling stockholder pursuant to this
prospectus.
The May 2022 Warrants and
Placement Agent Warrants are not exercisable until November 18,
2022. In addition, a selling stockholder will not have the right to
exercise its May 2022 Warrants or Placement Agent Warrants to the
extent such exercise would cause the selling stockholder, together
with its affiliates, to beneficially own in excess of 4.99% or
9.99%, as applicable, of the then outstanding common stock
following such exercise, excluding for purposes of such
determination common stock issuable upon exercise of the May 2022
Warrants or Placement Agent Warrants which have not been exercised.
The number of shares in the second and fourth columns of the table
do not reflect these limitations. The selling stockholders may sell
all, some or none of their shares in this offering. See “Plan of
Distribution.”
We do not know how long the selling
stockholders will hold the Warrants, whether any will exercise the
Warrants, and upon such exercise, how long such selling
stockholders will hold the shares of common stock before selling
them. We currently have no agreements, arrangements or
understandings with the selling stockholders regarding the sale of
any of the shares.
Except as indicated by
the footnotes below, we believe, based on the information furnished
to us, that each of the selling stockholders has sole voting and
investment power with respect to all shares of common stock that
the selling stockholder owns, subject to applicable community
property laws. Except as otherwise described below, based on the
information provided to us by the selling stockholders, the selling
stockholders are not a broker-dealer or an affiliate of a
broker-dealer.
|
|
|
|
Shares Beneficially
Owned After Offering |
Name of Selling
Stockholder |
|
Shares
Beneficially Owned Before Offering |
|
Number of
Shares
Being Offered |
|
Number
of
Shares |
|
Percentage of
Class(1) |
Armistice Capital Master
Fund(2) |
|
|
12,546,287 |
|
|
|
3,050,000 |
(3) |
|
|
9,496,287 |
|
|
|
10.81 |
%(4) |
Bigger Capital Fund, LP
(5) |
|
|
890,000 |
|
|
|
250,000 |
(6) |
|
|
640,000 |
|
|
|
* |
|
District 2 Capital Fund LP
(5) |
|
|
890,000 |
|
|
|
250,000 |
(7) |
|
|
640,000 |
|
|
|
* |
|
Intracoastal Capital, LLC
(8) |
|
|
4,110,026 |
|
|
|
287,280 |
(9) |
|
|
3,822,746 |
|
|
|
4.67 |
% |
Michael Vasinkevich (10) |
|
|
2,263,653 |
|
|
|
577,125 |
(11) |
|
|
1,686,528 |
|
|
|
2.11 |
% |
Noam Rubinstein (10) |
|
|
1,204,301 |
|
|
|
283,500 |
(12) |
|
|
920,801 |
|
|
|
1.16 |
% |
Craig Schwabe (10) |
|
|
119,792 |
|
|
|
30,375 |
(13) |
|
|
89,417 |
|
|
|
* |
|
Charles Worthman (10) |
|
|
38,231 |
|
|
|
9,000 |
(14) |
|
|
29,231 |
|
|
|
* |
|
*
Less than 1%
(1) |
Based on
78,388,875 shares of our common stock issued and outstanding as of
September 20, 2022. In computing the percentage ownership of a
selling stockholder, we deemed outstanding shares of common stock
subject to Warrants held by that selling stockholder that are
exercisable within 60 days of September 20, 2022. We did not
deem these shares outstanding, however, for the purpose of
computing the percentage ownership of any other selling
stockholder. |
(2) |
The
shares are directly held by Armistice Capital Master Fund Ltd.
(“Master Fund”), a Cayman Islands exempted company, and may be
deemed to be indirectly beneficially owned by (i) Armistice
Capital, LLC (“Armistice”), as the investment manager of the Master
Fund; and (ii) Steven Boyd, as the Managing Member of
Armistice Capital. Armistice and Steven Boyd disclaim beneficial
ownership of the reported securities except to the extent of their
respective pecuniary interest therein. |
(3) |
Represents 3,050,000 shares of
common stock issuable upon the exercise of the May 2022 Warrants
that will become exercisable on November 18, 2022. Does not take
into account beneficial ownership limitations preventing Master
Fund from exercising any of the May 2022 Warrants to the extent
following such exercise its beneficial ownership would exceed
4.99%. |
(4) |
Does not take into account
beneficial ownership limitations preventing Master Fund from
exercising any of its warrants to the extent following such
exercise its beneficial ownership would exceed
4.99%. |
(5) |
Bigger Capital Fund GP, LLC
(“Bigger GP”) is a general partner of Bigger Capital Fund, LP
(“Bigger Capital”) and District 2 Capital LP (“District 2”) is the
investment manager of District 2 Capital Fund LP (“District 2 CF”).
Michael Bigger is the managing member of Bigger GP and District 2
and District 2 Holdings LLC (“District 2 Holdings”), which is the
managing member of District 2 GP LLC (“District 2 GP”), the general
partner of District 2 CF. Therefore, Mr. Bigger, District 2,
District 2 Holdings and District 2 CF may be deemed to be the
beneficial owner, and have the shared power to dispose of or direct
the disposition, of the shares reported as beneficially owned by
District 2 CF and Mr. Bigger and Bigger GP may be deemed to be the
beneficial owner, and have the shared power to dispose of or direct
the disposition, of the shares reported as beneficially owned by
Bigger Capital and District 2 CF. |
(6) |
Represents 250,000 shares of
common stock issuable upon the exercise of the May 2022 Warrants
that will become exercisable on November 18, 2022. The May 2022
Warrants are only exercisable to the extent that Bigger Capital and
its affiliates beneficially own no more than 4.99% of the
outstanding common stock after exercise. |
(7) |
Represents 250,000 shares of
common stock issuable upon the exercise of the May 2022 Warrants
that will become exercisable on November 18, 2022. The May 2022
Warrants are only exercisable to the extent that District 2 CF and
its affiliates beneficially own no more than 4.99% of the
outstanding common stock after exercise. |
(8) |
Mitchell P. Kopin (“Mr. Kopin”)
and Daniel B. Asher (“Mr. Asher”), each of whom are managers of
Intracoastal Capital, LLC (“Intracoastal”), have shared voting
control and investment discretion over the shares held by
Intracoastal. As a result, each of Mr. Kopin and Mr. Asher may be
deemed to have beneficial ownership (as determined under Section
13(d) of the Exchange Act) of the securities reported herein
that are held by Intracoastal. |
(9) |
Represents 287,280 shares of
common stock offered issuable upon the exercise of the May 2022
Warrants that will become exercisable on November 18, 2022. The May
2022 Warrants are only exercisable to the extent that Intracoastal
and its affiliates beneficially own no more than 9.99% of the
outstanding common stock after exercise. |
(10) |
The selling stockholder is
associated with Wainwright, a registered broker-dealer and the
placement agent for the May 2022 Offerings, and, as a designee of
Wainwright, received Placement Agent Warrants in the transactions
described under “The Company – May 2022 Concurrent Registered
Direct Offerings and Private Placement.” |
(11) |
Represents 577,125 shares of
common stock issuable upon the exercise of the Placement Agent
Warrants that will become exercisable on November 18, 2022. The
Placement Agent Warrants are only exercisable to the extent that
Michael Vasinkevich and his affiliates beneficially own no more
than 4.99% of the outstanding common stock after
exercise. |
(12) |
Represents 283,500 shares of
common stock issuable upon the exercise of the May 2022 Warrants
that will become exercisable on November 18, 2022. The May 2022
Warrants are only exercisable to the extent that Noam Rubinstein
and his affiliates beneficially own no more than 4.99% of the
outstanding common stock after exercise. |
(13) |
Represents 30,375 shares of
common stock issuable upon the exercise of the May 2022 Warrants
that will become exercisable on November 18, 2022. The May 2022
Warrants are only exercisable to the extent that Craig Schwabe and
his affiliates beneficially own no more than 4.99% of the
outstanding common stock after exercise. |
(14) |
Represents 9,000 shares of common
stock issuable upon the exercise of the May 2022 Warrants that will
become exercisable on November 18, 2022. The May 2022 Warrants are
only exercisable to the extent that Charles Worthman and his
affiliates beneficially own no more than 4.99% of the outstanding
common stock after exercise. |
PLAN OF DISTRIBUTION
We are registering the
resale by the selling stockholders or their permitted transferees
of up to 4,737,280 shares of common stock that are issuable upon
the exercise of the Warrants. The selling stockholders will act
independently of us in making decisions with respect to the timing,
manner and size of each sale. We will pay all fees and expenses
incident to the registration of the securities to be offered and
sold pursuant to this prospectus. The selling stockholders will
bear all commissions and discounts, if any, attributable to their
sale of securities.
The selling stockholders
or their permitted transferees may, from time to time, sell any or
all of shares of our common stock covered hereby on the Nasdaq
stock market, or any other stock exchange, market or trading
facility on which the shares are traded or in private transactions.
These sales may be at fixed prices, at prevailing market prices at
the time of sale, at varying prices or at negotiated prices. The
selling stockholders may use any one or more of the following
methods when selling securities:
|
· |
ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers; |
|
· |
underwritten transactions; |
|
· |
block trades (which may involve a cross trade) in which the
broker-dealer will attempt to sell the securities 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; |
|
· |
settlement of short sales; |
|
· |
in transactions through broker-dealers that agree with the
selling stockholders to sell a specified number of such securities
at a stipulated price per security; |
|
· |
through the distribution of shares by any selling stockholder
to its partners, members or stockholders; |
|
· |
through the writing or settlement of options or other hedging
transactions, whether through an options exchange or
otherwise; |
|
· |
a combination of any such methods of sale; or |
|
· |
any other method permitted
pursuant to applicable law. |
The selling stockholders
may also sell securities under Rule 144 under the Securities Act,
if available, rather than under this prospectus.
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, but, except as set forth in a
supplement to this prospectus, in the case of an agency transaction
not in excess of a customary brokerage commission in compliance
with FINRA Rule 2121; and in the case of a principal transaction a
markup or markdown in compliance with FINRA Rule 2121. Discounts,
concessions, commissions and similar selling expenses, if any, that
can be attributed to the sale of common stock will be paid by the
selling stockholders and/or the purchasers.
In connection with the
sale of the securities or interests therein, the selling
stockholders may enter into hedging transactions with
broker-dealers or other financial institutions, which may in turn
engage in short sales of the securities in the course of hedging
the positions they assume. The selling stockholders may also sell
securities short and deliver these securities to close out their
short positions, or loan or pledge the securities to broker-dealers
that in turn may sell these securities. The selling stockholders
may also enter into option or other transactions with
broker-dealers or other financial institutions or create one or
more derivative securities which require the delivery to such
broker-dealer or other financial institution of securities offered
by this prospectus, which securities such broker-dealer or other
financial institution may resell pursuant to this prospectus (as
supplemented or amended to reflect such transaction).
The selling stockholders
and any broker-dealers or agents that are involved in selling the
securities 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
profit on the resale of the shares purchased by them may be deemed
to be underwriting commissions or discounts under the Securities
Act.
We agreed to keep this
prospectus effective until no selling stockholder that was a
purchaser in the First Offering owns any May 2022 Warrants or
shares of common stock issuable upon exercise of the May 2022
Warrants.
Under applicable rules
and regulations under the Exchange Act, any person engaged in the
distribution of the resale of securities may not simultaneously
engage in market making activities with respect to the common stock
for the applicable restricted period, as defined in Regulation M,
prior to the commencement of the distribution. In addition, the
selling stockholders will be subject to applicable provisions of
the Exchange Act and the rules and regulations thereunder,
including Regulation M, which may limit the timing of purchases and
sales of securities of the common stock by the Selling Stockholders
or any other person. We will make copies of this prospectus
available to the selling stockholders and have informed them of the
need to deliver a copy of this prospectus to each purchaser at or
prior to the time of the sale.
LEGAL MATTERS
The validity of any
securities offered from time to time by this prospectus will be
passed upon by Maslon LLP, Minneapolis, Minnesota.
EXPERTS
Baker Tilly US, LLP, our independent registered public accounting
firm, has audited our consolidated financial statements as of and
for the years ended December 31, 2021 and 2020 included in our
Annual Report on Form 10-K for the year ended December 31, 2021,
which are incorporated by reference into this prospectus and
elsewhere in the registration statement, and are included in
reliance upon such report given on the authority of such firm as
experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the
SEC a registration statement on Form S-1 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 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.
We file annual, quarterly
and current reports, proxy statements and other information with
the SEC. The SEC maintains a website that contains reports, proxy
statements and other information regarding issuers that file
electronically with the SEC, including us. The address of the SEC
website is www.sec.gov.
We maintain a website at
www.predictive-oncology.com. Information contained in, or
accessible through, our 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 DOCUMENTS 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 the SEC. This means that we can disclose important
information to you by referring you to those documents 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 considered part of this prospectus. Second,
the information in documents that we file in the future will update
and supersede the current information in, and incorporated by
reference in, this prospectus until we file a post-effective
amendment that indicates the termination of the offering of the
common stock made by this prospectus.
We incorporate by
reference the documents listed below and any future filings we will
make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the
Exchange 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 contrary), 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:
|
• |
Our Annual Report on Form 10-K for the fiscal year ended
December 31, 2021 filed on March 31, 2022; |
|
• |
Our Quarterly Report on Form 10-Q for the quarter ended March
31, 2022 filed on May 12, 2022; |
|
• |
Our Quarterly Report on Form 10-Q for the quarter ended June
30, 2022 filed on August 11, 2022; |
|
• |
Our Current Reports on Form 8-K filed on January 4, 2022,
February 18, 2022, March 31, 2022, May 12, 2022, May 13, 2022, May
18, 2022, May 23, 2022, July 26, 2022, August 11, 2022, September
14, 2022 and September 16, 2022; |
|
• |
Our Current Report on Form 8-K/A filed on February 10, 2022;
and |
|
• |
The description of the Company’s common stock under the caption
“Description of Predictive Capital Stock – Common Stock” in the
Company’s Amendment No 2 to Registration Statement on Form S-4 as
filed with the SEC on January 24, 2019, as amended by the
description filed as Exhibit 4.14 to the Company’s Annual Report on
Form 10-K on March 31, 2022. |
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:
Predictive Oncology Inc.
Attention: Corporate Secretary
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
(651)
389-4800
PREDICTIVE ONCOLOGY INC.
4,737,280 Shares
Common Stock
______________________
PROSPECTUS
______________________
[•], , 2022
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other
Expenses Of Issuance And Distribution.
The following table sets
forth the costs and expenses, payable by the registrant in
connection with the sale of common stock being registered. All
amounts are estimates except the SEC registration fee and the
Nasdaq listing fee.
Securities and Exchange Commission registration fee |
|
$ |
166.44 |
|
NASDAQ listing
fee |
|
$ |
5,000.00 |
|
Printing and
engraving expenses |
|
$ |
3,000.00 |
|
Legal fees and
expenses |
|
$ |
25,000.00 |
|
Accounting fees
and expenses |
|
$ |
10,000.00 |
|
Miscellaneous |
|
$ |
1,833.56 |
|
Total |
|
$ |
45,000.00 |
|
Item 14. 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.
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 15. Recent Sales
of Unregistered Securities.
The Registrant has issued
the following securities that were not registered under the
Securities Act with the past three years:
(1) In June through
September 2019, we issued and sold to certain accredited investors
258 shares of Series E convertible preferred stock at a purchase
price of $10,000 per share, pursuant to a securities purchase
agreement. We agreed to pay to Dawson James Securities, Inc., as
placement agent, a commission of 8% of the gross proceeds raised
from the sale of the Series E convertible preferred stock and
warrants to purchase our common stock on a cashless basis based on
5% warrant coverage on the Series E convertible preferred stock
sold in the offering. We also agreed to reimburse the placement
agent for legal fees equal to $25,000 plus $4,000 per closing, plus
other reasonable out-of-pocket expenses not to exceed $5,000.
The Series E convertible
preferred stock and the warrants were issued pursuant to an
exemption from registration contained in Section 4(a)(2) of the
Securities Act and Rule 506 promulgated thereunder.
(2) On September 27,
2019, we issued to Oasis Capital, LLC (i) a secured promissory note
in the original principal amount of $847,500 that accrues interest
at a rate of 8% per annum (with six months of interest guaranteed)
and that matures six months from September 27, 2019 (“Oasis Note”),
and (ii) an aggregate of 8,857 shares of our common stock plus a
warrant to acquire up to 68,237 shares of the our common stock at
an exercise price of $6.21 per share, in exchange for a cash
investment of $700,000, pursuant to a securities purchase
agreement.
The issuance of the
forgoing securities was not registered under the Securities Act in
reliance upon the exemption from registration provided by Section
4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(3) On September 27,
2019, we issued 15,000 shares of common stock to L2 Capital, LLC
pursuant to an amendment to the Amended and Restated Senior Secured
Promissory Note dated September 28, 2018 and amended restated as of
February 7, 2019 (“L2 Note”), under which, among other things, L2
Capital, LLC waived its rights under the L2 Note to have the L2
Note repaid from the proceeds of any financing consummated by
us.
The shares of common
stock were issued pursuant to an exemption from registration
contained in Section 4(a)(2) of the Securities Act and/or Rule 506
promulgated thereunder.
(4) On October 24, 2019,
we issued to Oasis Capital, LLC 104,651 shares of our common stock
having an aggregate market value of $450,000, as consideration for
its commitment to purchase shares of our common stock having an
aggregate value of up to $15.0 million over a period of three
years, pursuant to that certain Equity Purchase Agreement dated
October 24, 2019.
The shares of common
stock were issued pursuant to an exemption from registration
contained in Section 4(a)(2) of the Securities Act and/or Rule 506
promulgated thereunder.
(5) On November 12, 2019,
we issued 10,356 shares of common stock valued at $34,923 in
payment for investor relations services.
The shares of common
stock were issued pursuant to an exemption from registration
contained in Section 4(a)(2) of the Securities Act and/or Rule 506
promulgated thereunder.
(6) On December 12, 2019,
we issued 15,000 shares of common stock to L2 Capital, LLC pursuant
to a second amendment to the L2 Note, under which, among other
things, L2 Capital, LLC waived its rights under the L2 Note to have
the L2 Note repaid from the proceeds of any financing consummated
by us.
The shares of common
stock were issued pursuant to an exemption from registration
contained in Section 4(a)(2) of the Securities Act and/or Rule 506
promulgated thereunder.
(7) On January 31, 2020,
we issued to Dr. Carl Schwartz, our CEO and director at that time,
(i) a promissory note in the original principal amount of
$2,115,000 that bears interest at 12% per annum and matures on
September 30, 2020 (“Schwartz Note”) and (ii) 50,000 shares of our
common stock, in exchange for, among other things, cancellation by
Dr. Schwartz of two existing promissory notes with a total
outstanding amount of $1,935,000 and warrants to purchase up to an
aggregate of 97,313 shares of our common stock at exercise prices
ranging from $7.04 to $11.88 per share, pursuant to an Exchange
Agreement dated January 31, 2020.
The issuance of the
forgoing securities was not registered under the Securities Act in
reliance upon the exemption from registration provided by Section
4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(8) On February 5, 2020,
we issued to Oasis Capital, LLC (i) a secured convertible
promissory note in the aggregate principal amount of $1,450,000
that accrues interest at a rate of 8% per annum (with six months of
interest guaranteed) and matures six months after February 5, 2020,
(ii) five-year warrants to purchase up to an aggregate of 280,031
shares of our common stock at an exercise price equal to $2.992 per
share and (iii) 46,875 shares of our common stock, in exchange for
a cash investment of $1,200,000 pursuant to a securities purchase
agreement dated as of February 5, 2020.
The issuance of the
forgoing securities was not registered under the Securities Act in
reliance upon the exemption from registration provided by Section
4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(9) On March 19, 2020,
pursuant to securities purchase agreement with certain accredited
investors, we issued, for aggregate gross proceeds of approximately
$3,500,000, (i) an aggregate of 260,000 shares of our common stock;
(ii) prefunded warrants to purchase 1,390,166 shares of our common
stock at an exercise price of $0.001 per share; (iii) Series A
warrants to purchase an aggregate of 1,650,166 shares of our common
stock at an exercise price of $1.88 per share; and (iv) Series B
warrants to purchase 1,650,166 shares of our common stock at an
exercise price of $1.88 per share.
Pursuant to a letter agreement dated March 15, 2020, we paid to
H.C. Wainwright & Co, LLC (“Wainwright”), which acted as
placement agent for the offering, an aggregate fee equal to 7.5% of
the aggregate gross proceeds received by us in the offering, a
management fee equal to 1% of the aggregate gross proceeds received
by us in the offering, $25,000 in non-accountable expenses and up
to $40,000 in legal and other out-of-pocket expenses. We also
issued to the placement agent warrants to purchase up to 123,762
shares of our common stock at an exercise of $2.65125 (equal to
125% of the offering price).
The
issuance of the forgoing securities was not registered under the
Securities Act in reliance upon the exemption from registration
provided by Section 4(a)(2) of the Securities Act and Rule 506
promulgated thereunder.
(10)
On March 19, 2020, we issued 30,000 shares of our common stock to
Oasis Capital, LLC pursuant to an amendment to the Oasis Note,
under which, among other things, Oasis Capital, LLC waived its
rights to have the Oasis Note repaid from the proceeds of any
financing consummated by us.
The
shares of common stock were issued pursuant to an exemption from
registration contained in Section 4(a)(2) of the Securities Act
and/or Rule 506 promulgated thereunder.
(11)
On April 21, 2020, we issued to Dr. Carl Schwartz, our CEO and
director at that time, 1,533,481 shares of our common stock in
exchange for cancellation of the Schwartz Note having a total
outstanding balance of $2,192,878 in principal and accrued
interest, pursuant to an exchange agreement dated April 21,
2020.
The
shares of common stock were issued pursuant to an exemption from
registration contained in Section 3(a)(9) of the Securities
Act.
(12)
On March 3, 2020, Peter Morawetz, a former Board member, was given
5,000 shares of common stock, valued at $9,800. On March 4, 2020,
we issued 150,000 shares of common stock at $2.35 per share in
payment for public relations services. The shares of common stock
were issued pursuant to an exemption from registration contained in
Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(13)
On May 27, 2020, we issued 125,000 shares of our common stock to
InventaBioTech, Inc. (“IBT”) and its designees pursuant to an asset
purchase agreement in exchange for substantially all of the assets
owned by and used or useful in the business of certain subsidiaries
of IBT.
The
shares of common stock were issued pursuant to an exemption from
registration contained in Section 4(a)(2) of the Securities Act
and/or Rule 506 promulgated thereunder.
(14)
On June 25, 2020, we issued warrants to purchase up to an aggregate
of 1,396,826 shares of our common stock at an exercise price of
$1.80 per share to certain accredited institutional investors
holding outstanding warrants to purchase our common stock that were
issued on May 8, 2020 (“May 2020 Warrants”). Such investors agreed
to exercise their May 2020 Warrants in cash at an exercise price of
$1.45 per share plus pay an additional $0.125 for each new warrant,
pursuant to a warrant exercise letter agreement. We received
approximately $2,200,000 in gross proceeds before deducting
placement agent fees and offering expenses payable by us.
Pursuant to an engagement letter dated May 6, 2020, we paid to
Wainwright, who acted as placement agent, a cash fee equal to 7.5%
of the gross proceeds received from the exercise and the sale of
the warrants, a management fee equal to 1% of the aggregate gross
aggregate gross proceeds received by us in the offering, $25,000 in
non-accountable expenses and up to $40,000 in legal and other
out-of-pocket expenses. In addition, we issued to the placement
agent or its designees warrants to purchase up to an aggregate of
104,763 shares of our common stock at an exercise price of $2.25
per share (equal to 125% of the exercise price of the new
warrants).
The
warrants were issued pursuant to exemptions from registration
contained in Section 4(a)(2) of the Securities Act and/or Rule 506
promulgated thereunder.
(15)
On July 1, 2020, we issued 954,719 shares of our common stock to
Quantitative Medicine LLC (“QM”) and its designees pursuant to an
asset purchase agreement in exchange for substantially all of the
assets owned by QM.
The
shares of common stock were issued pursuant to an exemption from
registration contained in Section 4(a)(2) of the Securities Act
and/or Rule 506 promulgated thereunder.
(16)
On January 12, 2021 we issued and sold to certain institutional and
accredited investors in a registered direct offering an aggregate
of 3,655,840 shares of our common stock, at a purchase price of
$0.842 per share, for gross proceeds of approximately $3,000,000
before deducting placement agent fees and offering expenses payable
by us. In a concurrent private placement, we also issued to such
investors warrants to purchase up to an aggregate of 1,825,420
shares of our common stock at an exercise price of $0.80 per share.
As partial compensation for Wainwright’s services as placement
agent in the registered direct offering, we issued to Wainwright’s
designees warrants to purchase up to 273,813 shares of our common
stock at an exercise price of $1.0525 per share (equal to 125% of
the offering price per share).
The
warrants issued to the investors and placement agent’s designees
were issued pursuant to exemptions from registration contained in
Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(17)
On January 21, 2021 we issued and sold to certain institutional and
accredited investors in a registered direct offering an aggregate
of 2,200,000 shares of our common stock, at a purchase price of
$1.00 per share, for gross proceeds of $2,200,000 before deducting
placement agent fees and offering expenses payable by us. In a
concurrent private placement, we also issued to such investors
warrants to purchase up to an aggregate of 1,100,000 shares of our
common stock at an exercise price of $1.00 per share. As partial
compensation for Wainwright’s services as placement agent in the
registered direct offering, we issued to Wainwright’s designees
warrants to purchase up to 165,000 shares of our common stock at an
exercise price of $1.25 per share (equal to 125% of the offering
price per share).
The
warrants issued to the investors and placement agent’s designees
were issued pursuant to exemptions from registration contained in
Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(18)
On January 26, 2021 we issued and sold to certain institutional and
accredited investors in a registered direct offering an aggregate
of 3,414,970 shares of our common stock, at a purchase price of
$1.20 per share, for gross proceeds of approximately $4,000,000
before deducting placement agent fees and offering expenses payable
by us. In a concurrent private placement, we also issued to such
investors warrants to purchase up to an aggregate of 1,707,485
shares of our common stock at an exercise price of $1.37 per share.
As partial compensation for Wainwright’s services as placement
agent in the registered direct offering, we issued to Wainwright’s
designees warrants to purchase up to 256,123 shares of our common
stock at an exercise price of $1.50 per share (equal to 125% of the
offering price per share).
The
warrants issued to the investors and placement agent’s designees
were issued pursuant to exemptions from registration contained in
Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(19)
On February 16, 2021 we issued and sold to certain institutional
and accredited investors in a registered direct offering an
aggregate of 4,222,288 shares of our common stock, at a purchase
price of $1.75 per share, for gross proceeds of approximately
$7,400,000 before deducting placement agent fees and offering
expenses payable by us. In a concurrent private placement, we also
issued to such investors warrants to purchase up to an aggregate of
2,111,144 shares of our common stock at an exercise price of $2.00
per share. As partial compensation for Wainwright’s services as
placement agent in the registered direct offering, we issued to
Wainwright’s designees warrants to purchase up to 316,672 shares of
our common stock at an exercise price of $2.1875 per share (equal
to 125% of the offering price per share).
The
warrants issued to the investors and placement agent’s designees
were issued pursuant to exemptions from registration contained in
Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated
thereunder.
(20)
On April 16, 2021, we issued 8,814 shares of common stock for
payment of $10,400 for professional research services. On August
30, 2021, we issued 4,505 shares of common stock for payment of
$5,000 for professional research services. On October 11, 2021, we
issued 3,760 shares of common stock for payment of $5,000 for
professional research services.
The
issuances of the forgoing shares of common stock were not
registered under the Securities Act in reliance upon the exemption
from registration provided by Section 4(a)(2) of the Securities Act
and/or Rule 506 promulgated thereunder.
(21)
In February 23, 2022, we entered into a securities purchase
agreement with certain accredited investors, pursuant to which we
issued and sold an aggregate of 9,043,766 shares of our common
stock, together with warrants to purchase 4,521,883 shares of our
common stock at an exercise price of $2.00 per share. Each share of
common stock accompanying warrant to purchase one-half share were
sold together at a combined offering price of $1.95. We received
approximately $17,600,000 in gross proceeds before deducting
placement agent fees and offering expenses payable by us.
Pursuant to an engagement letter dated May 6, 2020, we paid to
Wainwright, who acted as placement agent, a cash fee equal to 7.5%
of the gross proceeds received in the offering, a management fee
equal to 1% of the aggregate gross proceeds received by us in the
offering, $65,000 in non-accountable and legal expenses, and
$15,950 for clearing fees. In addition, we issued to Wainwright or
its designees warrants to purchase up to an aggregate of 678,282
shares of our common stock at an exercise price of $2.4375 per
share (equal to 125% of the offering price).
The
shares of common stock and warrants were issued pursuant to an
exemption from registration contained in Section 4(a)(2) of the
Securities Act and Rule 506 promulgated thereunder.
(22)
During the six months ended June, 30 2022, we issued an aggregate
of 29,346 shares of common stock for an aggregate payment of
$25,000 for professional research services.
The
shares of common stock were issued pursuant to an exemption from
registration contained in Section 4(a)(2) of the Securities Act and
Rule 506 promulgated thereunder.
(23)
On May 18, 2022 we issued and sold to certain institutional and
accredited investors in a registered direct offering an aggregate
of 3,837,280 shares of our common stock, at a purchase price of
$0.60 per share, for gross proceeds of approximately $2,300,000
before deducting placement agent fees and offering expenses payable
by us. In a concurrent private placement, we also issued to such
investors the May 2022 Warrants to purchase up to an aggregate of
3,837,280 shares of our common stock at an exercise price of $0.70
per share. As partial compensation for Wainwright’s services as
placement agent in the registered direct offering and a concurrent
registered direct offering of 8,162,720 shares of our common stock,
we issued to Wainwright’s designees Placement Agent Warrants to
purchase up to an aggregate of 900,000 shares of our common stock
at an exercise price of $0.75 per share (equal to 125% of the
offering price per share).
The
May 2022 Warrants and Placement Agent Warrants were issued pursuant
to exemptions from registration contained in Section 4(a)(2) of the
Securities Act and Rule 506 promulgated thereunder.
Item 16.
Exhibits.
Exhibit
Number |
|
Description |
|
|
|
2.1 |
|
Agreement and Plan of Merger dated November 24, 2021 by and
among the Company, Golden Gate Acquisition, Inc., zPREDICTA, Inc.
and Tom Kelly, as Representative (Filed on December 1, 2021as an
exhibit to our Current Report on Form 8-K and incorporated herein
by reference).
Exhibit 2.1 |
|
|
|
3.1 |
|
Certificate of Incorporation
(Filed on December 19, 2013 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit
3.1 |
|
|
|
3.2 |
|
Certificate 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 (Filed on October 24, 2014
as an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit
3.2 |
|
|
|
3.3 |
|
Certificate of Amendment to
Certificate of Incorporation regarding increase in share capital,
filed with the Delaware Secretary of State on July 24, 2015 (Filed
on June 30, 2015 as an appendix to our Information Statement on
Schedule 14C and incorporated herein by reference).
Exhibit
3.3 |
|
|
|
3.4 |
|
Certificate of Amendment to
Certificate of Incorporation to increase authorized share capital,
filed with the Delaware Secretary of State on September 16, 2016
(Filed on September 16, 2016 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit
3.4 |
|
|
|
3.5 |
|
Certificate 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 (Filed on October 27, 2016
as an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit
3.5 |
|
|
|
3.6 |
|
Certificate of Amendment to
Certificate of Incorporation regarding increase in share capital,
filed with the Delaware Secretary of State on January 26, 2017
(Filed on January 27, 2017 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit
3.6 |
|
|
|
3.7 |
|
Certificate of Amendment to
Certificate of Incorporation to effect reverse stock split, filed
with the Delaware Secretary of State on January 2, 2018 (Filed on
January 2, 2018 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit
3.7 |
|
|
|
3.8 |
|
Certificate of Amendment to
Certificate of Incorporation to effect name change, filed with the
Delaware Secretary of State on February 1, 2018 (Filed on February
6, 2018 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit
3.8 |
|
|
|
3.9 |
|
[Intentionally
omitted.] |
|
|
|
3.10* |
|
Second
Amended and Restated Bylaws effective as of September 9,
2022 |
|
|
|
3.11 |
|
Form of Certificate of Designation of Preferences, Rights and
Limitations of Series B Convertible Preferred Stock (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).
Exhibit 3.11 |
|
|
|
3.12 |
|
Certificate of Designation of Preferences, Rights and
Limitations of Series C Convertible Preferred Stock (Filed on
November 29, 2017 as an exhibit to our Current Report on Form 8-K
and incorporated herein by reference).
Exhibit 3.12 |
|
|
|
3.13 |
|
Certificate of Amendment
to Certificate of Incorporation dated March 22, 2019 (Filed on
March 22, 2019 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 3.13
|
3.14 |
|
Certificate of Designation Of Preferences, Rights
And Limitations of Series D Convertible Preferred Stock (Filed on
April 1, 2020 as an exhibit to our Annual Report on Form 10-K and
incorporated herein by reference). Exhibit
3.14 |
|
|
|
3.15 |
|
Certificate of
Designation of Preferences, Rights and Limitations of Series E
Convertible Preferred Stock Effective June 13, 2019 (Filed on June
19, 2019 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 3.15
|
|
|
|
3.16 |
|
Certificate of Amendment
of Certificate of Incorporation, changing name from Precision
Therapeutics Inc. to Predictive Oncology Inc. (Filed on June 13,
2019 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 3.16
|
|
|
|
3.17 |
|
Certificate of Amendment
of Certificate of Incorporation, amending number of shares of
common stock and preferred stock, effecting a reverse stock split
(Filed on October 28, 2019 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit 3.17
|
|
|
|
3.18 |
|
Certificate of Amendment
to the Certificate of Incorporation, doubling number of shares of
common stock and preferred stock due to stock split (Filed on
August 19, 2021 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 3.18
|
|
|
|
4.1 |
|
Form of specimen certificate
evidencing shares of Series B Convertible Preferred Stock (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).
Exhibit
4.1 |
|
|
|
4.2 |
|
Investor Warrant issued November
28, 2017 (Filed on November 29, 2017 as an exhibit to our Current
Report on Form 8-K and incorporated herein by reference.)
Exhibit
4.2 |
|
|
|
4.3 |
|
Series E Warrant Agency Agreement
by and between Skyline Medical Inc. and Corporate Stock Transfer,
Inc. dated January 9, 2018. (Filed on January 10, 2018 as an
exhibit to our Current Report on Form 8-K and incorporated herein
by reference).
Exhibit
4.3 |
|
|
|
4.4 |
|
Form of Series E Warrant
Certificate (Filed on January 10, 2018 as an exhibit to our Current
Report on Form 8-K and incorporated herein by reference).
Exhibit
4.4 |
|
|
|
4.5 |
|
Common Stock Purchase Warrant
issued to L2 Capital, LLC dated September 28, 2018 (Filed on
October 4, 2018 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit
4.5 |
|
|
|
4.6 |
|
Common Stock Purchase Warrant
issued to Peak One Opportunity Fund, LP dated September 28, 2018
(Filed on October 4, 2018 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit
4.6 |
|
|
|
4.7 |
|
Form of Unit Purchase Option
issued February 27, 2019 (Filed on March 1, 2019 as an exhibit to
our Current Report on Form 8-K and incorporated herein by
reference). Exhibit
4.7 |
|
|
|
4.8 |
|
Form of Common Stock
Purchase Warrant issued March 29, 2019 (Filed on April 2, 2019 as
an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit 4.8
|
|
|
|
4.9 |
|
Form of Unit Purchase
Option for the Purchase of Units issued March 29, 2019 (Filed on
April 2, 2019 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 4.9
|
|
|
|
4.10 |
|
Common Stock Purchase
Warrant Issued to Oasis Capital, LLC dated September 27, 2019
(Filed on September 30, 2019 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit 4.10
|
4.11 |
|
Form of Specimen Common
Stock Certificate (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).
Exhibit 4.11
|
|
|
|
4.12 |
|
Form of Common Stock
Purchase Warrant Issued on or about October 1, 2019 (Filed on
October 10, 2019 as an exhibit to our Current Report on Form 8-K
and incorporated herein by reference).
Exhibit 4.12
|
|
|
|
4.13 |
|
Common Stock Purchase
Warrant issued to Oasis Capital, LLC dated February 5, 2020 (Filed
on February 7, 2020 as an exhibit to our Current Report on Form 8-K
and incorporated herein by reference).
Exhibit 4.13
|
|
|
|
4.14 |
|
Description of
Registrant’s Securities (Filed on March 31, 2022 as an exhibit to
our Annual Report on Form 10-K and incorporated herein by
reference).
Exhibit 4.14
|
|
|
|
4.15 |
|
Common Stock Purchase Warrant
issued to Oasis Capital, LLC dated March 6, 2020 (Filed on April 6,
2020 as an exhibit to our Registration Statement on Form S-3 (File
No. 333-237581) and incorporated herein by reference).
Exhibit
4.15 |
|
|
|
4.16 |
|
Common Stock Purchase Warrant
issued to Oasis Capital, LLC dated April 5, 2020 (Filed on April 6,
2020 as an exhibit to our Registration Statement on Form S-3 (File
No. 333-237581) and incorporated herein by
reference). Exhibit
4.16 |
|
|
|
4.17 |
|
Form of Common Stock Purchase
Warrant issued June 29, 2020 (Filed on June 26, 2020 as an exhibit
to our Current Report on Form 8-K and incorporated herein by
reference).
Exhibit
4.17 |
|
|
|
4.18 |
|
Form of Helomics Common Stock
Purchase Warrant issued April 4, 2019 (Filed on October 10, 2019 as
an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit
4.18 |
|
|
|
4.19 |
|
Form of Common Stock Purchase
Warrant issued January 12, 2021 (Filed on January 12, 2021 as an
exhibit to our Current Report on Form 8-K and incorporated herein
by reference).
Exhibit
4.19 |
|
|
|
4.20 |
|
Form of Common Stock Purchase
Warrant issued January 19, 2021 (Filed on January 21, 2021 as an
exhibit to our Current Report on Form 8-K and incorporated herein
by reference).
Exhibit
4.20 |
|
|
|
4.21 |
|
Form of Common Stock
Purchase Warrant issued January 21, 2021 (Filed on January 26, 2021
as an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit 4.21
|
|
|
|
4.22 |
|
Form of Placement Agent
Warrant to H.C. Wainwright & Co., LLC or its designees in
connection with certain financing transactions in 2020 and 2021
(Filed on January 29, 2021 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit 4.22
|
|
|
|
4.23 |
|
Form of Common Stock
Purchase Warrant dated February 10, 2021 (Filed on February 12,
2021 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 4.23
|
|
|
|
4.24 |
|
Form of Common Stock Purchase
Warrant dated February 23, 2021 (Filed on February 22,
2021 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 4.24 |
|
|
|
4.25 |
|
Form of Common Stock Purchase
Warrant dated June 16, 2021 (Filed on June 16, 2021 as
an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit 4.25 |
|
|
|
4.26 |
|
Form of Placement Agent
Warrant dated June 16, 2021 (Filed on June 16, 2021 as an exhibit
to our Current Report on Form 8-K and incorporated herein by
reference).
Exhibit 4.26
|
|
|
|
4.27 |
|
Form of May 2022 Warrant
(Filed on May 18, 2022 as an exhibit to our Current Report on Form
8-K and incorporated herein by reference).
Exhibit 4.27
|
4.28
|
|
Form of Placement Agent
Warrant dated May 18, 2022 (Filed on May 18, 2022 as an exhibit to
our Current Report on Form 8-K and incorporated herein by
reference).
Exhibit 4.28
|
|
|
|
4.29
|
|
Form of Warrant Amendment
Agreement dated May 16, 2022 (Filed on May 18, 2022 as an exhibit
to our Current Report on Form 8-K and incorporated herein by
reference).
Exhibit 4.29
|
|
|
|
5.1* |
|
Opinion of
Maslon LLP |
|
|
|
10.1 |
|
Office Lease Agreement between
the registrant and Roseville Properties Management Company, as
agent for Lexington Business Park, LLC (Filed on November 12, 2008
as an exhibit to our Registration Statement on Form S-1 and
incorporated herein by reference).
Exhibit 10.1 |
|
|
|
10.2 |
|
Employment Agreement with Robert
Myers dated August 11, 2012 (Filed on November 5, 2012 as an
exhibit to our Registration Statement on Form S-1 and incorporated
herein by reference).**
Exhibit 10.2 |
|
|
|
10.3 |
|
Amended Lease with Roseville
Properties Management Company, Inc. dated January 29, 2013 (Filed
on February 8, 2013 as an exhibit to our Registration Statement on
Form S-1 (except for Exhibit 10.19, by incorporation by reference
from the Schedule 13D/A filed by Dr. Herschkowitz and other parties
on November 8, 2012) and incorporated herein by reference).
Exhibit 10.3 |
|
|
|
10.4 |
|
Amended
and Restated 2012 Stock Incentive Plan (Filed on March 22, 2019 as
an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit 10.4 |
|
|
|
10.5 |
|
Form of
Stock Option Agreement for Employees under Amended and Restated
2012 Stock Incentive Plan (Filed on March 31, 2022 as an exhibit to
our Annual Report on Form 10-K and incorporated herein by
reference).**
Exhibit 10.5 |
|
|
|
10.6 |
|
Form of Stock
Option Agreement for Executive Officers under Amended and Restated
2012 Stock Incentive Plan (Filed on March 31, 2022 as an
exhibit to our Annual Report on Form 10-K and incorporated herein
by reference). **
Exhibit 10.6 |
|
|
|
10.7 |
|
Form of Stock Option Agreement
for Directors under Amended and Restated 2012 Stock Incentive Plan
(Filed on March 31, 2022 as an exhibit to our Annual
Report on Form 10-K and incorporated herein by reference). **
Exhibit 10.7 |
|
|
|
10.8 |
|
Amendment to Employment
Agreement by and between the Issuer and Bob Myers dated August 20,
2018** (Filed on April 1, 2019 as an exhibit to our Annual Report
on Form 10-K and incorporated herein by reference).
Exhibit 10.8
|
|
|
|
10.9 |
|
Equity Purchase Agreement
by and between the Issuer and Oasis Capital, LLC dated October 24,
2019 (Filed on October 25, 2019 as an exhibit to our Current Report
on Form 8-K and incorporated herein by reference).
Exhibit 10.9
|
|
|
|
10.10 |
|
Registration Rights
Agreement by and between the Issuer and Oasis Capital, LLC dated
October 24, 2019 (Filed on October 25, 2019 as an exhibit to our
Current Report on Form 8-K and incorporated herein by reference).
Exhibit 10.10
|
|
|
|
10.11 |
|
Securities Purchase Agreement by and among the
Company and the Investors dated March 15, 2020 (Filed on March 16,
2020 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 10.11 |
|
|
|
10.12 |
|
Registration Rights
Agreement by and among the Company and the Investors dated March
15, 2020 (Filed on March 16, 2020 as an exhibit to our Current
Report on Form 8-K and incorporated herein by reference).
Exhibit 10.12
|
10.13 |
|
Form of
Securities Purchase Agreement dated January 8, 2021, by and between
Predictive Oncology Inc. and certain Purchasers (Filed on January
12, 2021 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit
10.13 |
|
|
|
10.14 |
|
Form of Securities Purchase
Agreement dated January 19, 2021, by and between Predictive
Oncology Inc. and certain Purchasers (Filed on April 6, 2020 as an
exhibit to our Registration Statement on Form S-3 (File No.
333-237581) and incorporated herein by reference).
Exhibit
10.14 |
|
|
|
10.15 |
|
Form of Securities
Purchase Agreement dated January 21, 2021, by and between
Predictive Oncology Inc. and certain Purchasers (Filed on January
21, 2021 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 10.15
|
|
|
|
10.16 |
|
Form of Securities
Purchase Agreement dated February 10, 2021, by and between
Predictive Oncology Inc. and certain Purchasers (Filed on February
12, 2021 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 10.16
|
|
|
|
10.17 |
|
Form of Securities
Purchase Agreement dated February 18, 2021, by and between
Predictive Oncology Inc. and certain Purchasers (Filed on February
22, 2021 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 10.17
|
|
|
|
10.18 |
|
Form of Registration
Rights Agreement dated February 18, 2021, by and between Predictive
Oncology Inc. and certain Purchasers (Filed on February 22, 2021 as
an exhibit to our Current Report on Form 8-K and incorporated
herein by reference).
Exhibit 10.18
|
|
|
|
10.19 |
|
Transition and Separation
Agreement by and between the Company and Carl Schwartz dated March
19, 2021 (Filed on March 23, 2021 as an exhibit to our Current
Report on Form 8-K and incorporated herein by reference).
Exhibit 10.19
|
|
|
|
10.20 |
|
Agreement and Release by
and between the Company and Carl Schwartz dated March 19, 2021
(Filed on March 23, 2021 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit 10.20
|
|
|
|
10.21 |
|
Offer Letter by and between the
Company and J. Melville Engle dated March 19, 2021** (Filed on
March 23, 2021 as an exhibit to our Current Report on
Form 8-K and incorporated herein by reference).
Exhibit 10.21 |
|
|
|
10.22 |
|
Employment Agreement by and between the Company
and J. Melville Engle dated effective as of March 19, 2021**
(Filed on April 7, 2021 as an exhibit
to our Current Report on Form 8-K and incorporated herein by
reference).
Exhibit 10.22
|
|
|
|
10.23 |
|
2021 Long Term Incentive Plan**
(Filed on May 20, 2021 as an exhibit
to our Current Report on Form 8-K and incorporated herein by
reference).
Exhibit 10.57
|
|
|
|
10.24 |
|
Form of Securities
Purchase Agreement, dated June 14, 2021, between Predictive
Oncology Inc. and certain Purchasers (Filed on June 16, 2021 as an
exhibit to our Current Report on Form 8-K and incorporated herein
by reference).
Exhibit 10.24
|
|
|
|
10.25 |
|
Form of Securities Purchase
Agreement, dated as of May 16, 2022, between Predictive Oncology
Inc. and certain Purchasers (First Offering) (Filed on May 18,
2022 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 10.25 |
|
|
|
10.26 |
|
Form of Securities Purchase
Agreement, dated as of May 16, 2022, between Predictive Oncology
Inc. and certain Purchasers (Second Offering) (Filed on May 18,
2022 as an exhibit to our Current Report on Form 8-K and
incorporated herein by reference).
Exhibit 10.26 |
*Filed herewith.
**Compensatory Plan or
arrangement required to be filed pursuant to Item 15(b) of Form
10-K.
Item 17. Undertakings.
The undersigned
registrant hereby undertakes:
|
(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; |
|
|
|
|
(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; |
|
(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.
provided, however, that: Paragraphs (a)(1)(i), (a)(1)(ii),
and (a)(1)(iii) of this section do not apply if the information
required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the
SEC by the registrant pursuant to Section 13 or Section 15(d) of
the Exchange Act 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 part of 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. |
|
|
|
|
|
|
(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. |
|
(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; |
|
|
|
|
(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) |
|
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. |
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as
amended, the registrant has duly caused this registration statement
to be signed on its behalf by the undersigned, thereunto duly
authorized in the City of Eagan, State of Minnesota, on September
30, 2022.
|
PREDICTIVE ONCOLOGY INC.
|
|
|
|
/s/ Bob Myers |
|
Bob
Myers |
|
Chief Financial
Officer |
POWER OF ATTORNEY
Each person whose
signature appears below hereby constitutes and appoints J. Melville
Engle and Bob Myers, and each of them, as his true and lawful
attorneys-in-fact and agents, with full power of substitution and
resubstitution, for him and in his name, place and stead, in any
and all capacities, to sign any and all amendments (including
post-effective amendments) to this registration statement, and any
and all additional 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 in connection
therewith, with the 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 could do in person, hereby ratifying and
confirming all that said attorney-in-fact and agent or his
substitutes or substitute, may lawfully do or cause to be done by
virtue hereof.
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:
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ J. Melville Engle |
|
Chief Executive Officer (principal |
|
September 30, 2022 |
J. Melville
Engle |
|
executive officer) and Director |
|
|
|
|
|
|
|
/s/ Bob Myers |
|
Chief Financial Officer (principal financial |
|
September 30, 2022 |
Bob Myers |
|
and accounting officer) |
|
|
|
|
|
|
|
/s/ Raymond Vennare |
|
Director |
|
September 30, 2022 |
Raymond Vennare |
|
|
|
|
|
|
|
|
|
/s/ Daniel E. Handley |
|
Director |
|
September 30, 2022 |
Daniel E.
Handley |
|
|
|
|
|
|
|
|
|
/s/ Gregory S. St. Clair, Sr. |
|
Director |
|
September 30, 2022 |
Gregory S. St. Clair,
Sr. |
|
|
|
|
|
|
|
|
|
/s/ Chuck Nuzum |
|
Director |
|
September 30, 2022 |
Chuck Nuzum |
|
|
|
|
|
|
|
|
|
/s/ Nancy Chung-Welch |
|
Director |
|
September 30, 2022 |
Nancy
Chung-Welch |
|
|
|
|
II-15
Predictive Oncology (NASDAQ:POAI)
Historical Stock Chart
From Jan 2023 to Feb 2023
Predictive Oncology (NASDAQ:POAI)
Historical Stock Chart
From Feb 2022 to Feb 2023