10-K
1
pktx_10k-123119.htm
FORM 10-K
U. S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
[ X ]
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31,
2019
[_]
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ___________ to
_____________
Commission File Number: 000-32917
PROTOKINETIX, INCORPORATED
(Name of small business issuer as specified
in its charter)
Nevada
94-3355026
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
412 Mulberry Street
Marietta, Ohio 45750
(Address of principal executive offices,
including zip code)
Registrant’s telephone number, including area code:
740-434-5041
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
N/A
Securities registered pursuant to Section 12(b) of the Act:
$.0000053 par value common stock
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act: ☐
Yes [X]
No
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act:
☐
Yes [X] No
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to
file such reports), and (2) has been subject to such filing requirements for the past 90 days. [X]
Yes ☐
No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). [X]
Yes ☐ No
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions
of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2
of the Securities Exchange Act of 1934.
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated
filer ☐
Smaller reporting company [X]
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).
Yes ☐
No [X]
The aggregate market value of the voting and
non-voting common equity held by non-affiliates of the registrant was approximately $40,250,581.77 based upon the closing price
of our common stock which was $0.21 as of June 28, 2019, the last business day of the Company’s most recently completed second
fiscal quarter. Shares of common stock held by each officer and director and by each person or group who owns 10% or more
of the outstanding common stock amounting to shares have been excluded in that such persons or groups may be deemed to be affiliates.
This determination of affiliate status is not necessarily a conclusive determination for other purposes.
As of February 18, 2020, there were 275,400,259
shares of our common stock that were issued and outstanding.
TABLE OF CONTENTS
FORM 10-K ANNUAL REPORT
_________________________
PROTOKINETIX, INCORPORATED
Part 1
Page
Item 1.
Business
4
Item 1A
Risk Factors
12
Item 1B
Unresolved Staff Comments
17
Item 2
Properties
17
Item 3
Legal Proceedings
17
Item 4
Mine Safety Disclosures
18
Part II
Item 5
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
19
Item 6
Selected Financial Data
24
Item 7
Management’s Discussion and Analysis of Financial Condition and Results of Operations
24
Item 7A
Quantitative and Qualitative Disclosures About Market Risk
27
Item 8
Financial Statements and Supplementary Data
27
Item 9
Changes in an Disagreements With Accountants on Accounting and Financial Disclosure
28
Item 9A
Controls and Procedures
28
Item 9B
Other Information
29
Part III
Item 10
Directors, Executive Officers and Corporate Governance
30
Item 11
Executive Compensation
32
Item 12
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
36
Item 13
Certain Relationships and Related Transactions, and Director Independence
37
Item 14
Principal Accountant Fees and Services
37
Part IV
Item 15
Exhibits and Financial Statement Schedules
39
Item 16
Form 10-K Summary
40
Signatures
41
3
PART I
ITEM 1. BUSINESS
ProtoKinetix, Incorporated (“ProtoKinetix,”
“we,” “us,” “our,” or the “Company”) is a research and development stage bio-technology
company focused on scientific medical research of AFGPs (Anti-Freeze Glycoproteins) or anti-aging glycoproteins, trademarked as
AAGPs ® . The Company has recently been in the process of directing major efforts to the practical side of commercial
validation. The commercial applications for AAGPs ® in large markets such as targeted health care solutions are numerous,
and ProtoKinetix is currently working with researchers, business leaders and advisors and commercial entities to bring AAGP ®
to market.
ProtoKinetix was incorporated as RJV
Network, Inc. under the laws of the State of Nevada on December 23, 1999 for the primary purpose of developing an internet-based
listing site that would provide detailed commercial real estate property listings and related data. In July 2003, the Company
entered into an assignment of license agreement with BioKinetix Research, Incorporated for the assignment of rights relating to
proprietary technologies of BioKinetix Research, Incorporated for the creation and commercialization of “superantibodies.”
On July 8, 2003, the Company changed its name to “ProtoKinetix, Incorporated.”
The Company’s executive (or corporate)
offices are located at 412 Mulberry Street, Marietta, Ohio 45750. Our telephone number is (740) 434-5041 and our website
is www.protokinetix.com .
Cautionary Note Regarding Forward-Looking
Statements
The information discussed in this Annual
Report on Form 10-K for the fiscal year ended December 31, 2019 as well as some statements in press releases and some oral statements
of the Company’s officers during presentations about the Company include “forward looking statements” within
the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange
Act of 1934 (the “Exchange Act”). All statements, other than statements of historical facts, included herein
and therein concerning, among other things, planned capital expenditures, future cash flows and borrowings, pursuit of potential
acquisition opportunities, our financial position, business strategy and other plans and objectives for future operations, are
forward looking statements. These forward looking statements are identified by their use of terms and phrases such as “may,”
“expect,” “estimate,” “project,” “plan,” “believe,” “intend,”
“achievable,” “anticipate,” “will,” “continue,” “potential,” “should,”
“could,” and similar terms and phrases. Although we believe that the expectations reflected in these forward
looking statements are reasonable, they do involve certain assumptions, risks and uncertainties and are not (and should not considered
to be) guarantees of future performance. Our results could differ materially from those anticipated in these forward looking statements
as a result of certain factors, including, among others:
•
Our capital requirements and the uncertainty of being able to obtain additional funding on terms acceptable to us;
•
Our plans to develop and commercialize products from the AAGP ® molecule;
•
Ongoing testing of the AAGP ® molecule;
•
Our intellectual property position;
•
Our commercialization, marketing and manufacturing capabilities and strategy;
•
Our ability to retain key members of our senior management and key scientific consultants;
•
The effects of competition;
•
Our potential tax liabilities resulting from conducting business in the United States and Canada;
•
The effect of further sales or issuances of our common stock and the price and volume volatility of our common stock; and our common stock’s limited trading history.
4
Finally, our future results will depend
upon various other risks and uncertainties, including, but not limited to, those detailed in the section entitled “Risk Factors”
included elsewhere in this Annual Report. All forward looking statements attributable to us or persons acting on our behalf
are expressly qualified in their entirety by the cautionary statements in this section and elsewhere in this Annual Report.
Other than as required under securities laws, we do not assume a duty to update these forward looking statements, whether as a
result of new information, subsequent events or circumstances, changes in expectations or otherwise.
BACKGROUND
Native AFGP Compound
AFGP (Anti-Freeze Glycoprotein) is found in
nature as a compound produced by some fish, insects, reptiles, bacteria and plants that enable survival in freezing temperatures.
One of the many accomplishments from pioneering
research of the U.S. Antarctic Program was the discovery, in the early sixties, that fish living year-long in subzero temperature
are extremely resistant to freezing. The substances that prevent these fish from freezing were isolated, characterized and
designated as AFGP. Various kinds of AFGP were isolated from many species of fishes, and in some amphibians, plants and insects.
All of the AFGPs share a common characteristic that prevents ice crystals from growing and connecting to each other. Research
has also confirmed a cell membrane stabilizing characteristic of native AFGP.
There has been much scientific research done
in an attempt to synthetically replicate AFGPs in research institutions because the protective properties of AFGPs could have commercial
applications, primarily in food and crop preservation at freezing temperatures. The native antifreeze glycoproteins are very large
molecules that are often made up of a repeating series of smaller molecules, glycoproteins. Glycoproteins are often very biologically
active, but they are inherently unstable. The oxygen-glycosidic link is readily cleaved by glycosidases, resulting in a low bio-availability
of these glycoconjugate based molecules.
Scientific research prior to AAGP ®
has focused on building a stable and more efficient compound with a strong bond.
AAGP ® – The
Core Technology of ProtoKinetix
AAGP ® Invention
Dr. Geraldine Castelot-Deliencourt, along with
Dr. Jean-Charles Quirion at the Research Institute of Organic Chemistry in Rouen, France, developed a patented process to stabilize
the oxygen-glycosidic bond in these sugar based molecules. This patented process replaces the weaker oxygen bond with a C-F 2 mimetic.
The resultant molecules are biologically active and stable over a pH range of 2 to 13. They are not broken down by glycosidases.
AAGP ® Toxicity Tests
Tests have shown that cells exposed to AAGP ®
at low and high concentrations have remained viable. A common viability test used on cell cultures using trypan blue dye exclusion
method has been used to show AAGP ® non-toxicity.
AAGP ® Stability Tests
AAGP ® molecules have remained
stable when subjected to three tests:
1.
pH ranging from a strong acid level of 1.8 (stronger than stomach acid) to a strong alkali level of 13.8. (the pH scale is calibrated from 1, highly acidic, to 14, highly alkali);
2.
Enzymatic action using protease, which targets the amino acid bonds, and glycosidase, which targets the amino acid bonds, and glycosidase, which targets the sugar molecules; and
3.
Temperatures ranging from -196°C (cryopreservation) to +37°C (body temperature).
5
Stress Tests on 12 Different Cell Lines
Cell lines are selected for their high level
of sensitivity. Cell lines are also selected for their potential role in adding value in medical applications, enhancing health
and extending life. All tests are designed to explore how cells from different cell lines act biologically in the presence of AAGP ®
when subjected to health and life threatening inflammatory stress conditions and agents.
Cell Lines Tested
§ Stem cells (human)
§ Adult skin fibroblast cells
§ Whole blood cells
§ Heart cells (cardiac myocytes)
§ Blood Platelet cells
§ Liver cells (hepatocytes)
§ Heart tissue
§ Embryonic skin fibroblast cells
§ Hela (cancer) cells
§ Islet cells (pancreatic)
§ Kidney (vero) cells
§ Stem cells (mouse)
Stress Conditions and Agents
Temperature
§
temperatures ranging from -80° C to +37° C
UV-C Radiation
§
harsh sterilizing radiation
§
254 nanometer wavelength
Oxidation
§
hydrogen peroxide (H2O2)
§
powerful oxidant
Starvation
§
serum free culture media
§
food/growth/nutrients factors (fetal bovine serum) withheld
Inflammation
§
Interleukin 1 Beta, a standard agent for stimulating inflammation in cell testing
Nonclinical Efficacy Testing (Human Islets)
For the last six years, AAGP ®
testing has been conducted pursuant to a comprehensive transplantation testing program in conjunction with the University of Alberta
transplant research team. The Company entered into a consulting agreement in May 2015 with Dr. James Shapiro to collaborate
with the James Shapiro Laboratory at the University of Alberta in Edmonton, Alberta, Canada. Dr. Shapiro directs the largest
clinical islet transplantation program in the world. Dr. Shapiro and his team have conducted extensive testing with our AAGP ®
molecule using human islet cells in transplantation, investigating its effect on engraftment, insulin production, protective effect
against anti-rejection drugs and investigation of the mechanism of action. The results provided consistent encouragement
to continue testing to develop protocols that can be applied to transplantation medicine. In December of 2016, the Governors
of the University of Alberta submitted an Investigational Testing Authorization Application To Health Canada to evaluate the safety
and efficacy of transplantation of AAGP ® treated human islets as an addition to the already established Edmonton
Protocol for the treatment of Type 1 Diabetes.
6
Additional studies will be expanded to include
whole organ transplantation and other cell therapies used in regenerative medicine.
AAGP ® testing is conducted to
international standards in outsourced research laboratories in North America and Europe. All tests are designed to explore both
the safety and effectiveness of AAGP ® when challenged to enhance the health and extend the life of cells.
Allogeneic transplantation is the transplanting
of cells, tissues or organs from the same species, but from a donor different than the recipient. Serious issues that have to be
addressed are the engraftment of the transplanted organ or cells and the subsequent protection against the immune rejection of
the foreign organ or cells. The protection, in the form of anti-rejection drugs, is toxic and causes damage to the graft.
AAGP ® has been shown in these nonclinical studies to increase engraftment and reduce the toxicity damage.
Dr. Shapiro and his team are developing
further testing based on two primary activities:
1.
The ongoing testing and refinement of cellular transplantation using human islet cells as the demonstrated model . In particular, AAGP ® may provide powerful protection against hostile agents that severely inhibit engraftment success. Cell therapies are currently being developed in the industry around the world for the treatment of spinal cord injury, damaged heart tissue, stroke, diabetes as well as many other conditions.
2.
Human organ preservation . The program will assess the effect of AAGP ® in extending the transplant viability of donor organs. The Canadian National Transplant Research Program is a major national initiative involving the Federal Institutes of Health, all Provinces and the private sector (see http://www.cntrp.ca/ ). The first testing will be conducted on livers to determine whether AAGP ® can extend the ex-vivo functionality of the organ.
The Governors of the University of Alberta
submitted an Investigator Sponsored Clinical Trial Application to Health Canada. This trial will be conducted by Dr. Shapiro
and his team at the University of Alberta on the well-established, Edmonton Protocol used for treatment of Type 1 Diabetes through
islet cell transplants. Subsequent to December 31, 2016, the Investigator Sponsored Clinical Trial Application was approved
by Health Canada. In preparation for the Phase 1 / 2 clinical trials as well as for the Clinical Trial Application, ProtoKinetix
has:
·
Completed the production of AAGP ® under strict GMP (Good Manufacturing Practice) standards as required by Health Canada and US FDA (United States Food and Drug Administration) for human use;
·
Completed the validated sterilization and vialing of AAGP ® to become the drug product, designated PKX-001, that will be used in the clinical trials at the University of Alberta.
·
Completed stability tests on AAGP ® at different temperature ranges.
·
Completed genotoxicity studies under GLP (Good Laboratory Practice) at ITR Laboratories Canada, Inc..
·
Completed carryover studies, to comply with the clinical test protocols, at BRI Pharmaceutical Research, Inc..
·
Competed PK (Pharmacokinetics) studies at BRI Pharmaceutical Research, Inc. in Vancouver.
·
In 2019 Competed manufacturing of additional AAGP ® molecule for expanded clinical trials to begin in 2020. Sterilization and vialing of AAGP ® drug product designated PKX-001 is anticipated to be completed in the first quarter of 2020.
The Company
entered into a Clinical Supply Agreement (the “CSA”) on January 14, 2020 with Alberta Health Services and the Governors
of the University of Alberta (the “Institution”) and Dr. James Shapiro. The agreement requires Protokinetix to supply
PKX-001 free of charge and in sufficient quantity to conduct the clinical study by Dr. James Shapiro. The delivery date is estimated
to be late February 2020.
7
Nonclinical Efficacy Testing (Neuronal
Retinal Cells)
During the year ended December 31, 2016,
ProtoKinetix entered into a Collaborative Research Agreement with the University of British Columbia, under the guidance of Dr.
Gregory-Evans, to commence testing of neuronal retinal cells in living tissue for the treatment of Macular Degeneration.
AAGP ® has been tested previously in tissue culture in the lab and was found to improve the survival of cells.
Dr. Gregory-Evans is taking those results and applying them to living tissue. He has established a new type of model for
retinal degeneration in rabbits and is currently working on injecting neuronal stem cells plus AAGP ® to test for
long term improvements in cell survival and integration into the retina that should ultimately lead to vision restoration in the
animals. Final testing on this project was completed in March 2018. Based on the positive results of the 2018 project, we have
entered into a third phase program with two animal models for a definitive determination of functionality of transplanted cells.
Interim results completed in August
of 2019 showed very positive results and showed no adverse effects in animals when using AAGP®. Although results are
in relatively small numbers of animals this bodes exceptionally well for any proposed future clinical trial work and the in
vivo study was expanded to a six-month time period. In December of 2019 the Company announced
the completion of the in vivo study to assess the effect of AAGP® on the long-term survival and functional activity
of photoreceptor precursor cells (PPCs) in the animal ocular model of genetic retinal degeneration. In vivo tests demonstrated
that transplantation of PPCs pre-treated with AAGP® (PKX-001) resulted in statistically significant improvements in both the
visual behavioral (optokinetic tracking test) and functional analysis (electroretinogram test) responses as compared with PPCs
without pre-treatment. At the 6-month time point, the AAGP®-treated cells acquired the ability to express retinal and synaptic
proteins, confirming that AAGP® had no adverse effect on precursor cells’ maturation.
AAGP ® Commercial Applications
Health Care
Acute medical problems are increasingly reliant
on, and benefit from, solutions that can deal with the fundamental factors of inflammation and oxidation. Both are well-known causes
of life-threatening conditions and diseases, and accelerated aging. In addition, many acute medical problems are benefiting from
cell therapies and transplantation of cells, tissues and time sensitive organs.
Health Care Applications of AAGP ®
fall into two main categories: (i) harvesting, storage and transplanting cells, tissues and organs; and (ii) treatments for conditions
and diseases caused by stress factors, including UV radiation, oxidation and inflammation. These are all areas that expand into
many sub-categories of existing and future health care solutions.
In
November of 2019, the Company announced the initiation of a program testing AAGP® to develop a potential therapy to treat Dry
Eye Disease (DED). AAGP® has repeatedly demonstrated anti-inflammatory and cytoprotective properties, and also exhibits pharmaceutical
properties beneficial for topical formulations. The eye is extremely sensitive, so before efficacy testing can commence, an eye
irritation study will be conducted in accordance with both industry and regulatory requirements. This testing has been contracted
to ITR Laboratories of Montreal which is a well-recognized CRO in this area. This testing is scheduled to commence in early December
with results anticipated in the first quarter of 2020
In
anticipation of a successful result from ITR Laboratories, the Company contracted with EyeCRO, from Oklahoma City, to conduct the
efficacy testing. This testing will involve topical application of AAGP® and evaluations of its effects on ocular inflammation.
EyeCRO is a world-recognized, specialized CRO in the field of pre-clinical ocular drug research and development. This program is
expected to commence in early 2020 and run for 3-4 months.
Patents
On or about January 5, 2015, the Company entered
into an Assignment of Patents and Patent Application (the “Patent Assignment”) between the Company and Institut National
des Sciences Appliquées de Rouen (“INSA”) for the assignment of certain patents and all rights associated therewith
(the “Patents”). The Company and INSA had previously entered into a licensing agreement for the Patents in August
2004. The Patent Assignment transferred all of the Patents and rights associated therewith to the Company upon payment to
INSA of the sum of 25,000 Euros.
Through this assignment, ProtoKinetix is the
sole owner of all issued patents of the “Gem difluorinated C-glycopeptides, their preparation and their use for the preservation
of biological materials and/or in cryosurgery” family, and all the rights associated therewith. Importantly, this family
includes issued patents in Canada (Patent No. CA2,558,801), England, France, and Germany (Patent No. EP1,817,329) and the United
States (Patent No. US8,394,362).
8
On or about April 8, 2015, ProtoKinetix entered
into a Royalty Agreement (the “Agreement”) between the Company and the Governors of the University of Alberta (“UAB”)
for the assignment of UAB’s portion of certain patent applications and all rights associated therewith (the “Patent
Rights”). The Agreement also grants UAB a royalty of 5% of the gross revenue from the assignment, manufacturing, sale,
distribution, or licensing of the Patent Rights and any commercial products generated from the Patent Rights. The Company
had a now expired irrevocable option to purchase the royalty for CAD $5,000,000 (approximately US $4,000,000) for two years from
the earlier of September 1, 2015 or the first date UAB publishes its research related to the Patent Rights. UAB published
its research related to the Patent Rights on November 18, 2015. The Company’s option to purchase the royalty from UAB
expired on September 1, 2017.
Through this assignment, the Company has gained
UAB’s portion of US provisional patent application no. 62/007,626, and International Patent Application no. PCT/CA2015/050509,
and corresponding patent applications filed in Australia, Canada, China, Europe, India, Japan, Korea and New Zealand, as well as
U.S. Patent Application no. US 14/728,535, all of which claim priority from said provisional patent application related to the
use of anti-aging glycopeptides to enhance beta cell health, survival and improve transplant outcomes.
On or about April 22, 2015, ProtoKinetix entered
into a Technology Transfer Agreement with Grant Young for the assignment of Mr. Young’s portion of certain patent applications
and all rights associated therewith. In exchange for these rights, Mr. Young was paid $10,000 in cash and a five-year warrant
to purchase 6,000,000 shares of the Company’s common stock at an exercise price of $0.10 per share.
Through this assignment, the Company has gained
Mr. Young’s portion of US provisional patent application no. 62/007,626 and applications claiming priority therefrom as well
as patent issuing therefrom, related to the use of anti-aging glycopeptides to enhance beta cell health, survival and improve transplant
outcomes.
On or about May 20, 2016, Grant Young assigned
his intellectual property rights associated with US provisional patent application no. 62/287,657, and future applications to be
derived therefrom to ProtoKinetix, thus gaining Mr. Young’s rights to inventions related to the use of anti-aging glycopeptides
to enhance survival of neurosensory precursor cells, and all patents issuing from and claiming priority to such application.
These patent rights secure, amongst other things, key intellectual property rights to the Company’s use of the AAGP ®
lead compound in regenerative medicine.
The patents from INSA and patent rights from
UAB and Mr. Young secure, amongst other things, key intellectual property rights to the Company’s use of the AAGP ®
lead compound in regenerative medicine.
Consistent with our agreements with the licensors
of various technologies we license, we have no finished commercial product or products, and have received no FDA approvals for
any product or diagnostic procedures. We are focused on the research and development of one lead compound known as AAGP ® .
Trademarks
We filed a trademark application with the United
States Patent & Trademark Office on September 15, 2005 with a registration date of August 7, 2007 for the mark AAGP ® .
The application was subsequently cancelled on March 14, 2014 because we did not file a renewal declaration. We filed a new
application for registration of the mark and received approval of registration on November 7, 2017.
We are currently in the process of obtaining
trademark protection for AAGP ® in Canada, as well as filing our trademark application for ProtoKinetix with the
Canadian Intellectual Property office in February 2019. On September 10, 2019 the Company was granted trademark registration #5,856,730
for the trademark name ProtoKinetix ® , protecting the name in Canada and allowing the name to be marked with the
registration symbol.
Subject to our available financial resources,
our intellectual property strategy is to continue testing of the AAGP ® lead compound and develop marketable applications
of the compound.
Trade Secrets and Know-How
The Company has developed a substantial body
of trade secrets and know-how relating to the development, use and manufacture of AAGP ® , including but not limited
to the optimization of materials for efforts, and how to maximize sensitivity, speed-to-result, specificity, stability, purity
and reproducibility.
9
Competition
The markets that the Company is focusing on
are multi-billion dollar international industries which are intensely competitive. Many of the Company’s competitors
are substantially larger and have greater financial, research, manufacturing, and marketing resources.
Industry competition in general is based on the following:
§
Scientific and technological capability;
§
Proprietary know-how;
§
The ability to develop and market products and processes;
§
The ability to obtain FDA or other required regulatory approvals;
§
The ability to manufacture products that meet applicable FDA requirements, (i.e. FDA’s Quality System Regulations) see also Governmental Regulation section;
§
Access to adequate capital;
§
The ability to attract and retain qualified personnel; and
§
The availability of patent protection.
The Company’s ability to develop its
research is in large measure dependent on having sufficient and additional resources and/or collaborative relationships.
The Company’s access to capital is more
challenging, relative to most of its competitors. This is a competitive disadvantage. The Company believes however
that its access to capital may increase as it gets closer to the development of a commercially viable product.
The Company believes that its research has
enabled it to attract and retain qualified consultants. Because of the greater financial resources of many of its competitors,
the Company may not be able to complete effectively for the same individuals to the extent that a competitor uses its substantial
resources to attract any such individuals.
Governmental Regulation
The Company’s AAGPs ® have
commercial applications in markets and circumstances that fall under government regulations ranging from none to limited to extensive.
Although there is no such immediate need to
make any regulatory filing in the United States, the Company has limited or no experience with regard to obtaining FDA or other
required regulatory approvals. In February 2015, the Company appointed Dr. Julia Levy to its Business and Scientific Advisory Board
and intends to retain the services of additional appropriately experienced consultants. For this reason, should our research efforts
continue to show promise, we will need to hire consultants to assist the Company with such governmental regulations.
As the Company continues to conduct research
and testing programs, in collaboration with commercial entities, to expand and confirm the potential medical applications of AAGP ®
in a number of fields, including regenerative medicine, cell therapy, blood products, and transplants, the Company intends to utilize
the regulatory expertise of others, whether they are consultants or commercial entities involved on collaborative development programs
with the Company.
The following discussion relates to factors
that may come into play when and if the Company has a commercially viable product in an area which requires regulatory approval.
These products may be regulated by the European regulatory agencies, FDA, U.S. Department of Agriculture, certain state and local
agencies, and/or comparable regulatory bodies in other countries (collectively, these agencies shall be referred to as the “Agencies”).
Government regulation affects almost all aspects of development, production, and marketing, including product testing, authorizations
to market, labeling, promotion, manufacturing, and record keeping. The products regulated by FDA and U.S. Department of Agriculture
require some form of action by such agency before they can be marketed in the United States, and, after approval or clearance,
the products must continue to comply with other FDA requirements applicable to marketed products. Both before and after approval
or clearance, failure to comply with the FDA’s requirements can lead to significant penalties. The Company’s proposed
AAGP ® products will require government regulatory approval as a biologic agent. Such regulatory approval will be
granted only after the appropriate preclinical and clinical studies are conducted to confirm efficacy and safety.
10
Every company that manufactures biologic products
or medical devices distributed in the United States must comply with the FDA’s Quality System Regulations. These regulations
govern the manufacturing process, including design, manufacture, testing, release, packaging, distribution, documentation, and
purchasing. Compliance with the Quality System Regulations is required before the FDA will approve an application. These
requirements also apply to marketed products. Companies are also subject to other post-market and general requirements, including
compliance with restrictions imposed on marketed products, compliance with promotional standards, record keeping, and reporting
of certain adverse reactions or events. The FDA regularly inspects companies to determine compliance with the Quality System
Regulations and other post-approval requirements. Failure to comply with statutory requirements and the FDA’s regulations
can lead to substantial penalties, including monetary penalties, injunctions, product recalls, seizure of products, and criminal
prosecution.
The Clinical Laboratory Improvement Act of
1988 prohibits laboratories from performing in vitro tests for the purpose of providing information for the diagnosis, prevention
or treatment of any disease or impairment of, or the assessment of, the health of human beings unless there is in effect for such
laboratories a certificate issued by the U.S. Department of Health and Human Services applicable to the category of examination
or procedure performed. Although a certificate is not required for ProtoKinetix, the Company considers the applicability
of the requirements of the Clinical Laboratory Improvement Act in the potential design and development of its products.
The Company is also subject to regulations
in foreign countries governing products, human clinical trials and marketing, and may need to obtain approval or evaluations by
international public health agencies, such as the World Health Organization, in order to sell products in certain countries.
Approval processes vary from country to country, and the length of time required for approval or to obtain other clearances may
in some cases be longer than that required for U.S. governmental approvals. The extent of potentially adverse governmental
regulation affecting ProtoKinetix that might arise from future legislative or administrative action cannot be predicted.
Research and Development
Our business depends on our ability to sponsor
research and development activities. For the year ended December 31, 2018, the Company incurred total research and development
expenses of $337,067. For the year ended December 31, 2019, the Company incurred total research and development expenses
of $369,520. In order to reach the Company’s goals of developing a marketable product, we will need to increase the
funding of our research and development activities which at this time is limited by our ability to raise money to fund the Company.
Environmental Laws
To date, the Company has not encountered any
costs relating to compliance with any environmental laws.
Employees
To date, the Company does not have any employees.
The Company’s President and Chief Executive Officer and the Chief Financial Officer are both engaged as consultants to the
Company.
11
ITEM 1A. RISK FACTORS
The Company’s securities are highly speculative
and involve a high degree of risk, including among other items the risk factors described below. The below risk factors are
intended to generally describe certain risks that could materially affect the Company and its current business operations and activities.
You should carefully consider the risks
described below and elsewhere herein in connection with any decision whether to acquire, hold or sell the Company’s securities.
If any of the contingencies discussed in the following paragraphs or other materially adverse events actually occur, the business,
financial condition and results of operations could be materially and adversely affected. In such case, the trading price
of our common stock could decline, and you could lose all or a significant part of your investment.
Our Company has a lack of operating history
and lack of revenues from operations. Our Company has no revenues and very limited operating history. As of
the date of this Annual Report, our most significant assets are cash and our intellectual property. Our ability to successfully
generate revenues from our intellectual property is dependent on a number of factors, including availability of funds to complete
development efforts, to adequately test and refine our products, and to commercialize our products. There can be no assurance
that we will not encounter setbacks with our products, or that funding will be sufficient to bring our products to the point of
commercialization.
We are dependent on our key personnel,
and the loss of such personnel could adversely affect our business. We depend on the continued performance of the
members of our management team and our Business and Scientific Advisory Board who have contributed to the expertise of our team
and the position of our business. If we lose the services of members of our management teams, and are unable to locate a
suitable replacement in a timely manner, it could have a material adverse effect on our business. We do not expect to obtain
key man life insurance for any members of management in the foreseeable future.
We may experience difficulty implementing
our business plan. Our business plan is to continue with the development of the Company’s intellectual property
and to develop a product for sale commercially. We may require additional capital in order to develop our products for sale
commercially. There can be no assurance that we would be able to obtain additional capital on reasonable terms, or at all.
We have been and expect to be significantly
dependent on our collaborative agreements for the research, development and testing of AAGP ® , which exposes us to
the risk of reliance on the performance of third parties. In conducting our research and development activities,
we currently rely, and expect to continue to rely, on numerous collaborative agreements with third parties such as contract research
organizations, commercial partners, universities, governmental agencies and not-for-profit organizations for both strategic and
financial resources. The loss of, or failure to perform by us or our partners (who are subject to regulatory, competitive
and other risks) under any applicable agreements or arrangements, or our failure to secure additional agreements for our product
candidates, would substantially disrupt or delay our research and development and commercialization activities. Any such
loss would likely increase our expenses and materially harm our business, financial condition and results of operations.
12
We may have difficulty raising any needed
additional capital. We may have difficulty raising needed capital in the future as a result of, among other factors,
our lack of revenues from operations, as well as the inherent business risks associated with our Company and present and future
market conditions. Our business currently generates no revenue from operations. We will likely require additional funds
to conduct research and development, establish and conduct non-clinical and clinical trials, secure clinical and commercial-scale
manufacturing arrangements and provide for marketing and distribution. If adequate funds are unavailable, we may be required
to delay, reduce the scope of or eliminate one or more of our research, development or commercialization programs, product launches
or marketing efforts, any of which may materially harm our business, financial condition and results of operations.
We are a research and product development
stage company that has not yet developed or sold any products. To date, we have not yet developed
nor marketed a product. Ongoing testing of the AAGP ® molecule with three amino acids joined to a monosaccharide
by a gemdiflouride bond continues to show that there is significant promise in the field of medicine of preserving cells, tissue
and organs from various stresses. Tests have confirmed that the AAGP ® molecule improves the harvest of cells
from cryopreservation by 30% to 120%. We believe there is a market for AAGP ® to preserve cells, particularly various
stem cells, and we will continue testing with potential customers. At the same time, we are taking steps to improve the manufacturing
process to reduce costs and improve purity and biochemical activity.
Even if we develop product candidates
which obtain regulatory approval they may never achieve market acceptance or commercial success. Even if we develop
products and obtain FDA or other regulatory approvals, our products may not achieve market acceptance among physicians, patients
and third party payors and, ultimately, may not be commercially successful. Market acceptance of our product candidates for
which we receive approval depends on a number of factors. Any failure by our product candidates that obtain regulatory approval
to achieve market acceptance or commercial success would adversely affect our financial results.
The potential widespread acceptance of therapies
that are alternatives to ours may limit market acceptance of our formulations or products, even if commercialized. Many of
our targeted diseases and conditions can also be treated by other medication or technologies. These treatments may be widely
accepted in medical communities and have a longer history of use. The established use of these competitive drugs may limit
the potential for our technologies, formulations and products to receive widespread acceptance if commercialized.
The market for our product candidates
is rapidly changing and competitive, and new technologies treatments which may be developed by others could impair our ability
to maintain and grow our business and remain competitive. The pharmaceutical and biotechnology industries are subject
to rapid and substantial technological change. Developments by others may render our technologies and our product candidates
noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological
competition from pharmaceutical and biotechnology companies, universities, governmental entities and others now existing or diversifying
into the field is intense and is expected to increase. Many of these entities have significantly greater research and development
capabilities, human resources and budgets than we do, as well as substantially more marketing, manufacturing, financial and managerial
resources. These entities represent significant competition for us.
13
Risks Related to Product Development and
Regulation
Our ability to generate revenues will
be dependent on our ability to develop a product that complies with legal requirements. Although the laws and regulations
of the various jurisdictions in which we may operate vary in their technical requirements and are subject to amendment from time
to time, virtually all of these jurisdictions require licenses, permits, and other forms of approval. We will have to apply
for, and obtain, all requisite government licenses, registrations, findings of suitability, permits and approvals necessary for
us to do business in these new markets. We cannot offer any assurance that we will be able to obtain all necessary licenses,
registrations, findings of suitability, permits, or approvals.
Our failure to obtain costly government
approvals, including required FDA approvals, or to comply with ongoing governmental regulations relating to our technologies and
product candidates could delay or limit introduction of our products and result in failure to achieve revenues or maintain our
ongoing business. Our research and development activities and the manufacture and marketing of our product candidates
are subject to extensive regulation for safety, efficacy and quality by numerous government authorities in the United States and
abroad. Before receiving FDA or foreign regulatory clearance to market our proposed formulations and products, we will have
to demonstrate that our formulations and products are safe and effective in the population. Clinical trials, manufacturing
and marketing of drugs are subject to the rigorous testing and approval process of the FDA and equivalent foreign regulatory authorities.
The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern and influence the
testing, manufacture, labeling, advertising, distribution and promotion of drugs and medical devices. As a result, regulatory
approvals can take a number of years or longer to accomplish and require the expenditure of substantial financial, managerial and
other resources.
Conducting and completing the clinical
trials necessary for FDA and/or Health Canada approval is costly and subject to intense regulatory scrutiny as well as the risk
of failing to meet the primary endpoint of such trials. We will not be able to commercialize and sell our proposed
products and formulations without completing such trials. In order to conduct clinical trials that are necessary to obtain
approval by the FDA and/or Health Canada to market a formulation or product, it is necessary to receive clearance from the FDA
and/or Health Canada to conduct such clinical trials. The FDA and/or Health Canada can halt clinical trials at any time for
safety reasons or because we or our clinical investigators did not follow the FDA’s and/or Health Canada requirements for
conducting clinical trials. If we are unable to receive clearance to conduct clinical trials or the trials are permanently
halted by the FDA and/or Health Canada, we would not be able to achieve any revenue from such product as it is illegal to sell
any drug or medical device for human consumption or use without FDA and/or Health Canada approval.
We could be exposed to significant drug
product liability claims which could be time consuming and costly to defend, divert management attention and adversely impact our
ability to obtain and maintain insurance coverage. The testing, manufacturing, marketing and sale of our proposed
products involve an inherent risk that product liability claims will be asserted against us. Product liability insurance
may prove inadequate to cover claims and/or litigation costs. Product liability claims or other claims related to our products,
regardless of their outcome, could require us to spend significant time and money in litigation or to pay significant settlement
amounts or judgments. Any successful product liability or other claim may prevent us from obtaining adequate liability insurance
in the future on commercially desirable or reasonable terms. An inability to obtain sufficient insurance coverage at an acceptable
cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of our products
and product candidates. A product liability claim could also significantly harm our reputation and delay market acceptance
of our proposed formulations and products.
14
Risk Factors Related to Intellectual Property
and Obsolescence
We rely on patents and other intellectual
property to protect our business interests. We have attempted to protect our products and will attempt to protect other
products through a combination of trade secrets, confidentiality agreements, patents and other contractual provisions. Patents
only provide a limited protection against infringement, and patent infringement suits are complex, expensive, and not always successful.
Although the Company believes its patents will provide significant protection, there can be no assurance that they will be issued
and if they are, that they will provide enough protection.
Because it is difficult and costly to
protect our proprietary rights, we may not be able to ensure their protection. Our commercial success will depend in part
on maintaining patent protection and trade secret protection for our products, as well as successfully defending these patents
against third-party challenges. We will only be able to protect our technologies from unauthorized use by third parties to the
extent that valid and enforceable patents or trade secrets cover them.
The patent positions of pharmaceutical and
biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles
remain unresolved. No consistent policy regarding the breadth of claims allowed in pharmaceutical or biotechnology patents has
emerged to date in the United States. The patent situation outside the United States is even more uncertain. Changes in either
the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual
property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party
patents.
Our competitive position could be harmed
if we are unable to enforce confidentiality agreements. Our proprietary information is critically important to our
competitive position and is a significant aspect of our business plan. We generally enter into confidentiality agreements
with most of our employees and consultants, and control access to, and distribution of, our documentation and other proprietary
information. Despite these precautions, we cannot assure you that these strategies will be adequate to prevent misappropriation
of our proprietary information. Therefore, we could be required to expend significant amounts to defend our rights to proprietary
information in the future if a breach were to occur.
General Corporate Risk Factors
Insiders continue to have substantial
control over the Company. As of February 18, 2020, the Company’s directors and executive officers hold the
current right to vote approximately 36.5% of the Company’s outstanding voting stock; of which 31.4% is owned or controlled,
directly or indirectly by the Company CEO, Clarence Smith. In addition, the Company’s directors and executive officers have
the right to acquire additional shares which could increase their voting percentage significantly. As a result, Mr. Smith acting
alone, and/or many of these individuals acting together, may have the ability to exert significant control over the Company’s
decisions and control the management and affairs of the Company, and also to determine the outcome of matters submitted to stockholders
for approval, including the election and removal of a director, the removal of any officer and any merger, consolidation or sale
of all or substantially all of the Company’s assets. Accordingly, this concentration of ownership may harm a future market
price of the Company’s common stock by:
·
Delaying, deferring or preventing a change in control of the Company;
·
Impeding a merger, consolidation, takeover or other business combination involving the Company; or
·
Discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of the Company .
The Company may not be able to
continue as a going concern. Our independent public accountants noted that our recurring losses from operations
($4,197,897 and $1,216,343 for the years ended December 31, 2019 and 2018, respectively) and negative net operating cash flow ($850,658
and $453,493 for the years ended December 31, 2019 and 2018, respectively) raise substantial doubt about our ability to continue
as a going concern. This may hinder our future ability to obtain financing or may force us to obtain financing on less favorable
terms than would otherwise be available.
15
The Company is dependent upon
additional financing which it may not be able to secure in the future. As it has in the past, the Company will likely
continue to require financing to address its working capital needs, continue its development efforts, support business operations,
fund possible continuing operating losses, and respond to unanticipated capital requirements. There can be no assurance that
additional financing or capital will be available and, if available, upon acceptable terms and conditions. To the extent
that any required additional financing is not available on acceptable terms, the Company’s ability to continue in business
may be jeopardized and the Company may need to curtail its operations and implement a plan to extend payables and reduce overhead
until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will
be successful. Such a plan could have a material adverse effect on the Company’s business, financial condition and results
of operations, and ultimately the Company could be forced to discontinue its operations, liquidate and/or seek reorganization in
bankruptcy.
The Company has been delinquent
in filing certain income tax and information reporting returns. The Company was delinquent in filing certain income
tax returns with the U.S. Internal Revenue Service and reports disclosing its interest in foreign bank accounts on form TDF 90-22.1,
“Report of Foreign Bank and Financial Accounts” (“FBARs”). In September 2015, the Company filed the delinquent
income tax returns and has sought waivers of any penalties under the IRS Offshore Voluntary Disclosure Program for late filing
of the returns and FBARs. Under the program, the IRS has indicated that it will not impose a penalty for the failure to file
delinquent income tax returns if there are no underreported tax liabilities. On November 30, 2017, the Company received a
letter from the IRS concluding their review of the Company’s tax returns under the program and accepting the returns as filed.
No penalties have been assessed by the IRS to date, and management does not believe that the Company will incur any penalties relating
to the tax years submitted under the program.
Our management is relatively inexperienced
with running a public company and could create a risk of non-compliance. Management’s inexperience may cause
us to fall out of compliance with applicable regulatory requirements, which could lead to enforcement action against us and a negative
impact on our stock price.
Compliance with changing regulation
of corporate governance and public disclosure may result in additional expenses and could create a risk of non-compliance.
Changing laws, regulations and standards relating to corporate governance and public disclosure have created uncertainty
for public companies and significantly increased the costs and risks associated with accessing the public markets and public reporting.
These corporate governance standards are the product of many sources, including, without limitation, public market perception,
stock exchange regulations and SEC disclosure requirements. Our management team expects to invest significant management time and
financial resources to comply with both existing and evolving standards for public companies, which will lead to increased general
and administrative expenses and a diversion of management time and attention from revenue generating activities to compliance activities.
Management’s inexperience may cause us to fall out of compliance with applicable regulatory requirements, which could lead
to enforcement action against us and a negative impact on our stock price.
As a company with a class of securities
registered pursuant to the Exchange Act the Company has significant obligations under the Exchange Act. Having a class
of securities registered under the Exchange Act is a time consuming and expensive process and subjects the Company to increased
regulatory scrutiny and extensive and complex regulation. Complying with these regulations is expensive and requires
a significant amount of management’s time. For example, public companies are obligated to institute and maintain
financial accounting controls and for the accuracy and completeness of their books and records. These requirements could
necessitate additional corporate spending on procedures and personnel requiring us to reallocate funds from other business objectives.
Risk Factors Related to Our Common Stock
The Company will face significant
regulation by the SEC and state securities administrators. The holders of shares of the Company’s common stock
and preferred stock may not offer or sell the shares in private transactions or (should a public market develop, of which there
can be no assurance) public transactions without compliance with regulations imposed by the SEC and various state securities administrators.
To the extent that any holder desires to offer or sell any such shares, the holder must prove to the reasonable satisfaction of
the Company that he has complied with all applicable securities regulations, and the Company may require an opinion of the holder’s
legal counsel to that effect. Thus, there can be no assurance that the holder will be able to resell the shares or any interest
therein when the holder desires to do so.
Our existing shareholders could
experience further dilution if we elect to raise equity capital to meet our liquidity needs or finance a strategic transaction.
As part of our growth strategy we may desire to raise capital and or utilize our common stock to effect strategic business
transactions. Either such action will likely require that we issue equity (or debt) securities which would result in dilution
to our existing stockholders. Although we will attempt to minimize the dilutive impact of any future capital-raising activities
or business transactions, we cannot offer any assurance that we will be able to do so. If we are successful in raising additional
working capital, we may have to issue additional shares of our common stock at prices at a discount from the then-current market
price of our common stock.
16
Because we have no plans to pay dividends
on our common stock, investors must look solely to stock appreciation for a return on their investment in us. We
do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain
all future earnings to fund the development and growth of our business. Any payment of future dividends will be at the discretion
of our board of directors and will depend on, among other things, our earnings, financial condition, capital requirements, level
of indebtedness, statutory and contractual restrictions applying to the payment of dividends and other considerations that the
board of directors deems relevant. Investors must rely on sales of their common stock after price appreciation, which may
never occur, as the only way to realize a return on their investment. Investors seeking cash dividends should not purchase
our common stock.
As our stock is not listed on a national
securities exchange, trading in our shares will be subject to rules governing “penny stocks,” which will impair trading
activity in our shares. Our stock is not on a national securities exchange. Therefore, our stock is subject to rules
adopted by the SEC regulating broker dealer practices in connection with transactions in “penny stocks.” Those disclosure
rules applicable to “penny stocks” require a broker dealer, prior to a transaction in a “penny stock” not
otherwise exempt from the rules, to deliver a standardized list disclosure document prepared by the SEC. That disclosure document
advises an investor that investment in “penny stocks” can be very risky and that the investor’s salesperson or
broker is not an impartial advisor but rather paid to sell the shares. The disclosure contains further warnings for the investor
to exercise caution in connection with an investment in “penny stocks,” to independently investigate the security,
as well as the salesperson with whom the investor is working and to understand the risky nature of an investment in this security.
The broker dealer must also provide the customer with certain other information and must make a special written determination that
the “penny stock” is a suitable investment for the purchaser and receive the purchaser’s written agreement to
the transaction. Further, the rules require that, following the proposed transaction, the broker provide the customer with monthly
account statements containing market information about the prices of the securities.
The over-the-counter market for stock
such as ours is subject to extreme price and volume fluctuations. You may not be able to resell your shares at or above
the public sale price. The securities of companies such as ours have historically experienced extreme price and volume fluctuations
during certain periods. These broad market fluctuations and other factors, such as new product developments and trends in the industry
and in the investment markets generally, as well as economic conditions and quarterly variations in our operational results, may
have a negative effect on the market price of our common stock.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
The Company’s principal executive office,
for all operations, is located at 412 Mulberry Street, Marietta, Ohio 45750. The Company currently does not have a lease
for its principal executive office but rents month to month. A lease on the space is held by the CFO’s, company, The Guzzetta
Company LLC. The Company pays $1,050 per month for the office. ProtoKinetix does not own any real property.
ITEM 3. LEGAL PROCEEDINGS
The Company and its management are not aware
of any regulatory or legal proceedings or investigations pending involving the Company, any of its subsidiaries or affiliates,
or any of their respective officers, directors or employees.
17
ITEM 4. MINE SAFETY MATTERS
Not applicable.
18
PART II
ITEM 5.
MARKET FOR THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Our common stock is currently quoted on OTCQB
tier of the OTC Markets under the symbol “PKTX”. The table below sets forth the high and low bid prices of the
Company’s common stock during the periods indicated as reported on OTC Markets Inc. (www.otcmarkets.com). The quotations
are inter-dealer prices without retail markups, markdowns or commissions, and may not necessarily represent actual transactions.
2019
Low
High
First Quarter
$
0.050
$
0.088
Second Quarter
0.058
0.319
Third Quarter
0.080
0.289
Fourth Quarter
0.081
0.143
2018
Low
High
First Quarter
$
0.040
$
0.070
Second Quarter
0.030
0.120
Third Quarter
0.059
0.130
Fourth Quarter
0.050
0.130
Holders
As of February 18, 2020, there were approximately
89 shareholders of record of the Company’s common stock. This does not include an indeterminate number of persons who
hold our Common Stock in brokerage accounts and otherwise in “street name.”
Dividends
We have never paid cash dividends and have
no plans to do so in the foreseeable future. Our future dividend policy will be determined by our board of directors and
will depend upon a number of factors, including our financial condition and performance, our cash needs and expansion plans, income
tax consequences, and the restrictions that applicable laws, our current preferred stock instruments, and our future credit arrangements
may then impose.
Adoption of the 2015 Stock Option and Stock
Bonus Plan
On July 1, 2015, the Board of Directors of
the Company adopted the 2015 Stock Option and Stock Bonus Plan (the “2015 Plan”).
All awards granted under the 2015 Plan will
continue forward under the 2015 Plan until expired or exercised pursuant to the terms of each individual award agreement, however,
no new awards shall be granted under the 2015 Plan.
As of both December 31, 2019 and February 18,
2020, no options and 2,000,000 shares of fully vested common stock remained as granted under the 2015 Plan.
19
Adoption and Amendment of the 2017 Stock
Option and Stock Bonus Plan
On December 30, 2016, the Board of Directors
of the Company the (“Board”) adopted the 2017 Stock Option and Stock Bonus Plan (the "“2017 Plan”).
The Board adopted the 2017 Plan as it anticipates utilizing equity compensation as part of its ongoing standard corporate operations
and in connection with its contemplated activities going forward.
On November 9, 2018, the Board
amended the 2017 Stock Option and Stock Bonus Plan to increase the aggregate number of shares that may be issued under the 2017
Plan from 30,000,000 to 50,000,000 shares subject to adjustment as provided therein to continue to incentivize contractors and
future employees (if any) of the Company (the amended 2017 Plan is hereinafter referred to as the “Amended 2017 Plan”).
On July 15, 2019, the Board again amended the Amended 2017 Plan to increase the aggregate number of shares that may be issued under
the 2017 Plan from 50,000,000 to 89,700,000 shares.
The Amended 2017 Plan also provides
for the ability of the Board to extend the exercise period of an option and provides for flexibility in the event of a change in
control of the Company or consolidation or merger.
The Amended 2017 Plan is administered by the
Board, or a committee appointed by the Board. In addition to determining who will be granted options or bonuses, the committee
has the authority and discretion to determine when options and bonuses will be granted and the number of options and bonuses to
be granted. The committee also may determine a vesting and/or forfeiture schedule for bonuses and/or options granted, the
time or times when each option becomes exercisable, the duration of the exercise period for options and the form or forms of the
agreements, certificates or other instruments evidencing grants made under the Amended 2017 Plan. The committee may determine
the purchase price of the shares of common stock covered by each option and determine the fair market value per share. The
committee also may impose additional conditions or restrictions not inconsistent with the provisions of the Amended 2017 Plan.
The committee may adopt, amend and rescind such rules and regulations as in its opinion may be advisable for the administration
of the Amended 2017 Plan.
20
The committee also has the power to interpret
the Amended 2017 Plan, and the provisions in the instruments evidencing grants made under it, and is empowered to make all other
determinations deemed necessary or advisable for the administration of it.
Participants in the Amended 2017 Plan may be
selected by the committee from employees, officers, consultants and advisors (including board members) of ProtoKinetix. The
committee may take into account the duties of persons selected, their present and potential contributions to the success of ProtoKinetix
and such other considerations as the committee deems relevant to the purposes of the Amended 2017 Plan.
In the event of a change, such as a stock split,
is made in the Company’s capitalization which results in an exchange or other adjustment of each share of common stock for
or into a greater or lesser number of shares, appropriate adjustments will be made to unvested bonuses and in the exercise price
and in the number of shares subject to each outstanding option. The committee also may make provisions for adjusting the
number of bonuses or underlying outstanding options in the event the Company effects one or more reorganizations, recapitalizations,
rights offerings, or other increases or reductions of shares of its outstanding common stock. Options and bonuses may provide
that in the event of the dissolution or liquidation of ProtoKinetix, a corporate separation or division or the merger or consolidation
of ProtoKinetix, the holder may exercise the option on such terms as it may have been exercised immediately prior to such dissolution,
corporate separation or division or merger or consolidation; or in the alternative, the committee may provide that each option
granted under the 2017 Plan shall terminate as of a date fixed by the committee.
The exercise price of any option granted under
the Amended 2017 Plan must be no less than 100% of the “fair market value” of ProtoKinetix’s common stock on
the date of grant. Any incentive stock option granted under the Amended 2017 Plan to a person owning more than 10% of the
total combined voting power of the common stock must be at a price of no less than 110% of the fair market value per share on the
date of grant.
The exercise price of an option may be paid
in cash, in shares of ProtoKinetix common stock or other property having a fair market value equal to the exercise price of the
option, or in a combination of cash, shares, other securities and property. The committee determines whether or not property
other than cash or common stock may be used to purchase the shares underlying an option and shall determine the value of the property
received.
As of both December 31, 2019 and February 18,
2020, 89,450,000 options remain as granted under the Amended 2017 Plan.
As of both December 31, 2019 and February 18,
2020, 2,000,000 options remain as granted not pursuant to any stock option plan.
21
Securities Authorized for Issuance Under Equity Compensation
Plans
The following table sets forth securities authorized for issuance
under equity compensation plans, including but not limited to the the Amended 2017 Plan and individual compensation arrangements
as of December 31, 2019:
Plan category
Number of securities
to be issued upon
exercise of outstanding options,
warrants and rights
Weighted-average
exercise price of
outstanding options, warrants and rights
Number of securities remaining available
for future issuance
under equity compensation plans (excluding securities
reflected in column (a))
(a)
(b)
(c)
Equity compensation plans approved by security holders
—
—
—
Equity compensation plans not approved by security holders
92,450,000
$ 0.15
250,000
Total
92,450,000
$ 0.15
250,000
During the year ended December 31, 2019, warrants
to purchase 6,000,000 shares of common stock of the Company were outstanding (see Note 8 of the notes to the financial statements).
As of the year ended December 31, 2019, there were warrants and options outstanding representing a total of 8,500,000 and 91,450,000
shares of common stock respectively to be issued upon exercise, of which: (i) options to purchase no shares of common stock were
outstanding under the 2015 Plan; (ii) options to purchase 89,450,000 shares of common stock were outstanding under the Amended
2017 Plan; and (iii) warrants outstanding to purchase 8,500,000 shares of common stock not pursuant to any plan and options outstanding
to purchase 2,000,000 of common stock not pursuant to any plan.
To management’s knowledge, there are
no outstanding options, warrants or other rights to acquire the common stock of the Company that were issued pursuant to the Company’s
2003, 2004 or 2005 Stock Incentive Plans (the “Old Plans”) for the year ended December 31, 2019. To management’s
knowledge, the Old Plans have expired and terminated.
Recent Sales of Unregistered Securities and Use of Proceeds
On January 22, 2019, the Company issued 250,000
shares of common stock at a price of $0.06 per share for gross proceeds of $15,000 to an accredited investor and on February 4,
2019 Clarence E. Smith, CEO of the Company, was issued 500,000 shares of common stock at a price of $0.06 per share for gross proceeds
of $30,000 pursuant to a private placement. No solicitation was used in this offering. For both sales of securities, the
Company relied on the exemption from registration available under Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation
D promulgated under the Securities Act with respect to transactions by an issuer not involving any public offering. No commissions
were paid in connection with this issuance of securities. A Form D was filed on January 14, 2019.
22
Between April 1, 2019 and May 9, 2019, the
Company sold 10,000,000 shares of common stock for gross proceeds of $500,000 to accredited investors (one of which was the Company’s
President & CEO, Clarence E. Smith) in a private placement. No solicitation was used in the offering. The Company
relied on the exemption from registration available under Section 4(a)(2) of the 1933 Act and Rule 506(b) of Regulation D promulgated
under the 1933 Act with respect to transactions by an issuer not involving any public offering. No commissions were paid
in connection with these issuances of securities. A Form D was filed on April 8, 2019.
Between June 14, 2019 and June 18, 2019, the
Company sold 2,266,667 shares of common stock for gross proceeds of $272,000 to accredited investors in a private placement. No
solicitation was used in the offering. The Company relied on the exemption from registration available under Section 4(a)(2) of
the 1933 Act and Rule 506(b) of Regulation D promulgated under the 1933 Act with respect to transactions by an issuer not involving
any public offering. No commissions were paid in connection with these issuances of securities. A Form D was filed
on July 2, 2019.
On July 15, 2019, the Board of Directors of
the Company canceled a total of 16,000,000 options previously granted to its CEO, a director, and a consultant and granted a total
of 16,000,000 new options under the Amended 2017 Plan at an exercise price of $0.26 per share as follows: Clarence Smith, President,
CEO & Director (options to purchase 5,000,000 shares); Edward McDonough, Director (options to purchase 1,000,000 shares); and
Grant Young, a consultant (options to purchase 10,000,000 shares). Twenty-five percent of the shares vest on October 13, 2019 and
25% vest every three months thereafter. The options expire on July 14, 2024. Prior to a change in control of the Company, the vesting
schedule of the option shall immediately accelerate so that the option is fully vested and available for exercise.
Also on July 15, 2019, in connection with the
continued service of certain directors, officers and consultants, the Board granted options pursuant to the Amended 2017 Plan to
acquire shares of common stock of the Company at an exercise price of $0.26 per share as follows: Mr. Smith (an option to purchase
5,000,000 shares); Mr. McDonough (an option to purchase 2,000,000 shares); Michael Guzzetta, CFO (an option to purchase 4,000,000
shares); and Mr. Young (options to purchase 5,000,000 shares). Twenty-five percent of the shares vest on October 13, 2019 and 25%
vest every three months thereafter. The options expire on July 14, 2024. Prior to a change in control of the Company, the vesting
schedule of the option shall immediately accelerate so that the option is fully vested and available for exercise. The Company
also issued an option under the Amended 2017 Plan to a consultant to acquire 500,000 shares at an exercise price of $0.26 per share.
The option is identical to the others issued by the Board except that 250,000 shares vest on October 13, 2019 and 250,000 vest
three months thereafter.
For these grants of options, no solicitation
was used and the Company relied on the exemption from registration available under Section 4(a)(2) of the Securities Act of 1933,
as amended (the “1933 Act”) and/or Rule 506(b) of Regulation D promulgated under the 1933 Act with respect to transactions
by an issuer not involving any public offering. No commissions were paid in connection with these issuances of securities.
On September 24, 2019, the Company’s CFO exercised an option
to purchase 250,000 shares of common stock of the Company at $0.07 per share through a cashless exercise. The CFO received 97,826
shares and the Company received 152,174 as consideration for the exercise. The Company relied on the exemption from registration
under Section 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”) and/or Rule 506(b) of Regulation D
promulgated under the 1933 Act with respect to transactions not involving a public offering. No commissions were paid in connection
with the issuance of these securities.
On November 18, 2019, in connection with the
continued service of certain directors, officers and consultants, the Board granted options pursuant to the Amended 2017 Plan to
acquire shares of common stock of the Company at an exercise price of $0.11 per share as follows: Mr. Smith (an option to purchase
5,000,000 shares); Mr. McDonough (an option to purchase 1,000,000 shares); Michael Guzzetta, CFO (an option to purchase 4,000,000
shares); and Mr. Young (options to purchase 5,000,000 shares). Twenty-five percent of the shares vest on February 18, 2020 and
25% vest every three months thereafter. The options expire on November 17, 2024.
For these grants of options, no solicitation
was used and the Company relied on the exemption from registration available under Section 4(a)(2) of the Securities Act of 1933,
as amended (the “1933 Act”) and/or Rule 506(b) of Regulation D promulgated under the 1933 Act with respect to transactions
by an issuer not involving any public offering. No commissions were paid in connection with these issuances of securities.
Between October 16, 2019 and December 19, 2019, the Company sold
2,500,000 Units (each Unit comprised of one common share and one warrant to purchase one common share at $0.12) for gross proceeds
of $300,000 to accredited investors (one of which was the Company’s President & CEO, Clarence E. Smith) in a private
placement. The warrants were immediately vested and expire three years from the date of issuance. No solicitation was used in the
offering. The Company relied on the exemption from registration available under Section 4(a)(2) of the 1933 Act and Rule 506(b)
of Regulation D promulgated under the 1933 Act with respect to transactions by an issuer not involving any public offering.
No commissions were paid in connection with these issuances of securities. A Form D was filed on October 31, 2019, an amended
Form D was filed on each of November 4, 2019, December 17, 2019, and December 30, 2019.
23
ITEM 6. SELECTED FINANCIAL DATA
As a smaller reporting company, we are not required to provide the
information required by this item.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The following discussion provides information
regarding the results of operations for the years ended December 31, 2019 and 2018, and our financial condition, liquidity and
capital resources as of December 31, 2019 and 2018. The financial statements and the notes thereto contain detailed information
that should be referred to in conjunction with this discussion.
The following discussion and analysis should
be read in conjunction with and our historical financial statements and the accompanying notes included elsewhere in this Annual
Report on Form 10-K, as well as the Risk Factors and the Cautionary Note Regarding Forward-Looking Statements included above.
Results of Operations
For the Years Ended
2019
2018
Operating Expenses
Amortization
$ 3,000
$ 3,000
General and Administrative
280,438
78,074
Interest Expense
—
306
Professional Fees
149,619
149,123
Research and Development
369,520
337,067
Share-Based Compensation
3,395,319
648,773
Total operating expenses
4,197,897
1,216,343
Loss from Operations
(4,197,897 )
(1,216,343 )
Other Income
Gain on Settlement of Short-Term Loans
—
—
Total other income
—
—
Net Loss
$ (4,197,897 )
$ (1,216,343 )
Revenues
We had no revenues for the years ended December 31, 2019 and 2018.
24
Gross profit and expenses
The Company’s net loss was $4,197,897
for the year ending December 31, 2019 compared to $1,216,343 for the year ending December 31, 2018. These expenses were primarily
incurred for professional fees, share-based compensation related to the operations of the Company’s business, research and
development and other general and administrative expenses. Significant changes from the prior year include:
·
Professional fees remained flat year over year going to $149,619 from $149,123 as legal, accounting and auditing activity all remained relatively unchanged over prior year totals.
·
Share-based compensation increased sharply by $2,746,546 from $648,773 to $3,395,319 primarily as a result of the sharp increase of stock price at grant date of certain options and a change in accounting based on new FASB guidance for valuation of share based payments to non-employees. Additionally, we granted a higher number of stock options in 2019.
·
Research and development increased by $32,453 from $337,067 to $369,520 primarily as a result of management’s current year investment in further testing and development of the AAGP ® molecule and expanded study lines.
·
General and administrative expenses increased by $202,364 from $78,074 to $280,438 due to the engagement of two investor relations firms and the engagement of a marketing firm to build a new website and expand public awareness of the Company through new social media applications.
Our expenses in 2019 were $4,197,897 which
included $149,619 in professional fees. We operate the Company by hiring outside consultants to assist us with management, strategic
planning, organization and daily operations. This resulted in $3,395,319 in share-based compensation recognized based on
the fair value of equity instruments granted as compensation. These professional consulting services related to marketing
and accounting, capitalization and merger opportunities as well as research development services. The Company also incurred
total research and development expenses of $369,520 and general and administrative costs of $280,438 during the year ended December
31, 2019.
Liquidity and Capital Resources
As at
December 31,
2019
2018
Cash
$ 377,349
$ 136,029
Working Capital
$ 352,879
$ 58,194
At December 31, 2019, we had $377,349 in cash
and $378,399 in total current assets. As of December 31, 2018, we had a working capital equity position of $58,194.
Although as of the date of this Annual Report we believe we have sufficient capital to meet cash flow projections and carry forward
our business objectives in the short-term, the Company needs additional working capital to continue its medical research or to
be successful in any future business activities and continue to pay its liabilities. There can be no assurance that in the
future we will be able to raise capital from outside sources in sufficient amounts to fund our business.
The failure to secure adequate outside funding
would have an adverse effect on our plan of operation and results therefrom and a corresponding negative impact on stockholder
liquidity.
25
Sources and Uses of Cash for the Years
ended December 31, 2019 and 2018
Net Cash Used in Operating Activities
During the year ended December 31, 2019, net
cash used in operating activities increased $397,165 from $453,493 to $850,658 for the years ended December 31, 2018 and 2019,
respectively. This increase was predominantly due to the increased spending on marketing and investor relations. Additionally,
new research and development contributed to the year-over- year increase of cash used in operations.
Net Cash Used in Investing Activities
During the year ended December 31, 2019, net
cash used in investing activities decreased by $10,436 primarily due to lower costs of patent maintenance and patent application
spending. Net cash from investing activities for the year ended December 31, 2018 was $35,458. Net cash used for investing
activities for the year ended December 31, 2019 was $25,022.
Net Cash Provided by Financing Activities
During the year ended December 31, 2019, net
cash provided by financing activities increased by $794,962 from $322,038 to $1,117,000 for the years ended December 31, 2018 and
2019, respectively. This increase was predominantly due to an increase in private placements completed.
Going Concern
The accompanying financial statements have
been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”), which
contemplate continuation of the Company as a going concern. The history of losses and the potential inability for the Company
to make a profit from selling a good or service has raised substantial doubt about our ability to continue as a going concern.
In spite of the fact that the current cash obligations of the Company are relatively minimal, given the cash position of the Company,
we have very little cash to operate. We intend to fund the Company and attempt to meet corporate obligations by selling common
stock. However, the Company’s common stock is at a low price and trading is not consistent.
Off-Balance Sheet Arrangements
None.
Contractual Obligations
As a smaller reporting company, we are not
required to provide the information required by paragraph (a)(5) of this Item.
Critical Accounting Policies
The preparation of financial statements in
conformity with U.S. GAAP requires management to make a variety of estimates and assumptions that affect (i) the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements, and (ii)
the reported amounts of revenues and expenses during the reporting periods covered by the financial statements.
Our management routinely makes judgments and
estimates about the effect of matters that are inherently uncertain. As the number of variables and assumptions affecting the future
resolution of the uncertainties increase, these judgments become even more subjective and complex. Although we believe that our
estimates and assumptions are reasonable, actual results may differ significantly from these estimates. Changes in estimates and
assumptions based upon actual results may have a material impact on our results of operation and/or financial condition. Our significant
accounting policies are disclosed in Note 2 to the Financial Statements included in this Form 10-K.
While all of the significant accounting policies
are important to the Company’s financial statements, the following accounting policies and the estimates derived there from
have been identified as being critical.
26
Share-Based Compensation
The Company has granted warrants and options
to purchase shares of the Company’s common stock to various parties for consulting services. The fair values of the
warrants and options issued have been estimated using the Black-Scholes Option Pricing Model.
The Company accounts for stock compensation
with persons classified as employees for accounting purposes in accordance with ASC 718 “Compensation – Stock Compensation”,
which recognizes awards at fair value on the date of grant and recognition of compensation over the service period for awards expected
to vest. Cliff Vesting is used and awards vest on the last day of the vesting period. The fair value of stock options is determined
using the Black-Scholes Option Pricing Model. The fair value of common shares issued for services is determined based on the Company’s
stock price on the date of issuance.
The Company accounts for stock compensation
arrangements with persons classified as non-employees for accounting purposes in accordance with ASC 505-50 “Stock-Based
Transactions with Nonemployees”, which requires that such equity instruments are recorded at their fair value on the measurement
date. The measurement of share-based compensation is subject to periodic adjustment as the underlying instruments vest. The fair
value of stock options is estimated using the Black-Scholes Option Pricing Model and the compensation charges are amortized over
the vesting period.
Intangible Assets – Patent and Patent
Application Costs
The Company owns intangible assets consisting
of certain patents and patent applications. Intangible assets acquired separately are measured on initial recognition at cost.
Following initial recognition, intangible assets are carried at cost less any accumulated amortization and any accumulated impairment
losses. Subsequent expenditures are capitalized only when they increase the future economic benefits embodied in the specific asset
to which they relate. All other expenditures are recognized in profit or loss as incurred.
As at December 31, 2019, the Company does not
hold any intangible assets with indefinite lives.
Intangible assets with finite lives are amortized
over the useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be impaired.
The amortization method and amortization period of an intangible asset with a finite life is reviewed at least annually.
Changes in the expected useful life or the
expected pattern of consumption of future economic benefits embodied in the asset is accounted for by changing the amortization
period or method, as appropriate, and are treated as changes in accounting estimates.
Amortization is recognized in profit or loss
on a straight-line basis over the estimated useful lives of the Company’s patents, whereas no amortization has been recognized
on the patent application costs as at December 31, 2019.
Sales and Marketing
The Company is currently not selling or marketing any products.
Inflation
Although management expects that our operations
will be influenced by general economic conditions, we do not believe that inflation had a material effect on our results of operations
during the year ending December 31, 2018.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
As a smaller reporting company, we are not required to provide the
information required by this item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by this Item begins on page F-1 of this
Annual Report on Form 10-K and is incorporated into this part by reference.
27
ITEM 9. CHANGES IN AND DISAGREEMENTS
WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Disclosure controls and procedures are controls
and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under
the 1934 Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange
Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed
to ensure that information required to be disclosed in our reports filed under the 1934 Act is accumulated and communicated to
management, including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions
regarding required disclosure.
Our management, under the direction of our
Chief Executive Officer (who is our principal executive officer), and Chief Financial Officer (who is our principal accounting
officer) has evaluated the effectiveness of our disclosure controls and procedures as required by 1934 Act Rule 13a-15(b) as of
December 31, 2019 (the end of the period covered by this report). Based on that evaluation, our principal executive officer and
our principal accounting officer concluded that these disclosure controls and procedures are effective to provide reasonable assurance
that information required to be disclosed by the Company in the reports that it files or submits under the 1934 Act is accumulated
and communicated to management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions
regarding required disclosure and are effective to provide reasonable assurance that such information is recorded, processed, summarized
and reported within the time periods specified by the SEC’s rules and forms.
The Company, including its Chief Executive
Officer and Chief Financial Officer, does not expect that its internal controls and procedures will prevent or detect all error
and all fraud. A control system, no matter how well conceived or operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met.
Management’s Annual Report on Internal
Control Over Financial Reporting
In accordance with Item 308 of SEC Regulation
S-K, management is required to provide an annual report regarding internal controls over our financial reporting. This report,
which includes management’s assessment of the effectiveness of our internal controls over financial reporting, is found below.
Inasmuch as the Company is neither an accelerated filer nor a large accelerated filer, the Company is not obligated to provide
an attestation report on the Company’s internal control over financial reporting by the Company’s registered public
accounting firm.
Internal Control Over Financial Reporting
Our management is also responsible for establishing
and maintaining adequate internal control over financial reporting (“ICFR”) as defined in Rules 13a-15(f) and 15d-15(f)
under the 1934 Act. Our ICFR are intended to be designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our ICFR are expected
to include those policies and procedures that management believes are necessary that:
(1)
Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company;
(2)
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures of the Company are being made only in accordance with proper authorizations of management and our directors; and
(3)
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.
28
Management recognizes that there are inherent
limitations in the effectiveness of any system of internal control, and accordingly, even effective internal control can provide
only reasonable assurance with respect of financial statement preparation and may not prevent or detect misstatements. In addition,
effective internal control at a point in time may become ineffective in future periods because of changes in conditions or due
to deterioration in the degree of compliance with our established policies and procedures.
As of December 31, 2019, management (with the
participation of the Chief Executive Officer and the Chief Financial Officer) conducted an evaluation of the effectiveness of the
Company’s ICFR based on the framework set forth in Internal Control--Integrated Framework (2013) issued by the Committee
of Sponsoring Organizations of the Treadway Commission (COSO) and SEC guidance on conducting such assessments by smaller reporting
companies and non-accelerated filers. Based on that assessment, management (with the participation of the Chief Executive Officer
and the Chief Financial Officer) concluded that, during the period covered by this report, such internal controls and procedures
were not effective as of December 31, 2019.
Material Weaknesses Identified
In connection with the preparation of our financial
statements for the year ended December 31, 2019, certain significant deficiencies in internal control became evident to management
that, in the aggregate, represent material weaknesses, which include the following:
Insufficient segregation of duties in our finance
and accounting functions due to limited personnel. During the year ended December 31, 2019, we used outside services to perform
all aspects of our financial reporting process, including, but not limited to, access to the underlying accounting records and
systems, the ability to post and record journal entries and responsibility for the preparation of the financial statements.
This creates a lack of review over the financial reporting process that would likely result in a failure to detect errors in spreadsheets,
calculations, or assumptions used to compile the financial statements and related disclosures as filed with the SEC. These
control deficiencies could result in a material misstatement to our interim or annual financial statements that would not be prevented
or detected.
Insufficient corporate governance policies.
Although we have a code of ethics which provides broad guidelines for corporate governance, our corporate governance activities
and processes are not always formally documented. Specifically, decisions made by our Board of Directors to be carried out
by management should be documented and communicated on a timely basis to reduce the likelihood of any misunderstandings regarding
key decisions affecting our operations and management.
Plan for Remediation of Material Weaknesses
We intend to take appropriate and reasonable
steps to make the necessary improvements to remediate these deficiencies provided that we have the resources to implement them.
This Annual Report does not include an attestation
report of our registered public accounting firm regarding internal control over financial reporting. Management’s report
is not subject to attestation by our registered public accounting firm.
There was no change in our internal control over financial reporting
that occurred during the year ended December 31, 2019, that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
Not applicable.
29
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS
AND CORPORATE GOVERNANCE
As of February 18, 2020, the Company’s current officers and
directors consist of the following persons:
Name
Age
Title
Year Appointed
Clarence E. Smith
56
Chairman, Chief Executive Officer, President
February 2015
Director
June 2014
Michael R Guzzetta
62
Chief Financial Officer
November 2017
Edward P. McDonough
67
Director
July 2015
Clarence E. Smith was appointed President
and Chief Executive Officer for the Company on February 19, 2015 and was previously appointed a member of the Board of Directors
of the Company on June 1, 2014. Prior to joining the Company as President and CEO, Mr. Smith served and continues to serve
as managing member of Tombstone Resources and Smith Equipment, LLC, a privately held company that holds operating oil and gas wells
and Smith Equipment Company, a privately held company that leases out construction equipment. In 1981, Mr. Smith started
Arvilla Well Service in West Virginia which provided construction services to oil and gas companies in the Appalachian Basin.
After merging Arvilla Well Service into Arvilla Pipeline Construction Co., Inc., Mr. Smith sold the company in 2008. Mr.
Smith also purchased Arrow Oilfield Services in 2004, which was renamed Arvilla Oilfield Services, LLC and subsequently merged
with Trans Energy, a publicly traded company in 2004. Mr. Smith served as Chairman of the Board and CEO of Trans Energy,
Inc. from 2005 to 2006. Mr. Smith graduated from St. Marys High School in West Virginia in 1981.
Michael R. Guzzetta was appointed Chief
Financial Officer of the Company on November 14, 2017. Mr. Guzzetta is a Certified Public Accountant with a practice located
in Central & Northeast Ohio providing services including business and individual taxation, non-profit accounting, corporate
policy and procedure development, business organization and consulting. Prior to opening his practice, he spent 20 years
in corporate management in the communications and energy industries. Between 2014 and 2015, Mr. Guzzetta served as Treasurer
and principal financial officer of Trans Energy Inc., a publicly traded energy company, where his responsibilities included corporate
banking, risk management, maintaining fiscal control, budgeting, taxation and SEC reporting. His prior positions include
Midwest Region Business Manager for a Fortune 100 company and Controller for an energy marketing company. Mr. Guzzetta also
served as an Adjunct Professor at Stark State College and taught courses in accounting, finance, business management, and economics.
He is a graduate of Walsh University where he graduated Magna Cum Laude with a BA in Accounting. He earned his MBA from Capital
University in Columbus, Ohio. Mr. Guzzetta has been a past member of both the Ohio Society of Certified Public Accountants
and the American Institute of Certified Public Accountants. He has served on the boards of the Canton Ballet, the ALS CARE
Project and the Finance Committee of Stark County Board of Developmental Disabilities.
Edward P. McDonough was appointed as
a member of the Board of Directors of the Company on July 1, 2015. In addition to serving as a director of the Company, Mr.
McDonough is a managing shareholder and President of McDonough, Eddy, Parsons & Baylous, A.C., a certified public accountant
firm in Parkersburg, West Virginia since 1985. The firm originated in the early 1950s, employs 15 professional certified
public accountants and accountants, and serves as certified public accountants for approximately 400 private corporations, firms,
and individuals in various commercial, business, professional, and industrial fields. Mr. McDonough became a Certified Public
Accountant in 1978, a Certified Valuation Analyst in 1996, and a Chartered Global Management Accountant in 2012. Since 1986,
Mr. McDonough has served as a Director and Chairman of the Board of Community Bank of Parkersburg, held by Community Bankshares,
Inc. He is also a Member of the American Institute of Certified Public Accountants (AICPA), has served as a Past President
and Member of the West Virginia Board of Accountancy, is a Life Member, Past Director and Past President of the West Virginia Society
of Certified Public Accountants and is a Member and Past President of the Parkersburg Chapter of the West Virginia Society of CPAs.
Mr. McDonough acquired his Bachelor of Science in Business Administration with a Major in Accounting at West Virginia University
in Morgantown, West Virginia in 1973.
30
Family Relationships
There are no family relationships among any
of our executive officers and directors.
Term of Office
Each director shall hold office until the next
annual meeting of shareholders or until his successor shall have been elected and qualified, or until there is a decrease in the
number of directors.
Involvement in Legal Proceedings
See Item 3—Legal Proceedings.
Corporate Governance
Code of Ethics
On July 8, 2019, the Board adopted a new Code
of Business Conduct and Ethics and Whistleblower Policy (“Code of Ethics”) which replaced in its entirety the Company’s
prior code of ethics. The Code of Ethics applies to all directors, officers, employees and consultants of the Company and amends
and restates the Company’s prior code of ethics to update certain provisions for business and regulatory developments and
to provide additional guidance and greater detail on certain issues such as conflicts of interest, reporting illegal or unethical
behavior, confidentiality and use of the Company’s assets, and hedging of Company securities. The Board also approved an
insider trading policy, related party transactions policy, and policy on trading blackout periods, benefit plans and SEC reporting.
Committees of the Board of Directors
The Company does not currently have a separately
designated audit committee. Instead, the Board of Directors as a whole acts as the Company’s audit committee. Consequently,
the Company does not currently have a designated audit committee financial expert.
The Company also does not have a separately
designated compensation committee. To date, the Company has not retained an independent compensation advisor to assist the Company
review and analyze the structure and terms of the Company’s executive officers.
Independent Directors
The Board of Directors has determined that
Mr. McDonough is the only independent member of the Board of Directors of the Company pursuant to SEC Rule 10A-3(b)(1) and NYSE
American Rule 803A.
Business and Scientific Advisory Board
Our Business and Scientific Advisory Board
exists to assist the Board of Directors with understanding both the regulatory and business aspects of the biopharmaceutical industry
are particularly valuable for the expansion and commercialization of AAGP ® applications. The members on the
board are:
·
Dr. Julia Levy, PhD, Chairman, Business and Scientific Advisory Board. Dr. Levy is a founder, former President and former Chief Scientific Officer of QLT, Inc., where she and her colleagues developed the first medical treatment for macular degeneration, a leading cause of blindness among the elderly. She has received numerous awards and honorary degrees. In her honor the Julia Levy B.C. Leadership Chair in Macular Research at the University of British Columbia was established.
·
Mr. Peter Jensen, former director of the Company.
31
Delinquent Section 16(a) Reports
Section 16(a) of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), requires the Company’s directors, executive officers and holders of
more than 10% of the Company’s common stock to file with the Securities and Exchange Commission initial reports of ownership
and reports of changes in ownership of common stock and other equity securities of the Company. To our knowledge, based solely
on a review of copies of Forms 3, 4 and 5 and any amendments thereto filed with the Securities and Exchange Commission and stockholder
reports from our transfer agent and written representations that no other reports were required, during the fiscal year ended December
31, 2019 our officers, directors and 10% or more stockholders complied with all Section 16(a) filing requirements applicable to
them except that: (i) Mr. Smith filed four Forms 4 late representing 20 transactions not reported on a timely basis; (ii) Mr. Guzzetta
filed one Form 4 late representing two transactions not reported on a timely basis; and (iii) Mr. Young filed one Form 4 late representing
seven transactions not reported on a timely basis. A majority of Mr. Smith’s late reported transactions were purchases on
the open market and Mr. Smith will no longer purchase shares on the open market on a regular basis.
ITEM 11. EXECUTIVE COMPENSATION
The following table summarizes the annual compensation paid to ProtoKinetix’s
named executive officers for the two years ended December 31, 2019 and 2018:
Summary Compensation Table for Executive
Officers
Name and Principal Position
Fiscal
Year
Salary
($)
Bonus
($)
Stock
Awards
($)
Option
Awards(1)
($)
Non-equity
Incentive
Plan
Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)
All Other
Compensation
($)
Total
($)
Clarence E. Smith
President & CEO
2019
—
—
—
941,688
—
—
—
941,688
2018
—
—
—
212,739
—
—
—
212,739
Michael R Guzzetta
Chief Financial Officer
2019
60,000
—
—
515,147
—
—
—
575,147
2018
60,000
—
—
41,757
—
—
—
101,757
(1) Represents the grant date full fair value of compensation costs of stock options granted during the respective year for financial statement reporting purposes, using the Black-Scholes option pricing model. Assumptions used in the calculation of these amounts are included in the Company’s consolidated financial statements. Refer to the Outstanding Equity Awards at Fiscal Year End schedule regarding option details on an award-by-award basis.
Consulting Agreements
We have entered into
consulting agreements with certain Company officers as set forth below.
Clarence E.
Smith – Mr. Smith is Chief Executive Officer and President of the Company. He entered into a consulting agreement
with the Company dated March 30, 2015 (effective January 1, 2015). On December 21, 2015, Mr. Smith and the Company entered
into a new consulting agreement effective January 1, 2016, superseding the prior agreement (the “2016 Smith Agreement”).
The 2016 Smith Agreement provided for a one-year term through December 31, 2016 and for an annual salary of $1.00 and a termination
fee.
32
In connection with the 2016 Smith Agreement,
the Company issued Mr. Smith an option pursuant to the Company’s 2015 Plan to purchase 5,000,000 shares of common stock of
the Company at a price of $0.08 per share with 1,250,000 shares vesting every three months starting March 31, 2016.
On or about December 30, 2016, the Company
entered into a new consulting agreement with Mr. Smith, effective January 1, 2017 (the “2017 Smith Agreement”) which
replaced the 2016 Smith Agreement, terminating December 31, 2016.
The 2017 Smith Agreement provides for a one-year
term through December 31, 2017 and for an annual salary of $1.00. Mr. Smith is entitled to receive a bonus payment equal
to 2.5% of the aggregate value of any application sale or license of any patent rights or products effected during the term of
the 2017 Smith Agreement.
Mr. Smith is also entitled to a termination
fee if the agreement is terminated for the following two reasons:
·
A termination without cause: If Mr. Smith is terminated without cause he will be entitled to a termination fee of $100,000 per year of service (including the pro-rata amount for partial years of service);
·
A termination upon a change of control event: Following a change of control event he will be entitled to a termination fee equal to $100,000 per year of service (including the pro-rata amount for partial years of service) plus 2.5% of the aggregate transaction value of the change of control.
In connection with the 2017 Smith Agreement,
the Company issued Mr. Smith an option pursuant to the Amended 2017 Plan to purchase 5,000,000 shares of common stock of the Company
at a price of $0.05 per share with 1,250,000 shares vesting every three months starting March 31, 2017.
On September 1, 2017, Mr. Smith and the Company
entered into an amendment to the 2017 Smith Agreement (the “September Amendment”), whereby the term of the agreement
was extended from December 31, 2017 to December 31, 2018 and automatically renews for one-year increments under the same terms
and conditions of the 2017 Smith Agreement, unless either party gives written notice to the other party at least 30 days prior
to the end of such calendar year.
In connection with the September Amendment,
the Company issued Mr. Smith an option pursuant to the Company’s Amended 2017 Plan to purchase 5,000,000 shares of common
stock of the Company at a price of $0.06 per share, with 1,250,000 shares vesting every three months starting December 31, 2017.
In connection with Mr. Smith’s continued
service to the Company, on November 9, 2018, the Company issued options pursuant to the Amended 2017 Plan to acquire 5,000,000
shares of common stock of the Company at an exercise price of $0.09 per share with 1,250,000 shares vesting every three months
starting March 31, 2019. Prior to a change in control of the Company, the vesting schedule of the option shall immediately accelerate
so that the option is fully vested and available for exercise by Mr. Smith.
Please refer to “Recent Sales
of Unregistered Securities and Use of Proceeds” for a description of the option grants canceled and issued to Mr. Smith during
2019.
Michael R. Guzzetta – Mr.
Guzzetta is Chief Financial Officer of the Company. He entered into a consulting agreement with the Company dated November
14, 2017. The consulting agreement term is from November 14, 2017 to December 1, 2018, with automatic renewal in one-year increments
with both parties having a right to terminate by giving either party notice 30 days prior to the end of the term. It also provides
for a monthly consulting fee of $5,000. In 2019, the Company paid Mr. Guzzetta $60,000 in consulting fees, and reimbursed The Guzzetta
Company LLC $12,600 in office rent. In 2018, he received $60,000 in consulting fees and The Guzzetta Company LLC was reimbursed
$12,600 for office rent of $1,050 monthly.
In connection with the consulting agreement,
the Company issued Mr. Guzzetta an option pursuant to the Amended 2017 Plan to purchase 1,000,000 shares of common stock of the
Company at a price of $0.07 per share with 250,000 shares vesting every three months starting February 14, 2018.
On November 9, 2018, in connection with Mr.
Guzzetta’s continued service to the Company, the Company issued options pursuant to the Amended 2017 Plan to acquire 4,000,000
shares of common stock of the Company at an exercise price of $0.09 per share with 1,000,000 shares vesting every three months
starting March 31, 2019. Prior to a change in control of the Company, the vesting schedule of the option shall immediately accelerate
so that the option is fully vested and available for exercise by Mr. Guzzetta.
Please refer to “Recent Sales
of Unregistered Securities and Use of Proceeds” for a description of the option grants canceled and issued to Mr. Guzzetta
during 2019.
33
Outstanding Equity Awards at Fiscal Year-End
The following table provides information as
to option awards held by each of the named executive officers of ProtoKinetix
as of December 31, 2019.
Name
Number of
Securities
Underlying
Unexercised Options
(#)
Exercisable
Number of
Securities
Underlying
Unexercised Options
(#)
Unexercisable
Option
Exercise
Price
($)
Option
Expiration
Date
Clarence E. Smith
5,000,000 (1)
—
0.05
12/31/2020
5,000,000 (2)
—
0.06
8/31/2021
5,000,000 (3)
—
0.09
11/08/2023
1,250,000 (4)
3,750,000
0.26
07/14/2024
1,250,000 (4)
3,750,000
0.26
07/14/2024
— (5)
5,000,000
0.11
11/17/2024
Michael R. Guzzetta
1,000,000 (6)
—
0.07
11/14/2021
4,000,000 (7)
—
0.09
11/08/2023
1,000,000 (8)
3,000,000
0.26
07/14/2024
— (9)
4,000,000
0.11
11/17/2024
(1)
Represents options granted pursuant to the Amended 2017 Plan on January 1, 2017 at $0.05 per share with 1,250,000 vesting every three months beginning March 31, 2017.
(2)
Represents options granted pursuant to the Amended 2017 Plan on September 1, 2017 at $0.06 per share with 1,250,000 vesting every three months beginning December 31, 2017.
(3)
Represents options granted pursuant to the Amended 2017 Plan on November 9, 2018 at $0.09 per share with 1,250,000 vesting every three months beginning March 31, 2019.
(4)
Represents options granted pursuant to the Amended 2017 Plan on July 15, 2019 at $0.26 per share with 1,250,000 vesting every three months beginning October 13, 2019.
(5)
Represents options granted pursuant to the Amended 2017 Plan on November 18, 2018 at $0.11 per share with 1,250,000 vesting every three months beginning February 18, 2020.
(6)
Represents options granted pursuant to the Amended 2017 Plan on November 14, 2017 at $0.07 per share with 250,000 vesting every three months beginning February 14, 2018.
(7)
Represents options granted pursuant to the Amended 2017 Plan on September 1, 2017 at $0.09 per share with 1,000,000 vesting every three months beginning March 31, 2019.
(8)
Represents options granted pursuant to the Amended 2017 Plan on July 15, 2019 at $0.26 per share with 1,000,000 vesting every three months beginning October 13, 2019.
(9)
Represents options granted pursuant to the Amended 2017 Plan on November 18, 2018 at $0.11 per share with 1,000,000 vesting every three months beginning February 18, 2020.
34
Director Compensation
The following table sets forth a summary of the compensation
earned by each non-employee director who served on the Board during the fiscal year ended December 31, 2019:
Director Compensation
Fees
Earned or Paid in Cash
Bonus
Stock
Awards (1)
Option
Awards (2)
Nonequity
Incentive
Plan
Compensation
Nonqualified
Deferred
Compensation
Earnings
All Other
Compensation
Total
Director
($)
($)
($)
($)
($)
($)
($)
($)
Edward P. McDonough
-
—
—
247,889 (3)
—
—
—
247,889
(1)
The aggregate grant date fair value of these stock awards was computed in accordance with ASC 718.
(2)
Represents the grant date full fair
value of compensation costs of stock options granted during the respective year for financial statement reporting purposes, using
the Black-Scholes Option Pricing Model. Assumptions used in the calculation of these amounts are included in the Company’s
audited financial statements.
(3)
As of December 31, 2019, Mr. McDonough
held options to acquire 7,000,000 shares of the Company’s common stock, of which 3,750,000 were vested and exercisable.
On July 1, 2015, the Company entered
into a consulting agreement with Mr. McDonough for director services dated July 1, 2015. On December 21, 2015, Mr. McDonough
and the Company entered into a new director consulting agreement, superseding the prior agreement (the “2016 McDonough Agreement”)
which provides for a one-year term through December 31, 2016. In connection with the 2016 McDonough Agreement, the Company
issued Mr. McDonough an option pursuant to the 2015 Plan to purchase 1,000,000 shares of common stock of the Company at a price
of $0.08 per share with 250,000 shares vesting every three months starting March 31, 2016.
On or about December 30, 2016, the Company
entered into a new consulting agreement with Mr. McDonough, effective January 1, 2017 (the “2017 McDonough Agreement”)
which replaced the 2016 McDonough Agreement, terminating December 31, 2016.
The 2017 McDonough Agreement is for a one-year
term through December 31, 2017. In connection with the 2017 McDonough Agreement, the Company issued Mr. McDonough an option pursuant
to the Amended 2017 Plan to purchase 1,000,000 shares of common stock of the Company at a price of $0.05 per share with 250,000
shares vesting every three months starting March 31, 2017.
On September 1, 2017, the Company entered into
an amendment to the 2017 McDonough Agreement, effective immediately. This new agreement is effective through December 31, 2018,
but shall automatically renew for one-year increments under the same terms and conditions of the 2017 McDonough Agreement unless
by stockholder vote or 30 days prior to the end of such calendar year written notice is given by either party to the other notifying
them of a desire to terminate.
In connection with the amendment to the 2017
McDonough Agreement, the Company granted Mr. McDonough options pursuant to the Amended 2017 Plan to purchase 1,000,000 shares of
common stock of the Company at an exercise price of $0.06 per share with 250,000 shares vesting every three months starting December
31, 2017.
On November 9, 2018, in connection with continued
service to the Company, the Company granted Mr. McDonough options pursuant to the Amended 2017 Plan to purchase 1,000,000 shares
of common stock of the Company at an exercise price of $0.09 per share with 250,000 shares vesting every three months starting
March 31, 2019. Prior to a change in control of the Company, the vesting schedule of the option shall immediately accelerate so
that the option is fully vested and available for exercise by Mr. McDonough.
Please refer to “Recent Sales
of Unregistered Securities and Use of Proceeds” for a description of the option grants canceled and issued to Mr. McDonough
during 2019.
35
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth certain information
regarding our shares of common stock beneficially owned as of February 18, 2020, for (i) each stockholder known to be the beneficial
owner of more than 5% of our outstanding shares of common stock (ii) each named executive officer and director, and (iii) all executive
officers and directors as a group. A person is considered to beneficially own any shares: (a) over which such person, directly
or indirectly, exercises sole or shared voting or investment power, or (b) of which such person has the right to acquire beneficial
ownership at any time within 60 days through an exercise of stock options, warrants or convertible debt. Shares underlying such
options, warrants, and convertible promissory notes, however, are only considered outstanding for the purpose of computing the
percentage ownership of that person and are not considered outstanding when computing the percentage ownership of any other person.
Unless otherwise indicated, voting and investment power relating to the shares shown in the table for our directors and executive
officers is exercised solely by the beneficial owner or shared by the owner and the owner’s spouse or children.
Name & Address of Beneficial Owner
Amount and
Nature of
Beneficial
Ownership
Beneficial
Ownership
Percentage
as of
February 18, 2020 (1)
More than 5% Stockholders
Grant Young (2)
40,896,850
13.4%
Directors and Named Executive Officers
Clarence E. Smith(3)
93,951,825
31.4%
Michael R. Guzzetta(4)
8,923,313
2.0%
Edward P. McDonough(5)
5,500,000
3.1%
All directors and executive officers as a group:
108,375,138
36.5%
(1)
Based on 275,400,259 shares of common stock outstanding on February 18, 2020, and, with respect to each individual holder, rights to acquire common stock exercisable within 60 days of February 18, 2020.
(2)
Consists of 10,021,250 shares of common stock owned by Mr. Young directly; 1,125,600 shares held by Mr. Young’s wife; the right to acquire 6,000,000 shares of common stock upon warrant exercise; and the right to acquire 23,750,000 shares of common stock upon option exercise. The principal address of Mr. Young is 6438 Rosebery Ave, West Vancouver, BC V7W 2C6, Canada.
(3)
Consists of 54,899,999 shares of common stock owned by Mr. Smith directly, 13,235,160 held by Mr. Smith’s trusts, 1,850,000 held by Mr. Smith’s retirement account, the right to acquire 23,750,000 shares of common stock upon option exercise, and the right to acquire 216,666 shares upon warrant exercise. The principal address of Mr. Smith is 1845 County Road #214, St. Augustine, FL 32084.
(4)
Consists of 173,313 shares of common stock owned by Mr. Guzzetta directly, and 8,750,000 shares of common stock issuable upon the exercise of stock options. The principal address of Mr. Guzzetta is 7187 Steel Dust Dr, New Albany, OH 43054.
(5)
Consists of 5,500,000 shares of common stock issuable upon the exercise of stock options. The principal business address of Mr. McDonough is 1226 Washington Avenue, Parkersburg, WV 26101.
36
ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The following is a description of transactions
during the last fiscal year in which the transaction involved a material dollar amount and in which any of the Company’s
directors, executive officers or holders of more than 5% of the Company’s common stock had or will have a direct or indirect
material interest, other than compensation which is described under “Executive Compensation.” Management believes the
terms obtained or consideration that was paid or received, as applicable, in connection with the transactions described below were
comparable to terms available or the amounts that would be paid or received, as applicable, in arms’ length transactions:
As at December 31, 2019, there is no amount due to or due
from a related party.
Please refer to “Recent Sales
of Unregistered Securities and Use of Proceeds” for a description of the option grants canceled and issued to Mr. Smith during
2019 as well as securities purchased by Mr. Smith directly from the Company.
Please refer to “Recent Sales
of Unregistered Securities and Use of Proceeds” for a description of the option grants canceled and issued to Mr. Young during
2019.
See also Item 1, page 8 for a description of
the patent rights assignments made by Mr. Young to the company in 2016 as well as Item 11 for a description of the consulting agreements
with the officers and directors of the Company.
ITEM 14.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
Audit Fees
For the years ended December 31, 2019 and 2018,
Davidson & Company LLP, Chartered Professional Accountants (“Davidson”) the Company’s principal accountants
billed the Company $25,000 and $24,293, respectively for fees for the audit of the Company’s annual financial statements.
All amounts are in U.S. dollars.
Audit-Related Fees
For the years ended December 31, 2011 and 2016,
Davidson did not provide the Company with any assurances or related services reasonably related to the performance of the audit
or review of the Company’s financial statements and are not reported above under “Audit Fees.”
37
Tax Fees
For the years ended December 31, 2019 and 2018,
Davidson billed $3,500 in 2019 and $4,300 in 2018 for professional services for tax compliance, tax advice, and tax planning.
All Other Fees
For the years ended December 31, 2019 and 2018,
Davidson did not bill the Company for fees associated with the preparation and filing of the Company’s registration statements,
the creation of pro forma financial statements and other related matters.
For the years ended December 31, 2019 and 2018,
Davidson billed the Company $19,282 and $14,550 for fees for the review of the Company’s quarterly financial statements.
All amounts are in U.S. dollars.
Audit Committee Pre-Approval Policies
The Company currently does not have a formal
audit committee. The Company’s Board of Directors currently approves in advance all audit and non-audit related services
performed by the Company’s principal accountants and appointed Ed McDonough as the responsible director to review all financial
information of the Company and correspond with the independent auditors regarding the same.
38
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENTS
AND SCHEDULE
EXHIBIT INDEX
The following documents are being filed
with the Commission as exhibits to this Annual Report on Form 10-K.
Exhibit
Description
3.1
Certificate of Incorporation(1)
3.2
Bylaws(1)
4.2
Amended 2017 Stock Option and Stock Bonus Plan(2)
4.3
Amendment to Amended 2017 Stock Option and Stock Bonus Plan as approved on July 15, 2019(5)
10.1
Royalty Agreement between the Company and The Governors of the University of Alberta, dated April 8, 2015(3)
10.2
Collaborative Research Agreement between the Company and the University of British Columbia, dated May 31, 2016(4)
10.3
Consulting Agreement between the Company and Clarence E. Smith, dated December 30, 2016(2)
10.4
Director Consulting Agreement between the Company and Edward P. McDonough, dated December 30, 2016(2)
10.5
Consulting Agreement between the Company and Grant Young, dated December 30, 2016(8)
10.6
First Amendment to Consulting Agreement between Clarence E. Smith and the Company dated September 1, 2017(7)
10.7
First Amendment to Consulting Agreement between Grant Young and the Company dated September 1, 2017(7)
10.8
First Amendment to Consulting Agreement between Edward P. McDonough and the Company dated September 1, 2017(7)
10.9
Consulting Agreement between ProtoKinetix Incorporated and Michael Guzzetta, dated November 14, 2017(6)
14.1
Code of Business Conduct and Ethics and Whistleblower Policy as approved on July 8, 2019(5)
31.1
Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
31.2
Certification of the Principal Financial Officer and Principal Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
32.1
Certification of the Principal Executive Officer and the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002**
101.INS
XBRL Instance Document
101.SCH
XBRL Schema Document
101.CAL
XBRL Calculation Linkbase Document
101.DEF
XBRL Definition Linkbase Document
101.LAB
XBRL Label Linkbase Document
101.PRE
XBRL Presentation Linkbase Document
39
1.
Incorporated by reference from the Company’s registration statement on Form 10-SB filed on June 22, 2001 with the SEC.
2.
Incorporated by reference from the Company’s Annual Report on Form 10-K filed on February 21, 2017 with the SEC.
3.
Incorporated by reference from the Company’s Annual Report on Form 10-K filed on April 14, 2015 with the SEC.
4.
Incorporated by reference from the Company’s Quarterly Report on Form 10-Q filed on August 15, 2016 with the SEC.
5.
Incorporated by reference from the Company’s Current Report on Form 8-K filed on July 17, 2019 with the SEC.
6.
Incorporated by reference from the Company’s Current Report on Form 8-K filed on November 15, 2017 with the SEC.
7.
Incorporated by reference from the Company’s amended Current Report on Form 8-K filed on September 12, 2017 with the SEC.
8.
Incorporated by reference from the Company’s Quarterly Report on Form 10-Q filed on November 13, 2017 with the SEC.
*.
Filed herewith.
**
Furnished, not filed herewith.
ITEM 16. Form 10-K Summary
This Item is optional and the registrant
is not required to furnish this information.
40
SIGNATURES
Pursuant to the requirements of Section
13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report to be signed on its behalf
by the undersigned, thereunto duly authorized.
PROTOKINETIX, INCORPORATED
Dated: February 18, 2020
By:
/s/ Clarence E. Smith
Clarence E. Smith
Principal Executive Officer
Dated: February 18, 2020
By:
/s/ Michael R. Guzzetta
Michael R. Guzzetta
Principal Financial Officer & Principal Accounting Officer
Pursuant to the requirement of the Securities Exchange Act
of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the
dates indicated:
Dated: February 18, 2020
By:
/s/ Clarence E. Smith
Clarence E. Smith
Chief Executive Officer (principal executive officer)
& Chairman of the Board
Dated: February 18, 2020
By:
/s/ Edward P. McDonough
Edward P. McDonough
Director
41
PROTOKINETIX, INC.
(A Development Stage Company)
FINANCIAL STATEMENTS
December 31, 2019
(Stated in US Dollars)
C O N T E N T S
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
F-2
FINANCIAL STATEMENTS
BALANCE SHEETS
F-3
STATEMENTS OF OPERATIONS
F-4
STATEMENT OF STOCKHOLDERS' EQUITY
F-5
STATEMENTS OF CASH FLOWS
F-7
NOTES TO FINANCIAL STATEMENTS
F-8
F- 1
Report
of Independent Registered Public Accounting Firm
To the Shareholders and Directors of
Protokinetix, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets
of Protokinetix, Inc. (the “Company”), as of December 31, 2019 and 2018, and the related statements of operations,
stockholders’ equity, and cash flows for the years ended December 31, 2019 and 2018, and the related notes (collectively
referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material
respects, the financial position of Protokinetix, Inc. as of December 31, 2019 and 2018, and the results of its operations and
its cash flows for the years ended December 31, 2019 and 2018 in conformity with accounting principles generally accepted in the
United States of America.
Going Concern
The accompanying financial statements have
been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the
Company has not generated any significant revenues to date and has suffered recurring losses from operations. This raises substantial
doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note
1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based
on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with
the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement, whether due to error or fraud.
Our audits included performing procedures to
assess the risks of material misstatements of the financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made
by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a
reasonable basis for our opinion.
We have served as the Company’s auditor
since 2008.
“DAVIDSON & COMPANY LLP”
Vancouver, Canada Chartered Professional Accountants
February 18, 2020
F- 2
PROTOKINETIX, INC.
(A Development Stage Company)
BALANCE SHEETS
As of December 31, 2019
2019
2018
ASSETS
Current Assets
Cash
$ 377,349
$ 136,029
Prepaid expenses and deposits (Note 3)
1,050
1,050
Total current assets
378,399
137,079
Intangible assets (Note 4)
207,508
187,771
Total assets
$ 585,907
$ 324,850
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable and accrued liabilities
$ 25,520
$ 78,885
Total current liabilities
25,520
78,885
Stockholders' Equity
Common stock, $0.0000053 par value; 400,000,000 common shares authorized; 275,400,259 and 259,785,766 shares issued and outstanding for 2019 and 2018 respectively (Note 7)
1,472
1,389
Additional paid-in capital
36,107,058
31,594,822
Accumulated deficit
(35,548,143 )
(31,350,246 )
Total stockholders' equity
560,387
245,965
Total liabilities and stockholders' equity
$ 585,907
$ 324,850
Basis of Presentation –
Going Concern Uncertainties (Note 1)
Commitments and Contingency
(Note 9)
See Notes to Financial Statements
F- 3
PROTOKINETIX, INC.
(A Development Stage Company)
STATEMENTS OF OPERATIONS
For the Years Ended December 31, 2019
and 2018
2019
2018
EXPENSES
Amortization – intangible assets (Note 4)
$ 3,000
$ 3,000
General and administrative
280,438
78,074
Interest
—
306
Professional fees (Note 8)
149,619
149,123
Research and development
369,520
337,067
Share-based compensation (Notes 5 and 8)
3,395,319
648,773
(4,197,897 )
(1,216,343 )
Net loss for the year
$ (4,197,897 )
$ (1,216,343 )
Net loss per common share (basic and diluted)
$ (0.02 )
$ (0.00 )
Weighted average number of common shares outstanding (basic and diluted)
268,984,776
256,217,173
See Notes to Financial Statements
F- 4
PROTOKINETIX, INC.
(A Development Stage Company)
STATEMENT OF STOCKHOLDERS' EQUITY
For the Years Ended December 31, 2019 and 2018
Common Stock
Additional
paid-in
Accumulated
Shares
Amount
capital
deficit
Total
Balance, December 31, 2017
251,352,433
$ 1,344
$ 30,506,094
$ (30,133,903 )
$ 373,535
Fair value of compensatory options issued
—
—
648,773
—
648,773
Exchange debt for common stock
2,359,240
13
117,949
—
117,962
Issuance of common stock pursuant to private placement offering
1,000,000
5
49,995
—
50,000
Issuance of common stock pursuant to private placement offering
3,240,760
17
162,021
—
162,038
Issuance of common stock pursuant to private placement offering
1,833,333
10
109,990
—
110,000
Net loss for the year
—
—
—
(1,216,343 )
(1,216,343 )
Balance, December 31, 2018
259,785,766
$ 1,389
$ 31,594,822
$ (31,350,246 )
$ 245,965
See Notes to Financial Statements
F- 5
PROTOKINETIX, INC.
(A Development Stage Company)
STATEMENT OF STOCKHOLDERS' EQUITY
For the Years Ended December 31, 2019 and 2018
Common Stock
Additional
paid-in
Accumulated
Shares
Amount
capital
deficit
Total
Balance, December 31, 2018
259,785,766
$ 1,389
$ 31,594,822
$ (31,350,246 )
$ 245,965
Fair value of compensatory options issued
—
—
3,395,319
—
3,395319
Issuance of common stock pursuant to cashless option exercise
97,826
1
(1 )
—
—
Issuance of common stock pursuant to private placement offering
15,516,667
82
1,116,918
—
1,117,000
Net loss for the year
—
—
—
(4,197,897 )
(4,197,897 )
Balance, December 31, 2019
275,400,259
$ 1,472
$ 36,107,058
$ (35,548,143 )
$ 560,387
See Notes to Financial Statements
F- 6
PROTOKINETIX, INC.
(A Development Stage Company)
STATEMENTS OF CASH FLOWS
For the Years Ended December 31, 2019
and 2018
2019
2018
CASH FLOWS USED IN OPERATING ACTIVITIES
Net loss for the year
$ (4,197,897 )
$ (1,216,343 )
Adjustments to reconcile net loss to cash used in operating activities:
Amortization – intangible assets
3,000
3,000
Fair value of compensatory options granted
3,395,319
648,773
Accrued interest expense
—
306
Changes in operating assets and liabilities:
Prepaid expenses and deposits
—
61,077
Accounts payable and accrued liabilities
(51,080 )
49,694
Net cash used in operating activities
(850,658 )
(453,493 )
CASH FLOWS FROM (USED IN) INVESTING ACTIVITIES
Purchase of intangible assets
(25,022 )
(35,458 )
Net cash used in investing activities
(25,022 )
(35,458 )
CASH FLOWS FROM (USED IN) FINANCING ACTIVITIES
Issuance of common stock for cash
1,117,000
322,038
Net cash from financing activities
1,117,000
322,038
Net change in cash
241,320
(166,913 )
Cash, beginning of year
136,029
302,942
Cash, end of year
$ 377,349
$ 136,029
Cash paid for interest
$ —
$ —
Cash paid for income taxes
$ —
$ —
Supplementary information – non-cash transactions:
Intangible asset costs included in accounts payable and accrued liabilities
$ —
$ 2,285
See Notes to Financial Statements
F- 7
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 1. Basis of Presentation –
Going Concern Uncertainties
ProtoKinetix, Inc. (the "Company"),
a development stage company, was incorporated under the laws of the State of Nevada on December 23, 1999. The Company is
a medical research company whose mission is the advancement of human health care.
The Company is currently researching the benefits
and feasibility of synthesized Antifreeze Glycoproteins ("AFGP") or anti-aging glycoproteins, trademarked AAGP.
During the year ended December 31, 2015, the Company acquired certain patents and rights for cash consideration of $30,000 (25,000
Euros), as well as additional patent applications for cash consideration of $10,000 and 6,000,000 share purchase warrants with
a fair value of $25,000 (Note 4).
The Company's financial statements are prepared
consistent with accounting principles generally accepted in the United States applicable to a going concern.
The Company has not developed a commercially
viable product, has not generated any significant revenue to date, and has incurred losses since inception, resulting in a net
accumulated deficit at December 31, 2019. These factors raise substantial doubt about the Company's ability to continue as
a going concern.
The Company needs additional working capital
to continue its medical research or to be successful in any future business activities and continue to pay its liabilities.
Therefore, continuation of the Company as a going concern is dependent upon obtaining the additional working capital necessary
to accomplish its objective. Management is presently engaged in seeking additional working capital through equity financing
or related party loans.
The accompanying financial statements do not
include any adjustments to the recorded assets or liabilities that might be necessary should the Company fail in any of the above
objectives and is unable to operate for the coming year.
Note 2. Summary of Significant Accounting
Policies
Basis of Presentation
The accompanying financial statements have
been prepared by the Company in accordance with accounting principles generally accepted in the United States of America ("US
GAAP") and are expressed in United States dollars.
F- 8
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 2. Summary of Significant Accounting
Policies (cont'd)
Use of Estimates
Preparation of financial statements in conformity
with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses
during the reporting period. Actual results could differ from those estimates. The more significant accounting estimates
inherent in the preparation of the Company's financial statements include estimates as to valuation of equity- related instruments
issued, deferred income taxes and the useful life and impairment of intangible assets.
Cash
Cash consists of funds held in checking accounts.
Cash balances may exceed federally insured limits from time to time.
Fair Value of Financial Instruments
Financial instruments, which includes cash,
accounts payable and accrued liabilities are carried at amortized cost, which management believes approximates fair value due to
the short-term nature of these instruments.
The Company measures the fair value of financial
assets and liabilities pursuant to ASC 820 "Fair Value Measurements and Disclosures" which defines fair value, establishes
a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 establishes a fair value hierarchy,
which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair
value. The policy describes three levels of inputs that may be used to measure fair value:
Level 1 – quoted prices in
active markets for identical assets or liabilities.
Level 2 – quoted prices for
similar assets and liabilities in active markets or inputs that are observable.
Level 3 – inputs that are unobservable
(for example cash flow modeling inputs based on assumptions).
Level 1 inputs are used to measure cash. At
December 31, 2019, there were no other assets or liabilities subject to additional disclosure.
Income Taxes
The Company accounts for income taxes following
the assets and liability method in accordance with the ASC 740 "Income Taxes." Under such method, deferred tax
assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance
issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by
prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements
as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods,
disclosure and transition Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable
income in the years that the asset is expected to be recovered or the liability settled.
F- 9
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 2. Summary of Significant Accounting
Policies (cont'd)
Intangible assets – patent and
patent application costs
The Company owns intangible assets consisting
of certain patents and patent applications. Intangible assets acquired separately are measured on initial recognition at cost.
Following initial recognition, intangible assets are carried at cost less any accumulated amortization and any accumulated impairment
losses. Subsequent expenditures are capitalized only when they increase the future economic benefits embodied in the specific asset
to which they relate. All other expenditures are recognized in profit or loss as incurred.
As at December 31, 2019, the Company does not
hold any intangible assets with indefinite lives.
Intangible assets with finite lives are amortized
over the useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be impaired.
The amortization method and amortization period of an intangible asset with a finite life is reviewed at least annually.
Changes in the expected useful life or the
expected pattern of consumption of future economic benefits embodied in the asset is accounted for by changing the amortization
period or method, as appropriate, and are treated as changes in accounting estimates.
Amortization is recognized in profit or loss
on a straight-line basis over the estimated useful lives of the Company's patents, whereas no amortization has been recognized
on the patent application costs at December 31, 2019.
Research and Development Costs
Research and development costs are expensed
as incurred.
Loss per Share and Potentially Dilutive Securities
Basic loss per share is computed by dividing
the net loss available to common stockholders by the weighted average number of common shares outstanding in the period.
Diluted loss per share takes into consideration common shares outstanding (computed under basic earnings per share) and potentially
dilutive securities. The effect of 91,450,000 stock options (December 31, 2018 – 58,600,000) and 8,500,000 warrants
(December 31, 2018 – 6,000,000) were not included in the computation of diluted earnings per share for all periods presented
because it was anti-dilutive due to the Company's losses.
Share-Based Compensation
The Company has granted warrants and options
to purchase shares of the Company's common stock to various parties for consulting services. The fair values of the warrants
and options issued have been estimated using the Black-Scholes Option Pricing Model.
The Company accounts for stock compensation
with persons classified as employees for accounting purposes in accordance with ASC 718 "Compensation – Stock Compensation",
which recognizes awards at fair value on the date of grant and recognition of compensation over the service period for awards expected
to vest. Cliff Vesting is used and awards vest on the last day of the vesting period. The fair value of stock options is
determined using the Black-Scholes Option Pricing Model. The fair value of common shares issued for services is determined based
on the Company's stock price on the date of issuance.
F- 10
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 2. Summary of Significant Accounting
Policies (cont'd)
Share-Based Compensation (cont'd)
Share-based compensation for non-employees
in exchange for goods and services used or consumed in an entity’s own operations are also recorded at fair value on the
measurement date and accounted for in accordance with ASC 718. The measurement of share-based compensation is subject to periodic
adjustment as the underlying instruments vest. The fair value of stock options is estimated using the Black-Scholes Option Pricing
Model and the compensation charges are amortized over the vesting period.
Common stock
Common stock issued for non-monetary consideration
are recorded at their fair value on the measurement date and classified as equity. The measurement date is defined as the earliest
of the date at which the commitment for performance by the counterparty to earn the common shares is reached or the date at which
the counterparty's performance is complete. Transaction costs directly attributable to the issuance of common stock, units and
stock options are recognized as a deduction from equity, net of any tax effects.
Related Party Transactions
A related party is generally defined as (i)
any person that holds 10% or more of the Company's securities and their immediate families, (ii) the Company's management, (iii)
someone that directly or indirectly controls, is controlled by or is under common control with the Company, or (iv) anyone who
can significantly influence the financial and operating decisions of the Company. A transaction is considered to be a related
party transaction when there is a transfer of resources or obligations between related parties.
Recent Accounting Pronouncements
In February 2016, the FASB issued ASU 2016-02,
Leases (Topic 842) , or “ASU 2016-02”, to increase transparency and comparability among organizations by requiring
the recognition of right-of-use assets and lease liabilities for most lease arrangements on the balance sheet. Under the standard,
disclosures are required to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty
of cash flows arising from leases.
ASU 2016-02 was originally required to be adopted
on a modified retrospective basis, meaning the new leasing model would need to be applied to the earliest year presented in the
financial statements and thereafter. However, in July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements,
or “ASU 2018-11" which permits companies to apply the transition provisions of the lease accounting standard at
its effective date (i.e. comparative financial statements are not required). Furthermore, in December 2018, the FASB issued ASU
No. 2018-20, Leases (Topic 842): Narrow Scope Improvements for Lessors or "ASU 2018-20", which clarifies that
lessor costs paid directly to a third-party by a lessee on behalf of the lessor, are no longer required to be recognized in the
lessor's financial statements.
The Company adopted this standard on January
1, 2019. The adoption did not have any impact on the Company’s financial statements.
F- 11
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 3. Prepaid Expenses and Deposits
The following summarizes the Company's prepaid
expenses and deposits outstanding as at December 31, 2019 and 2018:
2019
2018
Rental deposit
$ 1,050
$ 1,050
$ 1,050
$ 1,050
F- 12
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 4. Intangible Assets
Intangible asset transactions are summarized
as follows:
Patent Rights
Patent Application
Rights
Total
Cost
Balance, December 31, 2017
$ 30,000
$ 130,528
$ 160,528
Additions
—
37,743
37,743
Balance, December 31, 2018
$ 30,000
$ 168,271
$ 198,271
Additions
—
22,737
22,737
Balance, December 31, 2019
$ 30,000
$ 191,008
$ 221,008
Accumulated amortization
Balance, December 31, 2017
$ 7,500
$ —
$ 7,500
Amortization
3,000
—
3,000
Balance, December 31, 2018
$ 10,500
$ —
$ 10,500
Amortization
3,000
—
3,000
Balance, December 31, 2019
$ 13,500
$ —
$ 13,500
Net carrying amounts
December 31, 2017
$ 22,500
$ 130,528
$ 153,028
December 31, 2018
$ 19,500
$ 168,271
$ 187,771
December 31, 2019
$ 16,500
$ 191,008
$ 207,508
During the year ended December 31, 2015, the
Company entered into an Assignment of Patents and Patent Application (effective January 1, 2015) (the "Patent Assignment")
with the Institut National des Sciences Appliquees de Rouen ("INSA") for the assignment of certain patents and all rights
associated therewith (the "Patents"). The Company and INSA had previously entered into a licensing agreement for the
Patents in August 2004. The Patent Assignment transfers all of the Patents and rights associated therewith to the Company upon
payment to INSA in the sum of $30,000 (25,000 Euros) (paid). During the year ended December 31, 2019, the Company recorded $3,000
(2018 - $3,000) in amortization expense associated with the Patents based on a 10-year useful life.
During the year ended December 31, 2015, the
Company entered into a Technology Transfer Agreement with Grant Young for the assignment of his 50% ownership of certain patents
and all rights associated therewith (the "Patent Application Rights"). In exchange for the Patent Application Rights,
the Company agreed to pay $10,000 (paid) and to issue 6,000,000 warrants (issued) to purchase shares of the Company's common stock
at an exercise price of $0.10 per share for a period of five years. The Patent Application Rights had a total fair value of $35,000,
which was allocated as $10,000 to the cash consideration paid, with the remaining $25,000 being allocated to the warrant component
of the overall consideration. The Company incurred an additional $156,008 in direct costs relating to the Patent Application Rights,
$22,737 of which were incurred during the year ended December 31, 2019.
F- 13
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 4. Intangible Assets (cont’d)
The remaining 50% ownership of the Patent Application
Rights was acquired from the Governors of the University of Alberta in exchange for a future gross revenue royalty.
During the year ended December 31, 2016, the
Company entered into a Universal Assignment with Grant Young for the assignment of his ownership of certain new and useful improvements
in an invention entitled "Use of Anti-Aging Glycoprotein for Enhancing Survival of Neurosensory Precursor Cells" (the
"New Patent Application Rights"). In exchange for the New Patent Application Rights, the Company agreed to pay
$1 (paid). The Company incurred $2,415 in direct costs relating to the New Patent Application Rights during the year ended
December 31, 2016.
No amortization was recorded on the Patent
Application Rights or the New Patent Application Rights to December 31, 2019.
Note 5. Stock Options
On December 30, 2016, the Board of Directors
of the Company adopted the 2017 Stock Option and Stock Bonus Plan (the "2017 Plan", as amended on November 9, 2018).
The Board of Directors adopted the 2017 Plan as it anticipates utilizing equity compensation as part of its ongoing standard
corporate operations and in connection with its contemplated activities going forward.
The aggregate number of shares that may be
issued under the 2017 Plan is 89,700,000 shares subject to adjustment as provided therein. The 2017 Plan includes two types
of options. Options intended to qualify as incentive stock options under Section 422 of the Internal Revenue Code of 1986,
as amended are referred to as incentive options. Options which are not intended to qualify as incentive options are referred
to as non-qualified options.
As of December 31, 2019, there are 89,450,000
options and no shares of common stock granted and outstanding under the 2017 Plan.
F- 14
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 5. Stock Options (cont'd)
The 2017 Plan is administered by the Board
of Directors, or a committee appointed by the Board of Directors. In addition to determining who will be granted options
or stock bonuses, the committee has the authority and discretion to determine when options and bonuses will be granted and the
number of options and bonuses to be granted. The committee also may determine a vesting and/or forfeiture schedule for bonuses
and/or options granted, the time or times when each option becomes exercisable, the duration of the exercise period for options
and the form or forms of the agreements, certificates or other instruments evidencing grants made under the 2017 Plan.
The committee may determine the purchase price
of the shares of common stock covered by each option and determine the fair market value per share. The committee also may
impose additional conditions or restrictions not inconsistent with the provisions of the 2017 Plan. The committee may adopt,
amend and rescind such rules and regulations as in its opinion may be advisable for the administration of the 2017 Plan.
The committee also has the power to interpret
the 2017 Plan, and the provisions in the instruments evidencing grants made under it and is empowered to make all other determinations
deemed necessary or advisable for the administration of it.
Participants in the 2017 Plan may be selected
by the committee from employees, officers, consultants and advisors (including board members) of the Company. The committee
may take into account the duties of persons selected, their present and potential contributions to the success of the Company and
such other considerations as the committee deems relevant to the purposes of the 2017 Plan.
In the event that a change, such as a stock
split, is made in the Company's capitalization which results in an exchange or other adjustment of each share of common stock for
or into a greater or lesser number of shares, appropriate adjustments will be made to unvested bonuses and in the exercise price
and in the number of shares subject to each outstanding option. The committee also may make provisions for adjusting the
number of bonuses or underlying outstanding options in the event the Company effects one or more reorganizations, recapitalizations,
rights offerings, or other increases or reductions of shares of its outstanding common stock. Options and bonuses may provide
that in the event of the dissolution or liquidation of the Company, a corporate separation or division or the merger or consolidation
of the Company, the holder may exercise the option on such terms as it may have been exercised immediately prior to such dissolution,
corporate separation or division or merger or consolidation; or in the alternative, the committee may provide that each option
granted under the 2017 Plan shall terminate as of a date fixed by the committee.
The exercise price of any option granted under
the 2017 Plan must be no less than 100% of the "fair market value" of the Company's common stock on the date of grant.
Any incentive stock option granted under the 2017 Plan to a person owning more than 10% of the total combined voting power of the
common stock must be at a price of no less than 110% of the fair market value per share on the date of grant.
The exercise price of an option may be paid
in cash, in shares of the Company's common stock or other property having a fair market value equal to the exercise price of the
option, or in a combination of cash, shares, other securities and property. The committee determines whether or not property
other than cash or common stock may be used to purchase the shares underlying an option and shall determine the value of the property
received.
F- 15
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 5. Stock Options (cont'd)
Stock option transactions are summarized as
follows:
Number of
Stock Options
Weighted Average Exercise Price
Weighted Average Remaining Life
$
(Years)
Outstanding, December 31, 2018
58,600,000
0.07
Options cancelled
(16,000,000 )
0.07
Options exercised
(250,000 )
0.07
Options granted
49,100,000
0.21
Outstanding, December 31, 2019
91,450,000
0.14
3.51
Number of
Stock Options
Weighted Average Exercise Price
Weighted Average Remaining Life
$
(Years)
Outstanding, December 31, 2017
44,100,000
0.06
Options granted
16,400,000
0.05
Options expired
(1,900,000 )
0.10
Outstanding, December 31, 2018
58,600,000
0.07
2.60
Total share-based compensation for stock options
granted during the year ended December 31, 2019 was $3,156,694 (2018 - $648,773). The fair values of the stock options granted
during the years ended December 31, 2019 and 2018 were estimated using the Black-Scholes Option Pricing Model. The weighted
average assumptions used in the pricing model for these options are as follows:
December 31, 2019
December 31, 2018
Risk-free interest rate
2.42
%
1.50
%
Dividend yield
0.00
%
0.00
%
Expected stock price volatility
140.21
%
125.00
%
Expected forfeiture rate
0.00
%
0.00
%
Expected life
4.95 years
3.45 years
The following non-qualified stock options were
outstanding and exercisable at December 31, 2019:
Expiry date
Exercise Price
Number of Options
Outstanding
Number of
Options
Exercisable
$
February 25, 2020
0.04
2,000,000
—
December 31, 2020
0.05
12,200,000
12,200,000
August 31, 2021
0.06
11,000,000
11,000,000
November 14, 2021
0.07
750,000
750,000
December 31, 2022
0.06
800,000
800,000
August 31, 2023
0.08
600,000
600,000
November 08, 2023
0.09
15,000,000
15,000,000
May 2, 2023
0.13
1,600,000
1,600,000
July 14, 2024
0.26
32,500,000
8,250,000
November 17, 2024
0.11
15,000,000
—
91,450,000
50,200,000
F- 16
PROTOKINETIX
, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 5. Stock Options (cont'd)
As at December 31, 2019, the aggregate intrinsic
value of the Company's stock options is $1,005,350 (December 31, 2018 – $572,000). The weighted average fair value of stock
options granted during the year ended December 31, 2019 is $0.18 (2018 - $0.07), and the weighted average exercise price of exercisable
stock options is $0.10 (2018 - $0.06).
Note 6. Warrants
On July 15, 2019, the Company cancelled and
concurrently replaced 6,000,000 warrants previously issued to a consultant in 2015. The replacement warrants granted have a term
of 5 years and are exercisable at a price of $0.26 per share, expiring July 15, 2024.
In accordance with ASC 718, the 6,000,000 replacement
warrants were accounted for as a modification of the terms of the cancelled award, with the incremental cost being measured as
the excess of the fair value of the replacement warrants over the fair value of the cancelled warrants at the cancellation date.
Total share-based compensation of $238,625 was recorded in connection with the warrant modification, based on the following assumptions
used in the Black-Scholes Option Pricing Model:
Warrants on cancellation
Warrants replaced
Risk-free interest rate
2.41
%
2.41
%
Dividend yield
0.00
%
0.00
%
Expected stock price volatility
170.47
%
143.71
%
Expected forfeiture rate
0.00
%
0.00
%
Expected life
0.77 years
5 years
Warrant transactions are summarized as follows:
Number of
Warrants
Weighted Average Exercise Price
$
Outstanding, December 31, 2017
6,500,000
0.11
Warrants expired
(500,000 )
0.25
Outstanding, December 31, 2018
6,000,000
0.10
Warrants cancelled
(6,000,000 )
0.10
Warrants granted
8,500,000
0.22
Outstanding, December 31, 2019
8,500,000
0.22
The following warrants were outstanding
and exercisable as at December 31, 2019:
Number of Warrants
Exercise Price ($)
Expiry Date
6,000,000
0.26
July 14, 2024
833,333
0.12
October 15, 2022
250,000
0.12
October 21, 2022
116,667
0.12
November 1, 2022
83,334
0.12
November 12, 2022
833,333
0.12
December 1 , 2022
166,667
0.12
December 18, 2022
216,666
0.12
December 18, 2022
8,500,000
0.22
F- 17
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 7. Stockholders' Equity
The Company is authorized to issue 400,000,000
(December 31, 2018 – 400,000,000) shares of $0.0000053 par value common stock. Each holder of common stock has the
right to one vote but does not have cumulative voting rights. Shares of common stock are not subject to any redemption or sinking
fund provisions, nor do they have any preemptive, subscription or conversion rights. Holders of common stock are entitled to receive
dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders
of all classes of stock outstanding having priority rights as to dividends. No dividends have been declared or paid as of December
31, 2019 (December 31, 2018 - $nil).
During the year ended December 31, 2019, the Company:
a)
Issued 750,000 shares of common stock to investors at $0.06 per share for gross proceeds of $45,000.
b)
Issued 10,000,000 shares of common stock to investors at $0.05 per share for gross proceeds of $500,000.
c)
Issued 2,266,667 shares of common stock to investors at $0.12 per share for gross proceeds of $272,000.
d)
Issued 97,826 shares of common stock to its CFO pursuant to a cashless exercise of 250,000 stock options.
e)
Issued 2,500,000 shares of common
stock to investors (one of which was the President and CEO of the Company)
at $0.12 per share for gross proceeds
of $300,000 and warrants to purchase 2,500,000 shares of common stock exercisable at $0.12 per share for three years.
During the year ended December 31, 2018, the Company:
a)
Issued 2,359,240 shares of common stock to the President and CEO of the Company at $0.05 per share in exchange for debt to the President and CEO of $117,962.
b)
Issued 1,000,000 shares of common stock to investors at $0.05 per share for gross proceeds of $50,000.
c)
Issued 3,240,760 shares of common stock to investors (one of which was the President and CEO of the Company) at $0.05 per share for gross proceeds of $162,038.
d)
Issued 1,833,333 shares of common
stock to investors (one of which was the President and CEO of the Company)
at $0.06 per share for gross proceeds
of $110,000.
F- 18
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 8. Related Party Transactions and Balances
During the year ended December 31, 2019, the Company:
a)
Entered into a consulting agreement
with an effective date of January 1, 2017 with the Company's President and CEO whereby he will be compensated at a nominal amount
of $1 for services. The agreement also stipulates a termination fee that would pay the Company's President and CEO $100,000 per
year of service if terminated without cause or, in the case of termination upon a change of control event, the termination fee
would be equal to $100,000 per year of service plus 2.5% of the aggregate transaction value of the change of control. In addition,
the agreement stipulates that he would be entitled to a bonus payment equal to 2.5% of the aggregate transaction value of a sale
or license of any Patent Rights, Patent Application Rights or products effected during the term of his agreement. On November 9,
2018, the President and CEO was granted an additional 5,000,000 stock options for continued service. The options are exercisable
until November 8, 2023 at a price of $0.09 per share (Note 5) and vest quarterly in equal installments beginning March 31, 2019.
On July 15, 2019, pursuant to a mutual
agreement, the CEO’s vested options for 5,000,000 shares at $0.08 per share, expiring December 31, 2019, were cancelled.
New stock options were granted for 5,000,000 shares of common stock at a price of $0.26 per share and expiring July 14, 2024. The
options vest in equal installments quarterly starting October 13, 2019. On July 15, 2019, the CEO was also granted stock options
for continued service for 5,000,000 shares of common stock at a price of $0.26 per share, expiring July 14, 2024. The options vest
in equal installments quarterly starting October 13, 2019. On November 18, 2019, the CEO was granted additional stock options for
5,000,000 stock options at a price of $0.11 per share, expiring November 17, 2024. The options vest in equal installments quarterly
starting February 18, 2020.
b)
Pursuant to a consulting agreement
with an effective date of November 14, 2017, a total of $60,000 (2018 - $60,000) was paid or accrued to the Company's CFO. On November
9, 2018, the CFO was granted 4,000,000 stock options for continued service. The options are exercisable until November 8, 2023
at a price of $0.09 per stock option (Note 5) and vest quarterly in equal installments beginning March 31, 2019. On July 15, 2019,
the CFO was granted an additional 4,000,000 stock options for continued service. The options are exercisable until July 14, 2024
at a price of $0.26 per share. On November 18, 2019, the CFO was granted 4,000,000 stock options at a price of $0.11 per share,
expiring November 17, 2024. The options vest in equal installments quarterly starting February 18, 2020. During the year ending
December 31, 2019, the Company reimbursed a company controlled by the CFO a total of $12,600 (2018 - $12,600) in office rent.
c)
Entered into a directorship agreement
with an effective date of January 1, 2017 with a director of the Company. On November 9, 2018, the director was granted 1,000,000
stock options for continued service. The options are exercisable until November 8, 2023 at a price of $0.09 per share (Note 5)
and vest quarterly in equal installments beginning March 31, 2019.
On July 15, 2019, pursuant to a mutual
agreement, the director’s vested options for 1,000,000 shares at $0.08 per share, expiring December 31, 2019, were cancelled.
New stock options were granted for 1,000,000 shares of common stock at a price of $0.26 per share and expiring July 14, 2024. The
options vest in equal installments quarterly starting October 13, 2019. On July 15, 2019, the director was also granted stock options
for continued service for 2,000,000 shares of common stock at a price of $0.26 per share, expiring July 14, 2024. The options vest
in equal installments quarterly starting October 13, 2019. On November 18, 2019, the director was granted additional stock options
for 1,000,000 stock options at a price of $0.11 per share, expiring November 17, 2024. The options vest in equal installments quarterly
starting February 18, 2020.
d)
The Company recognized $1,704,723 (2018 - $310,962)
in share-based compensation associated with stock options granted to key management personnel.
F- 19
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 9. Commitments and Contingency
Commitments
As at December 31, 2019, the Company has the following commitments:
a)
Entered into a consulting agreement
with an effective date of January 1, 2017 whereby the Company would pay the consultant $7,000 per month for providing research
and development services. On November 9, 2018, the consultant was granted an additional 5,000,000 stock options for continued service.
The options are exercisable until November 8, 2023 at a price of $0.09 per share (Note 5) and vest quarterly in equal installments
beginning March 31, 2019.
On July 15, 2019, pursuant to a mutual
agreement, the consultant’s vested options for 5,000,000 shares at $0.04 per share, expiring February 28, 2020, and vested
options for 5,000,000 shares at $0.08 per share, expiring December 31, 2019, were cancelled. New stock options were granted for
10,000,000 shares of common stock at a price of $0.26 per share and expiring July 14, 2024. The options vest in equal installments
quarterly starting October 13, 2019. On July 15, 2019, the consultant was also granted stock options for continued service for
5,000,000 shares of common stock at a price of $0.26 per share, expiring July 14, 2024. The options vest in equal installments
quarterly starting October 13, 2019. On November 18, 2019, the consultant was granted additional stock options for 5,000,000 stock
options at a price of $0.11 per share, expiring November 17, 2024.
b)
Entered into a consulting agreement
for research and investor relations consulting services effective January 1, 2018. The consultant was granted 400,000 stock options
exercisable into common shares of the Company at a price of $0.06 per share until December 31, 2022 (Note 5). The options vest
in equal instalments on a quarterly basis beginning March 31, 2018. On September 1, 2018, the consultant was granted an additional
600,000 stock options exercisable into common shares of the Company at a price of $0.08 per share until August 31, 2023. The options
vest in equal instalments on a quarterly basis beginning December 31, 2018.
c)
On June 29, 2018, the Company entered
into an amendment to a Collaborative Research Agreement (the “CREA”) initially entered into with the University of
British Columbia during fiscal 2016 which required two additional instalments of CAD $54,600 ($41,369) due on June 30, 2018 and
CAD $54,600 ($41,392) due on December 1, 2018. The CREA can be terminated by either party with 30 days’ written notice. As
of December 31, 2019, a total of $nil is included in prepaid expenses and deposits (December 31, 2018 - $nil) pertaining to the
CREA.
On January 4, 2018, the Company entered
into an additional agreement with the University of British Columbia, making a payment of CAD $50,001 ($40,140) for research services
to be provided over a term of 1 year.
F- 20
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 9. Commitments and Contingency (cont’d)
Commitments (cont’d)
d)
Entered into a consulting agreement effective January 1, 2018, whereby the Company would pay the consultant $1,000 per month for a term of 1 year for providing public relations services, unless otherwise terminated by either party with at least 30 days’ notice. The consultant was also granted 400,000 stock options exercisable into common shares of the Company until December 31, 2022 at a price of $0.06 per share (Note 5). The options vest quarterly in equal installments beginning March 31, 2018.
e)
On May 1, 2019, entered into consulting agreements for investor relations consulting services with two firms. The consultants were granted 800,000 stock options each (for a total of 1,600,000) exercisable into common shares of the Company at a price of $0.13 per share until May 6, 2023. (Note 5). The options vest 400,000 shares to each of the two consultants on May 6, 2019 and 400,000 each, one on July 17, 2019 and one on August 1, 2019. The agreements also call for monthly payments of $5,000 to each of the two consultants over a term of 1 year. The agreements can be cancelled at any time with 30 days’ notice.
f)
Entered into a consulting agreement
effective April 1, 2019, whereby the Company would pay the consultant $1,500 per month minimum plus travel expenses for a term
of 1 year for providing research consulting services, unless otherwise terminated by either party with at least 30 days’
notice. On July 15, 2019, the consultant was also granted 500,000 stock options exercisable into common shares of the Company until
July 14, 2024 at a price of $0.26 per share. The options vest quarterly in equal installments beginning October 13, 2019.
g)
Entered into a Collaborative Research Agreement (the “CREA”) on February 20, 2019 with the University of Dalhousie until March 31, 2020. Pursuant to the CREA, the Company will pay a total of CAD $112,000. Dalhousie agrees to invoice the Company in four installments of CAD $28,000 ($20,982 USD) as research services progress. The CREA can be terminated by either party with 30 days’ written notice. As of December 31, 2019, a total of $nil is included in prepaid expenses and deposits (December 31, 2018 - $nil) pertaining to the CREA.
Contingency
The Company was delinquent in filing certain
income tax returns with the U.S. Internal Revenue Service and reports disclosing its interest in foreign bank accounts on form
TDF 90-22.1, "Report of Foreign Bank and Financial Accounts" ("FBARs"). In September 2015, the Company filed
the delinquent income tax returns and has sought waivers of any penalties under the IRS Offshore Voluntary Disclosure Program for
late filing of the returns and FBARs. Under the program, the IRS has indicated that it will not impose a penalty for the
failure to file delinquent income tax returns if there are no under reported tax liabilities. On November 30, 2017, the Company
received a letter from the IRS concluding their review of the Company's tax returns under the program and accepting the returns
as filed. No penalties have been assessed by the IRS to date, and management does not believe that the Company will incur
any penalties relating to the tax years submitted under the program.
F- 21
PROTOKINETIX, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
December 31, 2019
Note 10. Income Taxes
As a Nevada corporation,
the Company is liable for taxes in the United States. As of December 31, 2019, the Company did not have any income for tax
purposes and therefore, no tax liability or expense has been recorded in these financial statements (December 31, 2018 –
none).
A reconciliation
of income taxes at statutory rates with the reported taxes is as follows:
2019
2018
Net loss for the year
$ (4,197,897 )
$ (1,216,343 )
Expected income tax recovery
$ (882,000 )
$ (255,000 )
Non-deductible expenses
713,000
136,000
Impact of change of future tax rate
—
3,632,000
Adjustment to prior years provision versus statutory tax returns
69,000
(13,000 )
Change in valuation allowance
100,000
(3,500,000 )
Total income tax expense (recovery)
$ —
$ —
The Company’s deferred tax assets that have not been recognized are as follows:
Tax benefit of net operating loss carry forward
6,100,000
6,000,000
Valuation allowance
(6,100,000 )
(6,000,000 )
$ —
$ —
The Company has tax
losses of approximately $29,000,000 (December 31, 2018 - $28,360,000) to reduce future taxable income. The tax losses expire
in years starting from 2028.
The deferred tax asset
associated with the tax loss carry forward is approximately $6,100,000 (December 31, 2018 - $6,000,000). The Company has
provided a full valuation allowance against the deferred tax asset since it is more likely than not that the asset will not be
realized. The difference between the Company's statutory income tax rate of (21%) and its effective rate of zero is primarily
attributable to the valuation allowance provided on deferred taxes arising from net operating loss carry forwards.
Note 11. Subsequent Event
Entered into a
Clinical Supply Agreement (the “CSA”) on January 14, 2020 with Alberta Health Services and the Governors of the
University of Alberta (the “Institution”) and Dr. James Shapiro. The agreement requires Protokinetix to supply
PKX-001 free of charge and in sufficient quantity to conduct the clinical study by Dr. James Shapiro. The delivery date is
estimated to be late February 2020.
F- 22
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.