ProtoKinetix, Inc. 10-K

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 109 W Main St, Dalton, Ohio 44618. Our telephone number is (330) 445-4971 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, 2022 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. 3 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. Recent Developments In March 2020, the World Health Organization declared coronavirus COVID-19 a global pandemic. This contagious disease outbreak, which has continued to spread, and any related adverse public health developments, has adversely affected workforces, economies, and financial markets globally, potentially leading to an economic downturn. As of the date of this filing, the Company has regained a significant portion of its operational capacity and we continue to move forward with our research goals. Our supply of the patented AAGP® molecule has been manufactured and stored in the United States and we have adequate inventory to carry out the projects currently underway. The Company engages contract research organizations (CROs) located in both the United States and Canada. The CROs contracted by the Company for research projects have been able to meet milestone goals without disruption due to the pandemic. In January of 2020, Protokinetix signed a master supply agreement with University of Alberta that clears the way for testing of additional patients in the Phase I clinical trials. The global pandemic halted all work on clinical trials and research testing for most of 2020. Phase I trials were able restart mid-year 2021 but new strains of covid continue to plague the US and Canada. We cannot accurately predict a completion date of Phase I trials. We continue to monitor the status of the pandemic and will adjust our strategy accordingly in order to mitigate the impact on our research projects. The Company survived the adverse effects of the 2020 Covid-19 outbreak and as at December 31, 2022 continues to carry out operations including raising funds for ongoing research and product development. On February 11, 2022, the Company held its first annual stockholder meeting. The meeting was held solely by means of remote communication due to COVID-19 concerns. At the meeting, the Company: (i) elected Clarence Smith and Ed McDonough as directors of the Company; (ii) approved the amendment and restatement of the Company’s Articles of Incorporation to, among other things, increase the number of authorized shares of common stock to 500,000,000; (iii) voted, in an advisory vote, to approve the compensation of the Company’s named executive officers; (iv) voted, in an advisory vote, to conduct an advisory vote on compensation of the Company’s named executive officers every three years; and (v) approved the appointment of Davidson & Company LLP, Chartered Professional Accountants, as the Company’s independent accounting firm for the 2022 fiscal year. During the year 2022 the Company developed an ophthalmic formulation and completed efficacy testing in a dry eye formulation and various dosages. Phase I clinical trials conducted by Dr. James Shapiro were reactivated but access to qualified patients has been slow and progress minimal since global pandemic. The Company is making a concerted effort to find strategic partners and is the impressive accumulation of research data to attract potential partners or buyers of the Company. Industry leaders in biochemistry and pharmaceuticals, both domestic and international, are potential partners. Research and Development Our business depends on our ability to sponsor research and development activities. For the year ended December 31, 2021, the Company incurred total research and development expenses of $435,872. For the year ended December 31, 2022, the Company incurred total research and development expenses of $448,873. 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. 4