EDGAR 10-K Filing

Company CIK: 1559356
Filing Year: 2024
Filename: 1559356_10-K_2024_0001493152-24-014710.json

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ITEM 1. BUSINESS
ITEM 1. BUSINESS.
Overview
Biostax Corp. stands at the forefront of the pharmaceutical industry, dedicated to acquiring, developing, and commercializing pharmaceutical and biotechnology products with clear pathways to market success. Our approach is characterized by innovation and efficiency, driven by a unique biotech portfolio hub-and-spoke engine.
Through this engine, we intend to strategically advance small-scale biotechnology and pharmaceutical programs, leveraging subsidiaries, investment vehicles, and partnerships. This allows us to concentrate our resources on promising projects with high potential for success, ensuring focused and efficient development processes.
Our ultimate goal is to bring these innovative products to market, both domestically in the United States and internationally. We recognize the global demand for effective pharmaceutical solutions, and we are committed to addressing healthcare needs on a broad scale.
By deploying products from our programs in targeted markets, we aim to achieve initial commercialization and establish a strong foothold in key regions. This approach not only maximizes the impact of our developments but also facilitates sustainable growth and expansion.
At Biostax Corp., we are driven by a passion for innovation and a commitment to improving global health outcomes. Through our strategic initiatives and collaborative partnerships, we strive to make meaningful contributions to the pharmaceutical industry and enhance the well-being of individuals worldwide.
Business Model
Utilizing the Biostax Development Engine, Biostax intends to advance select and efficient small-scale biotechnology, pharmaceutical and MedTech programs through subsidiaries, investment vehicles and partnerships utilizing a biotech portfolio hub-and-spoke business model. Products will be deployed from these programs in targeted U.S. and international markets for initial commercialization.
Biostax is therapeutic and health tech agnostic, constantly seeking assets with low acquisition costs and high growth opportunities having significant clinical and commercial potential. The Company targets small-scale early-stage entrepreneurs, inventors, and universities interested in forming new companies around their inventions. Biostax creates efficient hyper-focused entities designed specifically to advance the development of the drugs or technology while providing shared resources and synergies among partners. Flexible deal-structuring practices enable rapid engagement of time-sensitive opportunities and provides Biostax with multiple options to build the best corporate structure for the development and commercialization of each product.
The Company’s growth forecast for the next three years is based on growing several internal and partner programs comprised of:
● JKB-122 - a therapy developed for the purposes of treating Autoimmune Hepatitis (AIH), Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) that shows anti-fibrotic, immune modulating, and/or anti-inflammatory effects when used for the treatment of various diseases. The Company will also be pursuing low-cost, open-label trials in the United States while simultaneously pursuing regulatory approval in emerging markets
● Londonal™ - Received Nigeria’s NAFDAC (National Agency for Food and Drug Administration and Control) approval to market and distribute Lodonal™ as a treatment for HIV/AIDS in Nigeria. Lodonal™ is a once-a-day immune system regulator for the management of human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS). We believe that this product is the only product with regulatory approval for low dose naltrexone therapy to be used for treatment of HIV.
● Low Dose Naltrexone (LDN) - a compound formula that is purported to provide immune-modulating benefits that include cancer, pain, autoimmune, and anti-aging.
JKB-122 is an investigational small molecule, long-acting toll-like receptor 4 (TLR4) antagonist developed for autoimmune hepatitis, nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) that has demonstrated anti-fibrotic, immuno-modulating, and anti-inflammatory activities in preclinical models and improved liver injuries by hepatoprotection property. Biostax late-stage three FDA granted Investigational New Drug (IND) 146955 147347 127303 for JKB-122 a small molecule for the treatment of AIH, NAFLD and NASH. The FDA has granted approval to initiate a Phase 2 in AIH and Phase 2B for NASH. Biostax has an inactive IND for Crohn’s Disease.
Initially, Biostax will seek regulatory approval, for JKB-122x in Ex-US Markets. By targeting territories with the highest unmet needs combined with lower barriers to market entry, Biostax will be able to bring an treatments for NAFLD and NASH to Africa. Once approved Ex-US we will seek FDA approval. While these territories represent a fraction of the U.S. and European markets, it provides the fasters t and most affordable way to market and revenue.
IRNXT 101 (Lodonal) lead investigational drug candidate, has been proven to be an immune modulatory drug that can reduce inflammation and improve immune function without the toxic side effects of existing therapies. Where the Company has a number of IND for late-stage development after discussion with the FDA and advisors goal is to file for a Phase 2b/3 Lodonal as an Adjunct Therapy for CD4+ T-Cell Recovery, Inflammation and Immune Activation in People Living With HIV infection causes both mucosal disruption and depletion of CD4+ T cells in gut-associated lymphoid tissue (GALT), altering the microbial composition (dysbiosis) and allowing microbial product to enter the circulatory system. Even with the introduction of antiretroviral therapy (ART), these two mechanisms lead to chronic immune activation and persistent inflammation that could also be enhanced by opportunistic co-infections. In turn, chronic activation, and persistent inflammation result in (i) immune exhaustion and premature immune senescence, and in (ii) a direct damage of organs, through the release of pro-inflammatory cytokines. Clinical Trials with Lodonal have shown that is an immune modulator that been shown to have anti-inflammatory effects; it inhibits central nervous system proinflammatory cytokine activity via TLR-4 antagonism in microglia.
TNIB International (TNIB, TNI): TNI expects to utilize well-established manufacturing, sales, and distribution partners in Africa through its wholly owned subsidiary TNIB International (TNI) to attempt to generate revenues from the sale of Lodonal™ which was approved by NAFDAC. The company has maintained both Drug and Marketing approval.
The Company intends to relaunch now that a Modified Agreement has been reached with AHAR Pharm and Biostax. The Company intends to expand approval for Lodonal for the following indication: non-opioid treatment for pain, adjunct to cancer therapy, and several autoimmune disease prevalent in Africa.
The Company also will continue to seek assets with low acquisition costs and high growth opportunities that have significant clinical and commercial potential. The Company targets small-scale, early-stage entrepreneurs, inventors, and universities that are interested in forming new companies around their inventions. This allows the Company to create efficient, hyper-focused entities that are designed specifically to advance the development of any acquired drugs or technology, while also providing its collaborators with shared resources. The Company’s flexible deal-structuring practices enable us to have a rapid engagement into time-sensitive opportunities and provides it with multiple options to build the best corporate structure for the development and commercialization of each of our anticipated products.
Corporate Structure and History
The Company was initially incorporated in Florida on December 2, 1993, as Resort Clubs International, Inc. (“Resort Clubs”). It was formed to manage and market golf course properties in resort markets throughout the United States. Galliano International Ltd. (“Galliano”) was incorporated in Delaware on May 27, 1998, and began trading in November 1999 through the filing of a 15C-211. On November 10, 2004, Galliano merged with Resort Clubs. Resort Clubs was the surviving corporation. On August 23, 2010, Resort Clubs changed its name to pH Environmental Inc. (“pH Environmental”). On April 23, 2012, pH Environmental completed a name change to TNI BioTech, Inc., and on April 24, 2012, we executed a share exchange agreement for the acquisition of all the outstanding shares of TNI BioTech IP, Inc. On September 4, 2014, a majority of our shareholders approved an amendment to our Amended and Restated Articles of Incorporation, as amended, to change our name to Immune Therapeutics, Inc. On February 28, 2023, we received a written consent from a majority of our outstanding shareholders to change the name of our Company to “Biostax Corp.” On March 27, 2023, we filed a definitive information statement on Schedule 14C and mailed the information statement to shareholders on record as of the date of the filing. We filed our name change amendment with the Secretary of State of Florida on October 5, 2023, and our new Company name and trading symbol (BTAX) became effective on October 20, 2023.
The consolidated financial statements of the Company include the following inactive subsidiaries: (1) TNI BioTech, Ltd., a BVI company in Tortola, British Virgin Islands incorporated in October 2012 which was set up to market and sell Naltrexone outside the United States, (2) TNI BioTech, LTD, United Kingdom incorporated in August 2013 which was set up as a micro, small or medium-sized enterprise to be able to sell administrative and financial assistance programs offered by European Medicines Agency, (3) Airmed Biopharma Limited, Dublin Ireland incorporated in March 2014 which was set up to qualify for tax incentives for Irish holding/headquartered companies to benefit from the network of double tax treaties that reduce withholding taxes and (4) Airmed Holdings Limited an Irish company domiciled in Bermuda incorporated in March 2014 set up to manage international distribution.
Our fiscal year ends on December 31. Neither we nor any of our predecessors have been in bankruptcy, receivership or any similar proceeding.
Our Market Opportunity
The pharmaceutical landscape is poised for significant growth and innovation across various therapeutic areas, as evidenced by recent developments and inactive status for adjunct treatment to the standard of care. This suggests an opportunity for innovative approaches to enhance existing treatments with Lodonal and JKB-122.
The company will seek approval for JKB-122 in West Africa as we did with Lodonal with NAFDAC. There are limited data from Africa, with variable prevalence reported using USS, from 9.5% to 68.8% in Nigeria, 50.3% in Sudan (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6465678/. The potential revenue and real-world data will provide funding for Phase 2b trial with the FDA for Autoimmune Hepatitis, where it is not a major market AIH has orphan drug status and can be fast-tracked.
The global HIV drugs market is projected to grow from $30.46 billion in 2021 to $45.58 billion in 2028 at a CAGR of 5.9% in forecast period, 2021-2028. (https://www.fortunebusinessinsights.com/industry-reports/hiv-aids-drugs-market-101115)
Autoimmune hepatitis, another area of focus, is expected to witness rapid growth, with the autoimmune hepatitis market projected to reach USD 210.61 million by 2029, registering a CAGR of 3.70%. Similarly, the Crohn’s disease treatment market is estimated to grow steadily, with a CAGR of 4.2% during the forecast period (2022-2030), reaching a value of US$ 10.92 billion in 2022.
Partnerships with Attune and Sciencare for the Naltrexone 6-month implant signal strategic collaborations to address substance use disorders, a market projected to grow significantly from $37.24 billion in 2022 to $60.18 billion by 2029, at a CAGR of 7.1%.
Overall, these trends underscore opportunities for innovation, collaboration, and market expansion in various therapeutic areas, promising significant growth and impact in the pharmaceutical industry.
TNI Biotech
Based upon the approval of Lodonal for HIV, Biostax intends to capitalize on existing relationships in emerging territories to market and distribute its products, swiftly connecting with patients in need. Multiple manufacturing, distribution, and contract sales organizations based in Africa will concentrate on expanding the approval Lodonal and JKB-122 for several indication, which will include Non-opioid treatment for pain, NASH, NAFLD, adjunct to cancer therapy, and autoimmune skin disease. Additionally, internal sales efforts will be ramped up to facilitate this expansion.
Nigeria, the most populous country in Africa, harbors one of the largest HIV epidemics globally and exhibits some of the highest rates of new infections in sub-Saharan Africa. Estimates suggest that between 2-3.5 million individuals live with HIV in this region.
Furthermore, there exists a significant gap in Non-Alcoholic Fatty Liver Disease (NAFLD) data from Africa. Some sources indicate a prevalence of 13%, though this figure likely underestimates the true prevalence. Globally, the percentage of individuals suffering from Non-Alcoholic Steatohepatitis (NASH) and/or NAFLD ranges from approximately 25% for NAFLD to 1.5-6.45% for NASH. JKB-122, offered by our company, provides effective and highly affordable treatment compared to existing alternatives. Beyond Nigeria, we are also establishing relationships and exploring opportunities in Equatorial Guinea, Malawi, and South Africa, with plans for further development in these regions.
will market and sell products it may successfully license or develop through TNIB International in the emerging territories it serves, and in the U.S. through a subsidiary or other commercial actions to be determined.
Research and Development
The Company targets small-scale early-stage entrepreneurs, inventors and universities interested in forming new companies around their inventions and R&D is focused around those early-stage ideas or licensable later-stage assets with a small group of founders at their core. Biostax empowers these small efficient biotechs that are ultimately responsible for research and development. We plan to pair our assets, subsidiaries and vehicles with executives, vendors and key opinion leaders (KOLs) having decades of experience, to create an infrastructure where capital goes significantly further, provide solutions to quickly change strategy and enable our partners navigate their way to a mutual success.
Competition
The industry for the treatment of humans is highly competitive and subject to rapid and significant technological changes. We believe that our technology rights provide our sublicensees with competitive advantages. Our sub-licensees will face potential competition from many different sources, including large pharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions, government agencies and research institutions.
Many of our sublicensee’s potential competitors have substantially greater financial, technical, and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of products and the commercialization of those products. Accordingly, those competitors may be more successful than our sublicensees’ may be in obtaining FDA approval for drugs and achieving widespread market acceptance. Their competitors’ drugs may be more effective, or more effectively marketed and sold, than any drug our sublicensees may commercialize and may render their product candidates obsolete or non-competitive before they can recover the expenses of developing and commercializing any of their product candidates. Further, the development of new treatment methods for the conditions our sub licensees are targeting could render their drugs non-competitive or obsolete. The ability of our sublicensees to overcome competitive factors will materially impact the value of our equity holdings in such licensees.
Competitive Strengths
● By being therapeutic and health technology agnostic, Biostax strives to build a Company with comprehensive diversification potentially lowering the overall risk profile of the Company.
● Where Biostax will be diversified across its subsidiaries, the subsidiaries will remain specialized allowing for greater expertise per subsidiary. The hyper focus and efficiency of these subsidiaries enables improved scale, increases the ability to attract key specialized talent, and preserves the original inventor’s entrepreneurial culture.
● Biostax provides operational efficiency to subsidiaries from shared resources and Synergies Among Partners (SAP). Support to subsidiaries can include governance, manufacturing, financing, business development, and legal support - functions often lacking in small-scale subsidiaries.
● The Biostax business model allows for flexible deal making and fundraising as subsidiaries are not bound to the fundraising strategy of the parent Company. A subsidiary could be private or public and benefit from diverse investment methods, along with debt financing. Biostax intends to maintain a mix of public and private subsidiaries.
● For investors, the Biostax model provides flexibility. Investors can invest directly in the parent Company, which allocate investments across its portfolio. They may also choose to invest directly in a subsidiary Company that they believe may produce the highest returns.
● The Biostax model provides for risk mitigation through a diverse subsidiary structure which potentially insulates the parent from potential failures with risk mostly consolidated in the subsidiary.
Due to Biostax’s portfolio operational efficiencies, the Company can support more assets across subsidiaries than a traditional biotech model and potentially provide more “shots on goal” to mitigate the impact of any single failure.
Intellectual Property
We believe we have a strong IP position that is continuously growing based on our out-license agreements with Forte Animal Health, Inc. and in-license agreement with TaiwanJ. Through our license with TawainJ, our patent portfolio includes licensed and assigned patents covering treatments for organ damage (liver, kidney and lung, rheumatoid arthritis, Crohn’s Disease, ulcerative colitis, and multiple sclerosis In addition, our portfolio includes patent families covering treatments to trigger a continuous immune response, treatments of inflammatory and ulcerative disease of the bowel with opioid antagonists, and for combinational therapies for the treatment of neoplasias using the opioid growth factor receptor.
Our success depends in part on our ability to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is to conduct surveillance of third-party patents and patent application publications periodically while developing and maintaining protection of our proprietary position by, among other methods, filing or in-licensing US and foreign patents and applications related to our technology, inventions, and improvements that are important to the development and implementation of our business.
We also rely on trademarks, trade secrets, know-how, continuing technological innovation, confidentiality agreements, and invention assignment agreements to develop and maintain our proprietary position. The confidentiality agreements are designed to protect our proprietary information and the invention assignment agreements are designed to grant us ownership of technologies that are developed for us by our employees, consultants, or other third parties. We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in our agreements and security measures, either may be breached, and we may not have adequate remedies. In addition, our trade secrets may otherwise become known or independently discovered by competitors.
Besides the specific patents mentioned below under the section “Patents” immediately below, we cannot be sure that patents will be granted with respect to any of our pending patent applications pending now or filed by us in the future, nor can we be absolutely certain to what degree, if any, our existing patents or any patents that may be granted to us in the future will be commercially useful in protecting our commercial products and methods of using and manufacturing the same.
Patents
Our Company has been granted, assigned, or licensed 28 patents from the United States, Germany, Russia, India, Ireland, the People’s Republic of China, and the United Kingdom. These patents have been substantially licensed from Statera Biopharma, (previously Cytocom, Inc.) and TaiwanJ, in license agreements as described below.
On September 30, 2022, the Company entered into a licensee agreement with TaiwanJ Pharmaceuticals a Taiwan corporation having a principal place of business 3F-4, No6-1 Sec2 ShenYi Rd, Chubei, Hsinchu, Taiwan (herein referred to as “TPEX” or “Licensor” for the product JKB-122.
A. Patent applications in relation to the composition of matter.
Country
Application No.
Title
USA
16/966,645
Pharmaceutical formulation for a solid dosage form of opioid receptor antagonists
B. Patents and patent applications in relation to the primary indication of use.
Multiple Indications
Country
Application No.
Patent No.
Patent Term
Utility Claim
Taiwan
I275591
2003/11/17
~
2023/11/16
Organ Damage (Liver, Kidney, Lung Damage)
Taiwan
I430992
2003/11/17
~
2023/11/16
Rheumatoid arthritis, Organ damage (Liver or kidney damages), Crohn’s Disease, Ulcerative colitis, Multiple sclerosis
Hong Kong
14104476.9
HK1192711
(License out)
官網資訊專利所有人為
TAIWANJ PHARMACEUTICALS
CO., LTD
(2022/4/20 瀏覽)
2003/05/16
~
2023/05/16
Organ Damage (Liver, Kidney, Lung Damages), Liver damage caused by alcohol abuse, hepatitis, cirrhosis, bacterial infection or environment toxins
India
3435/DELP/2004
IN240229
(License out)
官網沒有從TAIWANJ
讓渡出
去的文件(2022/4/20 瀏覽)
2003/05/16
~
2023/05/16
Organ Damage (Liver, Kidney, Lung Damages), Liver damage caused by alcohol abuse, hepatitis, cirrhosis, bacterial infection or environment toxins
Japan
JP5438250
(License out)
官網資訊權利者為タイワ
ンジェファーマシュティカ
ルズ カンパニー リミテ
ッド(2022/4/20 瀏 覽)
2003/05/16
~
2023/05/16
Liver and kidney damages associated with overproduction of TNF-α
Singapore
SG108388
(License out)
官網資訊專利所有人為
TAIWANJ PHARMACEUTICALS
CO., LTD
(2022/4/20 瀏覽)
2003/05/16
~
2023/05/16
Organ Damage (Liver, Kidney, Lung Damages), Liver damage caused by alcohol abuse, hepatitis, cirrhosis, bacterial infection or environment toxins
USA
10/936,431
US 7,923,454
2004/09/08
~
2025/01/27
Organ Damage (Liver, Kidney, Lung Damages), Rheumatoid arthritis, Crohn’s Disease, Multiple sclerosis
USA
12/400,344
US 8,017,622
2009/03/09
~
2023/05/16
Crohn’s Disease, Liver Damage
USA
13/228,527
US 9,776,971
2011/09/09
~
2023/05/16
Organ Damage (Liver, Kidney Damages), Crohn’s Disease, Pulmonary fibrosis
AIH (Autoimmune Hepatitis)
Country
Application No.
Patent No. & Current Status
Patent Term
Utility Claim
Taiwan
TWI612961
2016/03/24
~
2036/03/24
Nalmefene, naltrexone or derivatives thereof for use in treating AILD
USA
15/078,342
US 9,757,372
2016/03/23
~
2036/03/23
Nalmefene, naltrexone or derivatives thereof for use in treating AILD
Australia
AU2016235093
2016/03/24
~
2036/03/24
Nalmefene, naltrexone or derivatives thereof for use in treating AILD
Canada
CA2983121
2016/03/24
~
2036/03/24
Nalmefene, naltrexone or derivatives thereof for use in treating AILD
EPO
EP16769679.8
EP3273958 (DE, FR, GB)
2016/03/24
~
2036/03/24
Nalmefene, naltrexone or derivatives thereof for use in treating AILD
Korea
KR10-2064334
(Licensed out)
官網資訊權利所有
人為 타이완제이
파마슈티컬스
컴퍼니 리미티드(2022/4/20
瀏 覽)
2016/03/24
~
2036/03/24
Nalmefene, naltrexone or derivatives thereof for use in treating AILD
Russia
RU2707560
2016/03/24
~
2036/03/24
Nalmefene, naltrexone or derivatives thereof for use in treating AILD
NASH (Non-Alcoholic Steatohepatitis), NAFLD (Non-Alcoholic Fatty Liver Disease), ASH (Alcoholic Steatohepatitis)
Country
Application No.
Patent No. & Current Status
Patent Term
Utility Claim
USA
15/492,198
US 10,045,977
2017/04/20
~
2037/04/20
Nalmefene, naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
Taiwan
Undergoing Examination
-
Nalmefene, naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
Australia
2017/04/20
~
2037/04/20
Nalmefene, naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
Canada
3,021,788
2017/04/20
~
2037/04/20
Nalmefene, naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
China
201780024846.0
Undergoing Examination (Licensed
out)
官網沒有申
請權轉 移
資 訊
(2022/4/20
瀏覽)
-
Nalmefene, naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
Russia
RU2717677
2017/04/20
~
2037/04/20
Nalmefene, naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
License with Statera Biopharma Inc.
In December 2013, the Company formed Cytocom as a subsidiary of the Company, and transferred rights, titles and interests to the Company as follows:
(i) Patents, patent applications, and all divisional, continuations and continuations-in-part thereof, together with all reissues, reexaminations, renewals, and extensions thereof and all rights to obtain such divisional, continuations and continuations-in-part, reissues, reexaminations, renewals and extensions, and all utility models and statutory invention registrations and any other such analogous rights.
(ii) Trademarks, service marks, Internet domain names, trade dress, trade styles, logos, trade names, services names, brand names, corporate names, assumed business names and general intangibles and other source identifiers of a like nature, together with the goodwill associated with any of the foregoing, and all registrations and applications for registrations thereof, together with all renewals and extensions thereof and all rights to obtain such renewals and extensions.
(iii) Copyrights, mask work rights, database and design rights, moral rights and rights in Internet websites, whether registered or unregistered and whether published or unpublished, all registrations and recordings thereof and all applications in connection therewith, together with all renewals, continuations, reversions and extensions thereof and all rights to obtain such renewals, continuations, reversions and extensions.
(iv) Confidential and proprietary information, including, trade secrets and know-how.
On May 1, 2018, the Company entered into an amended and restated licensing agreement (the “Restated Agreement”) with Cytocom Inc. The Restated Agreement restates the licensing arrangement between the Company and Cytocom and grants the Company distribution and marketing rights for Lodonal™ and meta enkephalin (MENK) for humans in certain Emerging Markets. In addition, the Company was granted the rights to distribute and market Lodonal™ and MENK for animal use in the United States. The royalty due to Cytocom was reduced from 5% to 1% of sales in the Restated Agreement, and the Company no longer would have any ongoing obligations to pay for costs in connection with the assets of Cytocom. While the Company formalized the agreement in May 1 2018, Penn State University, a licensor that was part of the group of intellectual property that was to be moved, did not consent the move of their license or payables to Cytocom at the time of the Restated Agreement.
On April 8, 2019, the Company signed a second amendment to its licensing agreement (the “Second Amendment”) with Cytocom. The Second Amendment confirmed that, (as of its effective date December 31, 2018) the Company owned 15.57% of the Cytocom common shares issued and outstanding on that date. The Company agreed to assume responsibility to repay all accounts payable obligations and accrued liabilities owed by Cytocom as of the effective date, except those accounts’ payable obligations and accrued liabilities as specified in the Second Amendment. The Company also assumed the responsibility to repay all notes payable, together with any interest or fees payable thereon, owed by Cytocom as of the effective date, except those notes’ payable obligations, together with any interest or fees payable thereon, as specified by the Second Amendment. The parties further agreed that in the event of a change of control of Cytocom, and at the option of Cytocom, the Company would have the right to purchase outright the Company’s licensing rights to Emerging Markets for humans under the License Agreement at a price equal to value of those licensing rights as determined by and independent valuator acceptable to the Company and Cytocom.
On May 13, 2020, the Company and Cytocom entered into an Amendment to the Second Amendment (“Third Amendment”) that was effective December 31, 2018. The sublicense provides Cytocom with the Company’s previously licensed rights for LDN and MENK in Emerging Markets. The original terms for consideration for the sublicense were not finalized until August 12, 2020, at which time Cytocom and the Company signed a letter agreement in which Cytocom agreed to assume a combination of defaulted notes plus certain other liabilities. Such terms were amended, and the Company agreed to transfer all the rights, title, and interests to Cytocom in technology licensed from Penn State Research Foundation (“PSU”) in exchange for Cytocom assuming all past due and future obligations under the PSU license. While the Company formalized the agreement to assign all outstanding liabilities due to PSU, a vendor of the Company, PSU did not consent to the assignment of the payables to Cytocom. As of December 31, 2021, the Company had no outstanding accounts payable balances due to PSU.
On July 20, 2021, Cytocom and the Company agreed to modify the terms of the original sublicense. The renegotiated terms are presented below. The assignment of the Notes and associated accrued interest and penalties in default was fully executed in the third quarter of 2020 with the transfer of the notes upon the creditors’ signoff. The Company recognized a gain upon the assignment of these notes in the third quarter of 2020.
Consideration for License to Cytocom as of December 31, 2022
Consideration / Assumption of:
Notes and associated accrued interest in default $ 3,302,209
Accounts payable and accruals 230,000
Past Due Employee Obligations 1,110,567
Total anticipated Consideration $ 4,642,776
Recognized through December 31, 2020 (3,302,209 )
To Be Recognized upon Execution $ 1,340,567
In March 2023, the Company and Cytocom negotiated an amendment to the licensing agreement (“Third License Amendment”) which has been submitted to the board of directors of Cytocom for approval. The Third License Amendment:
● Restates the licensing arrangement between the Company and Cytocom and grants the Company manufacturing, distribution and marketing rights for LDN and MENK in humans for all indications except Crohn’s Disease (worldwide), and in animals (US only).
● Grants the Company the right grant sublicenses to third parties for the manufacturing, distribution and marketing of these products.
● Updates the royalty rates as follows:
Annual Sales of Royalty Qualifying Licensed Products Royalty Rate
<$500,000,000 2 %
500,000,000 to < $1,000,000,000 4 %
> $1,000,000,000) 6 %
As of December 31, 2023, the Notes transaction and Third License Amendment have not been fully executed. The Notes in default have been assigned and the transfer signed off by the creditors, but Cytocom still has not completed the assumption of the agreed upon obligations. Until the transaction is completed, Cytocom (now, Statera Biopharma, Inc.) does not have a clear title and interest to our Company’s technology.
TaiwanJ Pharmaceuticals Co. Ltd.
On September 30, 2022, the Company entered into an Intellectual Property License Agreement (the “Agreement”) with TaiwanJ Pharmaceuticals Co. Ltd., a Taiwanese corporation (“TaiwanJ”), pursuant to which TaiwanJ granted the Company an exclusive, royalty-bearing license, including the right to grant sublicenses, to commercialize and sell TaiwanJ’s pharmaceutical products including naltrexone, or any other small molecule composition that either alone or in combination can be formulated and used in humans to show anti-fibrotic, immune-modulating, and/or anti-inflammatory effects for the treatments of various diseases, (the “Products”).
The Company also received a non-exclusive worldwide right to make, manufacture, and receive technical manufacturing assistance from TaiwanJ for the creation of the Products.
The term of this Agreement is to be perpetual, but termination of the Agreement may occur upon (i) the Company providing sixty (60) days prior written notice to TaiwanJ of termination, (ii) termination of the agreement for a material breach of the agreement, and failure to cure that breach within ninety (90) days after receiving notice of such breach, (iii) the dissolution of the Company, or (iv) upon bankruptcy of either party, upon receiving sixty (60) days’ notice by Registered Mail.
The Company may grant sublicenses under the Agreement. Upon the granting of any such sublicense, the Company will pay TaiwanJ royalties based on the stage of development of the Products. The Company will pay a royalty of 30% of the cash proceeds received from any sublicense if the sublicense occurs before completing a clinical trial, 10% if the sublicence occurs after completing any trial, and 5% if sublicense occurs after any new drug application (“NDA”) submission.
Pursuant to the terms of the license in the Agreement, the Company shall adhere to a plan of development and attain certain milestones. As part of the Development Plan, the Company shall (i) use commercially reasonable efforts and cause its sublicenses to use commercially reasonable efforts to develop licensed Products, (ii) begin commercial sales of the Products in a country no less than eight (8) months after the first registration of the Products in that same country, and (iii) following commercialization, the Company must keep the Products reasonably available to the public.
Pursuant to the terms of the agreement, and for consideration of the license, the Company will provide (i) a non-refundable cash payment of $500,000 within ninety (90) days of September 30, 2022, (ii) a non-refundable cash payment of $500,000 at the earliest of either the National Agency for Food and Drug Administration and Control (“NAFDAC”) approval for JKB-122 in Africa for any indication, or the enrollment of the first patient in a Food and Drug Administration (“FDA”) trail for Crohn’s Disease, (iii) 250,000 shares of common stock of the Company within sixty (60) days of September 30, 2022, (iv) an annual payment of $100,000 each anniversary of the date of the agreement until the Company gains regulatory approval in Africa, (v) milestone payments (described below), and (vi) royalties on net sales. The 250,000 shares of common stock represent approximately 0.32% of the currently outstanding common stock of the Company.
The Company will be required to pay one-time payments and issuances of equity for the achievement of each of four milestones in the commercialization and development of the Products. In addition to the milestone payments, if there is any year that the Company is not required to pay a Milestone Payment, the Company will pay a royalty percentage payment based on the total net sales due within sixty (60) days after the end of each calendar quarter (the “Royalty Payment”).
If the Company fails to make any of the above-described payments upon their designated due date, the payment amount will bear the lower of (i) 1.5% interest per month or (ii) the maximum rate allowed by law, to be compounded quarterly. The interest will accrue beginning on the first day after the payment is due.
TaiwanJ will maintain, protect, and defend all patent-related intellectual property and the Company will reimburse TaiwanJ for any expenses related to intellectual property patent payments that exclusively benefit the Company. If either the Company or TaiwanJ becomes aware of any possible or actual infringement of any patent rights, then each party will notify the other, and provide it with details of such an infringement.
On January 19, 2023, the Company’s board of directors voted to issue an additional 250,000 shares of common stock to TaiwanJ. These shares were issued as a result of the Company’s delay in paying the required $500,000 up front license agreement fee.
On March 26, 2023, the Company paid $150,000 of the non-refundable up-front payment.
On April 13, 2023, the Company issued a note payable to TaiwanJ in the amount of $250,000, in order to reduce the balance of the up-front payment to $100,000. The note earns interest at 18.0% and matured on May 30, 2023. The note is currently in default.
Both the Company and TaiwanJ are limited in liability to the total amounts paid under this Agreement for any damages arising from negligence, strict liability, or any other equitable theory. Further, both the Company and TaiwanJ agree to indemnify and hold harmless each other, and their respective agents, for any claims or costs arising from this Agreement or any sublicenses for any cause of action relating to any product, process, service made, used, or sold pursuant to this Agreement.
Our Strategy
Our Company is focused on driving the development and commercialization of proprietary mechanisms to prevent, intercept, and improve such diseases at affordable costs. Our current efforts are focused on emerging markets where health challenges are prevalent, treatment expenses often limit availability for patients, and regulatory approval has previously been granted. We intend to advance select and efficient small-scale biotechnology, pharmaceutical, and Med Tech programs through subsidiaries, investment vehicles, and partnerships by using a biotechnology portfolio hub-and-spoke business model. Such products are anticipated to be deployed from these programs in targeted United States and international markets for initial commercialization.
Employees
As of December 31, 2023, our Company had no full-time employees.
Regulation
Our business is subject to significant and diverse regulations governing, among other things, research, operations and product approval. Regulatory compliance is critical to our ability to operate, our management of potential liabilities, and ultimately, our ability to sell our products. We also rely on our partners’ compliance with laws and regulations applicable to the products they produce. We do not independently monitor whether our collaborators comply with applicable laws and regulations. Please see the risk factor entitled “We do not currently manufacture Low Dose Naltrexone (LDN) and therefore must rely on third-party manufacturing to supply the drug for clinical trials.”
The areas of our business that these and other authorities regulate include, among others:
● product claims and advertising;
● product labels;
● product ingredients; and
● how we manufacture, package, distribute, import, export, sell and store our products.
In addition, our products sold in foreign countries are also subject to regulation under various national, local and international laws that include provisions governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and distribution of dietary supplements and over-the-counter drugs.
We are also subject to a variety of other regulations in the United States, including those relating to taxes, employment, import and export, and intellectual property.
Food and Drug Administration
In the United States, pharmaceuticals and biological products must receive approval from the FDA before being marketed. The FDA approves drug products other than biological products through its authority under the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations. The FDA licenses biological products, or biologics, through its authority under the Public Health Service Act, or PHSA, and implementing regulations. The development processes for obtaining FDA approval for a non-biological drug product under the FDCA and for biologic licensure under the PHSA are generally similar but have product-related differences reflected in regulations and in FDA guidance documents.
The process required by the FDA before a pharmaceutical product candidate may be marketed generally involves the following:
● Completion of preclinical laboratory tests and in vivo studies in accordance with applicable regulatory requirements, which may include the FDA’s current Good Laboratory Practice regulations and the Animal Welfare Act;
● Submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials commence;
● Performance of adequate and well-controlled human clinical trials according to the FDA’s Good Clinical Practices, or GCP, regulations, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed product candidate for each intended use;
● Preparation and submission to the FDA of an application for marketing approval that includes substantial evidence of safety, purity and potency for a biologic, or of safety and efficacy for a non-biologic drug, including from results of nonclinical testing and clinical trials;
● Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product candidate is produced to assess compliance with cGMP and that the methods and controls are adequate to assure the product candidate’s identity, safety, strength, quality, potency and purity;
● Potential FDA inspection of the nonclinical and clinical trial sites that generated the data in support of the application; and
● FDA review and approval of the application
Preclinical testing
Prior to testing any product candidate in humans in the United States, a company must develop preclinical data, which generally includes laboratory evaluation of the product candidate’s chemistry and formulation, as well as toxicological and pharmacological studies in animal species to assess safety and quality. Certain types of animal studies must be conducted in compliance with the FDA’s Good Laboratory Practice regulations and the Animal Welfare Act, which is enforced by the Department of Agriculture.
IND application
Prior to commencing clinical trials in the United States to evaluate a product candidate’s safety and efficacy, a person or entity must submit to the FDA, an IND application, which contains preclinical testing results and other data and information that allow the FDA to evaluate whether there is an adequate basis for testing the drug in humans. If the FDA does not object to the IND application within 30 days of submission, the clinical testing proposed in the IND may begin. Even after the IND has gone into effect and clinical testing has begun, the FDA may put clinical trials on “clinical hold,” suspending or, in some cases, ending them because of safety concerns or for other reasons.
Human clinical trials under an IND
Clinical trials involve administering the product candidate to healthy volunteers or patients under the supervision of qualified investigators. Clinical trials must be conducted and monitored in accordance with the FDA’s regulations, such as GCP requirements. Each clinical trial must also be conducted under a protocol that details, among other things, the study objectives, parameters for monitoring safety, and the efficacy criteria, if any, to be evaluated. The protocol is submitted to the FDA as part of the IND and reviewed by the agency. Further, each clinical trial must be reviewed and approved by an Institutional Review Board, or IRB, at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers, among other things, whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The sponsor of a clinical trial, the investigators, and IRBs each must comply with requirements and restrictions that govern, among other things, obtaining informed consent from each study subject, complying with the protocol and investigational plan, adequately monitoring the clinical trial, and timely reporting adverse events.
The sponsor of a clinical trial or the sponsor’s designated responsible party may be required to register certain information about the trial and disclose certain results on government or independent registry websites, such as clinicaltrials.gov.
Human clinical trials typically are conducted in three sequential phases that may overlap or be combined:
● Phase 1. The product candidate is introduced into a small number of healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain early understanding of its effectiveness. For some product candidates for severe or life-threatening diseases, especially when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with the targeted disease.
● Phase 2. The product candidate is administered and evaluated in a limited patient population to identify possible adverse effects and safety risks, to evaluate preliminary efficacy evidence for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.
● Phase 3. The product candidate is administered to an expanded patient population with the target disease or disorder, often at geographically dispersed clinical trial sites, in adequate and well-controlled clinical trials to generate sufficient data to evaluate the safety and efficacy of the non-biologic drug, or the safety, purity, and potency of the biologic. These clinical trials are intended to establish the overall risk/benefit profile of the product candidate and provide an adequate basis for product labeling.
● Post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted, or may be required to be conducted, after initial approval to further assess the risk/benefit profile of the product and to gain additional experience from treatment of patients in the intended indication, including for long-term safety follow-up.
United States review and approval processes
The results of the preclinical tests and clinical trials, together with detailed information relating to the product’s CMC and proposed labeling, among other things, are submitted to the FDA as part of an application requesting approval to market the product for one or more uses, or indications. When an application is submitted, the FDA makes an initial determination as to whether the application is sufficiently complete to be accepted for review. If the application is not, the FDA may refuse to accept the application for filing and request additional information. A refusal to file, which requires resubmission of the application with the requested additional information, delays review of the application. For gene therapies, selecting patients with applicable genetic defects is often a necessary condition to effective treatment and may require diagnostic devices that the FDA has cleared or approved prior to or contemporaneously with approval of the gene therapy.
Under the Pediatric Research Equity Act, or PREA, certain marketing applications generally must contain data to assess the safety and effectiveness of the product candidate for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product candidate is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, PREA does not apply to any product candidate for an indication for which orphan designation has been granted.
On the basis of the marketing application and accompanying information, including the results of the inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information for the FDA to reconsider the application. If those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the application, the FDA may issue an approval letter.
If a product candidate receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a Risk Evaluation and Mitigation Strategy, or REMS, or otherwise limit the scope of any approval. In addition, the FDA may require postmarketing clinical trials designed to further assess the risk/benefit profile of the product and to gain additional experience from treatment of patients in the intended indication, including for long-term safety follow-up.
Compliance with cGMP requirements
Drug and biologics manufacturers must comply with applicable cGMP regulations. Manufacturers and others involved in the manufacture and distribution of such products also must register their establishments with the FDA and certain state agencies. Both domestic and foreign manufacturing establishments must register and provide additional information to the FDA upon their initial participation in the manufacturing of drugs. Establishments may be subject to periodic, unannounced inspections by the FDA and other government authorities to ensure compliance with cGMP requirements and other laws. Discovery of problems may result in a government entity placing restrictions on a product, manufacturer or holder of an approved product application and may extend to requiring withdrawal of the product from the market.
Orphan Drug Designation in the United States
Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs and biological products intended to treat a “rare disease or condition,” which generally is a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation must be requested before submitting a marketing application or supplement seeking approval for the orphan indication. After the FDA grants orphan drug designation, the common identity of the therapeutic agent and its potential orphan use are publicly disclosed by the FDA.
Orphan drug designation does not-by itself-convey any advantage in, or shorten the duration of, the regulatory review and approval process. If a product that has an orphan drug designation subsequently receives the first FDA approval for that drug or biologic for the indication for which it has been designated, the product is entitled to an orphan exclusivity period in which the FDA may not approve any other applications to market the same drug or biologic for the same indication for seven years.
Exceptions to the seven-year exclusivity period may apply in limited circumstances, such as where the sponsor of a different version of the product is able to demonstrate that its product is clinically superior to the approved orphan drug product. This exclusivity does not prevent a competitor from obtaining approval to market a different product that treats the same disease or condition, or the same product to treat a different disease or condition. The FDA can revoke a product’s orphan drug exclusivity under certain circumstances, including when the holder of the approved orphan drug application is unable to assure the availability of sufficient quantities of the drug to meet patient needs. Orphan exclusivity operates independently from other regulatory exclusivities and other protections against generic or biosimilar competition.
A sponsor of a product application that has received an orphan drug designation is also granted tax incentives for clinical research undertaken to support the application. In addition, the FDA may coordinate with the sponsor on research study design for an orphan drug and may exercise its discretion to grant marketing approval on the basis of more limited product safety and efficacy data than would ordinarily be required, based on the limited size of the applicable patient population. Orphan drug designation does not, however, change the legal standard required for a product candidate to obtain FDA approval.
Fast Track Designation
The FDA has a number of expedited review programs for drugs that are intended for the treatment of a serious or life-threatening condition. As one example, under the agency’s Fast Track program, the sponsor of a new drug candidate may request the FDA to designate the product for a specific indication as a Fast Track product concurrent with or after the filing of the IND for the product candidate, if nonclinical and clinical data demonstrate the product’s potential to address unmet medical needs and the product is intended to treat a serious condition. The FDA must determine if the product candidate qualifies for Fast Track designation within 60 days after receipt of the sponsor’s request.
In addition to other benefits, such as the ability to have more frequent interactions with the FDA, the agency may initiate review of sections of a Fast Track product’s marketing application before the application is complete. This rolling review is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s review period for a Fast Track application does not begin until the last section of the marketing application is submitted. In addition, the Fast Track designation may be withdrawn by the FDA if the agency believes that the designation is no longer supported by data emerging in the clinical trial process.
Post-approval requirements
Rigorous and extensive FDA regulation of drugs and biologics continues after approval, including requirements relating to recordkeeping, periodic reporting, product sampling and distribution, adverse experiences with the product, cGMP, and advertising and promotion. Changes to the product, manufacturing process, or facility often require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval. Additionally, the FDA may require postmarketing studies or clinical trials, changes to a product’s approved labeling, including the addition of new warnings and contraindications, or the implementation of other risk management measures, including distribution restrictions, if new safety information emerges. Failure to comply with the applicable requirements may result in administrative, judicial, civil or criminal actions and adverse publicity. These actions may include FDA’s refusal to approve or delay in approving pending applications or supplemental applications, withdrawal of approval, clinical hold, suspension or termination of clinical trial, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines or other monetary penalties, refusals of government contracts, mandated corrective advertising or communications with healthcare providers, debarment, restitution, disgorgement of profits or other civil or criminal penalties.
Foreign regulation of human therapeutics
In addition to regulations in the United States, our subsidiaries, such as PGEN Therapeutics and ActoBio, and our collaborators that are focused on the development of human therapeutic products will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of the products enabled by our technologies. Whether or not the developer obtains FDA approval for a product, they must obtain approval by the comparable regulatory authorities of foreign countries or economic areas, such as the European Union, before they may commence clinical trials or market products in those countries or areas. The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval.
Anti-Kickback, False Claims, and Other Marketing and Fraud and Abuse Laws
Healthcare providers, physicians and others will play a primary role in the recommendation and prescription of any products for which we obtain marketing approval. Our future arrangements with healthcare providers, patients and third-party payers will expose us to broadly applicable United States fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and collaborative partners through which we market, sell and distribute any products for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations are discussed in the “Risk Factors” section below.
Privacy Laws
In the United States, we may be subject to data privacy and security laws and regulations by both the federal government and the states in which we conduct our business. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which may affect our business. Numerous federal and state laws and regulations, including state data breach notification laws, state health information and/or genetic privacy laws and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission, or FTC, Act and the California Consumer Privacy Act, as amended by the California Privacy Rights Act, or CCPA), govern the collection, use, disclosure, protection and other processing of health-related and other personal information. Many of these laws differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Compliance with these laws is difficult, constantly evolving, and time consuming. Federal regulators, state attorneys general, and plaintiffs’ attorneys, including class action attorneys, have been and will likely continue to be active in this space.
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes requirements relating to the privacy, security and transmission of individually identifiable health information. We may obtain health information from third parties, such as research institutions, that are subject to privacy and security requirements under HIPAA. Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
In addition, the CCPA establishes certain requirements for data use and sharing transparency, and provides California residents certain rights concerning the use, disclosure, and retention of their personal data. The CCPA and its implementing regulations have already been amended multiple times since their enactment. Similarly, there are a number of legislative proposals in the United States, at both the federal and state level that could impose new obligations or limitations in areas affecting our business. These laws and regulations are evolving and subject to interpretation, and may impose limitations on our activities or otherwise adversely affect our business. The CCPA and evolving legislation may require us, among other things, to update our notices and develop new processes internally and with our partners. Internationally, laws and regulations in many jurisdictions also apply broadly to the collection, use, storage, disclosure, protection and other processing of data that identifies or may be used to identify or locate an individual. Please see the risk factor entitled “Any failure by the Company to comply with existing health care and drug regulations could harm its reputation, operating results, the quality of the Company’s business strategy and the quality of the Company’s products.”
Environmental Regulation
Our facilities and operations, in common with those of similar industries making similar products, are subject to many federal, state, provincial and local requirements, rules and regulations relating to the protection of the environment and of human health and safety, including those regulating the discharge of materials into the environment. We continually examine ways to reduce our emissions, minimize waste and limit our exposure to any liabilities, as well as decrease costs related to environmental compliance. Costs to comply with current and anticipated environmental requirements, rules and regulations and any estimated capital expenditures for environmental control facilities are not anticipated to be material when compared with overall costs and capital expenditures. Accordingly, we do not anticipate that such costs will have a material effect on our financial position, results of operations, cash flows or competitive position.
New Legislation or Regulation
Legislation may be introduced which, if passed, would impose substantial new regulatory requirements on our products and pharmaceuticals. We cannot determine what effect additional domestic or international governmental legislation, regulations, or administrative orders, when and if promulgated, would have on our business in the future. New legislation or regulations may require the reformulation of certain products to meet new standards, require the recall or discontinuance of certain products or treatments not capable of reformulation, impose additional record keeping or require expanded documentation of the properties of certain products, expanded or different labeling or scientific substantiation.
Available Information
Current Reports on Form 8-K, and Quarterly Reports are electronically filed with or furnished to the Securities and Exchange Commission (SEC), and all such reports and amendments to such reports have been and will be made available, free of charge, through our website (http://www.biostaxcorp.com) as soon as reasonably practicable after such submission to the SEC. Such reports will remain available on our website for at least 12 months. The contents of our website are not incorporated by reference into this Annual Report on Form 10-K. The public may read and copy any materials filed by us with the SEC at the SEC’s Public Reference Room at 100 F Street, NW, Washington, D.C. 20549.

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ITEM 1A. RISK FACTORS
ITEM 1A. RISK FACTORS.
An investment in our securities involves a high degree of risk. You should carefully read and consider all of the risks described below, together with all of the other information contained or referred to in this report, before making an investment decision with respect to our securities. If any of the following events occur, our financial condition, business and results of operations (including cash flows) may be materially adversely affected. In that event, the market price of our shares could decline, and you could lose all or part of your investment.
Risks Related to our Business, Operations and Industry
We have a limited operating history and are expected to incur significant operating losses during the early stage of our corporate development.
We have a limited operating history. Our historical financial information consists only of an audit of our financial results at and for the years ended December 31, 2022 and 2023. There is limited historical financial information upon which to base an evaluation of our performance. We are an emerging Company, and thus our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operation, particularly in the pharmaceutical industry.
Since inception, we have invested a substantial portion of our time and financial resources in the acquisition and development due to the costs of continued development until LDN is approved by the FDA and foreign regulatory authorities for sale for the development our most advanced drug candidate, Low Dose Naltrexone, or Lodonal TM or LDN. We expect that our ability to generate material profits will be limited until Lodonal is approved by the FDA. We except to continue to incur losses as a result of the costs of continued development until LDN is approved by the FDA and foreign regulatory authorities for sale for our therapies. Even if regulatory approval is obtained, there is a risk that we will not be able to generate material sales of LDN, which would cause us to continue to incur losses.
We may never generate revenue, are not profitable and may never become profitable.
We expect to incur substantial losses and negative operating cash flow for the foreseeable future, and we may never achieve or maintain profitability. Even if we are able to launch LDN we expect to incur substantial losses for the foreseeable future and may never become profitable.
We may not generate significant revenue from the sale of our products for the foreseeable future. In addition, if approved, we expect to incur significant costs to commercialize our drug candidates and our drugs may never gain market acceptance. If our drug candidates fail to demonstrate safety and efficacy in clinical trials, do not gain regulatory approval, or do not achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. If we are unable to achieve and sustain profitability, the market value of our common stock will likely decline. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or whether we will become profitable.
We will see losses from our clinical trials conducted either directly or through our licensors for the foreseeable future, and if we or they fail at one or more of our clinical trials, it could affect the value of the Company’s stock.
We rely on financings to fund and conduct clinical trials directly or through our licensors needed for NDA submission with respect to LDN. Any of the following events or factors could have a material adverse effect on our ability to generate revenue from the commercialization of LDN:
● The Company or its licensor may be unable to successfully complete the clinical development of LDN;
● The Company or its licensor must comply with any possible additional requests and recommendations from the FDA, including additional clinical trials;
● The Company or its licensor may not obtain all necessary approvals from the FDA and similar foreign regulatory agencies;
● The Company or its licensor may not commit sufficient resources to the development, regulatory approval, marketing and distribution of LDN;
● LDN must be manufactured in compliance with requirements of the FDA and similar foreign regulatory agencies and in commercial quantities sufficient to meet market demand;
● LDN may not achieve market acceptance by physicians, patients, veterinarians and third party payers;
● LDN may not successfully compete against alternative products and therapies; and
● The Company or any other pharmaceutical organization may independently develop products that compete with LDN.
To obtain approval from the FDA of an NDA for LDN for treatment of humans, The Company or its licensor will need to demonstrate through evidence of adequate and well-controlled clinical trials that LDN is safe and effective for each proposed indication. However, LDN may not be approved even though it achieved its specified endpoints in future Phase III clinical trials intended to support an NDA, which may be conducted by the Company or its licensor. The FDA may disagree with the trial design and the interpretation of data from clinical trials, may ask the Company or licensor to conduct additional costly and time-consuming clinical trials in order to obtain marketing approval or approval to enter into an advanced phase of development, or may change the requirements for approval even after it has reviewed and commented on the design for our future clinical trials. The FDA may also approve LDN for fewer or more limited indications than the Company or its licensor may request or may grant approval contingent on the performance of costly post-approval clinical trials. In addition, the FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of LDN.
The development of new drugs is a highly risky undertaking which involves a lengthy process, and therefore our drug discovery and development activities may not result in products that are approved by the applicable regulatory authorities on the time schedule we have planned, or at all.
Our drug candidates for treatment of humans are in early stages of drug discovery or clinical trials and are prone to the risks of failure inherent in drug development. As of the date of this offering, both of our current drug candidates, MENK and LDN have been tested on human beings. We or our licensor will need to conduct additional clinical trials before we can demonstrate that our drug candidates are safe and effective to the satisfaction of the FDA and other regulatory authorities. Clinical trials are expensive and uncertain processes that can take multiple years to complete. We cannot assure you that our ongoing clinical trials or any future clinical trial of any of our other drug candidates, will be completed on schedule, or at all, or whether our planned clinical trials will start in a timely manner. The commencement of our planned clinical trials could be substantially delayed or prevented by a number of factors, including:
● delays or failures in obtaining sufficient quantities of the API and/or drug product;
● delays or failures in reaching an agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites and with the FDA or other foreign regulatory bodies;
● delays or failures in obtaining approvals to conduct a clinical trial at a prospective site;
● the need to successfully complete, on a timely basis, preclinical safety pharmacology studies (for MENK);
● the limited number of, and competition for, suitable sites to conduct the clinical trials;
● the limited number of, and competition for, suitable patients for enrollment in the clinical trials; and
● delays or failures in obtaining regulatory approval to commence a clinical trial.
The completion of clinical trials by us or its licensor could also be substantially delayed or prevented by a number of factors, including:
● slower than expected rates of patient recruitment and enrollment;
● failure of patients to complete the clinical trials;
● failure of our third party vendors to timely or adequately perform their contractual obligations relating to the clinical trials;
● inability or unwillingness of patients or medical investigators to follow our clinical trial protocols;
● inability to monitor patients adequately during or after treatment;
● termination of the clinical trials by one or more clinical trial sites;
● unforeseen safety issues;
● lack of efficacy demonstrated during clinical trial results;
● lack of adequate funding to continue the clinical trials;
● the need for unexpected discussions with the regulatory agencies regarding the scope or design of our clinical trials or the need to conduct additional trials;
● unforeseen delays by the regulatory agencies after submission of our results;
● an unfavorable FDA inspection of our contract manufacturers of APIs or drug products; and/or
● inspection of the clinical trial operations or trial sites by regulatory authorities resulting in the imposition of a clinical hold.
Any failure or significant delay in completing clinical trials for our licensor’s or our drug candidates will harm the commercial prospects for our drug candidates and adversely affect our financial results.
Additionally, changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes. Amendments may require us to resubmit our clinical trial protocols to regulatory agencies for reexamination, which may impact the costs, timing or successful completion of a clinical trial. If we experience delays in completion of a clinical trial, or if we terminate any of our clinical trials, the commercial prospects for our drug candidates may be harmed and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a drug candidate.
If we or our licensor are required to suspend or discontinue clinical trials due to side effects or other safety risks, or if we are required to conduct studies on the long-term effects associated with the use of our drug candidates, our efforts to commercialize our products could be delayed or halted.
Our or our licensor’s clinical trials may be suspended or terminated at any time for a number of safety-related reasons. For example, administering any drug candidate to humans may produce undesirable side effects. We may voluntarily suspend or terminate our clinical trials if at any time we believe that our drug candidates present an unacceptable safety risk to the clinical trial patients. In addition, agencies may order the temporary discontinuation or termination of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, including if they present an unacceptable safety risk to patients. The existence of undesirable side effects resulting from our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials of our drug candidates and could result in the regulatory agencies denying further development or approval of our drug candidates for any or all targeted indications.
Further, cytokine receptors and opiate growth factor receptors are a novel class of targets. As a result, we may experience unforeseen adverse side effects with our existing and future drug candidates, including MENK and LDN. As of the date of this registration statement, although we have not observed harmful side effects in prior studies of LDN or MENK, later trials could reveal such side effects. The pharmacokinetic profile and results of preclinical studies may not be indicative of results in any clinical trial.
Neither we nor or our licensor have not conducted studies on the long-term effects associated with the use of our drug candidates. Studies of long-term effects and chronic dosing (approximately 1 year of dosing); will be required for regulatory approval and may delay introduction of our therapies or our other drug candidates into the market. Additional studies could also be required at any time after regulatory approval of any of our drug candidates. Some or all of our drug candidates may prove to be unsafe for human use.
Even if our or our licensor’s drug candidates do obtain regulatory approval, they may never achieve market acceptance or commercial success.
Even if we or our licensor obtain regulatory approval, our drug candidates may not achieve market acceptance among physicians, veterinarians, patients and/or third-party payers or they may be used only in applications more restricted than we anticipate, and ultimately, may not be commercially successful. Our treatments, if successfully developed, will compete with a number of traditional products manufactured and marketed by major pharmaceutical and biotechnology companies. Our treatments may also compete with new products currently under development by such companies and others. Physicians or veterinarians will prescribe a product only if they determine, based on experience, clinical data, side effect profiles and other factors, that it is beneficial as compared to other products currently available and in use. Physicians or veterinarians also will prescribe a product based on their traditional preferences. Market acceptance of our drug candidates for which we receive approval depend on a number of factors, including:
● the efficacy and safety of our drug candidates as demonstrated in clinical trials;
● the clinical indications for which the drug is approved;
● acceptance by physicians or veterinarians, major operators of clinics and patients of the drug as a safe and effective treatment;
● the potential and perceived advantages of our drug candidates over alternative treatments;
● the safety of drug candidates seen in a broader patient group, including its use outside the approved indications;
● the cost of treatment in relation to alternative treatments;
● the availability of adequate reimbursement and pricing by third parties and government authorities;
● relative convenience and ease of administration;
● the prevalence and severity of adverse side effects; and
● the effectiveness of our sales and marketing efforts.
If our drug candidates that obtain regulatory approval fail to achieve market acceptance or commercial success, the Company’s financial results will be adversely affected.
Changes in pharmaceutical and biotechnology industry trends could adversely affect the Company’s operating results.
Industry trends, economic and political factors that affect pharmaceutical, biotechnology, medical device companies and academic/government entities sponsoring clinical research directly affect the Company’s business. For example, many companies in such industries and government organizations have been hiring companies to conduct large development projects. The Company’s operations, financial condition and growth rate could be materially and adversely affected if these industries reduce outsourcing of such projects. In the past, mergers, product withdrawals, liability lawsuits and other factors in the pharmaceutical industry have slowed decision making by pharmaceutical companies and correlating government bodies significantly delaying and/or halting drug development projects. Continuation or increases in such trends could have an adverse effect on the Company’s business. Additionally, numerous government agencies have undertaken efforts to control growing healthcare costs through legislation, regulation and voluntary agreements with medical care providers and pharmaceutical companies. If future regulatory cost-containment efforts limit potential profits derived from new drugs, the Company’s clients may reduce their drug discovery and development spending. A reduction in drug discovery and development spending could have a material adverse effect on the Company’s results and operations creating a significant reduction of the Company’s revenue.
We currently rely on our licensor and third parties to conduct all our clinical trials. If they do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize any of our drug candidates.
We currently do not have the ability to independently conduct clinical trials. We rely on medical institutions, clinical investigators, contract laboratories, collaborative partners and other third parties, such as contract research organizations, to conduct clinical trials on our drug candidates. The third parties with whom we contract for execution of our clinical trials play a significant role in the conduct of these trials and the subsequent collection and analysis of data. These third parties are not our employees, and except for contractual duties and obligations, we have limited ability to control the amount or timing of resources that they devote to our programs. Although we rely on these third parties to conduct our clinical trials, we remain responsible for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with its investigational plan and protocol. Moreover, foreign regulatory authorities require us to comply with regulations and standards, commonly referred to as current Good Clinical Practices (“cGCPs”) for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials.
In addition, the execution of preclinical studies and clinical trials, and the subsequent compilation and analysis of the data produced, requires coordination among various parties. In order for these functions to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with one another. Moreover, these third parties may also have relationships with other commercial entities, some of which may compete with us. In most cases, these third parties may terminate their agreements upon a material breach by us that is not cured within 30 days by providing us with 30 days’ prior written notice. Many of these agreements may also be terminated by such third parties under certain other circumstances, including our insolvency or our failure to comply with applicable laws. In general, these agreements require such third parties to reasonably cooperate with us at our expense for an orderly winding down of services of such third parties under the agreements. If the third parties conducting our clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical trial protocols or cGCPs, or for any other reason, we may need to enter into new arrangements with alternative third parties, which could be costly, and our clinical trials may be extended, delayed or terminated or may need to be repeated, and we may not be able to obtain regulatory approval for or commercialize the drug candidate being tested in such trials.
If any of our drug candidates receive marketing approval, and the Company or others later identify undesirable side effects caused by the drug candidate, our ability to market and derive revenue from the drugs could be compromised.
If the Company or others identify undesirable side effects caused by one of our drug candidates, any of the following adverse events could occur:
● regulatory authorities may withdraw approval of the drug or seize the drug;
● we may be required to recall the drug or change the way the drug is administered;
● additional restrictions may be imposed on the marketing or the manufacturing processes of the particular drug;
● we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
● we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
● we could be sued and held liable for harm caused to patients;
● the drug may become less competitive; and
● our reputation may suffer.
Any of these could result in the loss of significant revenues, which would materially and adversely affect our results of operations and business.
We may need additional financing and may be unable to raise capital on acceptable terms, or at all, when needed, which could force us to delay, reduce or eliminate our research and development programs and other operations or commercialization efforts.
We are advancing multiple drug candidates through discovery and development and will require substantial funds to conduct development, including preclinical studies and clinical trials, of our drug candidates. Commercialization of any drug candidate will also require substantial expenditures. To further the development and commercialization efforts of our drug candidates, we may need additional financing to hire additional employees to co-promote drug candidates or to commercialize drug candidates that may not be covered by our current collaboration agreements.
We do not believe that our available cash and cash equivalents will be sufficient to fund our anticipated level of operations for the next 12 months and we will likely need to seek outside sources of funding. Assuming that anticipated investment and revenue does not materialize, business operations would not be able to continue more than 60 days. We believe we require at least $5 million for our operations over the next 12 months. Our future financing requirements will depend on many factors, some of which are beyond our control, including:
● the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development activities;
● the timing of, and costs involved in, seeking and obtaining regulatory approvals;
● the continuation and success of our strategic alliances and future collaboration partners;
● the exercise of remaining options under current collaborative agreements;
● the costs of preparing, filing, prosecuting, maintaining and enforcing any patent claims and other intellectual property rights, including litigation costs and the results of such litigation;
● our ability to enter into additional collaboration, licensing, government or other arrangements and the terms and timing of such arrangements;
● potential acquisition or in-licensing of other products or technologies; and
● the technologies or other adverse market developments.
Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies. We currently have no understandings, commitments or agreements relating to any of these types of transactions.
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, debt financings, government grants and contracts and/or strategic collaborations. Additional financing may not be available to us when we need it or it may not be available on favorable terms, if at all. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or our commercialization efforts. We may be required to enter into collaborative partnerships for one or more of our drug candidate programs at an earlier stage of development or on less favorable terms, which may require us to relinquish rights to some of our drug candidates that we would otherwise have pursued on our own. We may also be required to pursue strategic alternatives that may affect our business or corporate structure in order to make ourselves more attractive to investors.
In addition, if the Company or any of its future collaboration partners does not perform in the manner we expect or fulfill its responsibilities in a timely manner, or at all, the clinical development, regulatory approval, and commercialization efforts related to LDN could be delayed or terminated. It may be necessary for us to assume the responsibility at our own expense for the development of LDN. In that event, we would likely be required to seek additional funding.
We may form additional strategic alliances in the future with respect to our independent programs, and we may not realize any benefits of such alliances.
We may form strategic alliances, create joint ventures or collaborations or enter into licensing arrangements with third parties with respect to our independent programs that we believe will complement or augment our existing business. For example, we plan to find a partner to co-develop and commercialize MENK and LDN outside North America upon completion of clinical development of LDN for the treatment of pediatric and adult patients with Crohn’s disease. We face significant competition in seeking appropriate strategic partners. The negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for any future product candidates and programs because our research and development pipeline may be insufficient, our product candidates and programs may be deemed to be at too early a stage of development for collaborative effort and/or third parties may not view our product candidates and programs as having the requisite potential to demonstrate safety and efficacy. We cannot be certain that, following a strategic transaction or license, we will achieve the revenues or specific net income that justifies such transactions. Any delays in entering into new strategic partnership agreements related to our product candidates could also delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market.
We do not currently manufacture Low Dose Naltrexone (LDN) and therefore must rely on third-party manufacturing to supply the drug for clinical trials. If one of our suppliers or manufacturers fails to perform adequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts to find new suppliers or manufacturers, which would cause delays in the development and commercialization of our drug candidates.
The manufacture of pharmaceutical products in compliance with cGMPs requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of pharmaceutical products often encounter difficulties in production, including difficulties with production costs and yields, quality control, including stability of the drug candidate and quality assurance testing, shortages of qualified personnel, as well as compliance with strictly enforced regulatory and cGMP requirements, other regulatory requirements, and foreign regulations. If our manufacturers were to encounter any of these difficulties or otherwise fail to comply with their obligations to us or under applicable regulations, our ability to provide study drugs in our preclinical studies and clinical trials would be jeopardized. Any delay or interruption in the supply of preclinical study or clinical trial materials could delay the completion of our preclinical studies and clinical trials, increase the costs associated with maintaining our preclinical study and clinical trial programs and, depending upon the period of delay, require us to commence new trials at significant additional expense or terminate the studies and trials completely.
All manufacturers of our drug candidates must comply with cGMP requirements. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation. Manufacturers of our component materials may be unable to comply with these cGMP requirements and with other regulatory requirements. Regulatory agencies at any time may also implement new standards, or change their interpretation and enforcement of existing standards for manufacture, packaging or testing of products. We have little control over our manufacturers’ compliance with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval. If the safety of any product supplied is compromised due to our manufacturers’ failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully commercialize our products, and we may be held liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical trials, regulatory submissions, approvals or commercialization of our drug candidates or entail higher costs or impair our reputation.
We source the API for LDN from third-party vendors. Another pharmaceutical company manufactures the API for MENK. Our current agreements with our suppliers provide for the entire supply of the API necessary for additional clinical trials or for full-scale commercialization. In the event that we and our suppliers cannot agree to the terms and conditions for them to continue to provide some or all of our API clinical and commercial supply needs, or if any single source supplier terminates the agreement in response to a breach by us, we would not be able to manufacture the API on a commercial scale until a qualified alternative supplier is identified, which could also delay the development of, and impair our ability to commercialize, our drug candidates.
Although alternative sources of supplies exist, the number of third-party suppliers with the necessary manufacturing and regulatory expertise and facilities are limited, and it could be expensive and take a significant amount of time to arrange for alternative suppliers, which could have a material adverse effect on our business. New suppliers of any API would be required to qualify under applicable regulatory requirements and would need to have sufficient rights to the method of manufacturing such ingredients under applicable intellectual property laws. Obtaining the necessary regulatory approvals or other qualifications under applicable regulatory requirements and ensuring non-infringement of third-party intellectual property rights could result in a significant interruption of supply and could require the new manufacturer to bear significant additional costs which may be passed on to us.
We currently have only a limited distribution organization with no direct sales and marketing staff. If we are unable to develop sales and marketing and expand distribution capability on our own or through collaborations with marketing partners, we will not be successful in commercializing our future products.
We currently have only a limited distribution organization with no sales or marketing staff. If our products are approved for sale in the United States, we will need to execute a number of sales and marketing agreements, but there can be no assurance that the Company will be able to sign an agreement to market and distribute our products. To the extent we rely on third parties for marketing and distributing our approved products, any revenue we receive will depend upon the efforts of third parties, which may not be successful, and are only partially within our control. Our reliance on third parties makes it likely that our product revenue is likely to be lower than if we directly marketed or sold our products. If we are unable to enter into arrangements with third parties to commercialize the approved products on acceptable terms or at all, we may not be able to successfully commercialize our future products or we will have to market these products ourselves, which will be expensive and require us to build our own sales force, which we do not have experience doing. We cannot assure you we will be successful in any of these initiatives. If we are not successful in commercializing our future products, either on our own or through collaborations with one or more third parties, our future product revenue will be materially adversely affected.
We are dependent on market acceptance of compounding pharmacies and compounded formulations, and physicians may be unwilling to prescribe, and patients may be unwilling to use, our proprietary LDN compounded formulation.
We are currently distributing our proprietary LDN formulation for human use through third-party compounding pharmacies and distributors in Emerging Markets. Our formulation has not undergone the FDA approval process and only limited data, if any, may be available with respect to the safety and efficiency of our formulation for any particular indication. Some physicians may be hesitant to prescribe, and some patients may be hesitant to purchase and use, this non-FDA approved compounded formulation. In addition, certain compounding pharmacies have been the subject of widespread negative media coverage in recent years, and the actions of these pharmacies have resulted in increased scrutiny of compounding pharmacy activities from regulatory agencies. As a result, physicians may be unwilling to prescribe a compounded formulation when an FDA-approved alternative is available, even if they believe the compounded formulation to be superior and less expensive. Other reasons physicians may be unwilling to prescribe or patients may be unwilling to use our proprietary LDN compounded formulation could include the following, among others: our proprietary formulation is not required to be, and has not been, approved for marketing and sale by the FDA; there may be limited or no data available with respect to the clinical efficacy or safety of our compounded formulation the physician is prescribing; and to the extent there is such data available, we are limited in our ability to discuss the efficacy or safety of our formulation with potential purchasers of our formulation.
We aim to generate revenue from our proprietary LDN formulation through agreements with compounding pharmacies outside of the United States, but we may not be successful in our efforts to generate revenue from such formulation.
One aspect of our business strategy is to enter into other sub-licensing arrangements with compounding pharmacies outside of the U.S., through which we can generate revenue from the sale of our proprietary LDN formulation. We have limited experience commercializing our formulation through licensing arrangements with compounding pharmacies. Even if we are successful, we may be unable to generate sufficient revenue to recover our costs.
We have minimal experience sub-licensing products to pharmacies and outsourcing facilities and we may not be successful in our efforts to develop our licensing arrangements. If we elect to sub-license our proprietary LDN formulation to one or more pharmacies or outsourcing facilities outside of the U.S., we may not be able to enter into licensing agreements when desired, on acceptable terms, or at all. Establishing licensing or other relationships with pharmacies and outsourcing facilities could be expensive and time consuming, disrupt our other operations, require significant capital expenditures and distract management and our other employees from other aspects of our business.
Failure to achieve and maintain effective internal controls could have a material adverse effect on our business.
Effective internal controls are necessary for us to safeguard our assets and provide reliable financial reports. If we cannot provide reliable financial reports, our operating results could be harmed. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
While we continue to evaluate and improve our internal controls, we are a small Company with limited staff, and we cannot be certain that the measures we implement will ensure that we design, undertake and maintain adequate controls over our financial processes and reporting in the future. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could harm our operating results or cause us to fail to meet our reporting obligations.
Failure to achieve and maintain an effective internal control environment could cause investors to lose confidence in our reported financial information, which could have a material adverse effect on our stock price. In addition, if our efforts to comply with new or changed laws, regulations, and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.
Our independent registered public accounting firm has identified material weaknesses in our financial reporting process.
In 2019, our independent registered public accounting firm has identified two material weaknesses in our financial reporting process. Specifically, our independent registered public accounting firm identified material weaknesses with respect to:
In April 2020, the full Board constituted itself as the audit committee and has met subsequently to oversee the Company’s financial reporting. We intend to remediate this weakness by increasing the size of our accounting staff when we have the financial resources to do so, and by appointing a separate audit committee with membership that is qualified to oversee the Company’s financial reporting. However, there can be no assurance that we will be able to successfully implement our plans to remediate the material weaknesses in our financial reporting process. Our failure to successfully implement our plans to remediate these material weaknesses could cause us to fail to meet our reporting obligations, to produce timely and reliable financial information, and to effectively prevent fraud. Additionally, such failure, or other weaknesses that we may experience in our financial reporting process or other internal controls, could cause investors to lose confidence in our reported financial information, which could have a negative impact on our financial condition and stock price.
We will need to increase the size of our organization, but we may experience difficulties in managing growth.
We will need to continue to expand our managerial, operational, financial and other resources in order to manage our operations and clinical trials, continue our development activities and commercialize our drug candidates. Our current management, personnel systems and facilities may not be adequate to support this future growth. Our need to effectively execute our growth strategy requires that we:
● manage our clinical trials effectively, including our clinical trials for LDN which will be conducted at numerous trial sites throughout the world;
● manage our internal development efforts effectively while carrying out our contractual obligations to licensors, contractors, collaborators, government agencies and other third parties;
● manage operations in both regulated and unregulated businesses;
● continue to improve our operational, financial and management controls and reporting systems and procedures; and
● identify, recruit, maintain, motivate and integrate additional employees.
If we are unable to expand our managerial, operational, financial and other resources to the extent required to manage our development and commercialization activities, our business will be materially adversely affected.
We face substantial competition. Our competitors may discover, develop or commercialize products faster or more successfully than us.
The biotechnology and pharmaceutical industries are highly competitive. We face significant competition from companies in the pharmaceutical, biotechnology and other related markets that are researching and marketing products designed to address inflammatory disorders, HIV/AIDS and cancer in Emerging Markets. Established pharmaceutical companies that currently sell or are developing drugs in our markets of interest include, for example; Abbott Laboratories, Glaxo Smith Kline, Pfizer, and ViiV in the field of cancer treatment. Johnson & Johnson, Merck, Merck Serono, Takeda, Novartis, Pfizer, Reata, Sanofi-Aventis and Teva compete with us in all fields. Many or all of these established competitors are also involved in research and drug development regarding various OGF receptors. Pharmaceutical and biotechnology companies which are known to be involved in immunotherapy research and related drug development include Pfizer, Bristol-Myers Squibb, Merck, Takeda, Sanofi-Aventis, Incyte, and UCB Pharma among others.
Many of our competitors have greater name recognition and financial, manufacturing, marketing, research and drug development resources than we do. Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. Large pharmaceutical companies in particular have extensive expertise in preclinical and clinical testing and in obtaining regulatory approvals for drugs. In addition, academic institutions, government agencies, and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products or technologies. These organizations may also establish exclusive collaborative or licensing relationships with our competitors, thus giving our competitors a significant advantage. We may be unable to respond to competitive forces presently in the marketplace, which would severely impact our business.
We may be subject to costly product liability claims related to our clinical trials and drug candidates and, if we are unable to obtain adequate insurance or are required to pay for liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage, a material liability claim could adversely affect our financial condition.
Because we conduct clinical trials in Emerging Markets with human patients, we face the risk that the use of our drug candidates may result in adverse side effects to patients and to otherwise healthy volunteers in our clinical trials. We face even greater risks upon any commercialization of our drug candidates. Although we will maintain product liability insurance for clinical trials, our insurance may be insufficient to reimburse us for any expenses or losses we may suffer, and we will be required to increase our product liability insurance coverage for the advanced clinical trials that we plan to initiate. We do not know whether we will be able to continue to obtain product liability coverage and obtain expanded coverage on acceptable terms, or at all. We may not have sufficient resources to pay for any liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage. There is also a risk that third parties that we have agreed to indemnify could incur liability. An individual may bring a product liability claim against us if one of our drug candidates, products or compounded formulations cause, or is claimed to have caused, an injury or is found to be unsuitable for consumer use. Any product liability claim brought against us, with or without merit, could result in:
● withdrawal of clinical trial volunteers, investigators, patients or trial sites;
● the inability to commercialize our drug candidates;
● decreased demand for our drug candidates;
● regulatory investigations that could require costly recalls or product modifications;
● loss of revenues;
● substantial costs of litigation;
● liabilities that substantially exceed our product liability insurance, which we would then be required to pay ourselves;
● an increase in our product liability insurance rates or the inability to maintain insurance coverage in the future on acceptable terms, if at all;
● the diversion of management’s attention from our business; and
● damage to our reputation and the reputation of our products.
Our business involves the use of hazardous materials. As a result, we, including our third-party manufacturers, must comply with environmental laws and regulations, which may be expensive and restrict how we do business.
Our third-party manufacturers’ activities involve the controlled storage, use and disposal of hazardous materials, including the components of our pharmaceutical products, test samples and reagents, biological materials and other hazardous compounds. We and our manufacturers are subject to foreign laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these hazardous materials. We currently carry no insurance specifically covering environmental claims relating to the use of hazardous materials. Although we believe that our safety procedures for handling and disposing of these materials and waste products comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental injury or contamination from the use, storage, handling or disposal of hazardous materials. In the event of an accident, applicable authorities may curtail our use of these materials and/or interrupt our business operations. In addition, if an accident or environmental discharge occurs, or if we discover contamination caused by prior operations, including by prior owners and operators of properties we acquire, we could be liable for cleanup obligations, damages and fines. The substantial unexpected costs we may incur could significantly harm our financial condition and results of operations.
Future financings may adversely affect our stockholders or impose restrictions on our assets or operations, which may harm our business.
If we raise additional capital by issuing equity securities or convertible debt securities, our existing stockholders’ ownership will be diluted and the terms of any new equity securities may have preferences over our common stock. If we raise additional capital through the issuance of debt securities, the debt will have rights senior to the holders of our common stock and may contain covenants that restrict our operational flexibility or impose liens or other restrictions on our assets. In addition, the terms of future financings may restrict our ability to raise additional capital, which would delay or prevent the further development or commercialization of our drug candidates.
If we raise additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish potentially valuable rights to our current drug candidates, potential products or proprietary technologies, or grant licenses on terms that are not favorable to us. Additionally, we may consider pursuing strategic opportunity for our business and corporate structure that may make us a more attractive investment candidate. If adequate funds are not available, our ability to achieve profitability or to respond to competitive pressures would be significantly limited and we may be required to delay, significantly curtail or eliminate the development of one or more of our drug candidates.
We may be adversely affected by the current economic environment.
Our ability to attract and retain collaboration partners or customers, invest in and grow our business and meet our financial obligations depends on our operating and financial performance, which, in turn, is subject to numerous factors, including the prevailing economic conditions and financial, business and other factors beyond our control, such as the rate of unemployment, the number of uninsured persons in the United States and inflationary pressures. We cannot anticipate all the ways in which the current economic climate and financial market conditions could adversely impact our business.
We are exposed to risks associated with reduced profitability and potential financial instability of our collaboration partners or customers, many of which may be adversely affected by volatile conditions in the financial markets. For example, unemployment and underemployment, and the resultant loss of insurance, may decrease the demand for healthcare services and pharmaceuticals. If fewer patients are seeking medical care because they do not have insurance coverage, our collaboration partners or customers may experience reductions in revenues, profitability and/or cash flow that could lead them to reduce their support of our programs or financing activities. If collaboration partners or customers are not successful in generating sufficient revenue or are precluded from securing financing, they may not be able to pay, or may delay payment of, accounts receivable that are owed to us. This, in turn, could adversely affect our financial condition and liquidity. To the extent economic challenges result in fewer individuals pursuing or being able to afford our products once commercialized, our business, results of operations, financial condition and cash flows could be adversely affected.
The effect of the COVID-19 pandemic on our operations, and the operations of our users, partners and content contributors, has had, and is expected to continue to have an effect on our business, financial condition, cash flows and results of operations.
In December 2019, a novel coronavirus disease, or COVID-19, was initially reported and on March 11, 2020, the World Health Organization characterized COVID-19 as a pandemic. COVID-19 has had a widespread and detrimental effect on the global economy as a result of the continued increase in the number of cases and affected countries and actions by public health and governmental authorities, businesses, other organizations, and individuals to address the outbreak, including travel bans and restrictions, quarantines, shelter in place, stay at home or total lock-down orders and business limitations and shutdowns.
Despite recent developments of vaccines, the duration and severity of COVID-19, mutations and possible additional mutations and the degree of their impact on our business is uncertain and difficult to predict. The continued spread of the outbreak could result in one or more of the following conditions that could have a material adverse impact on our business operations and financial condition: delays in drug testing, delays due to suppliers or other aspects of our drug testing and outsourced manufacturing process. We may also face increased competition; increased risk in collectability of accounts receivable; lost or reduced productivity due to illness and/or illness of family members; inability to hire key roles; adverse effects on our strategic partners businesses; and impairment charges. Our inability to respond to and manage the potential impact of such events effectively could have a material adverse effect on our business, financial condition, and results of operations.
Our efforts to help mitigate the negative impact of the outbreak on our business may not be effective, and we may be affected by a protracted economic downturn. Furthermore, while many governmental authorities around the world have and continue to enact legislation to address the impact of COVID-19, including measures intended to mitigate some of the more severe anticipated economic effects of the virus, we may not benefit from such legislation, or such legislation may prove to be ineffective in addressing COVID-19’s impact on our and our customer’s businesses and operations. Even after the COVID-19 outbreak has subsided, we may continue to experience impacts to our business as a result of COVID-19’s global economic impact and any recession that has occurred or may occur in the future. Further, as the COVID-19 situation is unprecedented and continuously evolving, COVID-19 may also affect our operating and financial results in a manner that is not presently known to us or in a manner that we currently do not consider that may present significant risks to our operations.
In addition, the overall uncertainty regarding the economic impact of the COVID-19 pandemic and the impact on our revenue growth, could impact our cash flows from operations and liquidity. To the extent the COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section.
Our internal computer systems, or the computer systems of our contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our drug development programs.
Despite the implementation of security measures, our internal computer systems and the computer systems of our contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs. For example, the loss of clinical trial data from completed or ongoing clinical trials for any of our drug candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our drug candidates could be delayed.
Our current and future operations substantially depend on our management team and our ability to have or recruit other key personnel, the loss of any of whom could disrupt our business operations.
The Company’s future success depends on the efforts and abilities of principal members of its senior management and scientific staff to provide strategic direction, business development, operations management and maintenance of a cohesive and stable work environment. If we are unable to recruit qualified personnel, or if we lose their services or the services of any other key member of management, it could be impossible to replace them.
Additionally, the Company’s ability to maintain, expand and renew existing business with its clients and maximize potential business opportunities from new clients (in both the drug development and the drug discovery areas) depends on its ability to hire and retain scientists with necessary skills. The scientists working for the Company must have the ability to lead ahead of continuing changes and trends in drug discovery and development technologies to create the most innovative products on the market in order to remain competitive within the drug development industry. The Company faces risks, challenges and competition attracting and retaining experienced scientists and healthcare providers.
The Company’s inability to hire qualified personnel may increase the workload for both existing and new personnel. The Company may not be successful in attracting new healthcare providers, scientists and management or in retaining/motivating existing personnel. The shortage of experienced healthcare providers and scientists or other factors may lead to increased recruiting, relocation and compensation costs for the Company. Such increased costs may reduce profit margins or make hiring necessary experts (i.e. healthcare providers or scientists) impracticable. If the Company is unable to attract or retain any of its key personnel its ability to execute a competitive and profitable business plan will be adversely affected. Services and products will be less competitive if not obsolete. If competing companies introduce superior technologies that compete with the Company’s services and products, the Company may not be able to make the necessary enhancements to its services and products that will maintain a competitive position in the marketplace. The Company’s competitive position, business, revenues and financial condition will be materially and adversely affected.
Any failure by the Company to comply with existing health care and drug regulations could harm its reputation, operating results, the quality of the Company’s business strategy and the quality of the Company’s products.
The Company has not experienced any failure to comply and has not received any notice or violation of either good clinical practices, laboratory practices or good manufacturing practices. Any future failure by the Company to comply with existing health care and drug regulations could result in the termination of ongoing research and/or the disqualification of data for submission to regulatory authorities. Failure to comply with existing regulations will harm the Company’s reputation, brand name, its prospects for immediate and future work and its operating results. For example, if the Company fails to verify that informed consent is obtained from patient participants in connection with a particular clinical trial or grant deviations from the inclusion/exclusion criteria in a study protocol, the data collected from that trial could be disqualified at which point the Company may be required to conduct the trial again at no further cost to its client. Furthermore, the issuance of an FDA notice based on a finding of a material violation of good clinical practice, good laboratory practice or good manufacturing practice requirements could materially and adversely affect the Company.
Proposed and future legislation or regulation may increase the cost of the Company’s business or limit its service and product offerings.
Authorities in Emerging Markets may adopt healthcare legislation or regulations that are more burdensome than existing regulations. Possible changes in regulation could increase the Company’s expenses or limit its ability to offer some of its services or products. For example, the confidentiality of patient-specific information and the circumstances under which it may be released for inclusion in the Company’s databases or used in other aspects of business are subject to substantial government regulation. Additional legislation or regulation governing the possession, use and dissemination of medical record information or other personal health information may require the Company to implement new security measures requiring substantial expenditures or limiting the ability to offer services and products. These regulations might also increase costs by creating new privacy requirements for the Company’s business mandating additional privacy procedures for its clinical research business.
If we are unable to attract suitable and willing investigators and volunteers for clinical trials and product development, business may suffer.
Our clinical research studies rely on the accessibility and participation of physician investigators and volunteer subjects. Investigators are typically located at hospitals, clinics or other sites and supervise administration of the study drug to patients during the course of a clinical trial. Volunteer subjects generally include individuals from the locale where the studies are conducted. Our clinical research development business could be adversely affected if it is unable to attract suitable and willing investigators or volunteers on a consistent basis.
We may not obtain government approval for our products and/or uses.
The development and commercialization of pharmaceutical products are subject to extensive governmental regulation in the United States and Emerging Markets. Government approvals are required to develop, market and sell potential drug candidates. Obtaining government approval to develop, market and sell drug candidates is time-consuming and expensive. The clinical trial results for a particular drug candidate might not satisfy necessary requirements to obtain government approvals. Even if we are successful in obtaining all required approvals to market and sell a drug candidate, post-approval requirements and the failure to comply with other regulations could result in suspension or limitation of government approvals.
In connection with drug discovery activities in Emerging Markets, we and our licensors will be subject to foreign regulatory requirements governing testing, approval, manufacturing, labeling, marketing and sale of pharmaceutical products. These requirements vary with location. Even if approval has been obtained by a licensor for a product in the United States, approval in a foreign country must be obtained prior to marketing the product. The approval process in foreign countries may be more or less rigorous than the United States and the time required for approval may be longer or shorter. Clinical studies conducted outside of a specific country may not be acceptable. The approval of a pharmaceutical product in one country does not guarantee approval in another.
Even if approved, the products that we may develop and market may be later withdrawn from the market or subject to promotional limitations.
We may not be able to obtain the labeling claims necessary or desirable for the promotion of our treatments if approved. We may also be required to undertake post-marketing clinical trials. If the results of such post-marketing studies are not satisfactory or if adverse events or other safety issues arise after approval, regulatory agency in Emerging Markets may withdraw marketing authorization or may condition continued marketing on commitments from us that may be expensive and/or time consuming to complete. In addition, if we or others identify adverse side effects after any of our products are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn and reformulation of our products, additional clinical trials, changes in labeling of our products and additional marketing applications may be required. Any reformulation or labeling changes may limit the marketability of our products if approved.
We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.
From time to time we expect to consider opportunities to acquire or make investments in other technologies, products and businesses that may enhance our capabilities, complement our current products or expand the breadth of our markets or customer base. Potential and completed acquisitions and strategic investments involve numerous risks, including:
● problems assimilating the purchased technologies, products or business operations;
● issues maintaining uniform standards, procedures, controls and policies;
● unanticipated costs associated with acquisitions;
● diversion of management’s attention from our core business;
● adverse effects on existing business relationships with suppliers and customers;
● risks associated with entering new markets in which we have limited or no experience;
● potential loss of key employees of acquired businesses; and
● increased legal and accounting compliance costs.
We have no current commitments with respect to any acquisition or investment. We do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired business, product or technology into our business or retain any key personnel, suppliers or distributors. Our ability to successfully grow through acquisitions depends upon our ability to identify, negotiate, complete and integrate suitable target businesses and to obtain any necessary financing. These efforts could be expensive and time-consuming, and may disrupt our ongoing business and prevent management from focusing on our operations. If we are unable to integrate any acquired businesses, products or technologies effectively, our business, results of operations and financial condition will be materially adversely affected.
We may expend our limited resources to pursue a particular opportunity and fail to capitalize on current research and products that may be more profitable or for which there is a greater likelihood of success.
Because we have limited financial and managerial resources, we have focused on specific research programs, treatments, and products. As a result, we may forego or delay pursuit of opportunities with other products or research that later may prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial treatments or profitable market opportunities. Our spending on current and future research and development programs may not yield any commercially viable treatments.
We are subject to risks associated with our operations in Emerging Markets.
The Foreign Corrupt Practices Act (“FCPA”) and similar worldwide anti-bribery laws in non-U.S. jurisdictions generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. The FCPA also imposes accounting standards and requirements on publicly traded U.S. corporations and their foreign affiliates which are intended to prevent the diversion of corporate funds to the payment of bribes and other improper payments, and to prevent the establishment of “off books” slush funds from which such improper payments can be made. Because of the predominance of government-sponsored healthcare systems around the world, many of our customer or regulatory relationships outside of the United States are with governmental entities and are therefore subject to such anti-bribery laws. Our internal control policies and procedures may not always protect us from reckless or criminal acts committed by our employees or agents. Violations of these laws, or allegations of such violations, could disrupt our operations, involve significant management distraction and result in a material adverse effect on our business, results of operations and financial condition. We also could suffer severe penalties, including criminal and civil penalties, disgorgement and other remedial measures, including further changes or enhancements to our procedures, policies and controls, as well as potential personnel changes and disciplinary actions.
Furthermore, we are subject to the export controls and economic embargo rules and regulations of the United States, including, but not limited to, the Export Administration Regulations and trade sanctions against embargoed countries, which are administered by the Office of Foreign Assets Control within the Department of the Treasury, as well as the laws and regulations administered by the Department of Commerce. These regulations limit our ability to market, sell, distribute or otherwise transfer our products or technology to prohibited countries or persons. A determination that we have failed to comply, whether knowingly or inadvertently, may result in substantial penalties, including fines and enforcement actions and civil and/or criminal sanctions, the disgorgement of profits, the imposition of a court-appointed monitor, the denial of export privileges and/or an adverse effect on our reputation.
These and other factors may have a material adverse effect on our international operations or on our business, results of operations and financial condition generally.
Our independent auditors have expressed substantial doubt about our ability to continue as a going concern.
Due to our net losses, negative cash flow and negative working capital, in their report on our audited financial statements for the years ended December 31, 2022 and 2021, our independent auditors included an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
We have incurred substantial losses since inception. Because of these losses, we will require additional working capital to develop our business operations. We intend to raise additional working capital through private placements, public offerings, bank financing and/or advances from related parties or shareholder loans.
There are no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations. To the extent that funds generated from operations and any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or, if available, will be on terms acceptable to us. If adequate working capital is not available, we may not increase our operations.
These conditions raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might be necessary should we be unable to continue as a going concern.
Risks Related to Intellectual Property
Our inability to adequately protect our intellectual property rights could hurt business.
Our commercial success will depend in part on obtaining and maintaining intellectual property protection for our products, formulations, processes, methods and other technologies. We will only be able to protect these technologies and products from unauthorized use by third parties to the extent that our licensor maintains valid and enforceable intellectual property rights, including patents or other market exclusionary rights.
The patent positions of pharmaceutical 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 such companies’ patents has emerged to date in the United States. The general environment for pharmaceutical patents outside the United States also involves significant uncertainty. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced, or that the scope of these patent rights could provide a sufficient degree of future protection that could permit us to gain or keep our competitive advantage with respect to these products and technologies. For example, we cannot predict:
● the degree and range of protection any patents will afford us against competitors, including whether third parties will find ways to make, use, sell, offer to sell or import competitive products without infringing our patents;
● if and when patents will issue;
● whether or not others will obtain patents claiming inventions similar to those covered by our patents and patent applications; or
● whether we or our licensor will need to initiate litigation or administrative proceedings in connection with patent rights, which may be costly whether we or the licensor win or lose.
Some of the patents we have licensed may be subject to challenge and possibly invalidated or rendered unenforceable by third parties. Changes in either the patent laws or in the interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property.
In addition, others may independently develop similar or alternative products and technologies that may be outside the scope of our intellectual property. Furthermore, others may have invented technology claimed by our patents before our licensors or we did so, and they may have filed patents claiming such technology before we did so, weakening our ability to obtain and maintain patent protection for such technology. Should third parties obtain patent rights to similar products or technology, this may have an adverse effect on our business.
We may also rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. Trade secrets, however, are difficult to protect. While we believe that we will use reasonable efforts to protect our trade secrets, our own or our strategic partners’ employees, consultants, contractors or advisors may unintentionally or willfully disclose our information to competitors. We seek to protect this information, in part, through the use of non-disclosure and confidentiality agreements with employees, consultants, advisors and others. These agreements may be breached, and we may not have adequate remedies for a breach. In addition, we cannot ensure that those agreements will provide adequate protection for our trade secrets, know-how or other proprietary information or prevent their unauthorized use or disclosure.
If competitors that have greater experience and financial resources learn our trade secrets, the competitors may copy or use our trade secrets and other proprietary information in the advancement of their products, methods or technologies. If we were to prosecute a claim that a third party had illegally obtained and was using our trade secrets, it could be expensive and time consuming and the outcome could be unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets than courts in the United States. Moreover, if our competitors independently develop equivalent knowledge, we would lack any legal or contractual claim to prevent them from using such information, and our business could be harmed.
We may become subject to intellectual property suits that could cause us to incur significant costs or pay significant damages or that could prohibit us from selling its products.
The Company’s competitors also seek to obtain patents or other protection of their proprietary rights. Third parties may claim in the future that the Company’s products infringe upon their proprietary rights. To date, there have been no claims of infringement. However, in the future, intellectual property claims could force the Company to alter its existing products or withdraw them from the market or could delay the introduction of new products.
Various patents have been issued to the Company’s competitors and these competitors may assert that the Company’s products infringe their patent or other proprietary rights. If those products are found to infringe third-party intellectual property rights, the Company may be unable to maintain its sub-license to use such technology, and it could incur substantial costs to redesign its products or to defend legal actions.
The drug discovery and development industry has a history of patent and other intellectual property litigation; thus, we may be involved in costly intellectual property lawsuits.
There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. We may be subject to third party claims in the future that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages, including treble damages and attorney’s fees if we are found to be willfully infringing a third party’s patents. Further, if a patent infringement suit were brought against us, we could be forced to stop or delay research, development, manufacturing or sales of the product or drug candidate that is the subject of the suit. As a result of patent infringement claims, or in order to avoid potential claims, we may choose to seek, or be required to seek, a license from the third party and would most likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we were able to obtain a license, the rights may be nonexclusive, which would give our competitors access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or forced to redesign it, or to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms. This could harm our business significantly.
In addition to infringement claims against us, if third parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to participate in interference proceedings with the United States Patent and Trademark Office (“USPTO”) to determine the priority of invention. We may also become involved in similar opposition proceedings in the European Patent Office regarding our intellectual property rights with respect to our products and technology.
The failure to obtain or maintain patents, licensing agreements and other intellectual property could impact our ability to compete effectively.
Our success will depend, in part, on our ability to obtain and maintain patent protection for our drug candidates, preserve our trade secrets, prevent third parties from infringing upon our licenses proprietary rights and operate without infringing upon the proprietary rights of others. While the patents we license have been issued, pending patent applications we have filed may not result in issued patents or may take longer than we expect to result in issued patents. We cannot be certain that patents will be issued as a result of any of our pending applications, and we cannot be certain that any of our issued patents, whether issued pursuant to our pending applications or licensed from third parties, will give us adequate protection from competing products.
Composition of Matter patents on APIs are generally considered to be the strongest form of intellectual property protection for pharmaceutical products, as they apply without regard to any method of use. Entirely new individual chemical compounds, often referred to as new chemical entities, are typically entitled to Composition of Matter coverage. However, we cannot be certain that the current law will remain the same, or that our drug candidates will be considered novel and non-obvious by patent regulators and courts.
In addition to Composition of Matter patents and patent applications, we also have licensed Method of Use patent applications. This type of patent protects the use of the product only for the specified method. However, this type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover, even if these competitors do not actively promote their product for our targeted indication, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to the infringement of Method of Use patents, the practice is common and such infringement is difficult to prevent or prosecute.
Patent applications in the United States and most other countries are confidential for a period of time until they are published. The publication of discoveries in scientific or patent literature typically lags actual discoveries by several months or more. As a result, we cannot be certain whether the Company or another inventor were the inventors of the issued patents and applications or that the Company or another inventor were the first to conceive of the inventions covered by such patents and pending patent applications or that the Company or another inventor were the first to file patent applications covering such inventions.
Others may obtain issued patents that could prevent us from commercializing our product candidates or require us to obtain licenses requiring the payment of considerable fees or royalties in order to enable us to conduct our business. As to those patents that we have licensed, our rights depend on maintaining our obligations to the licensor under the applicable license agreement, and we may be unable to do so.
We have numerous issued patents and some patent applications pending before the USPTO. The protection may lapse before we manage to obtain commercial value from the patents, which might result in increased competition and materially affect our position in the market.
We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.
Many of our employees were previously employed at universities, biotechnology, or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper our ability to commercialize, or prevent us from commercializing our drug candidates, which could severely harm our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
Some of our intellectual property that was discovered through government funded programs may be subject to federal regulation such as “march-in” rights, certain reporting requirements, and a preference for United States industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with foreign manufacturers.
Some of our existing drug candidates, including LDN and MENK, and some of the research and development work conducted before we had licensing rights may have been funded, at least in part, by the U.S. government and therefore would be subject to certain federal regulations. Under the “march-in” provisions of the Bayh-Dole Act, the government may have the right under limited circumstances to require the patent owners to grant exclusive, partially exclusive or non-exclusive rights to third parties for intellectual property discovered through the government-funded program. The government can exercise its march-in rights if it determines that action is necessary because the patent owner fails to achieve practical application of the new invention or because action is necessary to alleviate health concerns or address the safety needs of the public. Intellectual property discovered under the government-funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. Such intellectual property is also subject to a preference for U.S. industry, which may limit our ability to contract with foreign product manufacturers for products covered by such intellectual property. We may apply for additional U.S. government funding, and it is possible that we may discover compounds or drug candidates as a result of such funding. Intellectual property under such discoveries would be subject to the applicable provisions of the Bayh-Dole Act.
Risks Related to Government Regulation
The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of some or all of our drug candidates.
The research, testing, manufacturing, labeling, approval, selling, import, export, marketing and distribution of drug products are subject to extensive regulation by regulatory authorities in the United States and other countries. Regulations differ from country to country. Neither we nor our licensor are permitted to market our drug candidates until we receive approval of an NDA from the applicable regulatory agency. Neither we nor our licensor have submitted an application for or received marketing approval for any of our drug candidates. Obtaining approval of an NDA can be a lengthy, expensive and uncertain process. In addition, failure to comply with applicable U.S. and foreign regulatory requirements may subject us to administrative or judicially imposed sanctions, including:
● warning letters;
● civil and criminal penalties;
● injunctions;
● withdrawal of approved products;
● product seizure or detention;
● product recalls;
● total or partial suspension of production; and
● refusal to approve pending NDAs or supplements to approved NDAs.
Regulatory approval of an NDA or NDA supplement is not guaranteed, and the approval process is expensive and may take several years. Regulatory agencies have substantial discretion in the approval process. Despite the time and expense exerted, failure can occur at any stage, and we could encounter problems that cause us to abandon or repeat clinical trials, or perform additional preclinical studies and clinical trials. The number of preclinical studies and clinical trials that will be required for approval varies depending on the drug candidate, the disease or condition that the drug candidate is designed to address, and the regulations applicable to any particular drug candidate. The regulatory agencies can delay, limit or deny approval of a drug candidate for many reasons, including, but not limited to, the following:
● a drug candidate may not be deemed safe or effective;
● regulatory agency officials may not find the data from preclinical studies and clinical trials sufficient;
● regulatory agencies might not approve our or our third party manufacturer’s processes or facilities; or
● regulatory agencies may change their approval policies or adopt new regulations.
If any of our drug candidates fail to demonstrate safety and efficacy in clinical trials or do not gain regulatory approval, our business and results of operations will be materially and adversely harmed.
Even if we receive regulatory approval for a drug candidate, we will be subject to ongoing regulatory obligations and continued regulatory review which may result in considerable additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.
Once regulatory approval has been granted for us to sell our products, the approved product and its manufacturer are subject to continual review by regulatory agencies. Any regulatory approval that we or our licensors or our distributors receive for our drug candidates may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for potentially costly post-marketing follow-up studies to monitor the safety and efficacy of the product. In addition, if the regulatory agencies approve any of our drug candidates, we will be subject to extensive and ongoing regulatory requirements by regulatory agencies with regard to the labeling, packaging, adverse event reporting, storage, advertising, promotion and recordkeeping for our products. In addition, manufacturers of our drug products are required to comply with current cGMP regulations which include requirements related to quality control and quality assurance as well as the corresponding maintenance of records and documentation. Further, regulatory authorities must approve these manufacturing facilities before they can be used to manufacture our drug products, and these facilities are subject to continual review and periodic inspections by the regulatory agencies for compliance with cGMP regulations. If we or a regulatory authority discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from the market or suspension of manufacturing. If we, our drug candidates or the manufacturing facilities for our drug candidates fail to comply with regulatory requirements of the regulatory agencies, we could be subject to administrative or judicially imposed sanctions, including:
● warning letters;
● civil or criminal penalties;
● injunctions;
● suspension of or withdrawal of regulatory approval;
● suspension of any ongoing clinical trials;
● voluntary or mandatory product recalls and publicity requirements;
● refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications filed by us;
● restrictions on operations, including costly new manufacturing requirements; or
● seizure or detention of our products or import bans.
The regulatory requirements and policies may change and additional government regulations may be enacted for which we may also be required to comply. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or in other countries. If we are not able to maintain regulatory compliance, we will not be permitted to market our future products and our business will suffer.
The availability of adequate third-party coverage and reimbursement for newly approved drugs is uncertain, and failure to obtain adequate coverage and reimbursement from third-party payers could impede our ability to market any future products we may develop and could limit our ability to generate revenue.
There is significant uncertainty related to the third-party payor coverage and reimbursement of newly approved drugs. The commercial success of our future products in both domestic and international markets depends on whether such third-party coverage and reimbursement is available for our future products. Governmental payers, health maintenance organizations and other third-party payers are increasingly attempting to manage their healthcare expenditures by limiting both coverage and the level of reimbursement of new drugs and, as a result, they may not cover or provide adequate reimbursement for our future products. These payers may not view our future products as cost-effective, and coverage and reimbursement may not be available to our customers or may not be sufficient to allow our future products to be marketed on a competitive basis. Third-party payers are exerting increasing influence on decisions regarding the use of, and coverage and reimbursement levels for, particular treatments. Such third-party payers are challenging the prices charged for medical products and services, and many third-party payers limit or delay coverage and reimbursement for newly approved healthcare products. In particular, third-party payers may limit the covered indications. Cost-control initiatives could cause us to decrease the price we might establish for products, which could result in lower than anticipated product revenues. If the prices for our drug candidates decrease or if governmental and other third-party payers do not provide adequate coverage or reimbursement, our prospects for revenue and profitability will suffer.
Healthcare policy changes may have a material adverse effect on us.
Our business may be affected by the efforts of government and third-party payers to contain or reduce the cost of healthcare through various means. With regard to pharmaceutical products, among other things, legislation in Emerging Markets is expected to expand and increase industry rebates for drugs covered and make changes to the coverage requirements under that legislation. This adds to the uncertainty of the legislative changes enacted, and we cannot predict the impact that legislative or regulatory proposals will have on our business, in particular our access to licensed products for sale.
If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
Even though we do not and will not control referrals of healthcare services or bill directly to government or other third-party payers, certain healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by governments and regulators where we conduct our business. The regulations that may affect our ability to operate include, without limitation:
● healthcare anti-kickback statutes in our markets, which prohibit, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for an item or service or the purchasing or ordering of a good or service, for which payment may be made under healthcare programs;
● false claims statutes, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false claims, or knowingly using false statements to obtain payment from the federal government, and which may apply to entities like us which may provide coding and billing advice to customers;
● criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; and
● statutes that govern the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert Management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.
Regulators may not accept the results of clinical trials conducted outside of the United States.
It is possible that regulators in our markets may not accept the results of our clinical trials. We would also need to ensure that trials are conducted in accordance with local legal and regulatory requirements and all applicable International Conference on Harmonization of Good Clinical Practice guidelines and any other applicable regulatory requirements for the overall conduct of the clinical investigation.
Risks Related to our Common Stock
If our chief executive officer, our other executive officers, and our directors and principal stockholders acquire significant stock ownership, they may be able to exert control over us and our significant corporate decisions. Our other stockholders will have limited ability to influence corporate actions or decisions.
This concentration of ownership may harm the value of our common stock by, among other things:
● delaying, deferring or preventing a change in control of our Company;
● impeding a merger, consolidation, takeover or other business combination involving our company; or
● causing us to enter into transactions or agreements that are not in the best interests of all stockholders
As a group, at December 31, 2023, our officers, directors and certain related parties owned a majority of the outstanding common stock of the Company. Our other stockholders will have limited ability to influence corporate actions or decisions.
We have not paid in the past and do not expect to declare or pay dividends in the foreseeable future.
We have not paid in the past and do not expect to declare or pay dividends in the foreseeable future, as we anticipate that we will invest future earnings in the development and growth of our business. Therefore, holders of our common stock will not receive any return on their investment unless they sell their securities, and holders may be unable to sell their securities on favorable terms or at all.
The price of our common stock may be volatile, and you may not be able to resell your shares.
An active and liquid trading market for our common stock may not develop or be sustainable. Shareholders may be unable to sell shares of common stock at or above their purchase price due to fluctuations in the market price of our common stock. The market price of our common stock may fluctuate significantly in response to factors, some of which are beyond our control. Factors that could cause volatility in the market price of our common stock include, but are not limited to:
● results from, and delays in, clinical trial programs relating to LDN, MENK and other drug candidates;
● announcements of regulatory approvals or disapprovals of our drug candidates including LDN and MENK or delays in any regulatory agency review or approval processes;
● failure or discontinuation of any of our research programs;
● loss of significant clients or customers;
● loss of significant strategic relationships;
● announcements relating to future collaborations or our existing collaborations;
● our failure to achieve and maintain profitability;
● changes in earnings estimates and recommendations by financial analysts;
● changes in market valuations of similar companies;
● wholesalers’ buying patterns;
● addition or termination of clinical trials or funding support;
● regulatory developments affecting our drug candidates or those of our competitors;
● the Company’s sales decrease internationally;
● variations in the level of expenses related to our drug candidates or future development programs;
● ability to secure new government contracts and allocation of our resources to or away from performing work under government contracts;
● general economic conditions in the United States and our markets;
● acquisitions and sales of new products, technologies or business;
● market conditions in the pharmaceutical, biopharmaceutical and biotechnology sectors;
● the issuance of new or changed securities analysts’ reports or recommendations regarding us, our competitors or our industry in general;
● actual and anticipated fluctuations in our quarterly operating results;
● disputes concerning our intellectual property or other proprietary rights;
● introduction of technological innovations or new products by us or our competitors;
● manufacturing issues related to our drug candidates for clinical trials or future products for commercialization;
● market acceptance of our future products;
● deviations in our operating results from the estimates of analysts;
● third party payor coverage and reimbursement policies;
● new legislation relating to the sale or pricing of pharmaceuticals;
● regulatory actions affecting us or our industry;
● product liability claims or other litigation or public concern about the safety of our drug candidates or future drugs;
● our ability to obtain and maintain necessary intellectual property licenses including, those relating to LDN, MENK and other drug candidates;
● the outcome of any future legal actions to which we are a party;
● sales of our common stock by our officers, directors or significant stockholders;
● frequent, irregular, under market, or large sales of shares of our common stock by any shareholder;
● additions or departures of key personnel; and
● external factors, including natural disasters and other crises.
In addition, the stock markets in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that has often been unrelated to the operating performance of the issuer. These broad market fluctuations may adversely affect the trading price or liquidity of our common stock. In the past, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation suits against the issuer. If any of our stockholders were to bring such a lawsuit against us, we could incur substantial costs defending the lawsuit and the attention of our management would be diverted from the operation of our business.
Future sales of our common stock or securities convertible or exchangeable for our common stock may depress our stock price.
If our existing stockholders or holders of our convertible notes, options or warrants sell, or indicate an intention to sell substantial amounts of our common stock in the public market, the trading price of our common stock could decline. The perception in the marketplace that these sales may occur could also cause the trading price of our common stock to decline.
Certain holders of shares of our common stock, warrants to purchase our common stock, and shares of common stock issuable upon exercise of warrants will be entitled to rights with respect to the registration of their shares under the Securities Act. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates. In addition, our directors may, and we expect that our executive officers will establish programmed selling plans under Rule 10b5-1 of the Exchange Act, for the purpose of effecting sales of our common stock. Any sales of securities by these stockholders, or the perception that those sales may occur, including the entry into such programmed selling plans, could have a material adverse effect on the trading price of our common stock.
If we sell shares of our common stock in future financings, common stockholders may experience immediate dilution and, as a result, our stock price may decline.
We may from time to time issue additional shares of common stock at a discount from the current trading price of our common stock. As a result, our common stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such a discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred stock or common stock.
Provisions of our charter documents or Florida law could delay or prevent an acquisition of the Company, even if the acquisition would be beneficial to our stockholders, and could make it more difficult for stockholders to change management.
Provisions of our amended and restated articles of incorporation, as amended, and amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. In addition, these provisions may frustrate or prevent any attempt by our stockholders to replace or remove our current management by making it more difficult to replace or remove our board of directors.
We do not anticipate paying any cash dividends on our capital stock in the foreseeable future, therefore capital appreciation, if any, of our common stock will be our shareholders sole source of gain for the foreseeable future.
We have never declared or paid cash dividends on our capital stock. We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. As a result, capital appreciation, if any, of the common stock will be our shareholders sole source of gain for the foreseeable future.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on our Company. If no securities or industry analysts commence coverage of our Company, the trading price for our stock would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. In addition, if our operating results fail to meet the forecast of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.
Our board of directors is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval.
Our amended and restated articles of incorporation, as amended, authorize our board of directors, without the approval of our stockholders, to issue shares of our preferred stock, subject to limitations prescribed by applicable law, rules and regulations and the provisions of our amended and restated articles of incorporation, as amended, as shares of preferred stock in series, and to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations or restrictions thereof. The powers, preferences and rights of these additional series of preferred stock may be senior to or on parity with our common stock, which may reduce its value. We do not currently have any class of preferred stock authorized.
Our shares may be subject to the “penny stock” rules, which may subject you to restrictions on marketability and limit your ability to sell your shares.
Broker-dealer practices in connection with transactions in “Penny Stocks” are regulated by certain penny stock rules adopted by the SEC. Penny stocks generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on the NASDAQ system). The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the risk associated with the penny stock market. The broker-dealer must also provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules generally require that prior to a transaction in a penny stock, the broker-dealer must make a written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to the penny stock rules. The Company’s securities may be subject to the penny stock rules, and investors may find it more difficult to sell their securities.
An active and visible trading market for our common stock may not develop.
We cannot predict whether an active market for our common stock will develop in the future. In the absence of an active trading market:
● Investors may have difficulty buying and selling or obtaining market quotations;
● Market visibility for our common stock may be limited; and
● A lack of visibility for our common stock may have a depressive effect on the market price for our common stock
Our common stock is currently quoted on the OTC Market under the trading symbol “IMUN”. The OTC Market is unorganized, inter-dealers, over-the-counter markets that provides significantly less liquidity than the New York Stock Exchange or NASDAQ. No assurances can be given that we will ever obtain a listing for our securities on a senior exchange. The trading price of our common stock is therefore expected to be subject to significant fluctuations in response to variations in quarterly operating results, changes in analysts’ earnings estimates, announcements of innovations by us or our competitors, general conditions in the industry in which we operate and other factors. These fluctuations, as well as general economic and market conditions, may have a material or adverse effect on the market price of our common stock.
We may not register or qualify our securities with any state agency pursuant to blue sky regulations.
The holders of our shares of common stock and persons who desire to purchase them in the future should be aware that there may be significant state law restrictions upon the ability of investors to resell our shares. We currently do not intend to and may not be able to qualify securities for resale in other states which require shares to be qualified before they can be resold by our shareholders.

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ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 1B. UNRESOLVED STAFF COMMENTS.
Not applicable.

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ITEM 2. PROPERTIES
ITEM 2. PROPERTIES.
Our principal office is located at 2431 Aloma Ave., Suite 124, Winter Park, Florida 32792. The monthly lease cost is approximately $75 and is cancellable upon one month’s notice.

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ITEM 3. LEGAL PROCEEDINGS
ITEM 3. LEGAL PROCEEDINGS.
From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are not currently aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.

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ITEM 4. MINE SAFETY DISCLOSURE
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
PART II

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ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market Information
Our common stock is listed for quotation on the OTCQB marketplace under the symbol BTAX. Our common stock began trading in November 1999 on OTC under the name Galliano International Ltd. In March 2012, our stock began trading under the name of TNI BioTech, Inc. under the symbol TNIB. The symbol was changed to IMUN in December 2014, concurrent with our name change to Immune Therapeutics, Inc. In October 2023, the symbol was changed to BTAX, concurrent with our name change to Biostax Corp.
The following table sets forth the high and low sales prices per share of our common stock for the periods indicated as reported by the OTC Markets Group, Inc.
Price Range
High Low
Quarter Ended:
December 31, 2023 $ 0.10 $ 0.06
September 30, 2023 $ 0.90 $ 0.07
June 30, 2023 $ 0.60 $ 0.18
March 31, 2023 $ 0.79 $ 0.37
Quarter Ended:
December 31, 2022 $ 1.50 $ 0.57
September 30, 2022 $ 2.45 $ 1.00
June 30, 2022 $ 2.85 $ 1.03
March 31, 2022 $ 2.98 $ 1.17
Record Holders
As of March 31, 2024, there were approximately 675 shareholders of record of our common stock, our only outstanding class of securities. In computing the number of holders of record of our common stock, each broker-dealer and clearing corporation holding shares on behalf of its customers is counted as a single shareholder.
Securities Authorized for Issuance under Equity Compensation Plans
The information required by this Item regarding equity compensation plans is incorporated by reference to the information set forth in Item 12. “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”
Dividend Policy
We have not declared nor paid any cash dividends on our common stock in 2023 and 2022. We currently intend to retain all available funds and any future earnings for use in the operation of our business and do not anticipate paying any cash dividends on our common stock in the foreseeable future. We may also enter into credit agreements or other borrowing arrangements in the future that will restrict our ability to declare or pay cash dividends on our common stock. Any future determination to declare dividends will be made at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements, contractual restrictions, general business conditions and other factors that our board of directors may deem relevant. There are no restrictions that currently limit our ability to pay dividends on common stock other than those generally imposed by applicable state law.
See also Item 1A “Risk Factors-Risks Related Ownership of Our Common Stock-We have not paid in the past and do not expect to declare or pay dividends in the foreseeable future.”
Recent Sales of Unregistered Securities
We did not sell any equity securities during the 2023 fiscal year that were not previously disclosed in a quarterly report on Form 10-Q or a current report on Form 8-K filed during the 2023 fiscal year.
Purchases of Equity Securities
No repurchases of our common stock were made during the year ended December 31, 2023.

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ITEM 6. SELECTED FINANCIAL DATA
ITEM 6. [RESERVED]

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis is a summary of the significant factors affecting our operating results, financial condition, liquidity and cash flows as of and for the periods presented below. The following discussion and analysis should be read in conjunction with our financial statements and the related notes thereto included elsewhere in this report. The discussion contains forward-looking statements that are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. Actual results could differ materially from those discussed in or implied by forward-looking statements as a result of various factors, including those discussed below and elsewhere in this report, particularly in the sections titled “Item 1A Risk Factors” and “Introductory Notes - Special Note Regarding Forward-Looking Statements.”
Overview
Our Company is a developer and marketer of pharmaceutical, biotechnology, and MedTech products that have a well-defined path to market. We believe that we have deep expertise and strong partnerships in the fields of autoimmunity and immune restoration and are able to deliver solutions today for people that are living with autoimmunity, chronic inflammation, infection, and cancer.
Smaller Reporting Company
To the extent that we continue to qualify as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Exchange Act, certain exemptions may continue to be available to us as a smaller reporting company, including: (i) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act; (ii) scaled executive compensation disclosures; (iii) the requirement to provide only two years of audited financial statements, instead of three years; and (iv) compliance with certain greenhouse gas emissions disclosure and related third-party assurance requirements.
Recent Developments
On January 22, 2024, the Company issued 81,086 shares of common stock to an investor as payment of accrued interest on Notes payable through December 31, 2023.
Results of Operations
The following table sets forth key components of our results of operations during the years ended December 31, 2023 and 2022, both in dollars and as a percentage of our revenues.
Year End Change
Unaudited
Amount ($) Percent (%)
Operating expenses
Selling, general, and administrative $ 1,149,257 $ 957,114 (192,143 ) (16.72 )
Research and development expense 14,236 473,528 459,292 3,226.27
Depreciation and amortization expense - 54,308 54,308 100.00
Total operating expenses 1,163,493 1,484,950 321,457 27.63
Loss from operations (1,163,493 ) (1,484,950 ) (321,457 ) 27.63
Other income (expense)
Gain on issuance of Forte license 3,165,151 - (3,165,151 ) (100.00 )
Interest expense (120,403 ) (125,607 ) (5,204 ) 4.32
Change in market value of common shares (2,645,000 ) - 2,645,000 (100.00 )
(Loss) gain on settlement of obligations and conversion of debt (1,166,418 ) (40.000 ) 1,126,418 (96.57 )
Charge from warrant modification and debt settlement (1,605,913 ) - 1,605,913 (100.00 )
Total other income (2,372,583 ) (165,607 ) 2,206,976 (93.02 )
Net (loss) income (3,536,076 ) (1,650,557 ) 1,885,519 (53.32 )
Total revenues.
We had no revenues from operations for the years ended December 31, 2023 and 2022.
Cost of sales.
As we had no revenues, we also did not have any costs or expenses related to sales for the years ended December 31, 2023 and 2022.
Selling, general, and administrative expenses.
Selling, general and administrative expense for the years ended December 31, 2023 and 2022 were as follows (dollar amounts in thousands):
Selling, general and administrative $ 957 $ 1,149
Increase (decrease) from prior year $ (192 ) $ 564
Percent increase (decrease) from prior year (17 %) 96 %
In 2023, selling, general and administrative expenses were $957 thousand, compared to $1,149 thousand for 2022, a decrease of $192 thousand or 17%. For the years ended December 31, 2023 and 2022, selling, general and administrative expenses were made up as follows (dollar amounts in thousands):
Stock listing and investor relations $ 24 $ 22
Board fees
Professional fees and consulting
Related party consulting
Rent
Payroll and benefits -
Other
$ 957 $ 1,149
During the year ended December 31, 2023, the Company has focused on executing its restructuring plan and business development activities and the negotiation and finalization of certain licensing transactions described further in “Note 8. Licensing Agreements” in the notes to the consolidated financial statements.
The increase in selling, general and administrative expenses is reflected in the increase of professional and consulting fees, and general operating expenses, offset by a reduction of payroll costs, board fees and facility costs. Professional fees and consulting costs are incurred for legal, tax and accounting services as well as expanded management headcount. The increase in the professional costs reflects the Company’s financial reorganization efforts and licensing strategies underway with Cytocom, Forte and TaiwanJ Pharmaceuticals as described in Note 8 to the financial statements. The decrease in payroll and benefits reflect accrued wages payable to the Company’s former Chief Executive Officer and wages paid to a former, part-time financial analyst.
Depreciation and amortization.
The Company incurred $54 thousand of depreciation and amortization expense in 2023, compared to no depreciation or amortization expense in 2022. This expense is wholly attributed to the amortization of the TaiwanJ license.
Research and development expenses.
In 2023, research and development expenses were $474 thousand, compared to $14 thousand for 2022, an increase of $459 thousand or 3,226%. The increase was entirely a result of amounts payable to TaiwanJ for our license to use certain intellectual property.
A summary of our research and development expenses for the years ended December 31, 2023 and 2022 were as follows (dollar amounts in thousands):
Research and development $ 474 $ 14
Increase (decrease) from prior year $ 459 $ (138 )
Percent increase (decrease) from prior year 3,226 % (91 )%
The Company recorded $14 thousand of research and development costs during the year ended December 31, 2022 reflecting fees payable to AHAR Pharma related to the renewal of Lodonol marketing authorization in Nigeria.
Our research and development programs are managed internally and have historically focused on working with individuals and universities to identify and utilize patents we have sub-licensed or acquired since our inception. We continue to seek to expand our pipeline of intellectual property by reviewing other compounds, technologies, or capabilities. The Company continues to seek and identify innovative technologies to incorporate into our intellectual property assets.
For the years ended December 31, 2023 and 2022, research and development expenses were made up as follows (dollar amounts in thousands):
Patent expenses $ 446 $ -
Professional fees
$ 474 $ 14
Total other income (expense).
We had $166 thousand in total other expenses, net, for the year ended December 31, 2023, as compared to $2,373 for the year ended December 31, 2022. Other expenses, for the year ended December 31, 2023, consisted of $126 thousand of interest expense and a $40 thousand loss on the settlement of obligations and conversion of debt. Other expenses, net, for the year ended December 31, 2022 consisted of $3,165 thousand on the gain of the issuance of the license to Forte, $120 thousand of interest expense, $2,645 thousand expense on the change in the market value of common shares, a $1,166 thousand loss on the settlement of outstanding Company obligations and conversion of debt, and a $1,605 thousand other expense on the charge from warrant modification and debt settlement.
Gain on issuance of Forte license.
In 2022, we issued a license to Forte, substantially as described in “Item 1. Business - Intellectual Property- License with Forte Animal Health, Inc.” As a part of this license, we receive periodic milestone and licensing payments. As a result, in 2022, we received a gain of $3,165,151 from payments due to our Company under this license.
Interest Expense.
Interest expense for the years ended December 31, 2023 and 2022 were as follows (dollar amounts in thousands):
Interest expense $ 125 $ 120
Increase (decrease) from prior year $ (5 ) $ (91 )
Percentage increase (decrease) from prior year 4 % (43 )%
Interest expense is comprised of interest expense and amortization of loan origination fees owed by the Company. The increase year over year reflects the increase in outstanding notes payable.
Liquidity and Capital Resources.
As of December 31, 2023, we had cash of $29,785. To date, we have financed our operations primarily through revenue generated from sales of our securities and proceeds from notes payable. We have been dependent upon financing activities as we implement our acquisition strategy.
The Company does not expect to generate significant revenues in the coming twelve months. Additional funds will be required to execute our business plan and our strategy of acquiring additional pharmaceutical products and licenses. The funds required to execute this business plan will depend on the size, capital structure and purchase price consideration that the seller of a target license acceptable in a given transaction, as well as the drug development costs in order to maintain regulatory approval for our products.
Management continues to pursue new financing sources to support the business. We may be unable to raise additional working capital to meet operating obligations and expenditures and as such may be required to modify it business plan. If the Company is unable to generate sufficient cash flows from sales, or if it does not raise additional working capital to meet all its operating obligations and expenditures, the Company may have to modify its business plan. Over the next 12 months, the Company believes it will require between $500,000 and $1,000,000 to meet its ongoing expenses and obligations.
We intend to raise capital for additional acquisitions primarily through debt financing, additional equity offerings by the Company, or by undertaking a combination of any of the above. The sale of additional equity securities could result in dilution to our stockholders. The incurrence of indebtedness would result in increased debt service obligations and could require us to agree to operating and financial covenants that would restrict our operations. Financing may not be available in amounts or on terms acceptable to us, if at all.
There is no guarantee that we will be able to acquire additional businesses under the terms outlined above or that we will be able to find additional acquisition candidates should we terminate our plans for any of our current acquisition targets.
Summary of Cash Flow
The following table provides detailed information about our net cash flow for the years ended December 31, 2023 and 2022.
Year Ended December 31,
Unaudited
Net cash used in operating activities $ (656,534 ) $ (581,821 )
Net cash used in investing activities - (500,000 )
Net cash provided by financing activities 535,828 738,427
Net change in cash (120,706 ) (343,394 )
Cash and cash equivalents at beginning of year 150,491 493,885
Cash and cash equivalents at end of year $ 29,785 $ 150,491
Our net cash used in operating activities was $656,534 for the year ended December 31, 2022, as compared to $581,821 for the year ended December 31, 2022. For the year ended December 31, 2023, our net loss of $1,650,556 and license fees payable to TaiwanJ of $253,849; offset by $300,000 from the issuance of common stock for license fees and accrual of $709,858 of related party fees payable were the primary drivers for cash used in operations.
For the year ended December 31, 2022, our net loss of $3,536,076, $2,645,000 loss on impairment on investment in common stock, loss from warrant modification of $1,605,913, loss from settlement of obligations of $1,166,418, offset by a gain on issuance on license agreement of $3,165,151 were the primary drivers for cash used in operations.
In 2023 the Company did not generate any cash from investing activities. Our net cash used in investing activities for the year ended December 31, 2023, was $500,000, related to the purchase of intangible assets from Taiwain J.
Our net cash provided by financing activities was $535,828 for the year ended December 31, 2023, as compared to $738,427 for the year ended December 31, 2022. Net cash provided by financing activities for the year ended December 31, 2023, consisted of $100,000 received from related parties and $435,828 in proceeds from the issuance of notes payable.
Net cash provided by financing activities for the year ended December 31, 2022, consisted of $6,369 received as proceeds from undocumented investor advances, $417,058 from proceeds from related parties, and $315,000 in proceeds from the issuance of notes payable.
Outstanding Debt
Promissory Notes
As of December 31, 2023, the Company had $1,183,978 in notes payable to shareholders of record.
December 31, 2023
Promissory note issued in the first quarter of 2019. The note accrues interest at 6% and matured in February 2020. This note is in default. $ 231,478
Promissory note issued in 2019 for the settlement of debt in the same amount and matured in 2021. Lender earns interest at 15%. This note was modified in November 2022, extending maturity to September 2023. This note is in default. 150,000
Promissory note issued in 2022 and matured in July 2023. Lender earns interest at 6%. This note is in default. 65,000
Promissory note issued in 2022 and matured in July 2023. Lender earns interest at 6%. The holder of the note is a former Director and the former Chief Executive Officer of the Company. This note is in default. 200,000
Promissory note issued in 2022 and matured in December 2023. The lender earns interest at 7.75%. This note is in default. 50,000
Promissory note issued in March 2023 and matured in May 2023. The lender earns interest at 8%. This note was issued to H. Louis Salomonsky, a Director of the Company. This note is in default. 100,000
Promissory note issued in March 2023 and matured in June 2023.The lender earns interest at 8%. This note is in default. 50,000
Promissory note issued in April 2023 and matured in May 2023. The lender earns interest at 18%. This note is in default. 250,000
Promissory note issued in June 2023 and matures in June 2024. The lender earns interest at 8%. 15,000
Promissory note issued in July 2023 and matures in July 2025. The lender earns interest at 8.5%. This note was issued to Global Reverb Corporation, a related party of which Noreen Griffin is the sole beneficial owner. 7,500
Promissory note issued in November 2023 and matures in August 2024. Lender earns interest at 22.0% and is convertible into shares of common stock. 65,000
$ 1,183,978
Contractual Obligations
Our principal commitments consist mostly of obligations under the loans described above, the operating leases described under Item 2, “Properties” and obligations disclosed under various licensing agreements. We do not have any purchase obligations with any suppliers.
Off-Balance Sheet Arrangements
During the twelve months ended December 31, 2023, and 2022, the Company did not engage in any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial conditions, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Critical Accounting Policies
In accordance with the reporting requirements of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 825, “Financial Instruments”, the Company calculates the fair value of its assets and liabilities which qualify as financial instruments under this standard and includes this additional information in the notes to the condensed consolidated financial statements when the fair value is different than the carrying value of those financial instruments.
Cash, cash equivalents and accounts payable are accounted for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of the Company’s investment in the common stock of STAB reflects an asset impairment charge taken in the second quarter of 2022 and is carried at zero in the accompanying condensed consolidated balance sheets. The carrying value of notes payable is approximately fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.
Use of Estimates. The preparation of the Company’s financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from such estimates.
Concentration of Credit Risk. Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. The cash accounts are insured by the Federal Deposit Insurance Corporation up to $250,000.
Segment and Geographic Information. Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making.
Fair Value of Financial Instruments. In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “Financial Instruments”, the Company calculates the fair value of its assets and liabilities which qualify as financial instruments under this standard and includes this additional information in the notes to the financial statements when the fair value is different than the carrying value of those financial instruments.
Cash, cash equivalents and accounts payable are accounted for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of the Company’s investment in the common stock of Statera is measured based on the quoted per share price as reported on NASDAQ. The carrying value of notes payable approximate fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.
Derivative Financial Instruments. FASB ASC 815, Fair Value Measurements requires bifurcation of certain embedded derivative instruments in certain debt or equity instruments, and measurement at their fair value for accounting purposes. A holder redemption feature embedded in the Company’s note payable requires bifurcation from its host instrument and is accounted for as a freestanding derivative. The Company held no derivative financial instruments at December 31, 2023.
Research and Development Costs.
Research and development costs are charged to expense as incurred and are typically comprised of expenses associated with advancing the commercialization of our technologies.
Income Taxes
The Company follows ASC Topic 740, “Income Taxes”, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.
As of December 31, 2023 and 2022, and at the date of adoption, the Company did not have a liability for unrecognized tax uncertainties. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2023 and 2022, the Company has not accrued any interest or penalties related to uncertain tax positions.
Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration
The Company measures and recognizes compensation expense for share-based awards based on estimated fair values equaling either the market value of the shares issued, or the value of consideration received, whichever is more readily determinable. Generally, the non-cash consideration pertains to services rendered by consultants and others and has been valued at the fair value of the Company’s common stock at the date of the agreement.
The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 718, “Compensation-Stock Compensation.” The measurement date for the fair value of the equity instruments issued is determined at the earlier of (i) the date at which a commitment for performance by the consultant or vendor is reached or (ii) the date at which the consultant or vendor’s performance is complete.
The Company did not grant any stock-based compensation awards during the years ended December 31, 2023 and 2022.
Net Income per Share
Basic net income per share is calculated by dividing the net income attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents.
The Company’s potentially dilutive securities which include primarily shares of common stock from the potential conversion of notes payable, have been included in the computation of diluted net income per share for the twelve-month periods ended December 31, 2023 and 2022.
Going Concern
As of December 31, 2023, the Company had $29,785 in cash on hand, negative working capital of $4,529,374 and accumulated stockholders’ deficit of $384,619,050. For the year ended December 31, 2023, the Company reported net loss attributable to common shareholders of $1,650,557.
For the year ended December 31, 2022, the Company reported net loss attributable to common shareholders of $3,536,076. Included in net income for the year ended December 31, 2022 were non-cash non-operating loss aggregating $2,252,180 as follows:
Gain on assignment of debt and liabilities $ (1,166,418 )
Issuance of Forte license 3,165,151
Change in market value of investment in STAB common shares (2,645,000 )
Loss on re-measurement of warrant FMV (1,605,913 )
$ (2,252,180 )
Historically the Company has relied on the funding of operations through private equity financings and management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval, and commercialization of its current or future product candidates as they become available and the achievement of a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources.
Working capital at December 31, 2023 is not sufficient to meet the cash requirements to fund planned operations through the next twelve months without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.
Management has been executing on its strategy to re-capitalize the Company and position it for future growth. Key steps to this process include:
● Improve the condition of the financial position and balance sheet via license arrangements and capital infusions.
● Identify and acquire late-stage assets for commercialization.
● Build out operational infrastructure to generate revenue opportunities to grow shareholder value.
There can be no guaranties that the Company will be successful in securing adequate capital to continue operations and in identifying and acquiring assets for future development.
If the Company is unable to generate sufficient revenues or secure new working capital, other alternatives strategies will be required.
Historically, the Company has been able to acquire and develop assets, spin them out and retain both an equity stake and royalties and milestone payments. In so doing, the Company has acted as an incubator for late-stage drug development. Management believes that this strategy can continue to be successful. At this time, the Company is reviewing several opportunities which it may pursue as soon as funding is available. At present no definitive actions have been taken.
Recent Accounting Standards
The Company has reviewed the accounting pronouncements issued by the FASB during the twelve months ended December 31, 2023. Applicable pronouncements will be adopted by the Company in accordance with the accounting guidance and definition. Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s consolidated financial statements.
Management does not believe there are other significant accounting pronouncements which have had or will have a material impact on the Company’s condensed consolidated financial statements.

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK.
Not applicable.

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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
The full text of our unaudited consolidated financial statements begins on page of this Annual Report on Form 10-K.

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.

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ITEM 9A. CONTROLS AND PROCEDURES
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported, within the time period specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports filed under the Exchange Act is accumulated and communicated to management, including the Chief Executive Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on the evaluation, the Chief Executive Officer has concluded that our disclosure controls and procedures are ineffective to ensure that information disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms. This determination was based on the limited accounting staff, the lack of segregation of duties and the lack of an audit committee at December 31, 2023, which creates a material weakness. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. A material weakness means there is a risk that our financial reports or other filings may contain an error or inaccuracy or not submitted timely.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting for our Company. Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal executive officer and principal financial and accounting officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, and includes those policies and procedures that:
(1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with the authorization of our management and directors; and
(3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
Our management evaluated the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this evaluation, management used the framework established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO. The COSO framework summarizes each of the components of a company’s internal control system, including (i) the control environment, (ii) risk assessment, (iii) control activities, (iv) information and communication, and (v) monitoring. Based on this evaluation, because of the Company’s limited resources and limited number of employees, and the absence of an audit committee at December 31, 2023, management concluded that, as of December 31, 2023, our internal control over financial reporting is not effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles.
All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
This annual report does not include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s independent registered public accounting firm pursuant to permanent rules of the SEC that permit the Company to provide only management’s report in this Annual Report.
Changes in Internal Control over Financial Reporting
We regularly review our system of internal control over financial reporting and make changes to our processes and systems to improve controls and increase efficiency, while ensuring that we maintain an effective internal control environment. Changes may include such activities as implementing new, more efficient systems, consolidating activities, and migrating processes.
There have been no changes in our internal control over financial reporting during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitation on the Effectiveness of Internal Control.
The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute assurances. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business but cannot assure you that such improvements will be sufficient to provide us with effective internal control over financial reporting.

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ITEM 9B. OTHER INFORMATION
ITEM 9B. OTHER INFORMATION.
None.

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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Directors and Executive Officers
Set forth below is information regarding our directors and executive officers as of the date of this report.
Name
Age
Position
Noreen Griffin
Chief Executive Officer
Clay Caperton Reynolds
Director
Roger Craig Suro
Director
Glen Farmer
Chief Financial Officer
Kelly Wilson
Chief Operating Officer
The biographies of each director below contain information regarding the person’s service as a director, business experience, director positions held currently or at any time during the last five years, and information regarding involvement in certain legal or administrative proceedings, if applicable.
Noreen Griffin. Ms. Griffin was appointed as Chief Executive officer in July 2023. From November 2022 until August 2023, Ms. Griffin servied as Vice President. From August 2020 to March 2022, Ms. Griffin has been a founder and Executive Vice President of Cytocom, Inc., a clinical-stage biopharmaceutical company and former subsidiary of the Company. Since November 2012, Ms. Griffin has been the Manager of TNI Biotech International Ltd., a subsidiary of the Company. Ms. Griffin is also a director and the Chief Executive Officer of Forte Animal Health Inc., a position which she has held since January 2021. From April 2020 to September 2020, Ms. Griffin was the Chief Executive Officer of Cytocom Inc. (later Statera BioPharma Inc.) (Nasdaq: STAB), and she served as President until March 2022. From March 2012 to September 2019, Ms. Griffin, a co-founder of the Company, was the Chief Executive Officer and a director of the Company. Ms. Griffin attended North Florida Community College from 1978 to 1980 and left prior to graduation in order to pursue full-time employment opportunities.
Clay Caperton Reynolds. Ms. Reynolds joined the board in October 2023. Ms. Reynolds began her career in the Sports Management Industry and then expanded to working with not-for-profit organizations. She was a member of the Steward School Board of Trustees from 2016 until 2022 and that included her membership on the Advancement, Governance and Executive Committees. Since 2019, she has been a member of the Bon Secours Richmond Foundation Board and its Development Committee; since 2022 she has also been a member of the Riverside School Board of Trustees, where she is the vice chair of the Development & Governance Committees; since 2022 she has been a member of the Trinity Episcopal School Board of Trustees and is the Chair of its Advancement Committee. Ms. Reynolds holds a Bachelor of Science degree in Sociology and Anthropology from Virginia Commonwealth University. We believe that Ms. Reynolds is qualified to serve on our board of directors due to her previous extensive board experience, as well as experience with non-for-profit organizations.
Roger Craig Suro. Mr. Suro joined the board in November 2023. Mr. Suro began his career in the public sector where he was Virginia’s Assistant Secretary of Health and Human Resources under Secretary Jane Woods. He later became a real estate developer with Realty Venture Groups LLC and since 2009 Mr. Suro has been a partner at Varidian LLC, a chemical manufacturer. In 2010 he co-founded CareTime LLC, a software company that supports home care agencies and he currently remains a principal there. In 2014 Mr. Suro co-founded the Tangier Island Oyster Company, a not-for-profit advocacy organization. From 2020 to 2022 he worked as a consultant at Statera Biopharma where he analyzed national legislation and policy proposals and advised the company on their potential impacts. Since 2016 he has been on the HCA Hospitals of Richmond board of directors and the HCA Division Region Market Advisory Committee. He has also been on the Pharma Doctors Hospital Board since 2022, the Greater Richmond YMCA board since 2013 and volunteers on its Property and Facilities committee. He has also been on the Steward School Board of Trustees since 2023 and the Community Board for the Blue Ridge Bank since 2018. Mr. Suro holds a Bachelor of Science degree in Business Commerce from Clemson University and an Executive Mini MBA from the University of Richmond. We believe that Mr. Suro is qualified to serve on our board of directors due to his previous extensive non-profit experience, his entrepreneurial experience, and his involvement in the medical community.
Glen Farmer. Mr. Farmer was appointed as the Chief Executive Officer in August 2022. From April 2018 to July 2022, Mr. Farmer was the Vice President and U.S. Controller at iAnthus Capital Holdings, Inc. (CSE: IAN) (OTC: ITHUF), a healthcare company. Prior to his tenure at iAnthus, Mr. Farmer was Director of Finance, Integrated Specialty Pharmacy Division of Premier, Inc. (Nasdaq: PINC) from September 2015 to April 2018. Mr. Farmer received his bachelor’s degree in accounting from the University of Maryland, and his Master of Business Administration with a concentration in finance from Mount St. Mary’s University.
Kelly Wilson. Ms. Wilson has served as the Chief Operating Officer of the Company since August 2022. Ms. Wilson served as Interim Chief Executive Officer of the Company from November 2022 through July 2023. From 2013 to April 2020, Ms. Wilson was the Company’s Chief Technology Officer. From September 2016 to April 2020, Ms. Wilson also served as the Chief Technology and Information Officer of Cytocom Inc., a clinical-stage biopharmaceutical company and former subsidiary of the Company. Since December 2020, Ms. Wilson has also served as a director for Forte Animal Health, Inc., a veterinary immunotherapy company. From August 2016 to August 2019, Ms. Wilson was the Director of Program and Project Management of Cytocom; during that time Cytocom merged with Cleveland Biolabs Inc. and became Statera Biopharma Inc. (Nasdaq: STAB). From May 2022 to July 2022, Ms. Wilson was the Chief Operating Officer of Biostax, Inc., an immunotherapy startup. Ms. Wilson is also a director of Biostax, Inc., since May 2021. Ms. Wilson graduated with honors from the University of Central Florida with a master’s degree in systems design and a bachelor’s degree in English.
Family Relationships
Ms. Kelly Wilson, Chief Operating Officer is the daughter-in-law of Ms. Noreen Griffin, the Chief Executive Officer of the Company.
Involvement in Certain Legal Proceedings
To the best of our knowledge, except as described below, none of our directors or executive officers has, during the past ten years:
● been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offences);
● had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;
● been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;
● been found by a court of competent jurisdiction in a civil action or by the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
● been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
● been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act (15 U.S.C. 78c(a)(26))), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act (7 U.S.C. 1(a)(29))), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.
Corporate Governance
Governance Structure
We presently do not have a separate Chairman of the Board who is not our Chief Executive Officer due to the vacancies on the Board at the time of this filing. In the future, the Board will appoint a separate Chairman of the Board. We believe that a separate Chairman of the Board can act as a balance to the Chief Executive Officer, who also serves as a non-independent director.
The Board’s Role in Risk Oversight
The board of directors oversees that the assets of our Company are properly safeguarded, that the appropriate financial and other controls are maintained, and that our business is conducted wisely and in compliance with applicable laws and regulations and proper governance. Included in these responsibilities is the board’s oversight of the various risks facing our Company. In this regard, our board seeks to understand and oversee critical business risks. Our board does not view risk in isolation. Risks are considered in virtually every business decision and as part of our business strategy. Our board recognizes that it is neither possible nor prudent to eliminate all risk. Indeed, purposeful and appropriate risk-taking is essential for our Company to be competitive on a global basis and to achieve its objectives.
While the board oversees risk management, Company management is charged with managing risk. Management communicates routinely with the board and individual directors on the significant risks identified and how they are being managed. Directors are free to, and indeed often do, communicate directly with senior management.
Our board administers its risk oversight function as a whole by making risk oversight a matter of collective consideration; however, much of the work is delegated to committees, which will meet regularly and report back to the full board. The audit committee oversees risks related to our financial statements, the financial reporting process, accounting and legal matters, the compensation committee evaluates the risks and rewards associated with our compensation philosophy and programs, and that the nominating and corporate governance committee evaluates risk associated with management decisions and strategic direction.
Independent Directors
The Company is not currently listed on any national securities exchange that has a requirement that the board of directors be independent. The Company does not presently have any independent directors.
Committees of the Board of Directors
In February 2014, the Board authorized the formation of and adopted charters for an audit committee, compensation committee, compliance committee, and nominating committee. As of December 31, 2023, we had not yet appointed any directors of our Board to these committees. Since their formation, the functions of these committees have been managed by the entire Board. As of the date of this information statement, no members were appointed to the audit committee, compensation committee, compliance committee, and nominating committee. The compensation committee, compliance committee and nominating committee have not yet held any meetings.
The Board held no meetings in 2023.
Code of Ethics and Business Conduct
We have adopted a code of ethics that applies to all of our directors, officers and employees, including our principal executive officer, principal financial officer and principal accounting officer. Such code of ethics addresses, among other things, honesty and ethical conduct, conflicts of interest, compliance with laws, regulations and policies, including disclosure requirements under the federal securities laws, and reporting of violations of the code.
We are required to disclose any amendment to, or waiver from, a provision of our code of ethics applicable to our principal executive officer, principal financial officer, principal accounting officer, controller, or persons performing similar functions. We intend to use our website as a method of disseminating this disclosure, as permitted by applicable SEC rules. Any such disclosure will be posted to our website within four (4) business days following the date of any such amendment to, or waiver from, a provision of our code of ethics.
Insider Trading Policy
We have not adopted an insider trading policy but plan to do so in the future.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires our directors and executive officers, and persons who own more than 10% of a registered class of our equity securities, to file with the SEC initial reports of ownership and reports of changes in ownership of common stock and other equity securities of the Company. Officers, directors and greater than 10% stockholders are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file.

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ITEM 11. EXECUTIVE COMPENSATION
ITEM 11. EXECUTIVE COMPENSATION.
Summary Compensation Table - Years Ended December 31, 2023 and 2022
The following table sets forth information concerning all cash and non-cash compensation awarded to, earned by or paid to the named persons for services rendered in all capacities during the noted periods. No other executive officers received total annual salary and bonus compensation in excess of $100,000.
Name and Principal Position Year Salary Bonus Stock Awards Option Awards All Other Compensation Total($)
Noreen Griffin, Chief Executive Officer(1) - - - - $ 111,742 111,742
Kelly Wilson, Chief Operating Officer (2) - - - - $ 285,955 $ 285,955
- - - - $ 75,217 $ 75,217
Glen Farmer, Chief Financial Officer(3) - - - - $ 155,334 155,334
$ 88,750 88,750
(1) Noreen Griffin became Chief Executive Officer in July 2023. Ms. Griffin was not a named officer in 2022. Ms. Griffin accrues compensation pursuant to a consulting agreement. As of December 31, 2023, the accrued/unpaid amount under this agreement was $111,742. No stock compensation awards were issued to Ms. Griffin in 2023.
(2) Kelly Wilson served as Interim Chief Executive Officer from November 2022 through July 2023. Ms. Wilson accrues compensation pursuant to a consulting agreement. As of December 31, 2023, the accrued/unpaid amount under this agreement was $276,538. No stock compensation awards were issued to Ms. Wilson in 2023 or 2022.
(3) Glen Farmer has served as the Chief Financial Officer in August 2022. Mr. Farmer accrues compensation pursuant to a consulting agreement. As of December 31, 2023, the accrued/unpaid amount under this agreement was $99,422. No stock compensation awards were issued to Mr. Farmer in 2023 or 2022.
Griffin Agreement
Pursuant to a consulting agreement dated August 2, 2023 (the “Griffin Agreement”), Noreen Griffin agreed to provide a minimum of 40 hours of service to the Company per week as an independent consultant in connection with her duties as the Chief Executive Officer.
Ms. Griffin will be paid a monthly fee of $20,834, and a medical insurance stipend of up to $1,200 per month. Interest on accrued and unpaid amounts will accrue at a rate of 8.5% per annum.
The initial term of the Griffin Agreement is 12 months, and it began on August 2, 2023 and will renew automatically for up to three additional one-year terms unless notice is given in writing 30 days prior to the end of each term. The Grifin Agreement may be terminated without cause by either party with 30 days’ written notice. The Griffin Agreement contains customary non-disclosure and non-disparagement provisions.
Wilson Agreement
Pursuant to a consulting agreement dated November 8, 2022 (the “Wilson Agreement”), Kelly Wilson agreed to provide a minimum of 40 hours of service to the Company per week as an independent consultant in connection with her duties as the Interim Chief Executive Officer, Interim President, and Chief Operating Officer.
Ms. Wilson will be paid an initial fee of $31,500, a monthly fee of $21,000, and a medical insurance stipend of up to $2,800 per month. Ms. Wilson may alternatively elect to receive an amount of restricted shares of common stock equal to such cash compensation as valued at the lower of (a) 25% below any current offering price, or the most recent offering price of the common stock, or (b) 50% below the Company’s current common stock value, determined by the average of the previous 30 days’ closing market prices, in lieu of cash compensation. The election to receive shares may be made 30 days before and up to 60 days after the date that such cash compensation would have been payable to Ms. Wilson.
The initial term of the Wilson Agreement is 12 months, and it began on November 1, 2022 and will renew automatically for up to three additional one-year terms unless notice is given in writing 30 days prior to the end of each term. The Wilson Agreement may be terminated without cause by either party with 30 days’ written notice. The Wilson Agreement contains customary non-disclosure and non-disparagement provisions.
On April 13, 2023 the Wilson Agreement was amended to acknowledge that Ms. Wilson was serving as Interim Chief Executive Officer.
On July 25, 2023, the Wilson agreement was amended to remove the provision to convert accrued and unpaid amounts into shares of common stock and instead accrue interest on unpaid amounts at 8.5% per annum.
Farmer Agreement
On November 1, 2022, we entered into a consulting agreement with Glen Farmer, our Chief Financial Officer. Pursuant to the terms of the consulting agreement, we agreed to pay Mr. Farmer a monthly fee of $10,500 and a monthly insurance stipend of $2,800, in return for 20 hours of weekly services. In lieu of cash compensation, Mr. Farmer may elect to receive restricted shares of the Company’s Common stock valued at whichever is lower: (a) 25% below any current offering price (or the most recent offering price if the Company is not engaged in the offering) or (b) 50% below the Company’s current common stock value as determined by the average of the previous 30 days’ closing market prices. This election can be made 30 days before, and up to 90 days after, the date such cash should have been paid to Mr. Farmer. The agreement is for a term of one year, cancelleable with 30 days written notice by either party.
On July 25, 2023, the Farmer Agreement was amended to remove the provision to convert accrued and unpaid amounts into shares of common stock and instead accrue interest on unpaid amounts at 8.5% per annum.
Employment Agreements
Currently, we have no employment agreement with any of our executive officers.
Outstanding Equity Awards at Fiscal Year-End
No executive officer named above had any unexercised options, stock that has not vested or equity incentive plan awards outstanding as of December 31, 2023.
Additional Narrative Disclosure
Retirement Benefits
We have not maintained, and do not currently maintain, a defined benefit pension plan, nonqualified deferred compensation plan or 401(k) plan.
Director Compensation
The following table sets forth information regarding the compensation earned or paid during 2023 to non-executive directors who served on the Board during the year.
Name Fees Paid or Earned in Cash ($) Stock Awards ($) Option Awards ($) Non-Equity Incentive Plan Compensation Non-Qualified Incentive Plan Compensation All Other Compen-sation ($) Total ($)
Henry Louis Salomonsky (1) $ 45,000 $ -0- $ -0- $ -0- $ -0- $ -0- $ 45,000
Clay Caperton Reynolds $ 4,000 $ -0- $ -0- $ -0- $ -0- $ -0- $ 4,000
Roger Craig Suro $ 3,000 $ -0- $ -0- $ -0- $ -0- $ -0- $ 3,000
(1) Mr. Salomonsky became a director of the Company in October 2022 and served until he passed away on August 31, 2023.
Stock Incentive Plan
On July 8, 2014, our board adopted the TNI Biotech, Inc. 2014 Stock Incentive Plan, or the 2014 Plan, which was approved by our stockholders on September 4, 2014. The following is a summary of certain significant features of the 2014 Plan.
Purposes: The purpose of the 2014 Plan is to offer selected employees, consultants, advisors and outside directors the opportunity to acquire equity in our Company.
Types of Awards: Awards that may be granted include incentive stock options as described in section 422(b) of the Code, non-qualified stock options (i.e., options that are not incentive stock options) and awards of restricted stock. These awards offer our employees, consultants, advisors and outside directors the possibility of future value, depending on the long-term price appreciation of our common stock and the award holder’s continuing service with our Company or one or more of its subsidiaries.
Eligible Recipients: Persons eligible to receive awards under the 2014 Plan will be those employees, consultants, advisors and outside directors of our Company and its subsidiaries who are selected by the Administrator.
Administration: The 2014 Plan is administered by our compensation committee, but as a compensation committee has not yet established members, by our Board. Among other things, the administrator has the authority to select persons who will receive awards, determine the types of awards and the number of shares to be covered by awards, and to establish the terms, conditions, restrictions and other provisions of awards.
Shares Available: The maximum number of shares of common stock that may be delivered to participants under the 2014 Plan is 5,000, subject to adjustment for certain corporate changes affecting the shares, such as stock splits. Shares subject to an award under the 2014 Plan for which the award is canceled, forfeited or expires again become available for grants under the 2014 Plan. Shares subject to an award that is settled in cash will not again be made available for grants under the 2014 Plan. As of the date of this report, 5,000 shares remain available for issuance under the 2014 Plan and the Company has not awarded any equity awards under the 2014 Plan.
Stock Options:
General. Subject to the provisions of the 2014 Plan, the administrator has the authority to determine all grants of stock options. That determination will include: (i) the number of shares subject to any option; (ii) the exercise price per share; (iii) the expiration date of the option; (iv) the manner, time and date of permitted exercise; (v) other restrictions, if any, on the option or the shares underlying the option; and (vi) any other terms and conditions as the administrator may determine.
Option Price. The exercise price for stock options will be determined at the time of grant. Normally, the exercise price will not be less than the fair market value on the date of grant, as determined in good faith by the administrator. As a matter of tax law, the exercise price for any incentive stock option awarded may not be less than the fair market value of the shares on the date of grant. However, incentive stock option grants to any person owning more than 10% of our voting stock must have an exercise price of not less than 110% of the fair market value on the grant date.
Exercise of Options. An option may be exercised only in accordance with the terms and conditions for the option agreement as established by the administrator at the time of the grant. The option must be exercised by notice to us, accompanied by payment of the exercise price. Payments may be made in cash or, at the option of the administrator, by actual or constructive delivery of shares of common stock to the holder of the option based upon the fair market value of the shares on the date of exercise.
Expiration or Termination. Options, if not previously exercised, will expire on the expiration date established by the administrator at the time of grant. Options will terminate before their expiration date if the holder’s service with us terminates before the expiration date. The option may remain exercisable for specified periods after certain terminations of service, including terminations as a result of death, disability or retirement, with the precise period during which the option may be exercised to be established by the administrator and reflected in the grant evidencing the award.
Incentive and Non-Qualified Options. As described elsewhere in this summary, an incentive stock option is an option that is intended to qualify under certain provisions of the Code for more favorable tax treatment than applies to non-qualified stock options. Any option that does not qualify as an incentive stock option will be a non-qualified stock option. Under the Code, certain restrictions apply to incentive stock options. For example, the exercise price for incentive stock options may not be less than the fair market value of the shares on the grant date and the term of the option may not exceed ten years. In addition, an incentive stock option may not be transferred, other than by will or the laws of descent and distribution, and is exercisable during the holder’s lifetime only by the holder. In addition, no incentive stock options may be granted to a holder that is first exercisable in a single year if that option, together with all incentive stock options previously granted to the holder that also first become exercisable in that year, relate to shares having an aggregate fair market value in excess of $100,000, measured at the grant date.
Stock Appreciation Rights: Stock appreciation rights, or SARs, which may be granted alone or in tandem with options, have an economic value similar to that of options. When an SAR for a particular number of shares is exercised, the holder receives a payment equal to the difference between the market price of the shares on the date of exercise and the exercise price of the shares under the SAR. Again, the exercise price for SARs normally is the market price of the shares on the date the SAR is granted. Under the 2014 Plan, holders of SARs may receive this payment - the appreciation value - either in cash or shares valued at the fair market value on the date of exercise. The form of payment will be determined by us.
Restricted Awards: Restricted awards are shares awarded to participants at no cost. Restricted awards can take the form of awards of restricted stock, which represent issued and outstanding shares subject to vesting criteria, or restricted stock units, which represent the right to receive shares subject to satisfaction of the vesting criteria. Restricted stock awards are forfeitable and non-transferable until the shares vest. The vesting date or dates and other conditions for vesting are established when the shares are awarded. These awards will be subject to such conditions, restrictions and contingencies as the administrator shall determine at the date of grant. Those may include requirements for continuous service and/or the achievement of specified performance goals.
Performance Awards: A performance award is an award that may be in the form of cash or shares or a combination, based on the attainment of pre-established performance goals and other conditions, restrictions and contingencies identified by the administrator.
Performance Criteria: Under the 2014 Plan, one or more performance criteria will be used by the administrator in establishing performance goals. Any one or more of the performance criteria may be used on an absolute or relative basis to measure the performance of our Company, as the administrator may deem appropriate, or as compared to the performance of a group of comparable companies, or published or special index that the administrator deems appropriate. In determining the actual size of an individual performance compensation award, the administrator may reduce or eliminate the amount of the award through the use of negative discretion if, in its sole judgment, such reduction or elimination is appropriate. The administrator shall not have the discretion to (i) grant or provide payment in respect of performance compensation awards if the performance goals have not been attained or (ii) increase a performance compensation award above the maximum amount payable under the 2014 Plan.
Other Material Provisions: Awards will be evidenced by a written agreement, in such form as may be approved by the administrator. No more than 500 shares may be issued to a single participant pursuant to stock options and stock appreciation rights in a calendar year. Re-pricing of outstanding stock awards is not permitted under the 2014 Plan. Except as otherwise determined by the administrator at the date of grant, awards will not be transferable, other than by will or the laws of descent and distribution. Prior to any award distribution, we are permitted to deduct or withhold amounts sufficient to satisfy any employee withholding tax requirements. Our board also has the authority, at any time, to discontinue the granting of awards. The board also has the authority to alter or amend the 2014 Plan or any outstanding award or may terminate the 2014 Plan as to further grants, provided that no amendment will, without the approval of our stockholders, to the extent that such approval is required by law or the rules of an applicable exchange, increase the number of shares available under the 2014 Plan, change the persons eligible for awards under the 2014 Plan, extend the time within which awards may be made, or amend the provisions of the 2014 Plan related to amendments. No amendment that would adversely affect any outstanding award made under the 2014 Plan can be made without the consent of the holder of such award. The 2014 Plan will terminate upon the earlier of the adoption of a resolution of the Board terminating the 2014 Plan, or September 3, 2024.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Security Ownership of Certain Beneficial Owners and Management
The following table and footnotes thereto sets forth certain information with respect to the beneficial ownership of our common stock as of March 28, 2024 by (i) each director and named executive officer of the Company, (ii) each person known by us to be the beneficial owner of 5% or more of its issued and outstanding shares of Common Stock, and (iii) all executive officers and directors of the Company as a group. The Company has only one class of stock, Common Stock, and each share of Common Stock is entitled to one (1) vote.
In calculating any percentage in the following table of Common Stock beneficially owned by one or more persons named therein, the following table assumes 83,295,857 shares of Common Stock issued and outstanding. Unless otherwise further indicated in the following table, the persons and entities named in the following table have sole voting and sole investment power with respect to the shares set forth opposite the shareholder’s name, subject to community property laws, where applicable. Unless as otherwise indicated in the following table and/or the footnotes thereto, the address of each person beneficially owning in excess of 5% of the outstanding Common Stock named in the following table is 2431 Aloma Ave., Suite 124, Winter Park, FL 32792:
Name and Address of Beneficial Owner Position of Beneficial Owner Title of Class Amount and Amount and Nature of Beneficial Ownership(1) Percent of Class(2)
Kelly Wilson (3) Chief Operating Officer Common Stock 15,609,698 18.7 %
Glen Farmer(4) Chief Financial Officer Common Stock 409,000 *%
Noreen Griffin(3) Chief Executive Officer Common Stock 7,947,983 9.5 %
Robert Wilson(5) Director Common Stock 3,697,447 4.42 %
Clay Caperton Reylonds Director Common Stock - *%
Roger Craig Suro Director Common Stock - *%
All executive officers and directors (5 persons)
Common Stock 39,833,028 47.57 %
Robert J. Dailey 5% Beneficial Owner Common Stock 5,640,060 6.74 %
* This executive held less than 1% of the outstanding shares of common stock as of March 28, 2024.
(1) Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Under those rules, beneficial ownership includes any shares as to which the individual has sole or shared voting power or investment power, and also any shares which the individual has the right to acquire within 60 days of March 28, 2024, through the exercise or conversion of any stock option, convertible security, warrant or other right. Except as set forth below, each of the beneficial owners listed above has direct ownership of and sole voting power and investment power with respect to the shares of our common stock.
(2) Based on 83,738,939 shares of Common Stock issued and outstanding as of February 29, 2024. For each beneficial owner above, any options exercisable within 60 days have been included in the denominator.
(3) Consists of (i) 500 shares held directly by Ms. Wilson, (ii) 1,200 warrants exercisable into shares of Common Stock held directly Ms. Wilson, (ii) 15,607,998 shares held by Murphy Advisors, Inc. (“Murphy Advisors”), of which Kelly Wilson is the sole beneficial owner.
(4) Consists of 409,000 shares of Common Stock held directly by Mr. Farmer.
(5) Consists of (i) 429 shares held directly, (ii) 4,420 warrants exercisable into shares of Common Stock held directly by Ms. Griffin, (iii) 7,939,344 shares held by Global Reverb Corporation, of whose shares Noreen Griffin is the sole beneficial owner, (iv) 2,685 shares held by the Griffin Family Trust, of whose shares Noreen Griffin is the sole beneficial owner, (v) 705 shares held by Griffin Enterprises Group LLC, of whose shares Noreen Griffin is the sole beneficial owner, and (vi) 400 shares held by IMUN For Healthy Animals LLC, of whose shares Noreen Griffin is the sole beneficial owner. Her beneficially owned shares are included in the total for all officers and directors as a group.
(6) Consists of (i) 3,696,947 shares of Common Stock held through Pixelheads Inc., of which Robert Wilson is the sole beneficial owner and (ii) 500 shares of Common Stock issuable upon the exercise of warrants.
(7) Consists of (i) 20 shares of Common Stock held directly and (ii) 12,168,880 shares of Common Stock held by H. Louis Salomonsky Revocable Trust, of which Henry Louis Salomonsky is the sole beneficial owner.
Changes in Control
We do not currently have any arrangements which if consummated may result in a change of control of our Company.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table sets forth certain information about the securities authorized for issuance under our incentive plans as of December 31, 2023.
Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and rights
(a)
Weighted-average exercise price of outstanding options, warrants and rights
(b)
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
(c)
Equity compensation plans approved by security holders - - -
Equity compensation plans not approved by security holders - - -
Total - - -
On September 4, 2014, we established the 2014 Plan. As of December 31, 2023, the maximum number of shares of common stock that may be issued pursuant to awards granted under the 2014 Plan is 5,000 shares.

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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS.
The following includes a summary of transactions since the beginning of our 2021 fiscal year, or any currently proposed transaction, in which we were or are to be a participant and the amount involved exceeded or exceeds the lesser of $120,000 or one percent of the average of our total assets at year-end for the last two completed fiscal years, and in which any related person had or will have a direct or indirect material interest (other than compensation described under Item 11 “Executive Compensation” above). We believe the terms obtained or consideration that we 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 arm’s-length transactions.
On July 5, 2022, the Company’s board of directors approved the issuance of a $200,000 convertible promissory note to Noreen Griffin, for services performed in connection with the recapitalization of the Company. This note was converted into common shares at $0.05 per share during the quarter.
Under a Settlement Agreement and Release of Claims, dated July 1, 2022, among Kelly Wilson, Robert Wilson, and Noreen Griffin (collectively, the “Employees”), Murphy Advisors, and the Company (the “July 2022 Settlement Agreement”), the Company agreed to issue a convertible note in order to settle debts due to the Employees for past due wages and out-of-pocket reimbursable expenses. The Company owed $313,164 to Ms. Wilson for past due wages earned and $52,578 for out-of-pocket reimbursable expenses as of December 31, 2020, for an aggregate amount owed of $365,742. The Company owed Ms. Griffin $1,231,787 for past due wages as of December 31, 2020. Mr. Wilson was owed $230,000 for past due wages as of December 31, 2020. Collectively, the amount owed to the Employees was $1,827,530 (the “Debt”).
Pursuant to the July 2022 Settlement Agreement, the Company agreed to issue a 6% convertible promissory note payable to Murphy Advisors, of which Kelly Wilson is the sole beneficial owner, for $1,211,366 and with other terms including those described in this paragraph (the “Murphy Note”), and the Employees agreed that the July 2022 Settlement Agreement’s agreements and covenants constituted full payment of all claims related to employment, subject to potential indemnification obligations of the Company. The July 2022 Settlement Agreement also contains a non-disparagement covenant which provides that the Company may recover 50% of compensation paid under the Settlement Agreement for violation of the covenant. The Murphy Note allowed the holder to convert the principal amount plus all accrued and unpaid interest into shares of common stock for $0.05 per share of common stock at any time prior to July 22, 2022, upon notice to the Company. All principal and interest under the Murphy Note was repayable on its maturity date, July 14, 2023, subject to the Company’s right to extend the maturity date by six months. On July 25, 2022, Murphy Advisors converted the Murphy Note into 24,227,320 shares of common stock, of which Murphy Advisors received 15,604,818 shares, Pixelheads, Inc., of whose shares Mr. Wilson is the sole beneficial owner, received 3,695,358 shares, and Global Reverb Corporation, of whose shares Ms. Griffin is the sole beneficial owner, received the remaining 4,927,144 shares. All shares issued as a result of converting the Murphy Note are required to be restricted from transfer for 12 months following the date of issuance, then subject to a lock-up leak of 5% per quarter for three out of four quarters for the following 18 months
On March 24, 2023, the Company issued a $100,000 promissory note to H. Louis Salomonsky, a Director of the Company. The note matures in 90 days and pays interest of 8%. This note is currently in default.
Director Independence
We do not have any independent directors.

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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES.
The following is a summary of the fees billed to us for professional services rendered for the fiscal years ended December 31, 2023 and 2022. Fees for the year ended December 31, 2023 and 2022 includes fees paid to Turner, Stone & Company, L.L.P., our public accounting firm performing services in connection with engagements for which independence is required.
December 31, 2023 December 31, 2022
Audit Fees $ 59,000 $ 64,157
Audited Related Fees $ - $ -
Tax Fees $ - $ -
All Other Fees $ - $ -
TOTAL $ 59,000 $ 64,157
“Audit Fees” consisted of fees billed for professional services rendered by the principal accountant for the audit of our annual financial statements and review of the financial statements included in our annual Form 10-K and quarterly Form 10-Q or services that are normally provided by the accountant in connection with statutory and regulatory filings or engagements.
“Audit-Related Fees” consisted of fees billed for assurance and related services by the principal accountant that were reasonably related to the performance of the audit or review of our financial statements and are not reported under the paragraph captioned “Audit Fees” above.
“Tax Fees” consisted of fees billed for professional services rendered by the principal accountant for tax returns preparation.
“All Other Fees” consisted of fees billed for products and services provided by the principal accountant, other than the services reported above under other captions of this Item 14.
Pre-Approval Policies and Procedures
Under the Sarbanes-Oxley Act of 2002, all audit and non-audit services performed by our auditors must be approved in advance by our board of directors to assure that such services do not impair the auditors’ independence from us. In accordance with its policies and procedures, our board of directors pre-approved the audit service performed by Turner Stone, & Company, L.L.P. for our financial statements as of and for the year ended December 31, 2023.
PART IV

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ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES.
(a) List of Documents Filed as a Part of This Report:
(1) Index to Financial Statements:
Unaudited Consolidated Balance Sheets as of December 31, 2023 and 2022
Unaudited Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022
Unaudited Consolidated Statements of Stockholders’ Deficit for the Years Ended December 31, 2023 and 2022
Unaudited Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022
Unaudited Notes to Consolidated Financial Statements
(2) Index to Financial Statement Schedules:
All schedules have been omitted because the required information is included in the financial statements or the notes thereto, or because it is not required.
(3) Index to Exhibits:
See exhibits listed under Part (b) below.
(b) Exhibits:
(b) Exhibits:
Exhibit
Description
3.1
Restated Articles of Incorporation of Resort Clubs International, Inc. (incorporated by reference to Exhibit 3.1 to Amendment No. 1 to the Registration Statement on Form 10 filed on April 22, 2013).
3.2
Articles of Amendment to Restated Articles of Incorporation filed October 27, 2014, (incorporated by reference to Exhibit 3.2 to the Quarterly Report on Form 10-Q filed on August 16, 2021).
3.3
Articles of Amendment to Articles of Incorporation for Immune Therapeutics, Inc. filed on February 6, 2020 (incorporated by reference to Exhibit 10.68 to the Quarterly Report on Form 10-Q filed on June 29, 2020).
3.4
Articles of Amendment to Articles of Incorporation for Immune Therapeutics, Inc. filed on March 12, 2020 (incorporated by reference to Exhibit 10.69 to the Quarterly Report on Form 10-Q filed on June 29, 2020).
3.7
Amended and Restated Bylaws of TNI BioTech, Inc. (incorporated by reference to Exhibit 3.2 to the Registration Statement on Form 10 filed on April 22, 2013).
10.1+
Sale and Assignment of Patent and Transfer of Technology Agreement with Nicholas Plotnikoff dated March 4, 2012 (incorporated by reference to Exhibit 10.1 to Amendment No. 6 to the Registration Statement on Form 10 filed on November 21, 2013).
10.2
Agreement with Professor Shan dated March 15, 2013 (incorporated by reference to Exhibit 10.2 to Amendment No. 6 to the Registration Statement on Form 10 filed on November 21, 2013).
10.3+
Patent License Agreement with Penn State Research Foundation dated January 18, 2012 (incorporated by reference to Exhibit 10.3 to Amendment No. 6 to the Registration Statement on Form 10 filed on November 21, 2013).
10.4
Patent License Agreement Between Immune Therapeutics, Inc. and Jacqueline Young for the intellectual property of Dr. Bernard Bihari dated as of August 13, 2012 (incorporated by reference to Amendment No. 1 to the Registration Statement on Form 10 filed on June 7, 2013).
10.5+
Intellectual Property License Agreement, dated September 30, 2022, between Immune Therapeutics, Inc. and TaiwanJ Pharmaceuticals Co. Ltd. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on October 12, 2022).
10.6*
First Amendment to Promissory Note between Immune Therapeutics, Inc. and Ira Gaines dated November 4, 2022.
10.7*
Settlement Agreement between Immune Therapeutics, Inc. and Jack Brewer dated October 23, 2022.
10.8†
Executive Consulting Agreement between Immune Therapeutics, Inc. and Kelly Wilson, dated November 1, 2022 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on November 9, 2022).
10.9†
Executive Consulting Agreement between Immune Therapeutics, Inc. and Glen Farmer, dated November 1, 2022 (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on November 9, 2022).
14.1
Code of Business Ethics and Conduct
21.1
List of Subsidiaries of the registrant
101.INS
XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Filed herewith
+ Certain confidential information contained these exhibits has been omitted in accordance with Item 6.01(b)(10) because it is both (i) not material and (ii) is the type that we treat as private or confidential because it would be competitively harmful if publicly disclosed
† Executive compensation plan or arrangement