Real-time Form 4 intelligence. Smarter insider tracking.
YoY shift: Neutral
Year-over-year tone shift - average net-tone change across Risk Factors and MD&A vs the prior 10-K. This filing is 0.09pp more bullish than last year's.
Why YoY instead of absolute: the LM lexicon has ~6.6× more negative words than positive (legal/risk-disclosure language is heavy on hedging), so every 10-K reads bearish on raw tone. Year-over-year change strips that bias and surfaces the actual shift in management's framing.
Tone shift by section
The two components the gauge averages: how Risk Factors and MD&A each shifted in net tone versus last year's 10-K. The headline above is their average, so a green needle over a soft section just means the other section carried it.
Risk Factors
+0.00pp
Flat
Net-tone change vs last year's 10-K.
MD&A
+0.18pp
Flat
Net-tone change vs last year's 10-K.
Per-snippet highlights
Sentence-level sentiment highlighting with category and subcategory filters is coming once the snippet-scoring pipeline lands. For now, dig into the actual section text on the Sections tab.
Language change vs prior 10-K
Risk Factors (Item 1A) - words with the biggest YoY frequency increase
Negative rising
negatively+1
unable+1
Positive rising
achieve+1
Risk Factors (Item 1A)
3,596 words
Item 1A. Risk Factors
You should carefully consider the risks described below regarding our operations, financial condition, financing, our common stock and other matters. If any of the following or other material risks actually occur, our business, financial condition, or results or operations could be materially adversely affected.
We have identified material in our internal control over financial reporting, which could affect our financial condition, access to capital, and the market price of our common stock
Language change vs prior 10-K
MD&A (Item 7) - words with the biggest YoY frequency increase
Negative rising
losses+1
unfavorable+1
Positive rising
gain+2
MD&A (Item 7)
3,840 words
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation
Critical Accounting Policies and Estimates
In preparing the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP), we have adopted various accounting policies. Our most significant accounting policies are in Note 1 to the consolidated financial statements.
We have identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. These control deficiencies increase the risk that errors in our financial reporting may occur and remain undetected.
The existence of material weaknesses may also negatively affect our business in other ways. Investors and potential financing sources may view the presence of material weaknesses as increasing the risk of inaccurate financial reporting, which can reduce their willingness to invest in our securities or extend credit on favorable terms. As a result, our ability to raise capital, obtain debt financing, or maintain existing financing arrangements could be adversely affected. In addition, the perception of weak internal controls may negatively impact the market price of our common stock and investor confidence in our Company.
Our ability to continue as a going concern is in doubt absent obtaining adequate new debt or equity financing and achieving sufficient sales levels.
We incurred net losses of $2,047,392 and $1,285,663 for the years ended December 31, 2025 and 2024, respectively. We incurred net operating losses of $1,462,338 and $878,421 for the years ended December 31, 2025 and 2024, respectively. We anticipate that these operating losses will continue for the foreseeable future. We have a significant working capital deficiency, and have not reached a profitable level of operations, which raises substantial doubt about our ability to continue as a going concern. Our continued existence is dependent upon our achieving sufficient sales levels of our Nyloxin and Pet Pain Away products and obtaining adequate financing. Unless we can begin to generate material revenue, we may not be able to remain in business. We cannot assure you that we will raise enough money or generate sufficient sales to meet our future working capital needs.
We have a limited revenue producing history with significant losses and expect losses to continue for the foreseeable future.
We incurred net losses of $2,047,392 and $1,285,663 for the years ended December 31, 2025 and 2024, respectively. We incurred net operating losses of $1,462,338 and $878,421 for the years ended December 31, 2025 and 2024, respectively. As a result, at December 31, 2025, we had an accumulated deficit of $78,278,529. Our revenues have been insufficient to sustain our operations and we expect our revenues will be insufficient to sustain our operations for the foreseeable future. Our potential profitability will require the successful commercialization of our Nyloxin and Pet Pain-Away products; or a potential licensing of our therapies under development.
We will require additional financing to sustain our operations and without it will be unable to continue operations.
At December 31, 2025, we had a working capital deficit of $16,813,637. Our recurring losses from operations and working capital deficiency raise substantial doubt about our ability to continue as a going concern. We have a negative cash flow from operations of approximately $1.16 million and $0.42 million for the years ended December 31, 2025 and 2024, respectively. We have insufficient financial resources to fund our operations.
We have a history of failed distributors, which has negatively affected our revenues and may continue to do so if we fail to locate a successful distributor.
Due to poor performance, we cancelled our distribution agreement with our Cobroxin distributor, XenaCare in April 2011. We plan to re-launch Cobroxin, but we have not yet ordered product or provided planned sales. To date, we have only limited sales of Nyloxin and Pet Pain-Away through outside distributors. If we fail to improve our own marketing and distribution or fail to find a competent outside distributor our operations and financial condition will be negatively affected.
If we cannot sell a sufficient volume of our products, we will be unable to continue in business.
From October 2009 until December 31, 2025, our operations centered on the marketing of Cobroxin (our discontinued product), Nyloxin and Nyloxin Extra Strength. In December of 2014, we launched Pet Pain-Away and began actively marketing the product. In May of 2022, we began producing products for Avini Health Corporation. Avini Health distributes wellness and nutritional products through their network of independent distributors in the United States, Canada and the US Virgin Islands. The products that we provide for Avini Health include private label versions of our Nyloxin products and are sold as: Avini Plus Relief oral spray, Avini Plus Relief topical gel, Avini Plus Relief roll-on, and Avini Plus Relief for Pets. We also provided the following products: a dietary fiber blend sold as Avini Plus Fiber, a micronized and activated colloidal suspension of zeolite that is sold as Cell Defender, a mushroom and zeolite blend sold in capsules as ZMUNITY, and a caffeine adaptogenic 2oz energy shot sold as Avini Plus Energy. During fiscal year 2024, we earned revenues of $392,150, $77,217 of it was from sales of Nyloxin and $52,750 of it was from sales of Pet Pain-Away, $116,342 of it was from sales of private label clients, and $145,841 of it was from sales to Avini of products manufactured by the Company, including both Nutra-branded products and Avini-branded products. If we cannot achieve sufficient sales levels of our Nyloxin and Pet Pain-Away products, or if we are unable to secure financing, our operations will be negatively affected. During fiscal year 2025, we earned revenues of $385,307, $58,309 of it was from sales of Nyloxin and $55,185 of it was from sales of Pet Pain-Away, $144,118 of it was from sales of private label clients, and $127,695 of it was from sales to Avini of products manufactured by the Company, including both Nutra-branded products and Avini-branded products. If we cannot achieve sufficient sales levels of our Nyloxin and Pet Pain-Away products, or if we are unable to secure financing, our operations will be negatively affected.
We have a limited history of generating revenues on which to evaluate our potential for future success and to determine if we will be able to execute our business plan; accordingly, it is difficult to evaluate our future prospects and the risk of success or failure of our business.
You must consider our business and prospects in light of the risks and difficulties we will encounter as an early-stage revenue producing company. These risks include:
our ability to effectively and efficiently market and distribute our products;
our ability to obtain market acceptance of our current products and future products that may be developed by us; and
our ability to sell our products at competitive prices which exceed our per unit costs.
We may be unable to address these risks and difficulties, which could materially and adversely affect our revenue, operating results and our ability to continue to operate our business.
Our growth strategy reflected in our business plan may be unachievable or may not result in profitability.
We may be unable to implement our growth strategy reflected in our business plan rapidly enough for us to achieveprofitability. Our growth strategy is dependent on a number of factors, including market acceptance of our Nyloxin and Pet Pain-Away products and the acceptance by the public of using these products as pain relievers. We cannot assure you that our products will be purchased in amounts sufficient to attainprofitability.
Among other things, our efforts to expand our sales of Nyloxin and Pet Pain-Away will be adversely affected if:
we are unable to attract sufficient customers to the products we offer in light of the price and other terms required in order for us to attain the level of profitability that will enable us to continue to pursue our growth strategy;
adequate penetration of new markets at reasonable cost becomes impossible limiting the future demand for our products below the level assumed by our business plan;
we are unable to scale up manufacturing to meet product demand, which would negatively affect our revenues and brand name recognition;
we are unable to meet regulatory requirements in the intellectual marketplace that would otherwise allow us for wider distribution; and
we are unable to meet FDA regulatory requirements that would potentially expand our product base and potential revenues.
If we cannot manage our growth effectively, we may not become profitable.
Businesses, which grow rapidly often, have difficulty managing their growth. If we grow rapidly, we will need to expand our management by recruiting and employing experienced executives and key employees capable of providing the necessary support. We cannot assure you that our management will be able to manage our growth effectively or successfully.
Among other things, implementation of our growth strategy would be adversely affected if we were not able to attract sufficient customers to the products and services we offer or plan to offer in light of the price and other terms required in order for us to attain the necessary profitability.
If we are unable to protect our proprietary technology, our business could be harmed.
Our intellectual property, including patents, is our key asset. We currently have 3 active patents and several more in the application process. Competitors may be able to design around our patents for our Cobroxin, Nyloxin and Pet Pain-Away products and compete effectively with us. The cost to prosecuteinfringements of our intellectual property or the cost to defend our products against patent infringement or other intellectual property litigation by others could be substantial. We cannot assure you that:
pending and future patent applications will result in issued patents,
patents licensed by us will not be challenged by competitors,
our patents, licensed and other proprietary rights from third parties will not result in costlylitigation;
pending and future patent applications will result in issued patents,
the patents or our other intellectual property will be found to be valid or sufficiently broad to protect these technologies or provide us with a competitive advantage,
if we are sued for patent infringement, whether we will have sufficient funds to defend our patents, and
we will be successful in defendingagainst future patent infringementclaims asserted against our products.
Should any risks pertaining to the foregoing occur, our brand name reputation, results of operation and revenues will be negatively affected.
We are subject to substantial FDA regulations pertaining to Nyloxin and Pet Pain-Away, which may increase our costs or otherwise adversely affect our operations.
Our Nyloxin and Pet Pain-Away products are subject to FDA regulations, including manufacturing and labeling, approval of ingredients, advertising and other claims made regarding Nyloxin and Pet Pain-Away, and product ingredients disclosure. If we fail to comply with current or future regulations, the FDA could force us to stop selling Nyloxin and Pet Pain-Away or require us to incur substantial costs from adopting measures to maintain FDA compliance.
The inability to provide scientific proof for product claims may adversely affect our sales.
The marketing of Nyloxin and Pet Pain-Away involves claims that they assist in reducing Stage 2 chronic pain, while Nyloxin Extra Strength and Nyloxin Military Strength involves claims that they assist in reducing Stage 3 chronic pain. The marketing of Pet Pain-Away involves claims that they assist in relieving pain in dogs and cats. Under FDA and Federal Trade Commission (“FTC”) rules, we are required to have adequate data to support any claims we make concerning Nyloxin and Pet Pain-Away. We have scientific data for our Nyloxin and Pet Pain-Away product claims; however, we cannot be certain that these scientific data will be deemed acceptable to the FDA or FTC. If the FDA or FTC requests supporting information and we are unable to provide support that it finds acceptable, the FDA or FTC could force us to stop making the claims in question or restrict us from selling the products.
None of our ethical drug candidates have received FDA approval.
Our non-homeopathic or ethical products require a complex and costly FDA regulation process that takes several years for drug approval, if ever. None of the drug applications we have submitted to the FDA have received FDA approval. If we do not receive FDA approval for our drug applications, our operations and financial condition will be negatively affected.
If we are unable to secure sufficient cobra venom from available suppliers, our operating results will be negatively affected.
We secure cobra venom on an as-needed basis. If we do not have an available supplier to fill customer orders, there will be distribution delays and/or our failure to fulfill purchase orders, either of which will negatively affect our brand name reputation and operating results.
Our Nyloxin and Pet Pain-Away products may be unable to compete against our competitors in the pain relief market.
The pain relief market is highly competitive. We compete with companies that have already achieved product acceptance and brand recognition, including multi-billion dollar private label manufacturers and more established pharmaceutical and health products companies, or low cost generic drug manufacturers. As a result, many of our competitors have significantly greater financial strength, technical expertise, production capacity, and marketing reach than we do. Additionally, if consumers prefer our competitors’ products, or if these products have better safety, efficacy, or pricing characteristics, our results could be negatively impacted. If we fail to develop and actualize strategies to compete against our competitors we may fail to compete effectively, which will negatively affect our operations and operating results.
If we incur costs resulting from product liability claims, our operating results will be negatively affected.
If we become subject to product liability claims for Nyloxin and Pet Pain-Away that exceed our product liability policy limits, we may be subject to substantial litigation costs or judgments against us, which will negatively impact upon our financial and operating results.
Loss of any of our key personnel could have a material adverse effect on our operations and financial results.
We are dependent upon a limited number of our employees: (a) our Chief Executive Officer; (b) our Operations Manager who directs our operations and (c) our Chief Scientific Officer who conducts our research and development activities. Our success depends on the continued services of our senior management and key research and development employees as well as our ability to attract additional members to our management and research and development teams. The unexpectedloss of the services of any of our management or other key personnel could have a material adverse effect upon our operations and financial results.
We may be unable to maintain and expand our business if we are not able to retain, hire and integrate key management and operating personnel.
Our success depends in large part on the continued services and efforts of key management personnel. Competition for such employees is intense and the process of locating key personnel with the combination of skills and attributes required to execute our business strategies may be lengthy. The loss of key personnel could have a material adverse impact on our ability to execute our business objectives. We do not have any key man life insurance on the lives of any of our executive officers .
Cybersecurity Risk Management, Strategy, and Governance
The Company maintains processes designed to assess, identify, and manage material risks from cybersecurity threats, including routine system monitoring, access controls, data backup procedures, and periodic evaluation of system vulnerabilities. Cybersecurity risks are considered as part of the Company’s overall risk management framework, including risks associated with third-party service providers. Management is responsible for the day-to-day oversight of cybersecurity risk management, and the Board of Directors provides oversight as part of its general risk oversight responsibilities. To date, the Company has not experienced any cybersecurity incidents that have materially affected the Company’s business, results of operations, or financial condition; however, no assurance can be provided that such incidents will not occur in the future.
Risks Related to Our Common Stock
Because the market for our common stock is limited, persons who purchase our common stock may not be able to resell their shares at or above the purchase price paid by them.
Our common stock is presently on the OTC Market Group’s Expert Market, which means that the Company’s common stock is not eligible for proprietary broker-dealer quotes. There is currently only a limited public market for our common stock. We cannot assure you that an active public market for our common stock will develop or be sustained in the future. If an active market for our common stock does not develop or is not sustained, the price may decline.
Because we are subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our common stock, which adversely affects its liquidity and market price.
The SEC has adopted regulations, which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. The market price of our common stock on the OTC has been substantially less than $5.00 per share and therefore we are currently considered a “penny stock” according to SEC rules. This designation requires any broker-dealer selling these securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules limit the ability of broker-dealers to solicit purchases of our common stock and therefore reduce the liquidity of the public market for our shares.
Because the majority of our outstanding shares are freely tradable, sales of these shares could cause the market price of our common stock to drop significantly, even if our business is performing well.
As of December 31, 2025, we had 109,150,000 outstanding shares that were subject to the limitations of Rule 144 under the Securities Act of 1933. In general, Rule 144 provides that any non-affiliates, who have held restricted common stock for at least six-months, are entitled to sell their restricted stock freely, provided that we stay current in our SEC filings. After one year, a non-affiliate may sell without any restrictions.
An affiliate may sell after one year with the following restrictions: (i) we are current in our filings, (ii) certain manner of sale provisions, (iii) filing of Form 144, and (iv) volume limitations limiting the sale of shares within any three-month period to a number of shares that does not exceed 1% of the total number of outstanding shares. A person who has ceased to be an affiliate at least three months immediately preceding the sale and who has owned such shares of common stock for at least one year is entitled to sell the shares under Rule 144 without regard to any of the limitations described above.
An investment in our common stock may be diluted in the future as a result of the issuance of additional securities or the exercise of options or warrants.
In order to raise additional capital to fund our strategic plan, we may issue additional shares of common stock or securities convertible, exchangeable or exercisable into common stock from time to time, which could result in substantial dilution to any person who purchases our common stock. Because we have a negative net tangible book value, purchasers will suffer substantial dilution. We cannot assure you that we will be successful in raising funds from the sale of common stock or other equity securities.
Since we intend to retain any earnings for development of our business for the foreseeable future, you will likely not receive any dividends for the foreseeable future.
We have not and do not intend to pay any dividends in the foreseeable future, as we intend to retain any earnings for development and expansion of our business operations. As a result, you will not receive any dividends on your investment for an indefinite period of time.
Due to factors beyond our control, our stock price may continue to be volatile.
The market price of our common stock has been and is expected to be highly volatile. Any of the following factors could affect the market price of our common stock:
our failure to generate revenue,
our failure to achieve and maintain profitability,
short selling activities,
the sale of a large amount of common stock by our shareholders including those who invested prior to commencement of trading,
actual or anticipated variations in our quarterly results of operations,
announcements by us or our competitors of significant contracts, new products, acquisitions, commercial relationships, joint ventures or capital commitments,
the loss of major customers or product or component suppliers,
the loss of significant business relationships,
our failure to meet financial analysts’ performance expectations,
changes in earnings estimates and recommendations by financial analysts, or
changes in market valuations of similar companies.
In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A securities class action suit against us could result in substantial costs and divert our management’s time and attention, which would otherwise be used to benefit our business.
disclosed
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Our estimates and assumptions, including those related to the ability to continue as a going concern, the recoverability of inventory and long-lived assets, the fair value of stock-based compensation, the fair value of debt, the fair value of derivative liabilities, recognition of loss contingencies and deferred tax valuation allowances are updated as appropriate, which in most cases is at least quarterly. We base our estimates on historical experience, or various assumptions that are believed to be reasonable under the circumstances and the results form the basis for making judgments about the reported values of assets, liabilities, revenues and expenses. Actual results may materially differ from these estimates.
We believe that our critical accounting policies and estimates include our ability to continue as a going concern, revenue recognition, accounts receivable and allowance for doubtful accounts, inventory obsolescence, accounting for long–lived assets and accounting for stock based compensation.
Ability to Continue as a Going Concern: Our ability to continue as a going concern is contingent upon our ability to secure additional financing, increase ownership equity, and attainprofitable operations. In addition, our ability to continue as a going concern must be considered in light of the problems, expenses and complications frequently encountered in established markets and the competitive environment in which we operate.
Revenue Recognition: The Company accounts for revenue from contracts with customers in accordance with Financial Accounting Standard Board (“FASB”) Accounting Standard Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC Topic 606, revenue recognition has a five-step process: a) Determine whether a contract exists; b) Identify the performance obligations; c) Determine the transaction price; d) Allocate the transaction price; and e) Recognize revenue when (or as) performance obligations are satisfied.
Our revenues are primarily derived from customer orders for the purchase of our products. We recognize revenues as performance obligations are fulfilled upon shipment of products. We record revenues net of promotions and discounts. For certain product sales to a distributor, we record revenue including a portion of the cash proceeds that is remitted back to the distributor.
Accounts Receivable and Allowance for Credit Losses: We grant credit without collateral to our customers based on our evaluation of a particular customer’s credit worthiness. Accounts receivable are due 30 days after the issuance of the invoice. In addition, the Company maintains an allowance for credit losses to reflect the current expected credit losses (“CECL”) over the contractual life of the receivables. Accounts receivable are written off after collection efforts have been deemed to be unsuccessful. Accounts written off as uncollectible are deducted from the allowance for doubtful accounts, while subsequent recoveries are netted against the provision for doubtful accounts expense. We generally do not charge interest on accounts receivable. We use third party payment processors and are required to maintain reserve balances, which are included in accounts receivable.
Our accounts receivable are stated at estimated net realizable value. Accounts receivable are comprised of balances due from customers and third party payment processors, net of estimated allowances for uncollectible accounts. In determining collectability, historical trends are evaluated and specific customer issues are reviewed to arrive at appropriate allowances.
Inventory Obsolescence: Inventories are valued at the lower of cost or net realizable value. We periodically perform an evaluation of inventory for excess, impairments and obsolete items. At December 31, 2025, our inventory consisted entirely of raw materials and finished goods that are utilized in the manufacturing of finished goods. These raw materials generally have expiration dates in excess of 10 years. Commencing on October 1, 2019, we classify inventory as short-term or long-term inventory based on timing of when it is expected to be consumed.
Long-Lived Assets: The carrying value of long-lived assets is reviewed annually and when events or changes in circumstances may suggest impairment has occurred. If indicators of impairment are present, we determine whether the sum of the estimated undiscounted future cash flows attributable to the long-lived asset in question is less than its carrying amount. If less, we measure the amount of the impairment based on the amount that the carrying value of the impaired asset exceeds the discounted cash flows expected to result from the use and eventual disposal of the impaired assets.
Derivative Financial Instrument: Management evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported as charges or credits to income. For option-based simple derivative financial instruments, the Company uses the Black-Scholes option-pricing model to value the derivative instruments at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
We do not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks.
Convertible Debt: The Company adheres to ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) . The update eliminates certain separation models, including the beneficial conversion feature and cash conversion models, so convertible instruments issued after adoption are generally accounted for as a single liability or equity instrument, unless a conversion feature requires separate derivative accounting under ASC 815. ASU 2020-06 also amends diluted EPS guidance.
The Fair Value Measurement Option: We have elected the fair value measurement option for convertible debt with embedded derivatives that require bifurcation, and record the entire hybrid financing instrument at fair value under the guidance of ASC Topic 815, Derivatives and Hedging (“ASC Topic 815”). The Company reports interest expense, including accrued interest, related to this convertible debt under the fair value option, within the change in fair value of convertible notes and derivatives in the accompanying consolidated statements of operations.
Derivative Accounting for Convertible Debt: The Company evaluated the terms and conditions of the convertible debt under the guidance of ASC 815, Derivatives and Hedging . The conversion terms of some of the convertible notes are variable based on certain factors, such as the future price of the Company’s common stock. The number of shares of common stock to be issued is based on the future price of the Company’s common stock. The number of shares of common stock issuable upon conversion of the debt is indeterminate. Due to the fact that the number of shares of common stock issuable could exceed the Company’s authorized share limit, the equity environment is tainted, and all additional convertible debt is included in the value of the derivative liabilities. Pursuant to ASC 815-15, Embedded Derivatives , the fair value of the convertible debt and shares to be issued were recorded as derivative liabilities on the issuance date and revalued at each reporting period.
Share-Based Compensation: We record share-based compensation in accordance with FASB ASC 718, Stock Compensation . FASB ASC 718 requires that the cost resulting from all share-based transactions are recorded in the financial statements over the respective service periods. It establishes fair value as the measurement objective in accounting for share-based payment arrangements and requires all entities to apply a fair-value-based measurement in accounting for share-based payment transactions with employees. FASB ASC 718 also establishes fair value as the measurement objective for transactions in which an entity acquires goods or services from non-employees in share-based payment transactions.
Accomplishments during 2025 & Subsequent Accomplishments
In October of 2025, we expanded our online efforts to include marketing and social media consultants to expand sales of Nyloxin and Pet Pain-Away. This has led to a bigger footprint on Amazon as well as the placement of Pet Pain-Away on Chewy, the largest online pet site.
Throughout 2025, we have worked with our auditors and consultants to bring the Company’s financial reporting up to date. That allowed us to file seven reports in 2025 (The annual report for 2022, all reports for 2023 as well as the first two quarters of 2024. To date, we have filed an additional five reports in 2026 (3 rd quarter and annual report for 2024 as well as the first three quarters of 2025).
Results of Operations
Status of Operations
In November 2014, we announced the recertification of our laboratory facility as the first step in re-engaging our drug development activities. In September 2015, we received Orphan designation from the FDA for our lead drug candidate, RPI-78M for the treatment of Pediatric Multiple Sclerosis. This will allow us to shorten the timeline on clinical studies and may allow an eventual Fast Track through the approval process. We are currently working with our consultants to prepare a pre-IND meeting with the FDA in order to gain approval of a protocol for a Phase I/II clinical study in Pediatric MS. Our goal is to begin the study in late 2026.
We estimate that we will require approximately $1,500,000 to fund our existing operations over the next twelve months. These costs include: (i) compensation for seven (7) full-time employees; (ii) compensation for various consultants who we deem critical to our business; (iii) product liability insurance; and (iv) outside legal and accounting services. These costs reflected in (i) – (iv) do not include research and development costs or other costs associated with clinical studies.
We began generating revenues from the sale of Cobroxin in the fourth quarter of 2009 and from the sale of Nyloxin and Nyloxin Extra Strength in January of 2011. We began sales of Pet Pain-Away in December 2014. We began selling private label versions of our OTC products in 2021. While sales have increased year over year, they have been limited and inconsistent. Our ability to meet our future operating expenses is highly dependent on the amount of such future revenues. If future revenues from the sale of our private label products, Nyloxin and Pet Pain-Away are insufficient to cover our operating expenses we may need to raise additional equity capital, which could result in substantial dilution to existing shareholders. There can be no assurance that we will be able to raise sufficient equity capital to fund our working capital requirements on terms acceptable to us, or at all. We may also seek additional loans from our officers and directors; however, there can be no assurance that we will be successful in securing such additional loans.
Comparison of Years Ended December 31, 2025 and 2024
Net sales to unrelated customers were $257,612 for the year ended December 31, 2025, compared to $246,309 for the year ended December 31, 2024, representing an increase of $11,303, or approximately 4.59%. The increase was primarily driven by growth in private label customers and higher order volumes during 2025.
Net sales to a related party were $127,695 for the year ended December 31, 2025, compared to $145,841 for the year ended December 31, 2024, representing a decrease of $18,146, or approximately 12.44%. The decrease was primarily attributable to reduced sales volume and pricing during the current year compared to the prior-year period.
Cost of sales for the year ended December 31, 2025 is $183,679 compared to $84,827 for the year ended December 31, 2024. Our cost of sales includes the direct costs associated with manufacturing, shipping, handling costs, and inventory quality control personnel salaries. Our gross profit margin for the year ended December 31, 2025 is $196,628 or 51.03% compared to $247,323 or 63.07% for the year ended December 31, 2024. This gross margin includes reserves of $5,000 in the current year and $60,000 in the prior-year quarter for undelivered venom and slow-moving inventory. Excluding the reserve, gross margin for the current year would be 52.36% compared to 78.37% for the prior-year period, with the variance primarily attributable to the addition of inventory quality control personnel costs, higher manufacturing costs related to private label product sales to unrelated parties, as well as pricing changes in related party sales.
Operating expenses increased by $533,222, or 47.37%, from $1,125,744 for the year ended December 31, 2024 to $1,658,966 for the year ended December 31, 2025. The increase was primarily attributable to a $52,800 increase in the allowance for credit losses recorded during 2025, higher consulting fees related to general business advisory services, increased payroll and compensation-related expenses associated with expanded operational activities, and professional fees incurred in connection with the Company’s resumption of SEC filing activities, partially offset by a decrease in legal fees following the settlement of the SEC lawsuit. Consulting fees increased by approximately $154,000, payroll increased by approximately $75,000, and professional fees increased by approximately $367,000, partially offset by a decrease in legal fees of approximately $130,000, among other changes.
Other income was $58,750 and $103,450 for the years ended December 31, 2025 and 2024, respectively. Amounts attributable to the amortization of debt discounts on convertible notes receivable were $3,750 and $3,450 for the years ended December 31, 2025 and 2024, respectively. $50,000 and $100,000 of other income was recognized under a short-term research and development services contract during the years ended December 31, 2025 and 2024, respectively. The remaining $5,000 relates to a one-time related-party reimbursement for shared equipment usage recognized in the second quarter of 2025.
Interest expense, including related party interest expense, increased $116,492 or 36.00%, from $323,568 for the year ended December 31, 2024 to $440,060 for the year ended December 31, 2025. This increase was primarily due to an increase in amortization of loan discounts in the year ended December 31, 2025 compared to the year ended December 31, 2024.
We carry certain of our debentures at fair value. Due to the fact that the number of shares of common stock issuable could exceed the Company’s authorized share limit, the equity environment is tainted, and all additional convertible debt is included in the value of the derivative liabilities. For the years ended December 31, 2025 and 2024, the liability related to these hybrid instruments fluctuated, resulting in a loss of $257,270 and $220,902, respectively. Interest expense on these debentures is included in the change in fair value of convertible notes and derivatives in the accompanying consolidated statements of operations.
Gain on settlement of debts, accrued expense and vendor payable increased $19,748 or 58.46%, from a gain of $33,778 for the year ended December 31, 2024 to a gain of $53,526 for the year ended December 31, 2025. The higher gain in 2025 was primarily attributable to a debt settlement executed during the second quarter. In contrast, the gain recognized in the 2024 period primarily resulted from settlements through the issuance of common stock in the first quarter of 2024, with the amount of gain influenced by fluctuations in the Company’s stock price, as well as a gain on settlement of vendor payable recorded during the fourth quarter of 2024.
As a result of the foregoing, our net loss increased by $761,729 or 59.25%, from net loss of $1,285,663 for the year ended December 31, 2024 to a net loss of $2,047,392 for the year ended December 31, 2025.
For the year ended December 31, 2025, net cash used in operating activities was approximately $1.16 million, compared to approximately $0.42 million for the year ended December 31, 2024, representing an increase in cash used of approximately $0.74 million year over year.
The increase in cash used in operating activities was primarily attributable to less favorable changes in working capital during 2025 compared to the prior year, partially offset by higher non-cash adjustments. In 2025, working capital changes resulted in a net cash outflow of approximately $0.21 million, compared to a net cash inflow of approximately $0.39 million in 2024, reflecting a year-over-year unfavorable variance of approximately $0.18 million, largely attributable to higher consulting and professional fees. In 2025, non-cash adjustments totaled approximately $0.67 million, compared to approximately $0.47 million in 2024. The increase was primarily driven by $0.05 million of change in allowance for credit loss, $0.29 million of amortization of loan discounts, $0.26 million related to the change in fair value of convertible notes and derivatives, and $0.09 million of amortization of operating lease right-of-use assets. Additional non-cash items included $0.03 million of stock-based compensation and $0.01 million of depreciation, partially offset by a $0.05 million gain on settlement of debt and accrued expenses. Collectively, these factors led to higher cash used in operating activities in 2025 compared to 2024.
For the year ended December 31, 2025, net cash used in investing activities was approximately $0.05 million, primarily consisting of $0.03 million of purchases of property and equipment and $0.03 million of advances on convertible notes receivable. Unlike the prior year, there were no repayments on convertible notes receivable in 2025.
For the year ended December 31, 2025, net cash provided by financing activities was approximately $1.19 million. Financing inflows were primarily driven by $1.05 million of proceeds from convertible notes, $0.55 million of advances from the Company’s former CEO and an entity majority controlled by him, and $0.11 million from other notes payable, partially offset by $0.29 million of repayments of other notes payable, $0.20 million of repayments of officer loans, and $0.04 million of repayments of convertible notes. Overall, financing activity in 2025 reflects a significant increase in capital raising through convertible debt compared to the prior year, which was the primary source of liquidity during 2025.
Liquidity and Capital Resources
During December 31, 2025 and 2024, respectively, we had negative cash from operations of approximately $1.16 million and $0.42 million. Our lack of cash, significant losses and working capital deficits and stockholders’ deficits raise substantial doubt about our ability to continue as a going concern. For the years ended December 31, 2025 and 2024, we have experienced net loss of $2,047,392 and a net loss of $1,285,663, respectively, and had an accumulated deficit of $78,278,529 for the period from our inception to December 31, 2025. In addition, we had working capital and stockholders’ deficits at December 31, 2025 of $16,813,637 and $16,825,306, respectively.
Our ability to continue as a going concern is contingent upon our ability to secure additional financing, increase ownership equity and attainprofitable operations. In addition, our ability to continue as a going concern must be considered in light of the problems, expenses and complications frequently encountered in established markets and the competitive environment in which we operate.
As of December 31, 2025, we had $12,181 in cash and owed approximately $5.10 million in vendor payables and accrued expenses. We currently do not have sufficient cash to sustain our operations for the next 12 months and will require additional financing or an increase in sales in order to execute our operating plan and continue as a going concern. Our plan is to continue to increase sales of our products and attempt to secure adequate funding to bridge the commercialization of our Nyloxin and Pet Pain-Away products. We cannot predict whether additional financing will be in the form of equity, debt, or another form and we may be unable to obtain the necessary additional capital on a timely basis, on acceptable terms, or at all. In the event that these financing sources do not materialize, or that we are unsuccessful in increasing our revenues and profits, we may be unable to implement our current plans for expansion, repay our obligations as they become due or continue as a going concern, any of which circumstances would have a material adverse effect on our business prospects, financial condition and results of operations.
Current operations are primarily being funded through a combination of product sales, promissory notes and convertible notes. During the year ended December 31, 2025, the Company raised $1,051,805 from the issuance of convertible notes and $112,650 from promissory notes.
Historically, we have relied upon loans from our former Chief Executive Officer, Rik J Deitsch, to fund costs associated with our operations. As of December 31, 2025, the outstanding balance was $1,339,794, consisting entirely of amounts due to companies majority-owned and controlled by this officer, and is non-interest bearing. During the year ended December 31, 2025, the Company repaid an aggregate of $199,637 and received advances totaling $552,504.
Uncertainties and Trends
Our operations and possible revenues are dependent now and in the future upon the following factors:
Whether we successfully develop and commercialize products from our research and development activities.
If we fail to compete effectively in the intensely competitive biotechnology area, our operations and market position will be negatively impacted.
If we fail to successfully execute our planned partnering and out-licensing of products or technologies, our future performance will be adversely affected.
The recent economic downturn and related credit and financial market crisis may adversely affect our ability to obtain financing, conduct our operations and realize opportunities to successfully bring our technologies to market.
Biotechnology industry related litigation is substantial and may continue to rise, leading to greater costs and unpredictablelitigation.
If we fail to comply with extensive legal/regulatory requirements affecting the healthcare industry, we will face increased costs, and possibly penalties and business losses.
Off-Balance Sheet Arrangements
We have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidated with us under whom we have:
An obligation under a guarantee contract.
A retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit, liquidity or market risk support to such entity for such assets.
Any obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument.
Any obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by us and material to us where such entity provides financing, liquidity, market risk or credit risk support to, or engages in leasing, hedging or research and development services with us.
We do not have any off-balance sheet arrangements or commitments that have a current or future effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that is material, other than those which may be disclosed in this Management’s Discussion and Analysis of Financial Condition and the audited Consolidated Financial Statements and related notes.
