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What changed in BONK, INC.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of BONK, INC.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+326 added−238 removedSource: 10-K (2025-03-28) vs 10-K (2024-04-01)

Top changes in BONK, INC.'s 2024 10-K

326 paragraphs added · 238 removed · 100 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

25 edited+119 added−50 removed22 unchanged
Biggest changeGovernment Regulation The Safety Shot Beverage: The production, distribution and sale in the United States of the Safety Shot Beverage is subject to various U.S. federal, state and local regulations, including but not limited to: the Federal Food, Drug and Cosmetic Act (“FD&C Act”); the Occupational Safety and Health Act and various state laws and regulations governing workplace health and safety; various environmental statutes; the Safe Drinking Water and Toxic Enforcement Act of 1986 (“California Proposition 65”); data privacy and personal data protection laws and regulations, including the California Consumer Privacy Act of 2018 (as modified by the California Privacy Rights Act) and a number of other federal, state and local statutes and regulations applicable to the production, transportation, sale, safety, advertising, marketing, labeling, packaging, and ingredients of the Safety Shot Beverage. 6 Table of Contents We also may in the future be affected by other existing, proposed and potential future regulations or regulatory actions, including those described below, any of which could adversely affect our business, financial condition and results of operations.
Biggest changeThe Company owns three additional patents that relate to legacy products that the Company neither currently sells nor has any plans to sell in the future. 10 Table of Contents Government Regulation The Sure Shot Dietary Supplement: The production, distribution and sale in the United States of the Sure Shot Dietary Supplement is subject to various U.S. federal, state and local regulations, including but not limited to: the Federal Food, Drug and Cosmetic Act (“FD&C Act”); the Occupational Safety and Health Act and various state laws and regulations governing workplace health and safety; various environmental statutes; the Safe Drinking Water and Toxic Enforcement Act of 1986 (“California Proposition 65”); data privacy and personal data protection laws and regulations, including the California Consumer Privacy Act of 2018 (as modified by the California Privacy Rights Act) and a number of other federal, state and local statutes and regulations applicable to the production, transportation, sale, safety, advertising, marketing, labeling, packaging, and ingredients of the Sure Shot Dietary Supplement.
Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a dietary supplement, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a dietary supplement.
Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a dietary supplement, that is subject to premarket review and approval by the FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a dietary supplement.
From a product and sales perspective, there are no impediments or concerns raised by any governmental agency. It is essential to note that the Safety Shot Beverage is classified as a dietary supplement, exempt from the approval or filing requirements mandated for pharmaceutical drugs by the FDA or other regulatory authorities.
From a product and sales perspective, there are no impediments or concerns raised by any governmental agency. It is essential to note that the Sure Shot Dietary Supplement is classified as a dietary supplement, exempt from the approval or filing requirements mandated for pharmaceutical drugs by the FDA or other regulatory authorities.
(“GBB”), thereby gaining ownership of various assets, including the intellectual property, trade secrets, and trademarks associated with its dietary supplement Safety Shot Beverage (the “Safety Shot Beverage”). Concurrently with the asset purchase, the Company changed its name to Safety Shot, Inc. and changed its NASDAQ trading symbol to SHOT.
(“GBB”), thereby gaining ownership of various assets, including the intellectual property, trade secrets, and trademarks associated with its dietary supplement (the “Safety Shot Dietary Supplement”). Concurrently with the asset purchase, the Company changed its name to Safety Shot, Inc. and changed its NASDAQ trading symbol to SHOT.
It’s crucial to note that the Safety Shot Beverage is currently manufactured in a facility adhering to Good Manufacturing Practices (GMP), ensuring the highest standards of quality and safety throughout its production process. The Company currently maintains a workforce comprising eight full-time employees of its own.
It’s crucial to note that the Sure Shot Dietary Supplement is currently manufactured in a facility adhering to Good Manufacturing Practices (GMP), ensuring the highest standards of quality and safety throughout its production process. The Company currently maintains a workforce comprising eight full-time employees of its own.
All ingredients in the Safety Shot Beverage are deemed Generally Recognized as Safe (GRAS) and align with FDA standards, permitting their inclusion in supplements. In the event that the FDA or any governmental agency identifies an ingredient or aspect of our product as unsafe, we commit to promptly withdrawing that component in accordance with regulatory directives.
All ingredients in the Sure Shot Dietary Supplement are deemed Generally Recognized as Safe (GRAS) and align with FDA standards, permitting their inclusion in supplements. In the event that the FDA or any governmental agency identifies an ingredient or aspect of our product as unsafe, we commit to promptly withdrawing that component in accordance with regulatory directives.
ITEM 1. BUSINESS Overview Safety Shot Inc. (NASDAQ: SHOT) was formerly known as Jupiter Wellness Inc. In August 2023, the Company successfully completed the asset purchase of the functional beverage Safety Shot from GBB Drink Lab, Inc.
ITEM 1. BUSINESS Overview Safety Shot Inc. (NASDAQ: SHOT) was formerly known as Jupiter Wellness Inc. In August 2023, the Company successfully completed the asset purchase of the Safety Shot Dietary Supplement from GBB Drink Lab, Inc.
Additionally, we are collaborating with other companies to license our intellectual property, to create additional revenue streams and expand our global presence. At present, we do not experience concentration risk or dependence on major customers. We maintain a diverse network of raw material suppliers integral to our production processes.
In addition, we are seeking to collaborate with other companies to license our intellectual property, to create additional revenue streams and expand our global presence. At present, we do not experience concentration risk or dependence on major customers. We maintain a diverse network of raw material suppliers integral to our production processes.
Food and Drug Administration (the “FDA”) has regulations with respect to serving size information and nutrition labeling on food and beverage products, including a requirement to disclose the amount of added sugars in such products. Further, the U.S.
Food and Drug Administration (the “FDA”) has regulations with respect to serving size information and nutrition labeling on food and beverage products, including a requirement to disclose the amount of added sugars in such products and regulations about whether a product qualifies as a drug. Further, the U.S.
We believe our relations with our employees to be good. Properties Currently, we do not own any real property. We rent office space at 1061 E. Indiantown Rd., Ste. 110, Jupiter, FL 33477 for $15,038 per month.
Employees As of this prospectus, we had eight full-time employees. We believe our relations with our employees to be good. Properties Currently, we do not own any real property. We rent office space at 1061 E. Indiantown Rd., Ste. 110, Jupiter, FL 33477 for $15,038 per month.
As of the date hereof, the Company owns five patents, including the patent (US 9,186,350 B2) and patent (US 10,028,991 B2) for the composition of the Safety Shot Beverage used for minimizing the harmful effects associated with alcohol consumption.
Intellectual Property As of the date hereof, the Company owns five patents, including the patent (US 9,186,350 B2) and patent (US 10,028,991 B2) for the composition of the Sure Shot Dietary Supplement used for minimizing the harmful effects associated with alcohol consumption by supporting the metabolism of alcohol.
Our team includes individuals with scientific backgrounds, an experienced researcher, product developers, and business experts who collaborate to create new products and enhance existing ones. We also seek to partner with industry leaders and organizations to gain access to the latest technologies and expand our reach.
Our team includes individuals with scientific backgrounds, an experienced researcher, product developers, and business experts who collaborate to create new products and enhance existing ones. We also seek to partner with industry leaders and organizations to gain access to the latest technologies and expand our reach. The Sure Shot Dietary Supplement is currently sold through e-commerce and in retail stores.
Specializing in Consumer Packaged Goods, our focus centers on the commercialization of a 12-ounce beverage positioned as a dietary supplement. Beyond our existing product, we are actively pursuing a future product line, including a convenient powdered stick pack version.
Specializing in Consumer Packaged Goods, our focus centers on the commercialization of a 12-ounce product positioned as a dietary supplement. Beyond our existing product, we have introduced new product lines, including a convenient powdered stick pack version and a 4-ounce version of the Sure Shot Dietary Supplement.
We have conducted extensive research and experimentation involving a substantial number of volunteers under the influence of intoxicants. Our findings indicate that the Safety Shot Beverage can reduce a person’s Blood Alcohol Content, as measured by the premier Breathalyzer in the market. The observable enhancements in cognitive abilities among the test subjects have been carefully documented.
We have conducted extensive informal research and experimentation involving a substantial number of volunteers under the influence of alcohol. Our findings indicate that the Sure Shot Dietary Supplement can reduce a person’s Blood Alcohol Content, as measured by the premier Breathalyzer on the market.
We believe that the Safety Shot Beverage stands as a unique product in the dietary supplement beverage market. Nevertheless, our competitive landscape includes many companies involved in the production of health and welfare products, including beverages.
We believe that the Sure Shot Dietary Supplement stands as a unique product in the liquid dietary supplement market. Nevertheless, our competitive landscape includes many companies involved in the production of health and welfare products, including beverages. Recent Developments Settlement Agreement with Bigger Capital On January 20, 2025, the Company entered into the Bigger Settlement Agreement.
We are currently speaking with Big Box stores with the intention to launch end of the first quarter to early second quarter of 2024. Manufacturing, Logistics and Fulfillment We outsource the manufacturing of our products to contract manufacturers, who produce them according to our formulation specifications. Our products are manufactured by contract manufacturers in India and the US.
We launched the Sure Shot Dietary Supplement in stores such as BevMo! in the second quarter of 2024. Manufacturing, Logistics and Fulfillment We outsource the manufacturing of our products to contract manufacturers, who produce them according to our formulation specifications. Our products are manufactured by contract manufacturers in India and the US.
The Management believes that as we continue to expand our product portfolio, we believe that these partnerships with trusted suppliers play a pivotal role in upholding the standards that we expect of our brand.
The Management believes that as we continue to expand our product portfolio, we believe that these partnerships with trusted suppliers play a pivotal role in upholding the standards that we expect of our brand. Products Roadmap The Sure Shot Dietary Supplement was launched on our own website and through Amazon in December 2023 and with several Big Box stores.
Our product pipeline also includes a diverse range of products, such as hair loss treatments, vitiligo solutions, and sexual wellness products, that cater to different health and wellness needs and our commitment to supporting health and wellness by developing innovative solutions to a range of conditions but will focus our efforts on the commercialization of the Safety Shot Beverage.
The Company has discontinued the historical product lines of Jupiter Wellness which included a diverse range of products, such as hair loss treatments, vitiligo solutions, and sexual wellness products, that catered to different health and wellness needs and our commitment to supporting health and wellness by developing innovative solutions to a range of conditions.
Following such distribution, the Company owns 4.0 million of the 9,450,000 shares of common stock outstanding and SRM is now a minority owned subsidiary of the Company. 5 Table of Contents Our Competitive Strengths We are committed to driving continuous improvement through innovation.
Following such distribution, the Company owns 4.0 million of the 9,450,000 shares of common stock outstanding and SRM is now a minority owned subsidiary of the Company. To achieve our mission, we rely on our team of highly skilled and experienced professionals who are committed to advancing our vision of health and wellness.
See “Business-Research and Development” The Company incurred research and development expenses of $100,591 and $1,637,117 for the years ended December 31, 2023 and 2022, respectively. Sales and Marketing We primarily sell our products through e-commerce websites including Amazon. To drive loyalty, word-of-mouth marketing, and sustainable growth, we invest in customer experience and customer relationship management.
Sales and Marketing We primarily sell our products through e-commerce websites including Amazon and through retail stores. To drive loyalty, word-of-mouth marketing, and sustainable growth, we invest in customer experience and customer relationship management.
We use a limited number of logistics providers to deliver our products to both distributors and retailers, which allows us to lessen order fulfillment time, cut shipping costs, and improve inventory flexibility. SRM Entertainment The Company entered into a stock exchange agreement (the “Exchange Agreement”) with SRM Entertainment, Inc. (“SRM”) to govern the separation of SRM and the Company.
We use a limited number of logistics providers to deliver our products to both distributors and retailers, which allows us to lessen order fulfillment time, cut shipping costs, and improve inventory flexibility. 5 Table of Contents Our Competitive Strengths We are committed to driving continuous improvement through innovation.
The Company entered into the office lease effective July 1, 2021, which has a primary term of the lease of five years with one renewal option for an additional three years. Available Information We aim to provide our stakeholders with transparent and timely information on our company’s performance.
The Company entered into the office lease effective July 1, 2021, which has a primary term of the lease of five years with one renewal option for an additional three years. As part of the Separation Agreement, Caring Brands, Inc. has agreed to assume to lease obligations upon it reaching certain milestones.
Research and Development Our research and development team in continually looking to develop new therapeutic products, while continually improving and enhancing our existing products and product candidates to address customer demands and emerging trends to develop more effective formulas for our JW-700 product.
The participants will be selected based upon the parameters of the individual studies and the Company will follow the same protocols employed in the clinical trials at the CAHS described in more detail below in “Research and Development.” Research and Development Our research and development team in continually looking to develop new therapeutic products, while continually improving and enhancing our existing products and product candidates to address customer demands and emerging trends.
The Company launched its e-commerce sale of the Safety Shot Beverage in December 2023. The Safety Shot Beverage has been formulated to reduce the accumulation of blood alcohol. Noteworthy is the fact that the Safety Shot Beverage comprises 28 active ingredients, all falling under the Generally Regarded As Safe (GRAS) category.
Noteworthy is the fact that the Sure Shot Dietary Supplement comprises 28 active ingredients, all falling under the Generally Regarded As Safe (GRAS) category.
Concurrently to the PIPE Agreement, the Company entered into a Securities Purchase Agreement (the “RD Agreement”) with certain purchasers, pursuant to which on January 23, 2023, 4,315,787 shares of common stock, par value $0.001 (the “Common Stock”), at a price of $0.70 per share were issued to the purchasers (the “RD Offering”).
On April 4, 2024, the Company entered into a Securities Purchase Agreement with Core 4 Capital Corp. for the purchase of 2,369,668 shares of the Company’s common stock to Core 4 Capital Corp. at a price of $2.11 per share, which was the closing price on April 4, 2024.
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This strategic expansion aligns with our corporate vision to address evolving consumer demands, positioning the Company in the market for dietary supplements. We believe that this initiative not only enriches our product portfolio but also emphasizes our dedication to innovation and adaptability, catering to the discerning preferences of health-conscious consumers.
Added
The Company launched its e-commerce sale of the Safety Shot Dietary Supplement in December 2023. On October 9, 2024, the Company renamed the Safety Shot Dietary Supplement as the “Sure Shot Dietary Supplement.” The Sure Shot Dietary Supplement has been formulated to reduce the accumulation of blood alcohol.
Removed
The Company intends to continue its current product lines, except for its products which contain CBD, which the Company no longer sells.
Added
In connection therewith, on September 24, 2024, the Company entered into a Separation and Exchange Agreement with its subsidiary Caring Brands, Inc. whereby Caring Brands will seek to commercialize this product line. Caring Brands will be responsible for all costs associated with the operation of that line of business.
Removed
The Safety Shot Beverage has established a development infrastructure that the Company believes fits with its existing over-the-counter and prescription-grade health and wellness products. To achieve our mission, we rely on our team of highly skilled and experienced professionals who are committed to advancing our vision of health and wellness.
Added
The Company will focus its efforts on the commercialization of the Sure Shot Dietary Supplement. The Company will retain ownership of 3,000,000 shares of Caring Brands, Inc. The Company entered into a stock exchange agreement (the “Exchange Agreement”) with SRM Entertainment, Inc. (“SRM”) to govern the separation of SRM and the Company.
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We generate revenue through various channels, our primary sales include our “nostingz” suncare products which are sold through e-commerce platforms, licensing revenues from Photocil and sales of the Safety Shot Beverage. Photocil is currently sold in India through a licensing agreement.
Added
The Company is advancing several product formats and formulations to continue to offer a wide array of products that can be purchased at various locations that coincide with consumer shopping habits. In particular, the Company plans to develop new flavors for each of its current SKUs (12oz., 4 oz. and “Stick Pack”.
Removed
We received FDA approval of our labelling and composition to sell Photocil as an OTC product in the US and plan to relaunch the product in the US in the fourth quarter of 2024 through e-commerce channels. Safety Shot Beverage is currently sold through e-commerce and social media platforms.
Added
In addition, the current formula will be offered at various dosages and the Company plans to conduct additional research studies as follows: assessing varying dosages of the Sure Shot Dietary Supplement against body weight, gender and age, examining several current and proposed ingredients with respect to their specific role in reducing BAC and how they affect the enzymatic activity associated with the metabolism of alcohol, and finally, examining additional markers with respect to improving post-alcohol consumption symptoms and feelings. 4 Table of Contents The Company intends to perform the additional research studies in Q2 and Q3 of 2025.
Removed
As a result of recent changes to the laws governing CBD products, as well as the declining popularity of CBD products, the Company no longer markets or sells any CBD products. The Company hopes to find a suitor or partner to dispose of its CBD related assets but has not entered into any agreements to do so.
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The Company will continue to sponsor the studies and intends to work with the Center for Applied Health Sciences (“CAHS”) in Canfield, OH.
Removed
Products Roadmap The Safety Shot Beverage was launched on our own website and through Amazon in December 2023 and is currently speaking with Big Box stores with the intention to launch by the end of the first quarter or early second quarter of 2024.
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We have recently completed our clinical trials of the Sure Shot Dietary Supplement which have shown a statistically significant reduction in the Blood Alcohol Content (“BAC”) of the participants. The observable enhancements in cognitive abilities among the test subjects have been carefully documented.
Removed
The Company is advancing several formulations to address psoriasis and vitiligo (Photocil), increase the effectiveness of minoxidil to treat hair loss (JW-700 “minoxidil booster”), women’s sexual wellness (JW-500), and jellyfish sting prevention sunscreen (NoStingz). The Company halted testing related to its atopic dermatitis product and all other compounds and products containing CBD.
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The clinical trials took place from January 29, 2024, through June 10, 2024, at the CAHS located at 6570 Seville Drive, Canfield, OH 44406. The clinical trials were sponsored and paid for by the Company and consisted of 36 participants with a mean age of 36.3 years that were selected through advertising of the study.
Removed
Photocil was launched commercially in India in Q3 2022 as a treatment for vitiligo and psoriasis. Photocil is a topical cream that works with natural sunlight to provide patients with safe and effective phototherapy at home by blocking harmful radiation and permitting the passage of therapeutic UV radiation from the sun.
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The Company did not inquire about the participants typical level of alcohol consumption but each participant had to qualify based upon a complete medical history questionnaire, release from physicians and submitting to a standard bloodwork panel. Each participant consumed exactly 100 mL of alcohol and the BAC of the participants ranged from 0.047 % to 0.068 %.
Removed
The Company plans to re-launch Photocil in the US in the fourth quarter of 2024. The product is an OTC cosmetic product using a USP monographed compound as a skin protectant. The product labelling and ingredients were approved by the FDA.
Added
The participants were not employees of the Company nor affiliated with the Company in any way.
Removed
NoStingz provides an effective barrier against the stinging mechanism of jellyfish cnidocyte preventing the delivery of venom to the victim. Applied like other topical sun screen products, the product is clinically proven to protect users from jellyfish, sea lice, and UVA/UVB rays. It is not intended to treat jellyfish or sea lice bites.
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The clinical trials were a double-blind, randomized, placebo-controlled study that found that within 30 minutes of the consumption of the Sure Shot Dietary Supplement, the monitored participants saw a statistically significant drop of p=.002 in BAC and continued to see measurable drops in successive 30-minute increments.
Removed
As the product contains ingredients with well-established safety profiles it did not require pre-market FDA approval ahead of product launch.
Added
The results were measured by using a DOT-approved BACtrack S80 Breathalyzer on the participants to determine their BAC after ingesting several alcoholic beverages, followed by drinking 12 ounces of the Sure Shot Dietary Supplement and then measuring the participants’ BAC 30 minutes later.
Removed
Its manufacturing, labeling and components comply with FDA regulations for sunscreens. 4 Table of Contents JW-700, currently being licensed abroad and developed for US launch, the product has been clinically shown to increase the enzymes needed for minoxidil to work, sulfotransferase enzymes, by using the product topically in conjunction with topical minoxidil. Additional studies and formulation work are ongoing.
Added
In addition, cognitive responses were measured using the Visual Analogue Scale (“VAS”) and physical function assessed at the same intervals as the blood draws and breathalyzer assessments to correlate to function. The VAS consisted of a 10 cm, straight line with end points that measured from low-to-high for a number of physical feelings and sensations.
Removed
The Company intends to launch JW-700 in the U.S in the fourth Quarter of 2024. JW-500 was born out of clinical trials designed to establish a topical treatment for the restoration of nipple sensitivity for breast augmentation patients, in addition to patients who had undergone chemotherapy or lumpectomy surgery following a cancer diagnosis.
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The participants were asked to mark a point on the line that corresponded with their experience. The distance from the end to the point marked by the participant was then measured in millimeters to quantify their level of sensation.
Removed
The Company plans to complete the formulation and test launch the product in Q4, 2024. Design of SS-100 formulation will be completed after the reviewing the results of the on-going clinical trial of the Safety Shot Beverage.
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On each visit, participants were asked to perform the VAS tests and the VAS assessed subjective ratings for head discomfort (headache), nausea, fatigue, energy, tiredness, thirst and ability to concentrate. The Company also conducted further physical assessment by monitoring biometric measurements such as blood pressure and heart rate at various intervals.
Removed
Thereafter the Company plans to set up a Pre-IND meeting with the FDA, unlike Safety Shot Beverage which does not require FDA approval on grounds of being a dietary supplement product.
Added
The key assumptions in the study were that the participants would demonstrate a marked decrease in BAC following the consumption of the Sure Shot Dietary Supplement versus that of the placebo.
Removed
SS-100 will be classified as a drug as it will used to treat acute alcohol poisoning which the Company believes meets the definition of a rare disease as described below, and will require filing an IND with the FDA and conducting clinical trials to determine safety and efficacy.
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In addition, the study assumed that the participants would feel better and demonstrate marked improvement in cognitive skills and physical function following the consumption of the Sure Shot Dietary Supplement versus that of the placebo.
Removed
The Company plans to seek Orphan Drug Designation for SS-100, a modified version of Safety Shot Beverage.
Added
The Company had previously observed in our numerous, pre-clinical tests that participants who consumed significant amounts of alcohol (more than two drinks) experienced marked and rapid reductions in their BAC when measured by BACTrack S80 breathalyzers after consumption of the Sure Shot Dietary Supplement.
Removed
Given that the FDA defines a drug as Orphan if it is used for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US (which equates to approximately 6 cases per 10,000) and that Acute Alcohol Poisoning (which has ~ 10% fatality rate and has ~20,000 cases in US) meets these criteria and therefor it meets the criteria for Orphan Drug Designation.
Added
In addition, the Company observed in the pre-clinical tests that the participants showed significant improvement in motor function and reduction in slurred speech and other markers commonly associated with alcohol consumption. These findings led the Company to continue to develop the Sure Shot Dietary Supplement and commission a clinical study to prove our hypothesis.
Removed
Orphan Drug status provides certain benefits to the Company including exclusive marketing and development rights, tax credits and fee waivers. The development of the modified Safety Shot Beverage which we call SS-100 designed to treat acute alcohol poisoning will require the filing of an IND and controlled clinical trials to establish safety and efficacy.
Added
There were five adverse events amongst the participants in the study. Four of the adverse events were associated with the Sure Shot Dietary Supplement (three felt nauseous and one developed a rash) and none of the adverse events were serious. The final adverse event was associated with congestion of the placebo.
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As with any other drug, the Company will be required to take the steps necessary to have any drug approved.
Added
Since approximately 2010, the Company has performed 100s of pre-clinical tests in an effort to develop and perfect the Sure Shot Dietary Supplement. These informal, pre-clinical tests included friends, family and other volunteers who consumed alcohol at varying levels and then were tested prior to the consumption of the Sure Shot Dietary Supplement.
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The main steps are (i) the request for a pre-IND meeting with the FDA for feedback on clinical plans, (ii) based on the feedback from (i) to file an IND, (iii) subject to IND acceptance by the FDA conduct Phase 1, phase 2 and Phase 3 clinical trials and then submit an NDA for product approval.
Added
The pre-clinical tests were neither peer reviewed nor were the subjects screened prior to their participation. In addition, the VAS was not used nor were there any placebos or other control measures taken in the pre-clinical tests and as such these tests are considered informal and non-clinical.
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A company seeking orphan drug designation for a drug must submit a request for designation to the agency. The company requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information to support their designation request.
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The participants’ BAC was measured by using the BacTrack S80 after the consumption of various amounts of alcohol and prior to the consumption of the Sure Shot Dietary Supplement and then at 30 minutes, 45 minutes and one-hour intervals after consumption of the Sure Shot Dietary Supplement so we could assess the efficacy of the Company’s R&D efforts at that point in time.
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Orphan drug designation is a separate process from seeking approval or licensing. Drugs for rare diseases go through the same rigorous scientific review process as any other drug for approval or licensing. Without receiving such product approval, the drug product can’t be sold.
Added
The Company also observed motor function skills such as walking, balancing and speech at the same intervals following the consumption of 12 ounces of the Sure Shot Dietary Supplement.
Removed
For a detailed timeline of the products, please see “Our Business – Product Roadmap” section on page 43.
Added
The Company defined and noted the significant improvement in each area by observing participants’ walk and whether a participant’s gait was unsteady, or whether their balance was off while standing and whether their speech was clear or slurred. The Company incurred research and development expenses of $100,591 and $1,637,117 for the years ended December 31, 2022, and 2023, respectively.
Removed
Recent Developments On January 19, 2023, the Company entered into a Securities Purchase Agreement (the “PIPE Agreement”) with certain purchasers, for the issuance of 8,631,574 common stock warrants (the “PIPE Offering”) at a price of $0.125 per warrant, comprised of two common stock warrants (the “Common Warrants,”), each to purchase up to one share of Common Stock per Common Warrant with an exercise price of $1.00 per share, with (a) 4,315,787 Common Warrants being immediately exercisable for three years following 6 months from the closing of the PIPE Offering, and (b) 4,315,787 Common Warrants being immediately exercisable for five years following 6 months from the closing of the PIPE Offering.
Added
In exchange for a resolution to all issues and claims that relate to the previously filed action against the Company in the Supreme Court of the State of New York, New York County, Index No. 65018/2024.
Removed
The Common Stock was issued pursuant to a Registration Statement on Form S-3 filed by the Company with the Securities and Exchange Commission (the “Commission”) on September 28, 2022 (File No. 333-267644) and declared effective on November 9, 2022.
Added
Pursuant to the Bigger Settlement Agreement, the Company agreed to pay or issue to Bigger Capital the following: (i) pay Bigger Capital $375,000; (ii) issue a secured convertible note in the principal amount of $1.75 million maturing on December 31, 2026 (the “Secured Convertible Bigger Note”); (iii) a convertible note in the principal amount of $3.5 million maturing June 30, 2025 (the “Convertible Bigger Note,” and, together with the Secured Convertible Bigger Note, the “Bigger Notes”); and (iv) 5,332,889 shares of common stock issuable upon the exercise of common stock purchase warrants to purchase shares of common stock of the Company at an exercise price of $0.4348 per share (the “Bigger Warrants”).
Removed
The aggregate gross proceeds to the Company from both the PIPE Offering and the RD Offering were approximately $4.1 million, with the purchase price of one share, one 3-year warrant and one 5-year warrant as $0.95. The net proceeds were $3,450,675.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

39 edited+96 added−68 removed97 unchanged
Biggest changeIf we fail to comply with these requirements, we would be subject to possible regulatory action and may be limited in the jurisdictions in which we are permitted to sell our products and will lose time to market and potential revenues. 12 Table of Contents It is uncertain whether product liability insurance will be adequate to address product liability claims, or that insurance against such claims will be affordable or available on acceptable terms in the future.
Biggest changeIt is uncertain whether product liability insurance will be adequate to address product liability claims, or that insurance against such claims will be affordable or available on acceptable terms in the future. Clinical research involves the testing of products on human volunteers pursuant to a clinical trial protocol.
If we lack cash resources to cover these costs of being a public company in the future, our failure to comply with reporting requirements and other provisions of securities laws could negatively affect our stock price and adversely affect our potential results of operations, cash flow and financial condition after we commence operations.
If we lack cash resources to cover these costs of being a public company in the future, our failure to comply with reporting requirements and other provisions of securities laws could negatively affect our stock price and adversely affect our potential results of operations, cashflow and financial condition after we commence operations.
These delays could be caused by reviews by regulatory authorities and contractual discussions with individual clinical trial sites. Any delays in enrolling and/or dosing patients in our planned clinical trials could result in increased costs, delays in advancing our product candidates, delays in testing the effectiveness of our product candidates or in termination of the clinical trials altogether.
These delays could be caused by reviews by contractual discussions with individual clinical trial sites. Any delays in enrolling and/or dosing patients in our planned clinical trials could result in increased costs, delays in advancing our product candidates, delays in testing the effectiveness of our product candidates or in termination of the clinical trials altogether.
If we are unable to manage expanded operations effectively, we may experience operating inefficiencies, the quality of our products and services could deteriorate, and our business and results of operations could be materially adversely affected. Changes in tax laws and unanticipated tax liabilities could adversely affect our effective income tax rate and ability to achieve profitability.
If we are unable to manage expanded operations effectively, we may experience operating inefficiencies, the quality of our products and services could deteriorate, and our business and results of operations could be materially adversely affected. 17 Table of Contents Changes in tax laws and unanticipated tax liabilities could adversely affect our effective income tax rate and ability to achieve profitability.
Accordingly, our results could be materially and adversely affected by a variety of uncontrollable and changing factors relating to international business operations, including: ● Macroeconomic conditions adversely affecting geographies where we intend to do business; ● Foreign currency exchange rates; ● Political or social unrest or economic instability in a specific country or region; ● Higher costs of doing business in foreign countries; ● Infringement claims on foreign patents, copyrights or trademark rights; 15 Table of Contents ● Difficulties in staffing and managing operations across disparate geographic areas; ● Difficulties associated with enforcing agreements and intellectual property rights through foreign legal systems; ● Trade protection measures and other regulatory requirements, which affect our ability to import or export our products from or to various countries; ● Adverse tax consequences; ● Unexpected changes in legal and regulatory requirements; ● Military conflict, terrorist activities, natural disasters and medical epidemics; and ● Our ability to recruit and retain channel partners in foreign jurisdictions.
Accordingly, our results could be materially and adversely affected by a variety of uncontrollable and changing factors relating to international business operations, including: ● Macroeconomic conditions adversely affecting geographies where we intend to do business; ● Foreign currency exchange rates; ● Political or social unrest or economic instability in a specific country or region; ● Higher costs of doing business in foreign countries; ● Infringement claims on foreign patents, copyrights or trademark rights; ● Difficulties in staffing and managing operations across disparate geographic areas; ● Difficulties associated with enforcing agreements and intellectual property rights through foreign legal systems; ● Trade protection measures and other regulatory requirements, which affect our ability to import or export our products from or to various countries; ● Adverse tax consequences; ● Unexpected changes in legal and regulatory requirements; ● Military conflict, terrorist activities, natural disasters and medical epidemics; and ● Our ability to recruit and retain channel partners in foreign jurisdictions. 16 Table of Contents Compliance with new and existing laws and governmental regulations could increase our costs significantly and adversely affect our results of operations.
If we fail to develop, promote and maintain our brand and reputation successfully, our business and prospects could be materially harmed. We are subject to government regulation, and unfavorable changes could substantially harm our business and results of operations.
If we fail to develop, promote and maintain our brand and reputation successfully, our business and prospects could be materially harmed. 11 Table of Contents We are subject to government regulation, and unfavorable changes could substantially harm our business and results of operations.
In particular, because our planned clinical trials may be focused on indications with relatively small patient populations, our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate. 11 Table of Contents In addition, we may experience enrollment delays related to increased or unforeseen regulatory, legal and logistical requirements at certain clinical trial sites.
In particular, because our planned clinical trials may be focused on indications with relatively small patient populations, our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate. In addition, we may experience enrollment delays related to increased or unforeseen legal and logistical requirements at certain clinical trial sites.
If we do not successfully compete with these competitors, we could fail to develop market share and our future business prospects could be adversely affected. 8 Table of Contents If we are unable to develop and maintain our brand and reputation for our product offerings, our business and prospects could be materially harmed.
If we do not successfully compete with these competitors, we could fail to develop market share and our future business prospects could be adversely affected. If we are unable to develop and maintain our brand and reputation for our product offerings, our business and prospects could be materially harmed.
Patient enrollment may also be affected by other factors, including: ● coordination with clinical research organizations to enroll and administer the clinical trials; ● coordination and recruitment of collaborators and investigators at individual sites; ● size of the patient population and process for identifying patients; ● design of the clinical trial protocol; ● eligibility and exclusion criteria; ● perceived risks and benefits of the product candidates under study; ● availability of competing commercially available therapies and other competing products’ clinical trials; ● time of year in which the trials are initiated or conducted; ● severity of the diseases under investigation; ● ability to obtain and maintain subject consents; ● ability to enroll and treat patients in a timely manner; ● risk that enrolled subjects will drop out before completion of the trials; ● proximity and availability of clinical trial sites for prospective patients; ● ability to monitor subjects adequately during and after treatment; and ● patient referral practices of physicians.
Participant enrollment may also be affected by other factors, including: ● coordination with clinical research organizations to enroll and administer the clinical trials; ● coordination and recruitment of collaborators and investigators at individual sites; ● size of the participant population and process for identifying participants; ● design of the clinical trial protocol; ● eligibility and exclusion criteria; ● perceived risks and benefits of the product candidates under study; ● time of year in which the trials are initiated or conducted; ● ability to obtain and maintain subject consents; ● ability to enroll participants in a timely manner; ● risk that enrolled subjects will drop out before completion of the trials; ● proximity and availability of clinical trial sites for prospective participants; ● ability to monitor subjects adequately during and after treatment.
This provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the company and its directors, officers, or other employees and may discourage lawsuits with respect to such claims. This provision does not apply to actions arising under the Exchange Act or Securities Act.
This provision may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the company and its directors, officers, or other employees and may discourage lawsuits with respect to such claims.
At December 31, 2023, the Company had $3,833,349 in cash and the Company recognizes that it may need to raise additional capital in order to continue to execute its business plan in the future.
At December 31, 2024, the Company had $348,816 in cash and the Company recognizes that it may need to raise additional capital in order to continue to execute its business plan in the future.
We may also experience shortages equipment due to manufacturing difficulties. Multiple suppliers provide the components used in manufacturing our products. Our manufacturing operations could be disrupted by fire, earthquake or other natural disaster, a labor-related disruption, failure in supply or other logistical channels, electrical outages or other reasons.
Multiple suppliers provide the components used in manufacturing our products. Our manufacturing operations could be disrupted by fire, earthquake or other natural disaster, a labor-related disruption, failure in supply or other logistical channels, electrical outages or other reasons.
Identifying, screening and enrolling patients to participate in clinical trials of our product candidates is critical to our success, and we may not be able to identify, recruit, enroll and dose a sufficient number of patients with the required or desired characteristics to complete our clinical trials in a timely manner.
If we experience delays or difficulties in the enrollment of subjects to our clinical trials, our ability to complete such trials will be adversely affected Identifying, screening and enrolling patients to participate in clinical trials of our product candidates is critical to our success, and we may not be able to identify, recruit, enroll and dose a sufficient number of patients with the required or desired characteristics to complete our clinical trials in a timely manner.
Adverse publicity concerning any actual or purported failure by us to comply with applicable laws and regulations regarding any aspect of our business could have an adverse effect on the public perception of us.
Adverse publicity associated with our products or ingredients, or those of similar companies, could adversely affect our sales and revenue. Adverse publicity concerning any actual or purported failure by us to comply with applicable laws and regulations regarding any aspect of our business could have an adverse effect on the public perception of us.
Regardless of our technology being protected by patents or otherwise, there is a risk that other companies may employ the technology without authorization and without recompensing us. 17 Table of Contents The efforts we have taken to protect our proprietary rights may not be sufficient or effective.
Regardless of our technology being protected by patents or otherwise, there is a risk that other companies may employ the technology without authorization and without recompensing us. The efforts we have taken to protect our proprietary rights may not be sufficient or effective. Any significant impairment of our intellectual property rights could harm our business or our ability to compete.
At December 31, 2023, our officers and directors are the beneficial owners of approximately 20% our issued and outstanding voting securities. As a result, they possess significant influence over our elections and votes.
At March 25, 2025, our officers and directors are the beneficial owners of approximately 14.7% our issued and outstanding voting securities. As a result, they possess significant influence over our elections and votes.
If the Company is unable to obtain revenue producing contracts or financing or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may be forced to substantially curtail its operations or seek other business opportunities through strategic alliances, acquisitions or other arrangements that may dilute the interests of existing stockholders. 16 Table of Contents Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or other assets.
If the Company is unable to obtain revenue producing contracts or financing or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may be forced to substantially curtail its operations or seek other business opportunities through strategic alliances, acquisitions or other arrangements that may dilute the interests of existing stockholders.
Natural disasters and other events beyond our control could materially adversely affect us. Natural disasters or other catastrophic events may cause damage or disruption to our operations, international commerce and the global economy, and thus could have a strong negative effect on us.
Natural disasters or other catastrophic events may cause damage or disruption to our operations, international commerce and the global economy, and thus could have a strong negative effect on us. Our business operations are subject to interruption by natural disasters, fire, power shortages, pandemics and other events beyond our control.
Clinical research involves the testing of new drugs on human volunteers pursuant to a clinical trial protocol. Such testing involves a risk of liability for personal injury to or death of patients due to, among other causes, adverse side effects, improper administration of the new drug, or improper volunteer behavior.
Such testing involves a risk of liability for personal injury to or death of patients due to, among other causes, adverse side effects, improper administration of the new product, or improper volunteer behavior.
These activities may divert management’s attention from other business concerns, which could have a material adverse effect on our results of operations, financial condition or business. 18 Table of Contents As an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain temporary exemptions from various reporting requirements including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
As an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain temporary exemptions from various reporting requirements including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
The requirements of being a public company may strain our resources and distract our management, which could make it difficult to manage our business, particularly after we are no longer an “emerging growth company.” We are required to comply with various regulatory and reporting requirements, including those required by the SEC.
If some investors find our common stockless attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. 18 Table of Contents The requirements of being a public company may strain our resources and distract our management, which could make it difficult to manage our business, particularly after we are no longer an “emerging growth company.” We are required to comply with various regulatory and reporting requirements, including those required by the SEC.
We depend heavily on key personnel, and turnover of key senior management could harm our business. Our future business and results of operations depend in significant part upon the continued contributions of our senior management personnel.
These regulations and laws may cover taxation, tariffs, user pricing, distribution, consumer protection and the characteristics and quality of services. We depend heavily on key personnel, and turnover of key senior management could harm our business. Our future business and results of operations depend in significant part upon the continued contributions of our senior management personnel.
Any significant impairment of our intellectual property rights could harm our business or our ability to compete. In addition, protecting our intellectual property rights is costly and time consuming. There is a risk that we may have insufficient resources to counter adequately such infringements through negotiation or the use of legal remedies.
In addition, protecting our intellectual property rights is costly and time consuming. There is a risk that we may have insufficient resources to counter adequately such infringements through negotiation or the use of legal remedies. It may not be practicable or cost effective for us to fully protect our intellectual property rights in some countries or jurisdictions.
These milestones relate to technology and design improvements as well as dates for achieving development goals. If our products exhibit technical defects or are unable to meet cost or performance goals, our commercialization schedule could be delayed and potential purchasers of our initial commercial products may decline to purchase such products or may opt to pursue alternative products.
If our products exhibit technical defects or are unable to meet cost or performance goals, our commercialization schedule could be delayed, and potential purchasers of our initial commercial products may decline to purchase such products or may opt to pursue alternative products. We may also experience shortages of equipment due to manufacturing difficulties.
Claims that any products are ineffective, inappropriately labeled or have inaccurate instructions as to their use, could have a material adverse effect on the market demand for our products, including reducing our sales and revenue. We do not have and may never have any products on the market that have been approved for the treatment of disease.
Claims that any products are ineffective, inappropriately labeled or have inaccurate instructions as to their use, could have a material adverse effect on the market demand for our products, including reducing our sales and revenue. 12 Table of Contents If serious adverse or undesirable side effects are identified during the development of our product candidates, we may abandon or limit our development or commercialization of such product candidates.
(Nasdaq: SRM) valued at $1.41 per share (as of March 27, 2024) and are held as investment in affiliate and are accounted for using the Equity Method. These shares are not covered by an effective registration statement but may be sold subject to Rule 144.
(Nasdaq: SRM) valued at $0.63 per share (as of December 31, 2024) and these shares are considered trading shares and are held as marketable securities on the balance sheet. These shares are not covered by an effective registration statement but may be sold subject to Rule 144.
In connection with certain public and private offerings (the “Financing”), the Company offered warrants as part of the Financing packages. During the year ended December 31, 2023, the Warrant Holders exercised a total of 10,266,845 warrants for shares of common stock for a total exercise price of $8,887,837.
During the year ended December 31, 2024, the Warrant Holders exercised a total of 2,996,127 warrants for shares of common stock for a total exercise price of $3,962,714 and during the year ended December 31, 2023, the Warrant Holders exercised a total of 10,266,845 warrants for shares of common stock for a total exercise price of $8,887,837.
If we issue cumulative preferred stock in the future that has preference over our common stock with respect to the payment of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting power of our common stock, the market price of our common stock could decrease. 19 Table of Contents Anti-takeover provisions in the Company’s charter and bylaws may prevent or frustrate attempts by stockholders to change the board of directors or current management and could make a third-party acquisition of the Company difficult.
If we issue cumulative preferred stock in the future that has preference over our common stock with respect to the payment of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting power of our common stock, the market price of our common stock could decrease.
At December 12, 2023, the Company has 15,758,126 warrants outstanding at an average exercise price of $1.45. The Company expects, although there can be no assurance, that a majority of the outstanding warrants will be exercised in the near future. In addition to the unexercised warrants, the Company also holds 1,200,821 shares of Chijet Motor Company, Inc.
At December 31, 2024, the Company has 18,803,334 warrants outstanding at an average exercise price of $2.09. The Company expects, although there can be no assurance, that a majority of the outstanding warrants will be exercised in the near future. The Company also holds 2,623,342 shares of SRM Entertainment, Inc.
Our issuance of additional common stock or preferred stock may cause our common stock price to decline, which may negatively impact your investment. Issuances of a substantial number of additional shares of our common or preferred stock, or the perception that such issuances could occur, may cause prevailing market prices for our common stock to decline.
Issuances of a substantial number of additional shares of our common or preferred stock, or the perception that such issuances could occur, may cause prevailing market prices for our common stock to decline. In addition, our board of directors is authorized to issue additional series of shares of preferred stock without any action on the part of our stockholders.
We may seek additional capital through a combination of private and public equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements.
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or other assets. We may seek additional capital through a combination of private and public equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements.
We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions.
The Company has incurred and expects to continue to incur significant costs in pursuit of its expansion and development plans. These conditions raise doubt about the Company’s ability to continue as a going concern and accordingly our auditors have included a going concern opinion in our annual report.
These conditions raise doubt about the Company’s ability to continue as a going concern and accordingly our auditors have included a going concern opinion in our annual report. In connection with certain public and private offerings (the “Financing”), the Company offered warrants as part of the Financing packages.
The success of new product introductions depends on various factors, including, without limitation, the following: ● Successful sales and marketing efforts; 9 Table of Contents ● Timely delivery of new products; ● Availability of raw materials; ● Pricing of raw materials; ● Regulatory allowance of the products; and ● Customer acceptance of new products Adverse publicity associated with our products or ingredients, or those of similar companies, could adversely affect our sales and revenue.
We cannot be certain that we will be successful in selecting, developing, manufacturing and marketing new products or in enhancing existing products. ● The success of new product introductions depends on various factors, including, without limitation, the following: Successful sales and marketing efforts; ● Timely delivery of new products; ● Availability of raw materials; ● Pricing of raw materials; ● Regulatory allowance of the products; and ● Customer acceptance of new products.
Competition in the biopharmaceutical industry for technically proficient marketing, sales, and distribution personnel is intense and attracting and retaining such personnel may significantly increase our costs. There can be no assurance that we will be able to establish internal marketing, sales, or distribution capabilities or that these capabilities will be sufficient to meet our needs.
Competition in the dietary supplement industry for technically proficient marketing, sales, and distribution personnel is intense and attracting and retaining such personnel may significantly increase our costs.
At this point, the overall extent to which COVID-19 may impact our financial condition or results of operations is uncertain. We have a limited operating history upon which investors can evaluate our future prospects. We have a limited operating history upon which an evaluation of its business plan or performance and prospects can be made.
Such events could make it difficult or impossible for us to deliver our services to our customers and could decrease demand for our services. We have a limited operating history upon which investors can evaluate our future prospects. We have a limited operating history upon which an evaluation of its business plan or performance and prospects can be made.
As a result, any significant reduction in revenues may immediately and adversely affect our business, financial condition and operating results. We may not meet our product development and commercialization milestones. We have established milestones, based upon our expectations regarding our technologies at that time, which we use to assess our progress toward developing our products.
We have established milestones, based upon our expectations regarding our technologies at that time, which we use to assess our progress toward developing our products. These milestones relate to technology and design improvements as well as dates for achieving development goals.
Risks Related to our Financial Position and Capital Needs Our accountant has indicated doubt about our ability to continue as a going concern. As of December 31, 2023 and 2022, the Company had $3,833,349 and $1,931,068 in cash, accumulated deficit of $65,480,715 and $50,597,674 and cash flow used in operations of $10,515,314 and $6,395,942, respectively.
As of December 31, 2024, and 2023, the Company had $348,816 and $3,833,349 in cash, accumulated deficit of $115,090,347 and $65,480,715 and cash flow used in operations of $18,089,748 and $10,715,314, respectively. The Company has incurred and expects to continue to incur significant costs in pursuit of its expansion and development plans.
Any of these factors could have a material adverse effect on our business, financial condition, results of operations, cash flows, business prospects and the trading price of our common stock. Our ability to meet our capital needs may be harmed by the lo ss of revenue from SRM.
These activities may divert management’s attention from other business concerns, which could have a material adverse effect on our results of operations, financial condition or business.
Removed
These regulations and laws may cover taxation, tariffs, user pricing, distribution, consumer protection and the characteristics and quality of services. Existing or probable governmental regulations relating to CBD products may harm or prevent our ability to sell our product offering. A majority of state governments in the United States have legalized the growing, production, and use of CBD.
Added
There can be no assurance that we will be able to establish internal marketing, sales, or distribution capabilities or that these capabilities will be sufficient to meet our needs. 13 Table of Contents Natural disasters and other events beyond our control could materially adversely affect us.
Removed
However, cannabis remains illegal under federal law. In addition, in July 2017, the United States Drug Enforcement Agency issued a statement that certain CBD extractions fall within the definition of marijuana and are therefore a Schedule I controlled substance under the Controlled Substances Act of 1970, as amended.
Added
As a result, any significant reduction in revenues may immediately and adversely affect our business, financial condition and operating results.
Removed
Thus, the cannabis industry, including companies which sell products containing CBD, faces very uncertain regulation by the federal government.
Added
Our products and manufacturing activities are subject to extensive government regulation, and failure to comply with these laws and regulations, as they currently exist or as modified in the future, may increase our costs, limit or eliminate our ability to sell certain products, subject us or our suppliers to the risk of enforcement action, or otherwise adversely affect our business, results of operations and financial condition.
Removed
While the federal government has for several years chosen to not intervene in the cannabis business conducted legally within the states that have legislated such activities, there is, nonetheless, potential that the federal government may at any time choose to begin enforcing its laws against the manufacture, possession, or use of cannabis-based products such as CBD.
Added
The manufacture, packaging, labeling, advertising, promotion, distribution, import, export and sale of our products are subject to regulation by numerous national and local governmental agencies in the United States and other countries, including but not limited to the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
Removed
Similarly, there is the possibility that the federal government may enact legislation or rules that authorize the manufacturing, possession or use of those products under specific guidelines. Local, state and federal cannabis laws and regulations are broad in scope and subject to evolving interpretations.
Added
Failure to comply with FDA regulatory requirements may result in, among other things, injunctions, product withdrawals, recalls, product seizures, fines, and criminal prosecutions. Any action of this type by the FDA could materially adversely affect our ability to market our products successfully.
Removed
In the event the federal government was to tighten its regulation of the industry, we would likely suffer a material adverse effect on our business, including substantial losses. We have recently ceased the marketing and sale of CBD products. These regulations could negatively affect our ability to dispose of our CBD related assets.
Added
The manufacture of nutritional or dietary supplements and related products in the United States requires compliance with dietary supplement current Good Manufacturing Practice (GMP) regulations, which are based on the food-model GMP regulations, with additional requirements that are specific to dietary supplements.
Removed
We cannot be certain that we will be successful in selecting, developing, manufacturing and marketing new products or in enhancing existing products.
Added
We believe the manufacturing processes for the Safety Shot Dietary Supplement substantially complies with the applicable dietary supplement GMP requirements. Nevertheless, any FDA action determining that such processes do not comply with dietary supplement GMPs could materially adversely affect our ability to manufacture and market the Sure Shot Dietary Supplement in the United States.
Removed
Our business is highly dependent upon receiving approvals from various U.S. and international governmental agencies and will be severely harmed if we are not granted approval to manufacture and sell our product candidates. In order for us to commercialize a product for the treatment of any disease, we must obtain regulatory approvals of such treatment for that indication.
Added
In addition, the Dietary Supplement & Nonprescription Drug Consumer Protection Act requires dietary supplement manufacturers and distributors to notify the FDA when they receive reports of serious adverse events associated with their products that occur within the United States. Individual U.S. states also regulate nutritional supplements.
Removed
Satisfying regulatory requirements is an expensive process that typically takes many years and involves compliance with requirements covering research and development, testing, manufacturing, quality control, labeling, and promotion of drugs for human use. To obtain necessary regulatory approvals, we must, among other requirements, complete clinical trials demonstrating that our products are safe and effective for a particular indication.
Added
A state may seek to interpret claims or products presumptively valid under federal law as illegal under that state’s regulations, or otherwise seek to create restrictions to access under state law.
Removed
There can be no assurance that our products will prove to be safe and effective, that our clinical trials will demonstrate the necessary safety and effectiveness of our product candidates, or that we will succeed in obtaining regulatory approval for any treatment we develop even if such safety and effectiveness are demonstrated.
Added
For example, during the 204 legislative session, several states are considering bills that would restrict the sale of muscle building and/or weight management supplements to people over the age of 18.
Removed
Any delays or difficulties we encounter in our clinical trials may delay or preclude regulatory approval from the FDA or from international regulatory organizations. Any delay or preclusion of regulatory approval would be expected to delay or preclude the commercialization of our products.
Added
Government agencies, as well as legislative bodies, can change existing regulations, or impose new ones, or could take aggressive measures, causing or contributing to a variety of negative consequences, including: ● requirements for the reformulation of products to meet new standards; ● the recall or discontinuance of products; ● additional record-keeping requirements; ● expanded documentation of the properties of certain or all products; ● expanded or different labeling or advertising for products; ● expanded adverse event tracking and reporting requirements; and ● additional scientific substantiation to support product claims.
Removed
Examples of delays or difficulties that we may encounter in our clinical trials include without limitation the following: ● Clinical trials may not yield sufficiently conclusive results for regulatory agencies to approve the use of our products; ● Our products may fail to be more effective than current therapies, or to be effective at all; ● We may discover that our products have adverse side effects, which could cause our products to be delayed or precluded from receiving regulatory approval or otherwise expose us to significant commercial and legal risks; ● It may take longer than expected to determine whether or not a treatment is effective; ● Patients involved in our clinical trials may suffer severe adverse side effects even up to death, whether as a result of treatment with our products, the withholding of such treatment, or other reasons (whether within or outside of our control); ● We may fail to be able to enroll a sufficient number of patients in our clinical trials; ● Patients enrolled in our clinical trials may not have the characteristics necessary to obtain regulatory approval for a particular indication or patient population; 10 Table of Contents ● We may be unable to produce sufficient quantities of product to complete the clinical trials; ● Even if we are successful in our clinical trials, any required governmental approvals may still not be obtained or, if obtained, may not be maintained; ● If approval for commercialization is granted, it is possible the authorized use will be more limited than is necessary for commercial success, or that approval may be conditioned on completion of further clinical trials or other activities, which will cause a substantial increase in costs and which we might not succeed in performing or completing; and ● If granted, approval may be withdrawn or limited if problems with our products emerge or are suggested by the data arising from their use or if there is a change in law or regulation.
Added
We cannot predict the nature of any future laws, regulations, interpretations, or applications, nor can we determine what effect additional governmental regulations or administrative orders, when and if promulgated, could have on our business, financial condition, or results of operations.
Removed
Any success we may achieve at a given stage of our clinical trials does not guarantee that we will achieve success at any subsequent stage, including without limitation final FDA approval.
Added
We are subject to government regulations of the processing, formulation, packaging, labeling and advertising of our wellness and dietary supplement products.
Removed
We may encounter delays or rejections in the regulatory approval process because of additional government regulation resulting from future legislation or administrative action, or from changes in the policies of the FDA or other regulatory bodies during the period of product development, clinical trials, or regulatory review.
Added
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), companies that manufacture and distribute functional foods and dietary supplements, such as our Safety Shot Dietary Supplement, are limited in the claims that they are permitted to make about nutritional support on the product label without FDA approval.
Removed
Failure to comply with applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspension of production, or an injunction preventing certain activity, as well as other regulatory action against our product candidates or us.
Added
Any failure by us to adhere to the labeling requirements could lead to the FDA requiring that our products be repackaged and relabeled, which would have a material adverse effect on our business. In addition, companies are responsible for the accuracy and truthfulness of, and must have adequate scientific substantiation for, any nutritional or functional claims.
Removed
We have no experience in successfully obtaining regulatory approval for a product and thus may be poorly equipped to gauge, and may prove unable to manage, risks relating to obtaining such approval. Outside the U.S., our ability to market a product is contingent upon receiving clearances from appropriate non-U.S. regulatory authorities.
Added
These claims must be truthful and not misleading.
Removed
Non-U.S. regulatory approval typically includes all of the risks associated with FDA clearance discussed above as well as geopolitical uncertainties and the additional uncertainties and potential prejudices faced by U.S. pharmaceutical companies conducting business abroad. In certain cases, pricing restrictions and practices can make achieving even limited profitability very difficult.
Added
Promotional claims about foods and dietary supplements also must not include statements that the product can diagnose, mitigate, treat, cure or prevent a specific disease or class of disease. 14 Table of Contents We believe we are able to market our Sure Shot Dietary Supplement product in reliance on the self-affirmed Generally Recognized As Safe (GRAS) status of our formulation’s current ingredients.
Removed
We have limited experience in completing regulatory filings and any delays in regulatory filings could materially affect our financial condition. We are currently initiating clinical trials of our product candidates.
Added
No governmental agency or other third party has made a determination as to whether or not the Sure Shot Dietary Supplement has achieved GRAS status. We make this determination based on independent scientific opinions that the individual ingredients and formulation as a whole are not harmful under their intended conditions of use.
Removed
We have not, however, demonstrated the ability to obtain marketing approvals, manufacture product candidates at a commercial scale, or conduct sales and marketing activities necessary for the successful commercialization of a product. Consequently, we have no historical basis as a company by which one can evaluate or predict reliably our future success or viability.
Added
If the FDA, another regulatory authority or other third party denied our self-affirmed GRAS status for the Sure Shot Dietary Supplement, we could face significant penalties or be required to undergo the regulatory approval process in order to market our product, and our business, financial condition and results of operations will be adversely affected.
Removed
Additionally, while our team has experience at prior companies with regulatory filings, we have limited experience with regulatory filings with agencies such as the FDA or the European Medicines Agency, or EMA, and will rely on third-party expertise for this.
Added
We cannot guarantee that in such a situation the Sure Shot Dietary Supplement would be approved. The processing, formulation, packaging, labeling and advertising of our products may also be subject to regulation by the FTC, the Environmental Protection Agency (EPA), and various agencies of the states and localities in which the products are sold.
Removed
Any delay in our regulatory filings for our product candidates, and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including, without limitation, the FDA’s issuance of a “refuse to file” letter or a request for additional information, could materially affect our financial condition.

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Item 2. Properties

Properties — owned and leased real estate

1 edited+1 added−1 removed0 unchanged
Biggest changeWe do not own any real estate. 20 Table of Contents
Biggest changeAs part of the Separation Agreement, Caring Brands, Inc. has agreed to assume to lease obligations upon it reaching certain milestones. We do not own any real estate. 20 Table of Contents
Removed
ITEM 2. PROPERTIES Our principal executive office is located in leased premises of approximately 6,908 square feet at 1061 E. Indiantown Rd., Ste. 110, Jupiter, FL 33477. We believe that these facilities are adequate for our needs, including providing the space and infrastructure to accommodate our development work based on our current operating plan.
Added
ITEM 2. PROPERTIES Currently, we do not own any real property. We rent office space at 1061 E. Indiantown Rd., Ste. 110, Jupiter, FL 33477 for $15,038 per month. The Company entered into the office lease effective July 1, 2021, which has a primary term of the lease of five years with one renewal option for an additional three years.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

8 edited+6 added−10 removed13 unchanged
Biggest changeThe Litigation seeks compensatory general and liquidated damages in an amount to be proven at trial. The Company intends to defend itself vigorously against Alta’s claims and does not believe that the Litigation’s ultimate disposition or resolution will have a material adverse effect on the Company’s financial position, results of operations or liquidity.
Biggest changeThe Litigation seeks compensatory general and liquidated damages in an amount to be proven at trial. On or about January 29, 2025, the Company settled the Litigation by agreeing to pay $350,000 in exchange for a release of all claims by Alta.
LEGAL PROCEEDINGS On November 30, 2023, Intracoastal Capital, LLC (“Intracoastal”) filed a lawsuit against the Company in the New York County Supreme Court, alleging that (i) the Company is in breach of a common stock warrant issued to Intracoastal on or about July 26, 2021, and (ii) that the Company should be ordered by the court to deliver to Intracoastal 330,619 free trading shares of Company common stock (the “Litigation”).
LEGAL PROCEEDINGS On November 30, 2023, Intracoastal Capital, LLC (“Intracoastal”) filed a lawsuit against the Company in the New York County Supreme Court, alleging that (i) the Company is in breach of a common stock warrant issued to Intracoastal on or about July 26, 2021, and (ii) that the Company should be ordered by the court to deliver to Intracoastal 330,619 free trading shares of Company common stock (the “Intracoastal Litigation”).
Sabby’s initial complaint alleges that the Company has improperly refused to honor Sabby’s exercise of a Warrant to acquire 2,105,263 shares of common stock. On March 8, 2024, Sabby filed an amended complaint. The Company’s answer to the amended complaint is due on March 29, 2024.
Sabby’s initial complaint alleges that the Company has improperly refused to honor Sabby’s exercise of a Warrant to acquire 2,105,263 shares of common stock. On March 8, 2024, Sabby filed an amended complaint. The Company has answered the amended complaint is due on March 29, 2024.
The Company intends to defend itself vigorously against Sabby’s claims and does not believe that the Litigation’s ultimate disposition will have a material adverse effect on the Company’s financial position, results of operations or liquidity.
The Company intends to defend itself vigorously against Sabby’s claims and does not believe that the Litigation’s ultimate disposition will have a material adverse effect on the Company’s financial position, results of operations or liquidity. On January 10, 2024, Bigger Capital Fund, L.P.
The Company intends to vigorously defend itself against Sabby’s claims and does not believe that the Litigation’s ultimate disposition or resolution will have a material adverse effect on the Company’s financial position, results of operations or liquidity.
The Company intends to vigorously defend itself against Sabby’s claims and does not believe that the Litigation’s ultimate disposition or resolution will have a material adverse effect on the Company’s financial position, results of operations or liquidity. The case was dismissed with prejudice by the federal district court for the Southern District of New York on September 23, 2024.
(“Bigger”), filed a lawsuit against the Company in the Supreme Court for the State of New York, Case No. 650148/2024 (the “Litigation”). The Litigation stems from the Company’s warrant to purchase 1,656,050 shares of Company common stock issued to Bigger Capital on July 20, 2021, and asserts causes of action for Breach of Contract, Specific Performance and Declaratory Relief.
The Litigation stemmed from the Company’s warrant to purchase 1,656,050 shares of Company common stock issued to Bigger Capital on July 20, 2021, and asserts causes of action for Breach of Contract, Specific Performance and Declaratory Relief.
The Litigation seeks compensatory damages in an amount no less than $2 million, in addition to liquidated damages and attorney’s fees. The Company answered Intracoastal’s complaint on or about January 26, 2024.
The Intracoastal Litigation seeks compensatory damages in an amount no less than $2 million, in addition to liquidated damages and attorney’s fees. On January 14, 2025, the Company settled all issues and claims relating to the Intracoastal Litigation pursuant to the terms of the Intracoastal Settlement Agreement.
The Litigation seeks compensatory damages of $3 million, liquidated damages in an estimated amount of $4 million, specific performance, attorney’s fees and declaratory relief. On or about March 4, 2024, the Company filed its answer to Bigger’s complaint.
Pursuant to the Bigger Litigation, Bigger capital sought compensatory damages of $3 million, liquidated damages in an estimated amount of $4 million, specific performance, attorney’s fees and declaratory relief. On January 20, 2025, the Company entered into the Bigger Settlement Agreement.
Removed
The Company intends to vigorously defend itself against Intracoastal’s claims and does not believe that the Litigation’s ultimate disposition or resolution will have a material adverse effect on the Company’s financial position, results of operations or liquidity.
Added
Under the Intracoastal Settlement Agreement, the Company agreed to issue to Intracoastal Capital the following: (i) the Intracoastal Settlement Shares and (ii) a settlement payment of $175,000. The number of Intracoastal Settlement Shares shall be the greater of the Initial Share Amount or the Adjusted Share Amount. The Intracoastal Settlement Agreement is filed herein as Exhibit 10.33.
Removed
On December 8, 2023, the Company filed a lawsuit against Capybara Research (“Capybara”), Igor Appelboom (“Appelboom,” and together with Capybara Research, the “Capybara Parties”) and Accretive Capital LLC d/b/a Benzinga (“Capybara Parties and Accretive, together, the “Capybara Defendants”) in the United States District Court for the Southern District of New York.
Added
On October 10, 2024, Sabby filed an appeal of the Southern District’s dismissal to the United States Court of Appeals for the Second Circuit. The Company is awaiting the decision from the Court of Appeals for the Second Circuit.
Removed
The Company’s complaint alleges that (i) the Capybara Parties are liable for securities fraud to the Company for making false representations that were made to manipulate the price of the Company’s common stock to the benefit of the Capybara Parties, and (ii) the Capybara Defendants are liable for tortious interference with prospective business relations to the Company by misleading the investing public to—absent a legitimate basis and, instead, for the benefit of the Capybara Defendants—take short positions against Company common stock to wrongfully depress the price of the same.
Added
(“Bigger Capital”), filed a lawsuit against the Company in the Supreme Court for the State of New York, Case No. 650148/2024 (the “Bigger Litigation”).
Removed
On March 18, 2024, the United District Court for the Southern District of New York, awarded the Company a Default Judgment in its lawsuit against Capybara Research and Igor Appelboom for Securities Fraud and Tortious Interference for the defendants’ defamatory, unfounded and malicious article titled, Safety Shot Exposed $SHOT, Boca Raton Snake Oil: Unraveling the Fraud behind the Drink and Its Dubious Origins.
Added
In exchange for a resolution to all issues and claims that relate to the previously filed action against the Company in the Supreme Court of the State of New York, New York County, Index No. 65018/2024.
Removed
In a separate settlement agreement, Defendant Accreative Capital LLC d/b/a Benzinga, agreed to retract and remove the defamatory story from its website and cease from any future publication.
Added
Pursuant to the Bigger Settlement Agreement, the Company agreed to pay or issue to Bigger Capital the following: (i) pay Bigger Capital $375,000; (ii) issue a secured convertible note in the principal amount of $1.75 million maturing on December 31, 2026 (the “Secured Convertible Bigger Note”); (iii) a convertible note in the principal amount of $3.5 million maturing June 30, 2025 (the “Convertible Bigger Note,” and, together with the Secured Convertible Bigger Note, the “Bigger Notes”); and (iv) 5,332,889 shares of common stock issuable upon the exercise of common stock purchase warrants to purchase shares of common stock of the Company at an exercise price of $0.4348 per share (the “Bigger Warrants”).
Removed
On January 19, 2024, Coachella Music Festival, LLC filed a lawsuit against the Company in the federal district court for the Central District of California, Case No. 2:24-cv-537 (the “Litigation”). The Litigation asserts causes of action for Trademark Infringement under 15 U.S.C. Section 1114; False Designation of Origin under 15 U.S.C. Section 1125; False Advertising under 15 U.S.C.
Added
A significant shareholder of the Company and Bigger Capital entered into a voting agreement in favor of Bigger Capital in addition to the Bigger Settlement Agreement. The Bigger Settlement Agreement is filed herein as Exhibit 10.32. The Secured Convertible Bigger Note is filed herein as Exhibit 4.5 and the Convertible Bigger Note is filed herein as Exhibit 4.6.
Removed
Section 1125; violations of Cal. Bus. & Prof. Code Sections 17200 & 17500; Inducement of Trespass; Conversion; and Trespass to Chattels. The Litigation seeks injunctive relief, profits resulting from the Company’s alleged infringement, the value of a Coachella beverage sponsorship, costs of corrective advertising, attorney’s fees and punitive damages.
Removed
On or about February 26, 2024, the parties reached a settlement in this matter.
Removed
As part of the settlement, the Company agreed to terminate all activities in connection with the Festival, and stipulated to the entry of a permanent injunction and final judgment and a monetary payment that does not have a material adverse effect on the Company’s financial position, results of operations or liquidity. On January 10, 2024, Bigger Capital fund, L.P.
Removed
The Company intends to defend itself vigorously against Bigger’s claims and does not believe that the Litigation’s ultimate disposition or resolution will have a material adverse effect on the Company’s financial position, results of operations or liquidity.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe Consideration Shares were issued on August 29, 2023 and the acquisition was closed on August 31, 2023 Securities Authorized for Issuance under Equity Compensation Plans On October 31, 2023 and December 5, 2023, our Board of Directors and majority shareholders, respectively, approved the Safety Shot, Inc. 2023 Equity Incentive Plan (the “2023 Plan”), to be administered by our Compensation Committee.
Biggest changeIssuance of Unregistered Securities There were no sales of unregistered securities during the fiscal year ended December 31, 2024 other than those transactions previously reported to the SEC on our quarterly reports on Form 10-Q and current reports on Form 8-K. 22 Table of Contents Securities Authorized for Issuance under Equity Compensation Plans On July 31, 2023 and January 17, 2024, our Board of Directors and majority shareholders, respectively, approved the Safety Shot, Inc. 2024 Equity Incentive Plan (the “2024 Plan”), to be administered by our Compensation Committee.
The purchase price of each share of common stock purchasable under an award issued pursuant to the 2022 Plan, shall be determined by our Compensation Committee, in its sole discretion, at the time of grant, but shall not be less than 100% of the fair market of such share of common stock on the date the award is granted, subject to adjustment.
The purchase price of each share of common stock purchasable under an award issued pursuant to the 2024 Plan, shall be determined by our Compensation Committee, in its sole discretion, at the time of grant, but shall not be less than 100% of the fair market of such share of common stock on the date the award is granted, subject to adjustment.
Pursuant to the 2023 Plan, we are authorized to grant options and other equity awards to officers, directors, employees and consultants.
Pursuant to the 2024 Plan, we are authorized to grant options and other equity awards to officers, directors, employees and consultants.
Our Compensation Committee shall also have sole authority to set the terms of all awards at the time of the grant. Pursuant to the 2022 Plan, a maximum of 4,000,000 shares of our common stock shall be set aside and reserved for issuance, subject to adjustments as may be required in accordance with the terms of the 2022 Plan.
Our Compensation Committee shall also have sole authority to set the terms of all awards at the time of the grant. Pursuant to the 2024 Plan, a maximum of 15,000,000 shares of our common stock shall be set aside and reserved for issuance, subject to adjustments as may be required in accordance with the terms of the 2023 Plan.
On September 14, 2022, and December 22, 2022, our Board of Directors and majority shareholders, respectively, approved the Safety Shot, Inc. 2022 Equity Incentive Plan (the “2022 Plan”), to be administered by our Compensation Committee. Pursuant to the 2022 Plan, we are authorized to grant options and other equity awards to officers, directors, employees and consultants.
On October 31, 2023 and December 5, 2023, our Board of Directors and majority shareholders, respectively, approved the Safety Shot, Inc. 2023 Equity Incentive Plan (the “2023 Plan”), to be administered by our Compensation Committee. Pursuant to the 2023 Plan, we are authorized to grant options and other equity awards to officers, directors, employees and consultants.
As of March 18, 2024, there were 36 shareholders of record. Dividends We do not anticipate paying any cash dividends on our common stock in the foreseeable future and we intend to retain all of our earnings, if any, to finance our growth and operations and to fund the expansion of our business.
Dividends We do not anticipate paying any cash dividends on our common stock in the foreseeable future and we intend to retain all of our earnings, if any, to finance our growth and operations and to fund the expansion of our business.
Period High Low 2023 Fiscal Year: Fourth Quarter Ended December 31, 2023 $ 7.50 $ 1.04 Third Quarter Ended September 30, 2023 $ 1.58 $ 0.32 Second Quarter Ended June 30, 2023 $ 0.48 $ 0.27 First Quarter Ended March 31, 2023 $ 0.97 $ 0.28 2022 Fiscal Year: Fourth Quarter Ended December 31, 2022 $ 1.47 $ 0.59 Third Quarter Ended September 30, 2022 $ 1.03 $ 0.53 Second Quarter Ended June 30, 2022 $ 1.06 $ 0.54 First Quarter Ended March 31, 2022 $ 1.35 $ 0.57 We consider our common stock to be thinly traded and, accordingly, reported sales prices or quotations may not be a true market-based valuation of our common stock.
Period High Low 2024 Fiscal Year: Fourth Quarter Ended December 31, 2024 $ 1.35 $ 1.67 Third Quarter Ended September 30, 2024 $ 1.77 $ 1.55 Second Quarter Ended June 30, 2024 $ 2.46 $ 1.00 First Quarter Ended March 31, 2024 $ 4.05 $ 1.95 2023 Fiscal Year: Fourth Quarter Ended December 31, 2023 $ 7.50 $ 1.04 Third Quarter Ended September 30, 2023 $ 1.58 $ 0.32 Second Quarter Ended June 30, 2023 $ 0.48 $ 0.27 First Quarter Ended March 31, 2023 $ 0.97 $ 0.28 We consider our common stock to be thinly traded and, accordingly, reported sales prices or quotations may not be a true market-based valuation of our common stock.
No dividends may be declared or paid on our common shares, unless a dividend, payable in the same consideration or manner, is simultaneously declared or paid, as the case may be, on our shares of preferred stock, if any. Issuance of Securities On April 20, 2022, Safety Shot, Inc. (the “Company”) entered into a $1,500,000 Loan Agreement (the “Greentree Loan”).
No dividends may be declared or paid on our common shares, unless a dividend, payable in the same consideration or manner, is simultaneously declared or paid, as the case may be, on our shares of preferred stock, if any.
Removed
Pursuant to the Greentree Loan the Company issued a Convertible Promissory Note in the principal amount of $1,500,000 (the “Greentree Note”) and the issuance of a Common Stock Purchase Warrant for 1,100,000 shares of the Company’s common stock (the “Greentree Warrant”).
Added
As of March 30, 2025, there were 42 holders of record of our common stock, and no holders of record of our warrants.
Removed
The Greentree Note has a maturity date of January 31, 2024. 22 Table of Contents On April 20, 2022, the Company entered into a $500,000 Loan Agreement (the “L&H Loan,” collectively with Greentree Loan as the “Loan Agreements”).
Removed
Pursuant to the L&H Loan the Company issued a Convertible Promissory Note in the principal amount of $500,000 (the “L&H Note,” collectively with Greentree Note as the “Notes”) and the issuance of a Common Stock Purchase Warrant for 360,000 shares of the Company’s common stock (the “L&H Warrant,” collectively with Greentree Warrant as the “Warrants”).
Removed
The L&H Note has a maturity date of January 31, 2024.
Removed
On January 19, 2023, in a private placement, the Company entered into a Securities Purchase Agreement (the “PIPE Agreement”) with certain purchasers, for the issuance of 8,631,574 common stock warrants (the “PIPE Offering”) at a price of $0.125 per warrant, comprised of two common stock warrants (the “Common Warrants,”), each to purchase up to one share of Common Stock per Common Warrant with an exercise price of $1.00 per share, with (a) 4,315,787 Common Warrants being immediately exercisable for three years following 6 months from the closing of the PIPE Offering, and (b)4,315,787 Common Warrants being immediately exercisable for five years following 6 months from the closing of the PIPE Offering.
Removed
On February 14,2023, the Company filed an S-1 Registration Statement covering the underlying shares of the Warrants. On March 31, 2023 the Company entered into a Financial Advisory Agreement (“FSA”) with Greentree Financial Group, Inc. to render certain professional services to the Company. In connection with the FSA, The Company issued 500,000 restricted shares of its common stock to Greentree.
Removed
On July 10, 2023, the Company entered into an asset purchase agreement (the “APA”) with GBB Labs, Inc., a Delaware corporation (“Buyer”), GBB Drink Lab Inc., a Florida corporation (“Seller”), 2V Consulting LLC, a Florida limited liability company, the Jarrett A Boon Revocable Trust Dated October 22, 2014, Gregory D. Blackman, an individual and Brothers Investment 7777.
Removed
Pursuant to the Agreement, the Buyer shall purchase certain assets relating to the Seller’s an, an individual and Brothers business for a consideration comprising of: (a) the sum of Two Hundred Thousand U.S.
Removed
Dollars (US $200,000) (the “Cash Purchase Price”); and (b) 5,000,000 restricted Common Shares (the “Consideration Shares” and together with the Cash Purchase Price, collectively, the “Purchase Price, collectively, the “Purchase Price”).

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

19 edited+3 added−0 removed66 unchanged
Biggest changeOperating expenses for the year ended December 31, 2022 totaled $14,078,784 were in connection with our daily operations as follows: (i) marketing expenses of $84,689; (ii) research and development of $1,637,148 which included clinical trials; (iii) legal and professional expenses of $3,579,148 primarily for due diligence and legal work on two proposed mergers and litigation along with corporate advisory services, registration statement preparation fees, general corporate governance fees; (iv) rent and utilities of $170,973; (v) depreciation and amortization of $93,472; (vi) general and administrative expenses of $1,438,464, consisting of payroll and related taxes, travel, meals and entertainment, office supplies and expense and other normal office and administration expenses; (vii) stock based compensation of $4,581,921 consisting primarily of the fair value of options and warrants; (viii) an impairment to a promissory note of $1,000,000; and (ix) an impairment to Intellectual Property of $1,475,000.
Biggest changeOperating Expenses We had total operating expenses of $39,611,915 for the year ended December 31, 2024 compared to $12,524,869 for the year ended December 31, 2023. 29 Table of Contents Operating expenses for the year ended December 31, 2024, totaled $39,611,915 and were in connection with our daily operations as follows: (i) marketing expenses of $7,038,078; (ii) research and development of $232,161 which included clinical trials; (iii) legal and professional expenses of $8,063,858 primarily for due diligence and legal work on a proposed merger and litigation along with corporate advisory services, registration statement preparation fees, general corporate governance fees; (iv) rent and utilities of $275,247; (v) depreciation and amortization of $428,827; (vi) general and administrative expenses of $3,117,507, consisting of payroll and related taxes, travel, meals and entertainment, office supplies and expense and other normal office and administration expenses; and (vii) stock based compensation of $20,456,237 consisting of the fair value of stock issued in lieu of cash.
Critical Accounting Policies Our management’s discussion and analysis of our financial condition and results of operations is based on our audited financial statements for the year ended December 31, 2023 and 2022, which have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, and the rules and regulations of the Securities and Exchange Commission.
Critical Accounting Policies Our management’s discussion and analysis of our financial condition and results of operations is based on our audited financial statements for the year ended December 31, 2024 and 2023, which have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, and the rules and regulations of the Securities and Exchange Commission.
Our unaudited financial statements are stated in United States Dollars (US$) and are prepared in accordance with United States Generally Accepted Accounting Principles. The following discussion should be read in conjunction with our financial statements and the related notes that appear elsewhere in this annually report. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs.
Our audited financial statements are stated in United States Dollars (US$) and are prepared in accordance with United States Generally Accepted Accounting Principles. The following discussion should be read in conjunction with our financial statements and the related notes that appear elsewhere in this annually report. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs.
The Company provides an allowance for doubtful collections, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. During the years ended December 31, 2023 and 2022, the Company recognized no allowance for doubtful collections.
The Company provides an allowance for doubtful collections, which is based upon a review of outstanding receivables, historical collection information, and existing economic conditions. During the years ended December 31, 2024 and 2023, the Company recognized no allowance for doubtful collections.
Warrants are not considered in the calculations for the years ended December 31, 2023 and 2022, as the impact of the potential common shares would be to decrease the loss per share.
Warrants are not considered in the calculations for the years ended December 31, 2024 and 2023, as the impact of the potential common shares would be to decrease the loss per share.
The adoption of this standard has not had a significant impact on the Company’s results of operations, financial condition, cash flows, and financial statement disclosures. Results of Operations For the years ended December 31, 2023 and 2022 The following table provides selected financial data about us for the year ended December 31, 2022 and 2021, respectively.
The adoption of this standard has not had a significant impact on the Company’s results of operations, financial condition, cash flows, and financial statement disclosures. Results of Operations For the years ended December 31, 2024 and 2023 The following table provides selected financial data about us for the year ended December 31, 2024 and 2023, respectively.
Operating Expenses We had total operating expenses of $12,524,869 for the year ended December 31, 2023 compared to $14,078,784 for the year ended December 31, 2022. 29 Table of Contents Operating expenses for the year ended December 31, 2023 totaled $12,524,869 and were in connection with our daily operations as follows: (i) marketing expenses of $566,666; (ii) research and development of $100,591 which included clinical trials; (iii) legal and professional expenses of $4,856,586 primarily for due diligence and legal work on two proposed mergers and litigation along with corporate advisory services, registration statement preparation fees, general corporate governance fees; (iv) rent and utilities of $206,871; (v) depreciation and amortization of $215,175; (vi) general and administrative expenses of $4,296,899, consisting of payroll and related taxes, travel, meals and entertainment, office supplies and expense and other normal office and administration expenses; (vii) stock based compensation of $2,082,081 consisting of the fair value of stock issued in lieu of cash and (viii) impairment of a $200,000 advance to an affiliate.
Operating expenses for the year ended December 31, 2023, totaled $12,524,869 and were in connection with our daily operations as follows: (i) marketing expenses of $566,666; (ii) research and development of $100,591 which included clinical trials; (iii) legal and professional expenses of $4,856,586 primarily for due diligence and legal work on two proposed mergers and litigation along with corporate advisory services, registration statement preparation fees, general corporate governance fees; (iv) rent and utilities of $206,871; (v) depreciation and amortization of $215,175; (vi) general and administrative expenses of $4,296,899, consisting of payroll and related taxes, travel, meals and entertainment, office supplies and expense and other normal office and administration expenses; (vii) stock based compensation of $2,082,081 consisting of the fair value of stock issued in lieu of cash and (viii) impairment of a $200,000 advance to an affiliate.
Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. Recently Issued Accounting Pronouncements In June 2018, the FASB issued ASU 2018-07, which simplifies the accounting for non-employee share-based payment transactions.
Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned. Recent l y Issued Accounting Pronouncements In June 2018, the FASB issued ASU 2018-07, which simplifies the accounting for non-employee share-based payment transactions.
Our policy for recording interest and penalties associated with audits is to record such items as a component of income tax expense. The Company’s deferred tax asset at December 31, 2023 and 2022 consists of net operating loss carry forwards calculated using federal and state effective tax rates equating to approximately $8,658,484 and $6,674,042, respectively.
Our policy for recording interest and penalties associated with audits is to record such items as a component of income tax expense. The Company’s deferred tax asset at December 31, 2024 and 2023 consists of net operating loss carry forwards calculated using federal and state effective tax rates equating to approximately $14,660,582 and $8,658,484, respectively.
There were no cash equivalents as December 31, 2023 and 2022. 27 Table of Contents Foreign Currency Translation Assets and liabilities in foreign currencies are translated using the exchange rate at the balance sheet date, while revenue and expense accounts are translated at the average exchange rates prevailing during the period. Equity accounts are translated at historical exchange rates.
There were no cash equivalents as December 31, 2024 and 2023. 27 Table of Contents Fore ig n Currency Translation Assets and liabilities in foreign currencies are translated using the exchange rate at the balance sheet date, while revenue and expense accounts are translated at the average exchange rates prevailing during the period.
Due to the Company’s lack of earnings history, the deferred tax asset has been fully offset by a valuation allowance of $8,658,484 and $6,674,042 for the years ended December 31, 2023 and 2022. Research and Development The Company accounts for research and development costs in accordance with the Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”).
Due to the Company’s lack of earnings history, the deferred tax asset has been fully offset by a valuation allowance of $14,660,582 and $8,658,484 for the years ended December 31, 2024 and 2023. Research and Development The Company accounts for research and development costs in accordance with the Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”).
The Company incurred research and development expenses of $100,591 and $1,637,117 for the year ended December 31, 2023 and 2022, respectively. 28 Table of Contents Stock Based Compensation We recognize compensation costs to employees under FASB Accounting Standards Codification 718 “Compensation - Stock Compensation” (“ASC 718”).
The Company incurred research and development expenses of $ 271,719 and $100,591 for the year ended December 31, 2024 and 2023, respectively. 28 Table of Contents Stock Based Compensation We recognize compensation costs to employees under FASB Accounting Standards Codification 718 “Compensation - Stock Compensation” (“ASC 718”).
Gains and losses from foreign currency transactions and translation for the years ended December 31, 2023 and 2022 and the cumulative translation gains and losses as of December 31, 2023 and 2022 were not material. Accounts Receivable Accounts receivable are generated from sales of the Company’s products.
Equity accounts are translated at historical exchange rates. Gains and losses from foreign currency transactions and translation for the years ended December 31, 2024 and 2023 and the cumulative translation gains and losses as of December 31, 2024 and 2023 were not material. Accounts Receivable Accounts receivable are generated from sales of the Company’s products.
Other income and expense Other income and expense for the year ended December 31, 2023, included realized gains of $244,504 on the sale of marketable securities and $1,511,488 of unrealized losses on unsold marketable securities, unrealized loss of $864,418 on equity investment, net interest expense of $114,093 and other income of $23,308, compared to net interest expense of $1,284,664, which includes $1,104,477 fair value of warrants and net other income of $790 for the year ended December 31, 2022.
Other income and expense for the year ended December 31, 2023, included realized gains of $244,504 on the sale of marketable securities and $1,511,488 of unrealized losses on unsold marketable securities, unrealized loss of $864,418 on equity investment, net interest expense of $114,093 and other income of $23,308.
For the Years Ended December 31, 2023 2022 Numerator: $ (15,083,041 ) $ (15,223,028 ) Net (loss) Denominator: Denominator for basic earnings per share - Weighted-average common shares issued and outstanding during the period 30,877,804 22,106,703 Denominator for diluted earnings per share 30,877,804 22,106,703 Basic (loss) per share $ (0.49 ) $ (0.69 ) Diluted (loss) per share $ (0.49 ) $ (0.69 ) Cash We consider all short-term investments with a maturity of three months or less when purchased to be cash and equivalents for purposes of the statement of cash flows.
For the Years Ended December 31, 2024 2023 Numerator: (49,409,632 ) (15,083,041 ) Net (loss) Deemed Dividend (2,293,301 ) - Loss attributable to shareholders $ (51,702,933 ) $ (15,083,041 ) Denominator: Denominator for basic earnings per share - Weighted-average common shares issued and outstanding during the period 54.441,190 30,877,804 Denominator for diluted earnings per share 54,441,190 30,877,804 Basic (loss) per share $ (0.91 ) $ (0.49 ) Diluted (loss) per share $ (0.91 ) $ (0.49 ) Loss per share attributed to common shareholders $ (0.95 ) - Cash We consider all short-term investments with a maturity of three months or less when purchased to be cash and equivalents for purposes of the statement of cash flows.
Income and loss from discontinued operations For the year ended December 31, 2023 and 2022, The Company had losses from discontinued operations of $261,528 and income of $344,172, respectively. Income/Losses Net losses were $15,083,041 and $15,223,028 for the years ended December 31, 2023 and 2022, respectively.
Income and loss f rom discontinued operations For the year ended December 31, 2024 and 2023, The Company had losses from discontinued operations of $997,802 and $261,528, respectively. Income/Losses Net losses were $49,409,632 and $15,083,041 for the years ended December 31, 2024 and 2023, respectively.
Impact of Inflation We believe that inflation has had a negligible effect on operations since inception. We believe that we can offset inflationary increases in the cost of operations by increasing sales and improving operating efficiencies.
We believe that we can offset inflationary increases in the cost of operations by increasing sales and improving operating efficiencies.
As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant.
As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant. For options granted to employes, we use a plain vanilla Black-Scholes calculation to calculate fair value with standard market inputs.
December 31, December 31, 2023 2022 Sales $ 202,670 $ 120,727 Cost of Sales 277,127 325,169 Gross Profit (Loss) (74,457 ) (204,542 ) Total operating expenses 12,524,869 14,078,784 Other (income) expenses 2,222,187 1,283,874 Net Loss from continuing operations $ (14,821,513 ) $ (15,567,200 ) Income (loss) from discontinued operations (261,528 ) 344,172 Net Loss $ (15,083,041 ) $ (15,223,028 Revenues We generated $202,670 in revenues for the year ended December 31, 2023 compared to $120,727 revenues for the year ended December 31, 2022.
December 31, 2024 December 31, 2023 Sales $ 701,967 $ 202,670 Cost of Sales 3,147,724 277,127 Gross Profit (Loss) (2,445,757 ) (74,457 ) Total operating expenses 39,611,915 12,524,869 Other (income) expenses 6,354,158 2,222,187 Net Loss from continuing operations $ (48,411,830 ) $ (14,821,513 ) Income (loss) from discontinued operations (997,802 ) (261,528 ) Net Loss $ (49,409,632 ) $ (15,083,041 ) Deemed Dividend $ (2,293,301 ) - Loss attributable to shareholders $ (51,702,933 ) (15,083,041 ) Revenues We generated $701,967 in revenues for the year ended December 31, 2024 compared to $202,670 revenues for the year ended December 31, 2023.
Added
Other income and expense Other income and expense for the year ended December 31, 2024, included realized gains of $1,193,666 on the sale of marketable securities and $862,407 of unrealized losses on unsold marketable securities, net interest expense of $118,325 and other income of $6,567,092.
Added
Deemed Dividend In connection with the settlement with Bigger Capital, Company agreed to cancel 1,656,050 original warrants with an exercise price of $1.40 held by Bigger in exchange for 5,332,889 “exchange” warrants with an exercise price of $0.4348.
Added
The fair value of the exchange warrants is $2,732,329 which is offset by the fair value of the remaining life of the original warrant of $439,028 and is considered a deemed dividend attributable to the shareholders in the determination of earnings (loss) per share. Impact of Inflation We believe that inflation has had a negligible effect on operations since inception.

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