We are a wellness consumer products company. We offer several over-the-counter, or (OTC) and cosmetic, consumer products. Our method of operation is to ensure that (1) the mechanism of action of all products is established, (2) efficacy is determined through controlled clinical trials, (3) products are protected by issued and filed patents, and (4) products have acceptable commercial stability. Prior to its Q3 2022 commercial launch in India as a treatment for vitiligo and psoriasis, Photocil was briefly launched in the United States markets from December 2022 until February 2023, however, was subsequently removed from the market due to insufficient sales resulting from the lack of a dedicated sales and marketing team. We are currently preparing for its relaunch in the United States, which is targeted for 2025, as we explore manufacturing and marketing options. The product formulation has not been changed since its removal from the US markets, and no changes to the formulation are planned for the proposed U.S. market relaunch. Photocil is a narrow band UV filter that focuses UV in the 311nm range which is therapeutic for vitiligo and psoriasis. Dimethicone, also called polymethylsiloxane, is a silicon-based polymer used as a lubricant and conditioning agent. It is the USP (United States Pharmacopeia, which is the official compendium of standards for medicines and healthcare products in the United States) monographed ingredient in Photocil. Dimethicone is used to create a smooth feel and a water-resistant barrier on the skin. In addition to dimethicone, Photocil contains two UV filters that restrict the band width of UV rays on the skin to a narrow-range ~ 308 nm. This narrow-band UV has therapeutic properties. These proprietary technologies are not found in other sunscreens and Photocil does not contain conventional UV blockers found in the majority of sunscreens. The product is categorized as an OTC product in the United States, using an USP monographed ingredient as a skin protectant, with FDA-registered labeling (USP monographed: A reference to ingredients listed in the United States Pharmacopeia (USP), which is the official compendium of standards for medicines and healthcare products in the United States). Photocil does not require FDA pre-market approval as it uses GRASE (Generally Recognized as Safe and Effective) ingredients and is currently marketed in India under local cosmetic regulations. Photocil is a cosmetic product designed to block certain UV radiation while allowing other UV radiation to pass through when applied to the skin. The product contains ingredients that are listed in the USP monograph for skin protectants. As a cosmetic product, Photocil has not been evaluated by the FDA for safety and effectiveness. The product contains ingredients that are listed in the USP monograph for skin protectants and is marketed as a cosmetic product in compliance with FDA regulations for cosmetics. The Joint American Academy of Dermatology and National Psoriasis Foundation guidelines for the management and treatment of psoriasis with phototherapy, published in JAMA Dermatology in 2019, strongly recommend narrow-band UVB phototherapy as a monotherapy for treating plaque psoriasis in adults, supported by a systematic review and meta-analysis of 41 randomized controlled trials involving 2,416 patients. Phototherapy Management believes that phototherapy treatments, used for conditions such as psoriasis and vitiligo, are set for substantial growth globally. However, there can be no guarantees that this growth will materialize as expected, as it is subject to various market conditions, regulatory developments, and other external factors beyond the Company’s control. Specific market data focused solely on the Indian phototherapy treatment segment is limited, and the available market data focuses primarily on phototherapy devices. However, according to Future Market Insights (2023)(1), the Indian market is expected to experience strong growth, driven by the rising prevalence of skin disorders, increased healthcare spending, and improved access to treatment in both urban and rural areas. According to Future Market Insights (2023), the global phototherapy treatment market is projected to rise from ~ USD $1.9 billion in 2023 to ~ USD $3.23 billion by 2033, at a CAGR of around 5.2% during the forecast period from 2023 to 2033. In India, the market is expected to expand even faster, with an estimated CAGR of approximately 7.8% as of 2023, driven by a large patient base, increasing prevalence of skin disorders, greater awareness of noninvasive treatments, and improved healthcare infrastructure (Future Market Insights, 2023). Psoriasis According to a report by Nature Reviews Drug Discovery (2024)(2), the global psoriasis treatment market was worth ~ $34 billion globally in the 12 months ending June 2023. The report shows the US remains the dominant market for psoriasis therapies, accounting for approximately 78% of total sales and growing at a compound annual growth rate of approximately 18%. According to the same report (Nature Reviews Drug Discovery, 2024), with the current growth rate (CAGR of 8–10% from 2023 to 2030), the global market is expected to reach ~ USD $54-67 billion by 2030. Estimates from a report published on the National Center for Biotechnology Information(3), indicate that the prevalence of psoriasis in India ranges from 0.44% to 2.8% of the population, highlighting Management’s belief in the significant market opportunity in India. However, actual market growth may be influenced by factors such as regulatory changes, competition, and economic conditions, which could impact the overall demand for psoriasis treatments. Management believes that Psoriasis treatment with Photocil may only address a very small fraction of the market in the US and India. However, actual market penetration will depend on various factors, including the development of a dedicated sales and marketing team at Caring Brands, market demand, competitive landscape, and regulatory considerations. There can be no assurance that these efforts will result in significant market adoption. Vitiligo According to a report by Expert Market Research (2024)(4), the global vitiligo treatment market was valued at ~ USD 538.90 million in 2024. The global market is projected to grow at a compound annual growth rate (CAGR) of 4.60% from 2025 to 2034, reaching ~ USD 807.70 million by 2034 (Expert Market Research, 2024). According to Expert Market Research (2024), this growth is attributed to the increasing global prevalence of vitiligo and the rising demand for effective treatments, and Management believes that these factors may contribute to expanding market opportunities. However, actual market expansion may be influenced by factors such as regulatory changes, competition, and advancements in alternative therapies, which could impact the overall demand for vitiligo treatments. According to the report by Expert Market Research (2024), the US market is expected to remain the dominant market for vitiligo treatments. The report also states that the Asia Pacific region is expected to witness the fastest growth during the forecast period due to increasing awareness, emerging treatment options, growing research and development activities, and favorable government initiatives in developing nations. As part of this Asia Pacific region, management believes India presents a potential opportunity for market expansion. However, there is no certainty that this growth will materialize as expected, as it depends on various external factors, which will impact the overall demand. As per reports published on the National Centre for Biotechnology Information(5) (6), across studies from India, the prevalence of vitiligo has consistently been reported to be between 0.25%-4% (Cureus Report)(5) and can reach as high as 8.8% of the population in certain regions like Gujarat and Rajasthan (Indian Journal of Community Medicine)(6), making India a highly affected region globally. However, even though Management believes that this presents a potential market opportunity, Vitiligo treatment with Photocil is expected to address only a very small fraction of the total global market. Future market penetration is uncertain and subject to factors such as regulatory approvals, competitive dynamics, and effective marketing strategies. There can be no assurances that Photocil will achieve meaningful adoption in the market. Our licensee in India, Cosmofix and San Pellegrino Cosmetics, is currently exploring additional sub-licensing opportunities in Nepal, Bangladesh, Sri Lanka, Vietnam, Philippines, Malaysia, Cambodia, Laos, Indonesia, UAE, Egypt, Algeria, Tunisia, Congo, Nigeria, Kenya, Thailand, Bahrain, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, and Saudi Arabia. We are also in preliminary discussions regarding potential licensing opportunities in Europe and South America, though no formal agreements are currently in place. The results of clinical trials on Photocil have been published in Expert Opin Pharmacother, including 2014 Dec;15(18):2623-7; Dermatol Ther. 2014 Jul-Aug;27(4):195-7; Dermatol Ther. 2014 Sep-Oct;27(5):260-3. In July 2021, Safety Shot (then Jupiter Wellness) obtained an exclusive license from Applied Biology Inc. to manufacture and sell Photocil. Subsequently, in June 2022, Safety Shot (then Jupiter Wellness) acquired all assets of Applied Biology Inc., including Photocil, through an asset purchase agreement. The product was commercially launched in India in September 2022 under a licensing agreement with Cosmofix and San Pellegrino Cosmetics and entered the U.S. market in Q4 2022 via Amazon. However, it was removed from the U.S. market in February 2023 due to insufficient sales resulting from the lack of a dedicated sales and marketing team. In India, Photocil is currently marketed as an OTC product compliant with local regulatory standards. In the United States, it was previously commercialized with FDA-registered labeling as a Jupiter Wellness product. We plan to apply for a National Drug Code (NDC) number for FDA registration prior to relaunching the product in the U.S. market. Photocil has been evaluated in clinical trials for the treatment of vitiligo and psoriasis, demonstrating significant efficacy. Our Hair Enzyme Booster (JW-700), previously known as Minoxidil Booster, was initially developed by Applied Biology Inc. and was acquired by Safety Shot (then Jupiter Wellness) in June 2022 through an asset purchase agreement. The product received labelling approval as a cosmetic from the Central Drugs Standard Control Organization (CDSCO) and is currently being manufactured and sold in India through our agreement with Cosmofix and San Pellegrino Cosmetics. Hair Enzyme Booster (JW-700) was launched on Amazon on October 28, 2024, and became available on NOVODX’s e-commerce platform on December 11, 2024. As of the date of this prospectus, the Hair Enzyme Booster (JW-700) continues to be sold on both platforms. The Hair Enzyme Booster has been clinically shown to increase the enzymes needed for minoxidil (an FDA-approved over-the-counter medication used to treat hair loss and promote hair regrowth) to work, sulfotransferase enzymes, by using the product topically in conjunction with topical minoxidil. The Hair Enzyme Booster (JW-700) is marketed and sold as a cosmetic product in the U.S., containing GRASE ingredients that do not require FDA pre-market approval and complying with FDA labeling requirements. In India, it is currently marketed under local cosmetic regulations. The Company launched the Hair Enzyme Booster (JW-700) in the U.S in the fourth Quarter of 2024. The product is designed to improve Minoxidil efficacy and is available as a topical solution. It is designed to enhance the efficacy of minoxidil by increasing necessary enzyme levels and must be used in combination with FDA-approved minoxidil products. JW-700 does not independently treat hair loss or promote hair regrowth. Clinically shown to increase the sulfotransferase enzyme needed for minoxidil to work, has 2 granted and 5 pending patents. Minoxidil market was valued at $1.5 billion in 2022 and is expected to grow to $2.5 billion by 2032. Licensed to Taisho, a $2.6 billion revenue company and Japan’s leading seller of minoxidil products. They expect to launch the product commercially in 2025. The term of the Taisho License is for five (5) years with an automatic renewal of one (1) year unless terminated otherwise. As consideration, Caring Brands shall receive up to $200,000 in milestone payments and a 3% royalty subject to the terms and conditions of the Taisho License. On September 1, 2022, Safety Shot (then Jupiter Wellness), entered into a license agreement with Cosmofix and San Pellegrino cosmetics to market and manufacture the Hair Enzyme Booster (JW-700) and Photocil for the Indian market and 31 other companies in Africa and Far East. The license is for three years with an automatic renewal of one(1) year unless terminated otherwise. Photocil and the Hair Enzyme Booster (JW-700) are being sold in India. As consideration a 3% royalty subject to the terms and conditions of the Cosmofix/San Pellegrino license. The License was transferred to the Company, pursuant to the Separation and Exchange Agreement (as defined below). The Company launched the Hair Enzyme Booster (JW-700) in the US in 4Q, 2024. As the product contains components that are generally regarded as safe (GRASE) it does not require FDA approval. Clinical studies on the Hair Enzyme Booster (JW-700) have been published: Journal of Cosmetic Dermatology (2022), Vol.21, Issue 4, 1647-1650. The Hair Enzyme Booster (JW-700) has undergone multiple clinical trials, demonstrating its potential efficacy in treating androgenetic alopecia (AGA). The Hair Enzyme Booster (JW-700) is designed to enhance the efficacy of minoxidil by increasing necessary enzyme levels and must be used in combination with FDA-approved minoxidil products. The Hair Enzyme Booster (JW-700) does not independently treat hair loss or promote hair regrowth. CB-101 treatment for Atopic Dermatitis (Eczema) is a topical over-the-counter treatment for atopic dermatitis (eczema) with dual-action relief from aspartame (ASN or artificial sweetener being used in a new formulation for skin treatment) and colloidal oatmeal (an FDA-approved ingredient for skin protection and relief of minor skin irritations). In clinical studies of the prior formulation (containing CBD), JW-100 cleared or reduced eczema following 2 weeks of use and may prove potentially superior to existing prescription drugs. It currently has 4 pending patents, with the global eczema treatment market valued at $14 billion in 2022. 31.6 million Americans, or 10% of the population, have eczema; 86% are not satisfied with their treatment and want more and better treatment options. CB-101 eczema treatment is currently undergoing reformulation, which we expect to complete in Q1/Q2 2025, and it is anticipated to be available online in the US in the third quarter of 2025 as an over-the-counter product under a USP monograph. CB-101 will be marketed as an OTC product under the applicable USP monograph. It contains colloidal oatmeal, which is covered under the USP monograph for skin protectant products. The product will comply with all requirements outlined in the applicable USP monograph and will require FDA registration and an NDC number prior to marketing. The clinical study on JW-100 was published in the Journal of Cosmetic Dermatology, Vol. 21, Issue 4, April 2022, pp: 1647-1650. The primary endpoint of this research was a reduction in the Investigator’s Static Global Assessment (ISGA) score. The treatment group achieved an average ISGA score reduction of 1.28 compared to 0.70 in the placebo group (p=0.042). Additionally, 50% of subjects in the treatment group achieved an ISGA rating of “clear” or “almost clear” with a two-grade improvement, compared to 15% in the placebo group (p=0.028). No adverse events were reported during the study. The original formulation, JW-100, contained CBD as an active ingredient, while the new formulation, CB-101, removes CBD, while maintaining aspartame (ASN) and introducing colloidal oatmeal as key ingredients. This dual-action formulation is designed to provide relief from eczema symptoms and allows the product to be marketed as an OTC product under a USP monograph for skin protectants. The reformulated product retains the therapeutic approach of the original while utilizing ingredients compliant with applicable USP monographs. The development process is currently in the final stages, with $150,000 allocated to completing formulation development, $200,000 planned for the initial production run, and $50,000 for clinical testing. The target launch date for the product is Q4 2025. NoStingz is currently being re-formulated under Caring Brands as a sunscreen product designed to provide protection against both UV rays and jellyfish stings. NoStingz was previously commercialized in the United States market from July 2022 and was removed from the market in September 2023 due to insufficient sales resulting from the lack of a dedicated sales and marketing team. The previously commercialized version contained FDA-compliant sunscreen active ingredients, and we are currently reformulating the product and conducting stability testing. All actives will meet the USP specifications mandated by the FDA in its sunscreen monograph. The new formulation, which is currently in development stages, is exploring a combination of rubidium iodide and menthol, which has demonstrated promising results in a small trial conducted in the Florida Keys. Trial Details The trial was conducted from May 29 - June 17, 2023, in Key West, Florida to evaluate the efficacy of NoStingz formulations against Portuguese man-o’-war (Physalia physalis) stings. The study was conducted by independent researchers who collected specimens from Atlantic waters near Key West. Methodology and Design The researchers developed a controlled, blind testing protocol using preserved Portuguese man-o’-war specimens collected from the Atlantic waters near Key West. The methodology involved carefully preserving the stinging tentacles through a controlled dehydration process, followed by systematic rehydration of small portions for standardized testing applications. The study evaluated multiple formulation types, including mineral-based sprays and lotions with SPF levels of 30 and 50. To ensure scientific validity, the researchers incorporated placebo controls using untreated skin areas. The evaluators assessed sting responses and protective efficacy of the different formulations against the control areas. Results and Safety The combination of rubidium iodide and menthol demonstrated promising initial results in reducing sting severity. However, we note that this was a small preliminary trial and further testing is needed to establish statistical significance. No adverse events or safety concerns were reported during the trial period. Mechanism of Action Rubidium iodide and menthol were selected based on their potential protective properties: . Rubidium iodide acts as a potential inhibitor of the nematocyst discharge mechanism . Menthol provides a cooling sensation and may help reduce localized inflammatory response We are currently conducting additional stability testing and formulation work before proceeding with larger scale trials to validate these preliminary findings. The reformulated product is designed to provide dual protection against both UV rays and jellyfish stings. We have not yet established a timeline for commercial launch. As the product contains ingredients with well-established safety profiles, it does not require FDA approval. NoStingz will be regulated as a sunscreen product and will comply with the FDA’s sunscreen guidelines. It will contain FDA-approved sunscreen active ingredients and will require FDA registration and an NDC number prior to marketing. Our products are tested for quality and stability each time they are manufactured. One of our manufacturers is Stella Industries Ltd., Haryana, India, which manufactures the Hair Enzyme Booster (JW-700) and Photocil for the Indian market. Stability on commercial batches manufactured in India indicates a shelf life of at least 24 months. Stella Industries is compliant with the FDA’s Current Good Manufacturing Practice, or CGMP, regulations in accordance with 21 CFR 210/211 required for over-the-counter drug products. It is ISO-9001 certified. Another manufacturer is DCR Labs, Daytona Beach, Florida, which is also fully compliant with the FDA’s Current Good Manufacturing Practice, or CGMP, for cosmetic products. We expect to continually update and expand upon our corporate website and further refine our online retail strategies on an ongoing basis. CaringBrands.com is our primary corporate website, which will serve as the primary source of information about us for investors and will contain press releases, clinical trial pipeline, lab reports, blog posts, and additional information about each of our brands. We have built an e-commerce platform designed to connect us directly to consumers. We use the platform to sell products, educate customers, and build brand loyalty. Our principal executive offices are located in Jupiter, Florida.
Free CABR Stock Alerts