OTC: XAGE

Longevity Health Holdings, Inc.

CIK 0001842939 · SIC 2840 · Soap & Cleaning Products

Micro Revenue $2M Assets $1M as of Sep 5, 2026

Unless the context requires otherwise, references in this Annual Report on Form 10-K (this “Annual Report”) to the “Company,” “Longevity,” “we,” “us,” or “our,” on or after July 14, 2023 are intended to refer to Longevity Health Holdings, Inc., a Delaware corporation, and its consolidated… About this business →

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8-K Filed Sep 4, 2026 · Period ending Aug 31, 2026

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424B3 Filed Aug 17, 2026

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8-K Filed Aug 17, 2026 · Period ending Aug 17, 2026

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424B3 Filed Aug 14, 2026

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424B3 Filed Aug 14, 2026

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10-Q Filed Aug 14, 2026 · Period ending Jun 30, 2026

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8-K Filed Aug 14, 2026 · Period ending Aug 13, 2026

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10-Q Filed May 15, 2026 · Period ending Mar 31, 2026

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10-K Filed Mar 31, 2026 · Period ending Dec 31, 2025

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10-K/A Filed Jun 17, 2025 · Period ending Dec 31, 2024

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424B5 Filed Apr 14, 2025

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10-K Filed Mar 31, 2025 · Period ending Dec 31, 2024

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S-1/A Filed May 30, 2024

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S-1 Filed May 10, 2024

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S-1 Filed Aug 7, 2023

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10-Q/A Filed Sep 13, 2022 · Period ending Sep 30, 2021

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Latest financial statements

From 10-Q filed Aug 14, 2026 (period ending Jun 30, 2026). As printed on the EDGAR/iXBRL face — not generated by the model.

As filed

Condensed Consolidated Statements of Operations (Unaudited)

Description Three months ended June 30, 2026 Three months ended June 30, 2025 Six months ended June 30, 2026 Six months ended June 30, 2025
Gross sales 444,967 535,978 869,357 1,070,921
Discounts and allowances (48,976) (32,366) (81,602) (56,956)
Net sales 395,991 503,612 787,755 1,013,965
Cost of sales 160,455 200,954 315,194 441,484
Gross profit 235,536 302,658 472,561 572,481
Operating expenses:
Selling and marketing 191,438 345,505 462,075 626,054
Research and development 73,351 228,606 128,839 425,518
General and administrative 681,559 1,564,967 1,905,913 2,840,128
Depreciation and amortization of intangible assets 13,338 22,184 28,376 46,136
Total operating expenses 959,686 2,161,262 2,525,203 3,937,836
Loss from operations (724,150) (1,858,604) (2,052,642) (3,365,355)
Other income (expense):
Other income 89 4,357 949 10,234
Interest expense (2,153) (2,561) (5,603) (7,554)
Change in fair value of earnout liabilities 55,996 (29,630) 152,049 (29,630)
Inventory write-down (38,917) (235,601)
Loss on litigation settlement (1,174,155) (1,174,155)
Total other income (expense) (1,159,140) (27,834) (1,262,361) (26,950)
Loss from operations before income taxes (1,883,290) (1,886,438) (3,315,003) (3,392,305)
Income tax expense
Net loss (1,883,290) (1,886,438) (3,315,003) (3,392,305)
Net loss per common share basic and diluted: (0.76) (1.56) (1.51) (3.08)
Weighted average of common shares outstanding basic and diluted 2,475,321 1,209,809 2,189,205 1,101,174

Condensed Consolidated Balance Sheets

Description June 30, 2026 (unaudited) December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents 35,471 706,740
Accounts receivable, net 19,546 36,500
Inventory, net 606,668 963,028
Prepaid expenses 50,031 243,823
Total current assets 711,716 1,950,091
Operating lease right of use asset 255,193 300,221
Property and equipment, net of accumulated depreciation of $801,887 and $775,783, respectively 75,517 101,621
Intangible assets, net of accumulated amortization of $57,924 and $55,652, respectively 12,822 15,094
Total assets 1,055,248 2,367,027
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable 5,039,806 4,494,923
Accrued expenses and other liabilities 2,042,944 1,843,464
Contingent liability 2,350,000 1,175,845
Loans payable 61,298 189,939
Operating lease liability 99,065 95,193
Earnout liabilities 49,153
Consideration payable 67,742
Total current liabilities 9,593,113 7,916,259
Long-term liabilities:
Earnout liabilities, net of current portion 102,896
Operating lease liability, net of current portion 161,582 214,745
Total liabilities 9,754,695 8,233,900
Commitments and contingencies (see Note 9)
Stockholders’ deficit:
Series A convertible voting preferred stock, $0.0001 par value; 4,243 shares authorized, -0- shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
Common stock, $0.0001 par value; 250,000,000 shares authorized, 2,475,321 and 1,781,738 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 247 178
Additional paid-in capital 70,392,253 69,909,893
Accumulated deficit (79,091,947) (75,776,944)
Total stockholders’ deficit (8,699,447) (5,866,873)
Total liabilities and stockholders’ deficit 1,055,248 2,367,027

Condensed Consolidated Statements of Cash Flows (Unaudited)

Description Six months ended June 30, 2026 Six months ended June 30, 2025
Cash flows from operating activities:
Net loss from continuing operations (3,315,003) (3,392,305)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation 224,686 309,152
Depreciation and amortization of intangible assets 28,376 46,136
Amortization of right of use assets 45,028 93,174
Change in fair value of earnout liabilities (152,049) 29,630
Inventory write-down 235,601
Changes in operating assets and liabilities:
Accounts receivable 16,954 26,155
Inventory 120,759 222,210
Prepaid expenses 217,249 321,096
Accounts payable 544,883 258,791
Accrued expenses and other liabilities 199,480 592,530
Contingent liabilities 1,174,155
Lease liability (49,291) (95,712)
Net cash used in operating activities (709,172) (1,589,143)
Cash flows from investing activities
Cash paid for Elevai Acquisition transaction costs (150,000)
Cash paid for offering costs (15,000)
Net cash used in investing activities (165,000)
Cash flows from financing activities:
Proceeds from issuance of Common Stock, net of costs 190,001 3,397,476
Proceeds from short-term borrowings 50,000
Repayment of loans (202,098) (249,273)
Net cash provided by financing activities 37,903 3,148,203
Net (decrease) increase in cash and cash equivalents (671,269) 1,394,060
Cash and cash equivalents beginning of period 706,740 157,139
Cash and cash equivalents end of period 35,471 1,551,199

Amounts as printed on the EDGAR/iXBRL face. Labels, columns, and figures are the filing face, not a GAAP stencil. Interactive statements & notes on EDGAR ↗

About Longevity Health Holdings, Inc.

Source: Item 1 (Business) from the 10-K filed March 31, 2026. Description as filed by the company with the SEC.

Item 1. Business.

Unless the context requires otherwise, references in this Annual Report on Form 10-K (this “Annual Report”) to the “Company,” “Longevity,” “we,” “us,” or “our,” on or after July 14, 2023 are intended to refer to Longevity Health Holdings, Inc., a Delaware corporation, and its consolidated subsidiaries and prior to such date are intended to refer to Carmell Regen Med Corporation (formerly Carmell Therapeutics Corporation), a Delaware corporation, (“Legacy Carmell”).

Forward-Looking Statements

This Annual Report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, forward-looking statements can be identified by terminology such as “may,” “might,” “should,” “could,” “will,” “would,” “expect,” “intend,” “plan,” “possible,” “potential,” “predict,” “project,” “anticipate,” “believe,” “estimate,” “continue,” “future,” or the negative of such terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Such statements include, but are not limited to, statements and expectations regarding our expected future growth and our ability to manage such growth, our estimates regarding anticipated operating losses, future revenue, capital requirements and our needs for, and ability to raise, financing in the future, our success in retaining or recruiting officers, key employees or directors, factors relating to our business, operations and financial performance, including our ability to commercialize our products, market acceptance of our products, our ability to compete effectively, market conditions within our industry, our ability to respond and adapt to change in technology or customer behavior as well as all other statements other than statements of historical fact included in this Annual Report.

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The forward-looking statements contained in this Annual Report are based on the Company’s current beliefs, opinions, expectations and projections concerning future developments and events and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements are subject to known and unknown risks, uncertainties, and assumptions about us that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, those listed under Part I, Item 1A. “Risk Factors,” Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Annual Report and those risks described in our other filings with the U.S. Securities and Exchange Commission (the “SEC”). Given these risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this Annual Report are made as of the date of this Annual Report. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. Any public statements or disclosures by us following this Annual Report that modify or impact any of the forward-looking statements contained in it will be deemed to modify or supersede such statements in this Annual Report.

Business Overview

We are focused on longevity and healthy aging, encompassing the latest scientific advances in regenerative bio-aesthetics. Our products are aimed at helping people look and feel their best at any age. We currently have two cosmetic product lines, Elevai ExosomesTM and Carmell SecretomeTM, that support skin and hair health. All of our cosmetic skincare and haircare products are tailored to meet the demanding technical requirements of professional care providers and discerning retail consumers. Our product pipeline also includes innovative regenerative bone and tissue healing products on which we have paused further research and development.

Recent Developments

Private Placement

On March 16, 2026 (the “Closing Date”), we closed a private placement (the “PIPE”), whereby we received gross proceeds of approximately $200,000 for the sale of 689,656 shares of our common stock, par value $0.0001 per share (“Common Stock”), at an offering price of $0.29 per share, to International Capital Partners LLC, a Florida limited liability company (“ICP”). The shares of Common Stock were offered and sold in the PIPE in reliance on the exemption from the registration requirements of the Securities Act, pursuant to Section 4(a)(2) thereof and/or Rule 506(c) of Regulation D promulgated thereunder, and applicable state securities laws.

Chairman and Chief Executive Officer Transition

Effective as of the Closing Date, we and Rajiv Shukla, our former Chairman and Chief Executive Officer, mutually agreed that Mr. Shukla would no longer serve as our Chairman, director and Chief Executive Officer. In connection with Mr. Shukla’s separation from the Company, he and the Company entered into a separation and release of claims agreement, dated March 13, 2026, pursuant to which Mr. Shukla will receive a monthly payment of $30,000 for a period of 12 months (the “Severance Period”), beginning in April 2026; provided that the Severance Period will increase to 18 months in the event that, within three months following the effective date of the

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Separation Agreement, the Company consummates a transaction or transactions resulting in any “person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) becoming a “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing 50% or more of the total power to vote for the election of directors of the Company. In addition, Mr. Shukla may receive a one-time, lump sum cash payment in satisfaction of his accrued and unpaid bonus in the amount of four hundred and eighty thousand dollars ($480,000) (the “Lump Sum Payment”) upon the closing of a capital raise of at least one million dollars ($1,000,000).

Janakiram Ajjarapu was appointed by the Company’s Board of Directors (the “Board”) as a director of the Company, the Chairman of the Board and the Company’s Chief Executive Officer effective as of the Closing Date. Mr. Ajjarapu is the managing member of, and holds a direct minority membership interest in, ICP and serves as the trustee of a family trust that holds the remaining outstanding membership interests in ICP.

Our Product Portfolio

Elevai ExosomesTM Cosmetic Skincare and Haircare Products

The skincare and haircare products acquired in conjunction with the Elevai Acquisition (as defined in Note 1 to the accompanying consolidated financial statements) in January 2025 utilize Elevai ExosomesTM, which are nano-sized extracellular vesicles containing growth factors, cytokines, peptides, and other small molecules involved in the body’s natural healing process. Our Elevai ExosomesTM are combined with carefully selected, high-quality active ingredients, such as hyaluronic acid and ceramides, to create our skincare and haircare products.

While our products contain no living cells, they leverage the use of ethically sourced and thoroughly tested human umbilical mesenchymal stem cells (“hUMSC”) that we culture in our lab to derive Elevai ExosomesTM. While exosomes are generated using some of the origin cell’s cellular material, the exosomes do not contain cells, nor are they explicitly cellular material. Instead, exosomes represent a powerful, nano-sized, natural delivery mechanism for protecting important biological factors, which enables them to be directed to where they are needed most. The use of exosomes has been found to penetrate the skin better, absorb more easily, and protect the active ingredients fused into our products, including stem cell derived proteins, peptides, and growth factors.

To maintain quality control over our Elevai ExosomesTM commercialization and manufacturing process, we only purchase hUMSCs that are derived and banked by a third-party manufacturer in accordance with Current Good Manufacturing Practices (“cGMP”) regulations. The hUMSCs are shipped to our laboratory, where we similarly operate our lab under strict good laboratory practice (“GLP”) protocols to produce the highest quality of exosomes for our products. Every stem cell line is carefully derived and closely monitored throughout the process by highly trained personnel to help ensure only high-quality stem cells are used to generate Elevai ExosomesTM. We produce our final products in a cGMP-compliant facility inspected by the U.S. Food and Drug Administration (the “FDA”). Not only are all our ingredients and products subject to multiple quality control tests before bottling, but each lot is also tested and batch-numbered to enhance safety and traceability. All Elevai products are manufactured in the United States.

The Elevai ExosomesTM skincare products include Elevai EmpowerTM and Elevai EnfinityTM and were formulated to enhance the outcome for individuals receiving aesthetic treatments who are in need of cosmetics to improve the appearance of skin, in addition to receiving these treatments from a physician or medical spa. Elevai EmpowerTM was developed to provide immediate post-treatment skin support, and Elevai EnfinityTM for ongoing daily aftercare. Both products contain our patent-pending Elevai ExosomesTM.

In addition, we launched our Elevai RenewTM Scalp Serum in the first quarter of 2025, which is also formulated with Elevai ExosomesTM. This product promotes healthy hair growth cycles and noticeable improvement to hair appearance, fullness, and thickness. In addition to Elevai ExosomesTM, our haircare product utilizes the proprietary compounds licensed from Yuva BioSciences, Inc. (“Yuva”). This license provides us with a non-exclusive, non-transferable, non-assignable, royalty-bearing right, with the right to sublicense, certain of Yuva’s intellectual property to develop, manufacture, and commercialize skincare products that contain Yuva’s proprietary compound and the Company’s exosome-based ingredients or skincare products in which Elevai ExosomesTM serve as a carrier for Yuva’s proprietary compound, in each case, in the United States, Canada, and other mutually agreed to territories.

In February 2026, we launched two new products, Elevai HOCL Allantoin Active CleanserTM and Elevai Hyper-Hydrating BoosterTM. Our Elevai HOCL Allantoin Active CleanserTM is a water-based solution designed to neutralize bacteria and soothe inflammation on contact. The formula of our Elevai Hyper-Hydrating BoosterTM mirrors components naturally found in the skin’s outer layer, supporting a smoother, refined appearance while remaining exceptionally lightweight. These new products are sold at a lower price point than our Elevai EmpowerTM and Elevai EnfinityTM products with the intention of introducing our product line to new customers.

To facilitate the launch of these new products, we created the Exosome Treatment Kit, which consists of a single-use tube of Elevai EmpowerTM post-treatment serum, and trial sizes of our Elevai EnfinityTM, Elevai HOCL Allantoin Active CleanserTM and Elevai Hyper-Hydrating BoosterTM products. This kit is being sold to physicians and medical spas for their patients receiving skin treatments.

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Carmell SecretomeTM Cosmetic Skincare Products

The Carmell SecretomeTM consists of a potent cocktail of growth factors, proteins, and peptides extracted from allogeneic human platelets. We have leveraged this proprietary formulation to create the world’s first cosmetic skincare line, which supports the body's own innate regenerative healing system. Our team of scientists and engineers has worked on past projects focused on the biologics and medical device space and has extensive experience and technical expertise in creating biologically active materials that are safe and effective. The Carmell SecretomeTM cosmetic skincare products are manufactured in our facilities in the United States.

We have extensively tested the technology underpinning the Carmell SecretomeTM, which utilizes a novel microemulsion formulation that enables the delivery of lipophilic and hydrophilic ingredients without relying on the Foul FourteenTM, which are 14 potentially harmful excipients that are commonly used by other companies to impart texture, stability, and other desirable physicochemical attributes to cosmetic products. These fourteen chemicals and excipients that may harm human health and the environment include sulfates, silicones, silicates, phthalates, petrolatum, parabens, parfums, formaldehydes, food allergens, ethanolamines, ethyl alcohols, PFAs (per- and polyfluoroalkyls), coal tar dyes, and benzene. Additionally, our microemulsion formulations do not utilize mineral or vegetable oils across our entire product line and are designed to be non-comedogenic.

Our Carmell SecretomeTM skincare products use allogeneic platelet-rich plasma (“PRP”) sourced from blood banks registered with the FDA and accredited by the American Association of Blood Banks. Before being processed into the Carmell SecretomeTM, each unit of PRP is individually tested to ensure that it is free from blood-borne pathogens. As an additional safety precaution, the pooled plasma is heat-treated and irradiated to inactivate any viruses. Carmell SecretomeTM manufacturing is a highly controlled process with multiple in-process checks and release testing. Two additional sterilization steps, including gamma irradiation, are incorporated into every batch. Our formulation contains over a thousand growth factors, proteins, and peptides, but no live cells.

Our technology is based on the premise that a healthy human body can heal itself from simple wounds and fight against microbes. Platelets play a key role in both fighting infections and healing. Platelets contain growth factors and other proteins that play a crucial role in the body’s healing response. Growth factors and proteins in PRP have been known to stimulate collagen production, tissue repair, and cell regeneration, which can lead to improved skin texture, reduced appearance of fine lines and wrinkles, and an overall rejuvenation of the skin.

When the body responds to a natural injury, platelets break apart to release proteins and growth factors to aid healing. This same natural process is utilized during the creation of Carmell SecretomeTM. Platelets are activated with calcium chloride, causing the release of their protein secretome, which is carefully processed to ensure safety and shelf stability. No intact cells or platelets remain. We have conducted protein assays to test for protein potency and stability testing under various temperature conditions to ensure that our product remains bioactive on the shelf in real-world conditions.

In addition, we have also developed a novel microemulsion formulation to help support the permeability of our ingredients into the stratum corneum, which is the outermost layer of the skin. Additionally, our microemulsion formulations do not utilize mineral or vegetable oils across our entire product line and are designed to be non-comedogenic. All our products are subject to multiple quality control tests before bottling, and each lot is tested and batch numbered to enhance safety and traceability.

Our Carmell SecretomeTM product portfolio includes the following:

Face and Neck Collection (Retail)


Regenerative Elixir – Reduces the appearance of wrinkles and blemishes


Brightening Glow – Extra strength skin brightening and anti-blemish formulation


Hydrating Dew – Intensive skin hydration and plumping crème

ProSynergy Collection (Doctors/Medspas)


ReInforce – Soothes and repairs the skin barrier before and after aesthetic treatments


ReTone – Improves skin tone and the appearance of wrinkles


ReTexture – Extra strength plumping and hydrating formulation


ReTone HP – High potency formula to address skin tone and pigmentation concerns


Rapid Recovery Crème– Supports scar and post-aesthetic procedure recovery

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Our Markets and Industry

According to a June 2025 study conducted by McKinsey & Company, The State of Fashion: Beauty (Volume 2), the global skincare and haircare market grew 7% annually from 2022 to 2024 and is expected to cool only slightly due to geopolitical and economic uncertainty, with 5% growth annually expected through 2030.

We currently sell our cosmetics products in the United States through three distinct channels, including business-to-business, direct-to-consumer, and, in the case of Elevai products, distributor sales channels. In markets outside the United States, we sell certain of our products directly to distributors under exclusive and non-exclusive agreements. Our three sales channels help us to optimize our sales reach and strategy.

In addition to the business-to-business sales channels, certain of our products are available for purchase direct-to-consumer via our online retail websites. Our direct-to-consumer channel allows consumers to purchase our products without the need to visit a medically directed business to make a purchase, or, if they prefer, the ease of purchasing our products online.

We specifically focus on selling our products directly to physicians’ offices and medically directed businesses through our direct sales force, comprised of employed and independently contracted aesthetic account managers. We believe that consumers are increasingly looking to their physicians for advice on cosmetic product selection because they are overwhelmed by the mass marketing that often creates unrealistic expectations and some degree of consumer confusion. Furthermore, we believe consumers are also looking for individualized skincare regimens and want to know from their physicians what works and what does not.

The term “physician-dispensed” refers to a sales channel where cosmetics products are exclusively sold in physician clinics or medically directed businesses by licensed medical professionals, or those that have a medical professional on staff. We include medical spas under this category, such as standalone or hospitality-affiliated clinics focused on cosmetic treatments such as injections, microneedling, and some plastic surgery services.

We believe consumers often turn to cosmetics to enhance the appearance of dull or aging skin and to brighten the skin by lessening the appearance of a myriad of aesthetic concerns such as hyperpigmentation, acne, melasma, and rosacea because these consumers view these products as alternatives to medications and often try cosmetics products before seeking medicinal solutions. We also believe that physicians value topical skincare products formulated with our biotechnology for their complementary aesthetic effects in conjunction with medications to improve skin appearance and to enhance the benefits of in-office procedures. The majority of our Elevai product sales are within the physician-dispensed market, primarily including dermatologists, plastic surgeons, and other physicians who are focused on medical aesthetics and therapeutic skincare, including some physicians practicing in medical aesthetician practices. Our products complement the medical aesthetics services provided in these professional settings.

Our business-to-business sales channel within the physician-dispensed cosmetics skincare market primarily utilizes our trained direct sales force, comprised of employed and independently contracted aesthetic account managers. This business-to-business sales channel is distinct from our leverage of non-exclusive distribution agreements with third-party distributors or resellers, who, in turn, sell our products to end customers. Under distribution agreements, our relationship with the end customer is more indirect because our distributors serve as intermediaries. However, we believe scaling our product lines through larger distribution sales channels will lead to faster brand expansion, recognition, and market reach.

We believe that the objective of the medical aesthetics industry is to offer medical care and education in a setting that includes spa facilities as well as conventional, complementary, and/or alternative aesthetics-focused therapies and cosmetic treatments. These medical aesthetics services include cosmetic procedures, such as microneedling, anti-wrinkle and fine line reduction therapies, acne surgery, fillers, and facial and massage services performed with highly specialized lasers and instruments.

In 2025, we refocused our sales and marketing efforts on the recently acquired Elevai skin and hair care products, which have an established customer base and deemphasized efforts on the Carmell SecretomeTM product line.

The beauty industry is relatively concentrated, with a significant portion of retail sales in the United States generated by brands owned by a few large multinational companies, such as L’Oréal, Estée Lauder, Coty, Revlon, Shiseido, Johnson & Johnson, and Procter & Gamble. These large multinational companies typically own multiple brands. In addition to the traditional brands against which we compete, small independent companies continue to enter the market with new brands and customized product offerings.

Bone and Tissue Healing Products

Our Bone Healing Accelerant (“BHA”) and tissue healing accelerant (“THA”) product candidates are based on patents licensed from Carnegie Mellon University (“CMU”) that claim the ability to plasticize allogeneic platelet-enriched plasma and crosslink proteins with genipin, a derivative of the gardenia plant, to provide a controlled degradation profile in vivo. BHA, a biologic, has been designated by

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the FDA as a combination product containing the Company’s core technology of plasma-based material plus b Tri-Calcium Phosphate (“b-TCP”), an already approved medical device.

Legacy Carmell’s early years were focused on discovering and formulating the plasma-based materials technology, filing for now-issued patents, conducting preclinical experiments aimed at exploring promising areas for accelerated and enhanced healing, and conducting a Phase 2 clinical trial. Beginning in 2016, Legacy Carmell focused on moving BHA and THA from research to development. BHA is designed to be used in multiple bone applications, such as trauma fixation surgeries, including severe tibia fractures, spinal fusion, foot/ankle fusion and dental bone graft substitutes. THA is designed to be used in chronic wound care and aesthetic applications and is similar in formulation to BHA minus one material, b-TCP. The form of these two product candidates would feel different to the physicians/surgeons, with BHA being a “putty” form (due to the b-TCP) and THA being a “paste” form.

We have conducted multiple preclinical studies that support our belief that BHA has the potential to heal wounds and accelerate bone healing of high quality, as measured by density, vascularity, and the presence of woven bone. The Company has submitted its BHA product candidate to the FDA as an Investigational New Drug (“IND”) in severe open tibia fractures, and the FDA agreed that the Company could pursue its proposed Phase 2 clinical trial under the IND. The FDA also granted a fast-track designation for the BHA program as the product candidate has the potential to meet a significant unmet need. However, we have deprioritized further research and development of these product candidates and ceased clinical studies to focus our efforts on the commercialization of our cosmetic skincare and haircare product lines.

The production of our product candidates and any future research and development activities related to our product candidates are subject to extensive regulation by numerous governmental authorities in the United States, including the FDA. Prior to marketing in the United States, any product candidate we develop must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetics Act (the “FDCA”). If we pursue research and development activities related to these product candidates in the future, there can be no assurance that we will not encounter problems in preclinical testing or clinical trials that will cause us or the FDA to delay or suspend the clinical trials for such product candidates or delay or prohibit us from initiating future clinical trials. The marketing of our product candidates, if approved, would also be subject to extensive regulation by numerous governmental authorities in the United States.

Trademarks and Other Intellectual Property

We believe that our intellectual property has substantial value and will contribute significantly to the success of our business. Our primary trademarks and the associated branding logos are registered or have registrations pending with the U.S. Patent and Trademark Office. Our trademarks are expected to be valuable assets that reinforce the distinctiveness of our brands and our consumers’ perception of our products. In addition to trademark protection, we own several domain names, including the domain names of our e-commerce websites. We also rely on and use commercially reasonable measures to protect our unpatented proprietary technology, which includes our expertise and product formulations, continuing innovation, and other know-how to develop and maintain our competitive position. In addition, the intellectual property related to our BHA and THA products includes twenty-one patents that include exclusive, worldwide licenses from CMU.

Government Regulation

Regulation of Cosmetics

We and our products are subject to various federal, state and international laws and regulations, including regulation in the United States by the FDA, the Consumer Product Safety Commission and the Federal Trade Commission (the “FTC”). These laws and regulations principally relate to the ingredients, proper labeling, advertising, packaging, marketing, manufacture, safety, shipment and disposal of our products.

In the United States, the FDCA defines cosmetics as articles or components of articles intended for application to the human body to cleanse, beautify, promote attractiveness, or alter the appearance, except for soap. The labeling of cosmetic products is subject to the requirements of the FDCA, the Fair Packaging and Labeling Act, the Poison Prevention Packaging Act and other FDA regulations.

Cosmetics are not subject to pre-market approval by the FDA; however, certain ingredients, such as color additives, must be pre-approved for the specific intended use of the product and are subject to certain restrictions on their use. If a company has not adequately substantiated the safety of its products or ingredients by, for example, performing appropriate toxicological tests or relying on already available toxicological test data, then a specific warning label is required. The FDA may, by regulation, require other warning statements on certain cosmetic products for specified hazards associated with such products. FDA regulations also prohibit or otherwise restrict the use of certain types of ingredients in cosmetic products.

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In addition, the FDA requires that cosmetic labeling and claims be truthful and not misleading. Moreover, cosmetics may not be marketed or labeled for their use in treating, preventing, mitigating, or curing disease or other conditions or in affecting the structure or function of the body, as such claims would render the products to be a drug and subject to regulation as a drug. The FDA has issued warning letters to cosmetic companies alleging improper drug claims regarding their cosmetic products. In addition to FDA requirements, the FTC, as well as state consumer protection laws and regulations, can subject a cosmetics company to a range of requirements and theories of liability, including similar standards regarding false and misleading product claims, under which FTC or state enforcement or class-action lawsuits may be brought.

In the United States, the FDA has not promulgated regulations establishing mandatory Good Manufacturing Practices (“GMPs”) for cosmetics. However, the FDA’s draft guidance on cosmetic GMPs, most recently updated in June 2013, provides recommendations related to process documentation, recordkeeping, building and facility design, equipment maintenance and personnel, and compliance with these recommendations can reduce the risk that the FDA finds such products have been rendered adulterated or misbranded in violation of applicable law. The FDA also recommends that manufacturers maintain product complaint and recall files and voluntarily report adverse events to the FDA.

The FDA monitors compliance of cosmetic products through market surveillance and inspection of cosmetic manufacturers and distributors to ensure that the products are not manufactured under unsanitary conditions or labeled in a false or misleading manner. Inspections may also arise from consumer or competitor complaints filed with the FDA. In the event the FDA identifies unsanitary conditions, false or misleading labeling, or any other violation of FDA regulation, the FDA may request, or a manufacturer may independently decide to conduct a recall or market withdrawal of products. In addition, under the Modernization of Cosmetic Regulation Act of 2022 (“MoCRA”), manufacturers of cosmetic products will become subject to more onerous FDA obligations once implemented via regulation, including adverse event reporting and record retention requirements, safety substantiation requirements, facility registration requirements, product listing requirements, mandatory GMP requirements and labeling requirements for certain products. Under MoCRA, the FDA was also granted new enforcement authorities over cosmetics, such as the ability to initiate mandatory recalls and to access certain product records.

The FTC regulates and can bring enforcement action against cosmetic companies for deceptive advertising and lack of adequate scientific substantiation for claims. The FTC requires that companies have a reasonable basis to support marketing claims. What constitutes a reasonable basis can vary depending on the strength or type of claim made, or the market in which the claim is made, but objective evidence substantiating the claim is generally required.

Regulation of BHA and THA

In the United States, biological products, including our BHA and THA products, are licensed by the FDA for marketing under the Public Health Service Act (the “PHS Act”) and regulated under the FDCA. Both the FDCA and the PHS Act and their corresponding regulations govern, among other things, the testing, manufacturing, safety, purity, potency, efficacy, labeling, packaging, storage, record keeping, distribution, marketing, sales, import, export, reporting, advertising and other promotional practices involving drug and biological products. FDA clearance of an IND must be obtained before initiating clinical testing of biologic products. FDA licensure also must be obtained before marketing biological products. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

Other Government Regulation

We are also subject to a number of federal, state, and international laws and regulations that impact companies conducting business on the Internet, including regulations related to consumer protection, the promotion and sale of merchandise, privacy, use and protection of consumer and employee personal information and data (including the collection of data from minors), behavioral tracking, and advertising and marketing activities, including sweepstakes, contests, and giveaways.

Supply Chain

We purchase the raw materials for all our products from various third parties. We also purchase packaging components that are manufactured to our design specifications. We collaborate with our suppliers to meet our stringent design and creative criteria. We believe that we currently have adequate sources of supply for all our products. We review our supplier base periodically with the specific objectives of improving quality, increasing innovation and speed-to-market, ensuring supply sufficiency, and reducing costs.

We have experienced no disruptions in our supply chain, and we actively work to anticipate and respond to actual and potential disruptions. We continually benchmark the performance of our supply chain, augment our supply base, enhance our forecasting and planning capabilities, and adjust our inventory strategy based on the business’s changing needs. We also continue to explore options to optimize our supply chain operations further as the sales of our cosmetic products grow.

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Environmental Compliance

We are subject to numerous federal, state, municipal, and local environmental, health and safety laws and regulations relating to, among other matters, safe working conditions, product stewardship, and environmental protection, including those relating to emissions to the air, discharges to land and surface waters, generation, handling, storage, transportation, treatment and disposal of hazardous substances and waste materials, and the evaluation of chemicals. We maintain policies and procedures to monitor and control environmental, health, and safety risks and to monitor compliance with applicable environmental, health, and safety requirements. Compliance with such laws and regulations pertaining to the discharge of materials into the environment or otherwise relating to the protection of the environment has not had a material effect on our capital expenditures, earnings, or competitive position.

Segments

Operating and reportable segments (referred to as “segments”) reflect the way the Company is managed and for which separate financial information is available and evaluated regularly by the Company’s chief operating decision maker (“CODM”) in deciding how to allocate resources and assess performance. Our chief executive officer, who is our CODM, views the Company’s operations and manages its business in one operating segment, which is principally the business of development and commercialization of bio-aesthetic and our bone and tissue healing products.

Employees and Human Capital

As of March 27, 2026, we have ten full-time employees. Our future performance depends in part on our ability to attract, retain, and motivate qualified employees. We endeavor to offer employees competitive compensation packages and a positive, dynamic, and creative work environment. We believe that we maintain a good working relationship with our employees and have not experienced any difficulty in recruiting staff for our operations.

Corporate Information

Legacy Carmell was incorporated under the laws of the State of Delaware on November 5, 2008. Upon the closing of the Business Combination (as defined in Note 11 to the accompanying consolidated financial statements) on July 14, 2023, Legacy Carmell became a wholly owned subsidiary of Alpha Healthcare Acquisition Corp. III, a Delaware corporation incorporated on January 21, 2021 (“Alpha”), and Alpha subsequently changed its name to “Carmell Corporation” on August 1, 2023. We filed an amendment to our Third Amended and Restated Certificate of Incorporation, as amended, with the Delaware Secretary of State on March 6, 2025, to change our name from “Carmell Corporation” to “Longevity Health Holdings, Inc.”

Our principal corporate office is located at 2403 Sidney Street, Suite 300, Pittsburgh, PA 15203, and our telephone number is (412) 894-8248. Our website is www.carmellcorp.com. The information contained in or accessible from our website is not incorporated by reference in this Annual Report or in any other filings we make with the SEC. We have included our website address in this Annual Report solely as an inactive textual reference.