Carmell Therapeutics (CTCX) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Unaudited Condensed Consolidated Financial Statements Unaudited condensed consolidated financial statements for Longevity Health Holdings, Inc., including balance sheets, operations, equity, and cash flows, with detailed notes Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets | ASSETS (Unaudited) | June 30, 2025 | December 31, 2024 | | :------------------------------------------------------------------------------------------------ | :------------ | :------------------ | | Cash | $1,551,199 | $157,139 | | Accounts receivable | $54,496 | $4,096 | | Inventory | $1,172,634 | $108,705 | | Total current assets | $3,240,887 | $955,554 | | Total assets | $3,719,342 | $1,473,980 | | LIABILITIES AND STOCKHOLDERS' DEFICIT (Unaudited) | June 30, 2025 | December 31, 2024 | | Accounts payable | $4,590,542 | $4,058,091 | | Accrued interest | $1,175,845 | $1,175,845 | | Total current liabilities | $6,913,648 | $5,876,705 | | Total liabilities | $7,456,876 | $6,186,642 | | Total stockholders' deficit | $(3,737,534) | $(4,712,662) | - The company's cash significantly increased from $157,139 at December 31, 2024, to $1,551,199 at June 30, 2025. Total assets more than doubled from $1,473,980 to $3,719,342, while total liabilities also increased from $6,186,642 to $7,456,876. Stockholders' deficit improved from $(4,712,662) to $(3,737,534)9 Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations | (Unaudited) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net sales | $503,612 | $12,320 | $1,013,965 | $12,320 | | Gross profit | $302,658 | $12,028 | $572,481 | $12,028 | | Total operating expenses | $2,161,262 | $1,203,515 | $3,937,836 | $2,583,860 | | Loss from operations | $(1,858,604) | $(1,191,487) | $(3,365,355) | $(2,571,832) | | Net loss | $(1,886,438) | $(3,304,538) | $(3,392,305) | $(6,575,497) | | Net loss per common share - basic and diluted | $(1.56) | $(4.78) | $(3.08) | $(9.04) | - Net sales for the three months ended June 30, 2025, increased significantly to $503,612 from $12,320 in the prior year, primarily due to the Elevai Acquisition. Similarly, for the six months ended June 30, 2025, net sales rose to $1,013,965 from $12,320. Despite increased sales, the company reported a net loss of $(1,886,438) for the three months and $(3,392,305) for the six months ended June 30, 2025, an improvement from the larger losses in the prior year, partly due to the absence of a significant loss on forward purchase agreement12 Condensed Consolidated Statements of Stockholders' Deficit Condensed Consolidated Statements of Stockholders' Deficit | (Unaudited) | Balance at March 31, 2025 | Common Stock issued, net of costs | Stock-based compensation expense | Net loss | Balance at June 30, 2025 | | :-------------------------------- | :------------------------ | :-------------------------------- | :------------------------------- | :------- | :----------------------- | | Common Stock (Amount) | $100 | $48 | — | — | $148 | | Additional Paid-in Capital | $66,572,144 | $1,759,818 | $194,323 | — | $68,526,285 | | Accumulated Deficit | $(70,377,529) | — | — | $(1,886,438) | $(72,263,967) | | Total | $(3,805,285) | $1,759,866 | $194,323 | $(1,886,438) | $(3,737,534) | - The total stockholders' deficit improved from $(4,712,662) at January 1, 2025, to $(3,737,534) at June 30, 2025. This improvement was primarily driven by the issuance of common stock, net of costs, totaling $3,397,476 for the six months ended June 30, 2025, and stock-based compensation expense of $309,152, partially offset by a net loss of $(3,392,305)15 Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows | (Unaudited) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(1,589,143) | $(2,214,254) | | Net cash used in investing activities | $(165,000) | $(748,796) | | Net cash provided by financing activities | $3,148,203 | $2,248,864 | | Net increase (decrease) in cash | $1,394,060 | $(714,186) | | Cash - end of the period | $1,551,199 | $2,198,275 | - Net cash used in operating activities decreased by 28% to $(1,589,143) for the six months ended June 30, 2025, compared to $(2,214,254) in the prior year. Net cash provided by financing activities increased by 40% to $3,148,203, primarily from common stock issuances. The company experienced a net increase in cash of $1,394,060, ending the period with $1,551,199 in cash17172175 Notes to Unaudited Condensed Consolidated Financial Statements NOTE 1 — NATURE OF THE ORGANIZATION AND BUSINESS - Longevity Health Holdings, Inc. is a bio-aesthetics company focused on longevity and healthy aging, selling cosmetic skincare and haircare products in the US through B2B, D2C, and distributor channels. The company completed the Elevai Acquisition on January 16, 2025, acquiring Elevai Skincare's assets and liabilities. A 1:30 reverse stock split was effected on May 12, 2025222324 NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - The company prepares its unaudited condensed consolidated financial statements in accordance with GAAP for interim information and has elected to use the extended transition period for new accounting standards as an 'emerging growth company'. The Elevai Acquisition was accounted for as an asset purchase, not a business combination, with assets and liabilities recognized at fair value. The company operates as a single segment focused on bio-aesthetic products2728293135 Fair Value Measurements of Financial Instruments (June 30, 2025) | Financial Instrument | Carrying Value | Estimated Fair Value | Fair Value Input Hierarchy | | :------------------- | :------------- | :------------------- | :------------------------- | | Money market accounts | $25,538 | $25,538 | Level 1 | | Earnout liabilities | $331,263 | $331,263 | Level 3 | - The fair value of earnout liabilities increased by $29,630 during the six months ended June 30, 2025, to a total of $331,263, reflecting initial recognition and changes in fair value59 NOTE 3 — GOING CONCERN AND MANAGEMENT'S LIQUIDITY PLANS - The company reported negative net working capital of $3,672,761 and a net loss of $3,392,305 for the six months ended June 30, 2025, raising substantial doubt about its ability to continue as a going concern. Management plans to address this through additional capital raises (e.g., $1.85M from 2025 Private Placement, $1.96M from ATM Financing, $1.0M from warrant exercises in July 2025), leveraging revenue from the Elevai Acquisition ($2.5M in 2024), and reducing operating expenses by terminating employees and leases6465666768 NOTE 4 — ELEVAI ACQUISITION - The Elevai Acquisition, completed on January 16, 2025, involved the issuance of 38,308 shares of Common Stock ($660,805 fair value) and 3,927 withheld shares ($67,742 fair value), assumption of liabilities, and earnout liabilities of $301,633. The total estimated value of consideration transferred was $1,180,180. The acquisition was treated as an asset purchase, not a business combination6970 Elevai Acquisition Purchase Consideration Allocation (as of Closing) | Category | Amount | | :-------------------------- | :------------- | | Accounts receivable | $76,555 | | Inventory | $1,286,139 | | Prepaid expenses and deposits | $94,567 | | Right of use asset | $51,721 | | Property and equipment | $47,618 | | Total assets | $1,556,600 | | Accounts payable | $309,974 | | Customer deposits | $13,806 | | Operating lease liability | $52,640 | | Net assets to be acquired | $1,180,180 | - The acquisition included earnout provisions: $56,525 cash upon sale of specific inventory and a one-time $500,000 payment if $500,000 net revenue from hair and scalp products is achieved within 24 months. Pro forma net sales for the six months ended June 30, 2025, including Elevai Skincare, would have been $1,166,346, and pro forma net loss $(3,033,608)697273 NOTE 5 — INVENTORY Inventory Composition | Category | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :------------------ | | Raw materials | $598,547 | $86,390 | | Work-in-process | $13,618 | $19,229 | | Finished goods | $560,469 | $3,086 | | Total | $1,172,634 | $108,705 | - Total inventory significantly increased from $108,705 at December 31, 2024, to $1,172,634 at June 30, 2025, primarily driven by increases in raw materials and finished goods, likely due to the Elevai Acquisition74 NOTE 6 — PROPERTY AND EQUIPMENT Property and Equipment, Net | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :------------------ | | Lab equipment | $732,844 | $696,648 | | Leasehold improvements | $115,333 | $115,333 | | Furniture and fixtures | $15,002 | $3,580 | | Less: accumulated depreciation | $(745,517) | $(701,655) | | Property and equipment, net | $117,662 | $113,906 | - Net property and equipment increased slightly from $113,906 at December 31, 2024, to $117,662 at June 30, 2025. Depreciation expense for the six months ended June 30, 2025, was $43,862, a slight decrease from $44,797 in the prior year75 NOTE 7 — ACCRUED EXPENSES AND OTHER LIABILITIES Accrued Expenses and Other Liabilities | Category | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :------------------ | | Accrued royalties | $74,576 | $0 | | Accrued severance | $26,911 | $0 | | Other accrued expenses | $818,562 | $313,713 | | Total | $920,049 | $313,713 | - Accrued expenses and other liabilities significantly increased from $313,713 at December 31, 2024, to $920,049 at June 30, 2025, primarily due to newly accrued royalties and severance, and a substantial increase in other accrued expenses76 NOTE 8 —DEBT - The company had $16,672 in outstanding principal for insurance premium financing as of June 30, 2025, down from $241,158 at December 31, 2024, due to the maturity of older agreements. Interest expense from these agreements decreased to $2,561 for the three months and $7,554 for the six months ended June 30, 2025, compared to $3,264 and $14,830 respectively in 2024. All 2023 Promissory Notes were repaid with Common Stock during the six months ended June 30, 20247778798084 NOTE 9 — COMMITMENTS AND CONTINGENCIES - The company is obligated to pay 5% royalties on net sales of Elevai's existing products for five years post-acquisition, recognizing $49,576 in royalty expense for the six months ended June 30, 2025. A minimum royalty of $50,000 is due for 2025 under the Yuva License Agreement for haircare products. The company is also involved in litigation with Puritan Partners LLC regarding Convertible Notes, with Puritan claiming over $4,050,000, which the company disputes, and has accrued $1,175,845 for interest payable85869091 NOTE 10 — PROFIT-SHARING PLAN - The company has 401(k) profit-sharing plans for employees, but no discretionary profit-sharing contributions were made during the three and six months ended June 30, 2025 and 202492 NOTE 11 — STOCKHOLDERS' EQUITY (DEFICIT) - As of June 30, 2025, the company had 1,483,738 shares of Common Stock outstanding, up from 696,969 at December 31, 2024. This increase is partly due to the issuance of 479,621 shares through an ATM Financing for $1.96 million gross proceeds and 268,840 shares in a private placement for $1.85 million gross proceeds. The Reverse Stock Split on May 12, 2025, adjusted all share and per-share amounts93949623 Warrant Activity (Six Months Ended June 30, 2025) | Category | Number of Shares Issuable on Exercise | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life in Years | Aggregate Intrinsic Value | | :------------------------ | :------------------------------------ | :------------------------------ | :----------------------------------- | :------------------------ | | Outstanding, Dec 31, 2024 | 154,744 | $303.30 | 3.62 | $36,242 | | Issued | 590,957 | $3.36 | 0.00 | — | | Outstanding, June 30, 2025 | 745,701 | $65.60 | 4.22 | — | | Exercisable, June 30, 2025 | 707,542 | $68.95 | 4.21 | — | - Stock-based compensation expense for options was $309,152 for the six months ended June 30, 2025. Unrecognized compensation expense related to unvested stock options totaled $1,563,753 as of June 30, 2025, to be recognized over a weighted average remaining vesting period of 2.6 years107 NOTE 12 – INCOME TAXES - The company did not record any income tax provision or benefit for the three and six months ended June 30, 2025 and 2024. A valuation allowance has been established against the net deferred tax asset due to uncertainty regarding the realization of taxable income109 NOTE 13 – DISCONTINUED OPERATIONS - The company completed the disposition of Axolotl Biologix, LLC (AxoBio) on March 26, 2024. The consideration for the disposition included the return and cancellation of 128,178 shares of Common Stock and 4,243 shares of Series A Preferred Stock, cancellation of $8,000,000 in notes payable, and termination of AxoBio Earnout obligations. For the six months ended June 30, 2024, discontinued operations resulted in a net loss of $(1,252,276) and a gain on sale of $1,534,479110111113 NOTE 14 – SUBSEQUENT EVENTS - The merger agreement with 20/20 Biolabs, Inc. terminated on July 8, 2025, with no termination fees. On July 14, 2025, the company entered into a merger agreement with True Health Inc. (THPlasma Merger), where True Health will become a wholly-owned subsidiary. The merger consideration includes 19,666,667 shares of Common Stock and an additional 6,666,667 performance-based shares. A $5 million cash payment for a License Purchase is contingent on a $5 million equity or debt financing. In July 2025, warrant exercises generated $1.0 million in proceeds from 298,000 shares of Common Stock114115116118121 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management's discussion and analysis of financial condition and operational results, covering performance, developments, going concern, and accounting policies Overview - Longevity Health Holdings, Inc. is a bio-aesthetics company focused on longevity and healthy aging, offering cosmetic skincare and haircare products through B2B, D2C, and distributor channels in the US. The company's product pipeline also includes regenerative bone and tissue healing products, though R&D is currently paused125 New Developments - The company entered into a merger agreement with True Health Inc. (THPlasma Merger) on July 14, 2025, involving the issuance of 19,666,667 shares of Common Stock and 6,666,667 performance-based shares. The prior merger agreement with 20/20 Biolabs, Inc. terminated on July 8, 2025. A 1:30 reverse stock split was effective May 12, 2025. The Elevai Acquisition was completed on January 16, 2025, and a private placement in January 2025 raised $1.85 million gross proceeds126128133135137139 - The company received Nasdaq delisting notices in August and September 2024 for failing to meet the Market Value of Listed Securities and Minimum Bid Price Requirements. A conditional compliance period was granted until September 2, 2025, with the THPlasma Merger and Reverse Stock Split intended to help regain compliance142143144145146 Impact of Macroeconomic Events - Global macroeconomic factors, including geopolitical conflicts (Russia-Ukraine, Israel-Hamas), US-China tensions, tariffs, inflation, and high interest rates, could negatively affect the company's ability to access capital and its liquidity. While current operations haven't been materially impacted, prolonged or worsening conditions could have adverse effects25147 Critical Accounting Policies and Estimates - The preparation of financial statements requires management to make significant estimates and assumptions, such as those for asset and liability valuations, which could differ from actual results. The Elevai Acquisition's accounting as an asset purchase required significant estimates for fair value allocation32148149 Going Concern and Management Plan - The company has negative net working capital of $3,672,761 and a net loss of $3,392,305 for the six months ended June 30, 2025, indicating substantial doubt about its ability to continue as a going concern. Management's plan includes raising additional capital through equity/debt, leveraging revenue from the Elevai Acquisition, and reducing operating expenses through employee terminations and lease cancellations150151152153 Comparison of Results of Operations for the Three Months Ended June 30, 2025 and 2024 Key Financials (Three Months Ended June 30) | Metric | 2025 (Unaudited) | 2024 | Change | % Change | | :------------------------------------ | :--------------- | :----- | :----- | :------- | | Gross sales | $535,978 | $12,720 | $523,258 | 4,114% | | Net sales | $503,612 | $12,320 | $491,292 | 3,988% | | Gross profit | $302,658 | $12,028 | $290,630 | 2,416% | | Selling and marketing expenses | $345,505 | $11,045 | $334,460 | 3,028% | | Research and development expenses | $228,606 | $104,066 | $124,540 | 120% | | General and administrative expenses | $1,564,967 | $1,064,874 | $500,093 | 47% | | Loss from operations | $(1,858,604) | $(1,191,487) | $(667,117) | 56% | | Net loss | $(1,886,438) | $(3,304,538) | $1,418,100 | -43% | - Net sales surged by 3,988% to $503,612, and gross profit increased by 2,416% to $302,658, primarily due to the Elevai Acquisition. Operating expenses significantly increased across selling and marketing (3,028%), R&D (120%), and G&A (47%). Net loss improved by 43% to $(1,886,438) due to the absence of a large loss on a forward purchase agreement seen in the prior year154156157158159160 Comparison of Results of Operations for the Six Months Ended June 30, 2025 and 2024 Key Financials (Six Months Ended June 30) | Metric | 2025 (Unaudited) | 2024 | Change | % Change | | :------------------------------------ | :--------------- | :----- | :----- | :------- | | Gross sales | $1,070,921 | $12,720 | $1,058,201 | 8,319% | | Net sales | $1,013,965 | $12,320 | $1,001,645 | 8,130% | | Gross profit | $572,481 | $12,028 | $560,453 | 4,660% | | Selling and marketing expenses | $626,054 | $11,045 | $615,009 | 5,568% | | Research and development expenses | $425,518 | $533,486 | $(107,968) | -20% | | General and administrative expenses | $2,840,128 | $1,992,268 | $847,860 | 43% | | Loss from operations | $(3,365,355) | $(2,571,832) | $(793,523) | 31% | | Net loss | $(3,392,305) | $(6,575,497) | $3,183,192 | -48% | - Net sales for the six months ended June 30, 2025, increased by 8,130% to $1,013,965, and gross profit rose by 4,660% to $572,481, primarily due to the Elevai Acquisition. Selling and marketing expenses increased by 5,568%, while R&D expenses decreased by 20% due to employee terminations in non-core areas. Net loss improved by 48% to $(3,392,305), largely due to the absence of a significant loss on a forward purchase agreement161162163164165166 Liquidity, Capital Resources, and Going Concern - As of June 30, 2025, the company had cash of $1,551,199, negative working capital of $3,672,761, a net loss of $3,392,305, and negative cash flows from operations of $1,589,143. These conditions raise substantial doubt about the company's ability to continue as a going concern. Management is exploring additional capital raises and out-licensing R&D programs to enhance liquidity, alongside cost-saving measures167168169170 Debt - As of June 30, 2025, the company's outstanding debt totaled $16,672, primarily related to insurance premium financing programs171 Cash Flows Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 | 2024 | Change | % Change | | :------------------------------ | :----------- | :----------- | :------- | :------- | | Net cash used in operating activities | $(1,589,143) | $(2,214,254) | $625,111 | -28% | | Net cash used in investing activities | $(165,000) | $(748,796) | $583,796 | -78% | | Net cash provided by financing activities | $3,148,203 | $2,248,864 | $899,339 | 40% | - Net cash used in operating activities decreased by 28% due to a lower net loss from continuing operations and reduced payments of accounts payable. Investing activities used less cash, primarily due to lower costs related to the Elevai Acquisition and the absence of AxoBio Disposition costs. Financing activities provided significantly more cash, up 40%, driven by proceeds from common stock issuances through private placement and ATM financing173174175 Contingencies - The company is defending against a lawsuit filed by Puritan Partners LLC regarding alleged breaches of Convertible Notes and Warrants, with claims totaling $2,725,000 plus additional fees and interest. The company has accrued $1,175,845 for interest payable related to these notes, and the litigation is in the discovery phase176 Contractual Obligations and Commitments - Contractual obligations include debt agreements, operating leases, and royalty payments, specifically related to the Asset Purchase Agreement (Elevai Royalties) and the Yuva License177 Emerging Growth Company and Smaller Reporting Company Status - The company qualifies as an 'emerging growth company' and has elected not to opt-out of the extended transition period for new accounting standards, adopting them at the same time as private companies. It is also a 'smaller reporting company,' allowing for reduced disclosure obligations, including presenting only two years of audited financial statements and reduced executive compensation disclosures178179180 Item 3. Quantitative and Qualitative Disclosures About Market Risk No quantitative and qualitative disclosures about market risk are required for the company - No quantitative and qualitative disclosures about market risk are required for the company181 Item 4. Controls and Procedures Evaluation of disclosure controls and procedures, concluding ineffectiveness as of June 30, 2025, due to a material weakness, now addressed by a new policy - Management concluded that disclosure controls and procedures were not effective as of June 30, 2025, due to a material weakness in internal controls over the accounting treatment for a complex transaction in 2024. The company has addressed this by adopting a policy requiring formal documentation for the accounting treatment of all material transactions183 - No other material changes in internal control over financial reporting occurred during the most recently completed fiscal quarter184 PART II. OTHER INFORMATION Item 1. Legal Proceedings This section refers to Note 9 of the financial statements for a description of the company's material pending legal proceedings - Material pending legal proceedings are described in Note 9 to the unaudited condensed consolidated financial statements186 Item 1A. Risk Factors Updates risk factors from the 2024 Annual Report, focusing on new risks related to the proposed THPlasma Merger, including potential failure, delays, valuation, dilution, and litigation Risks Related to the Merger - Failure to complete or delays in the THPlasma Merger could materially and adversely affect Longevity's operations, financial results, and stock price. The consummation is subject to conditions not entirely within Longevity's control, and uncertainty may disrupt business relationships and employee retention188189191 - The Merger Shares will not be adjusted based on market price fluctuations, meaning True Health stockholders could receive a value higher or lower than negotiated. Longevity stockholders will experience substantial ownership dilution, owning approximately 10% of the combined company on a fully-diluted basis post-merger190197200 - The combined company may need to raise additional capital, leading to further dilution or restrictive debt covenants. Longevity's directors and executive officers may have interests in the merger that differ from other stockholders. Lawsuits related to the merger could cause delays and divert management attention. Longevity's dependence on its ten remaining full-time employees poses a risk to merger consummation and day-to-day operations193194196205206 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section indicates that there were no unregistered sales of equity securities or use of proceeds to report - There were no unregistered sales of equity securities or use of proceeds to report during the period208 Item 3. Defaults Upon Senior Securities This section states that there were no defaults upon senior securities - There were no defaults upon senior securities during the period209 Item 4. Mine Safety Disclosures This section indicates that there are no mine safety disclosures to report - There are no mine safety disclosures to report210 Item 5. Other Information Reports no adoption, termination, or modification of Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by directors or officers during the six months ended June 30, 2025 - No directors or officers adopted, terminated, or modified Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the six months ended June 30, 2025211 Item 6. Exhibits Lists exhibits filed as part of the Form 10-Q, including merger agreements, certificates of incorporation, bylaws, and officer certifications - Exhibits include the Agreement and Plan of Merger with True Health Inc., various amendments to the Certificate of Incorporation, Amended and Restated Bylaws, and certifications from the Principal Executive Officer and Principal Financial Officer213 Signatures Contains the required signatures for the Form 10-Q report, confirming submission by Longevity Health Holdings, Inc.'s Chairman and CEO, and CFO on August 14, 2025 - The report was signed by Rajiv Shukla, Chairman and Chief Executive Officer, and Bryan J. Cassaday, Chief Financial Officer, on August 14, 2025216