Carmell Therapeutics (CTCX) - 2024 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Unaudited Condensed Consolidated Financial Statements Carmell Corporation's unaudited financial statements detail its balance sheet, operations, equity, and cash flows Condensed Consolidated Balance Sheets Total assets and liabilities decreased significantly due to the disposition of AxoBio Condensed Consolidated Balance Sheets | Metric | March 31, 2024 (unaudited) | December 31, 2023 | | :--- | :--- | :--- | | ASSETS | | | | Cash | $892,161 | $2,912,461 | | Total current assets | $5,189,224 | $62,900,114 | | Total assets | $6,180,343 | $63,948,803 | | LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | | | | Total current liabilities | $6,905,552 | $38,502,078 | | Total liabilities | $7,572,002 | $39,199,793 | | Total stockholders' (deficit) equity | $(1,391,659) | $24,749,010 | Condensed Consolidated Statements of Operations The company's net loss increased to $3.27 million, driven by a forward purchase agreement loss Condensed Consolidated Statements of Operations | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $429,420 | $740,325 | | General and administrative | $927,394 | $510,445 | | Total operating expenses | $1,380,345 | $1,274,871 | | Loss from operations | $(1,380,345) | $(1,274,871) | | Loss on forward purchase agreement | $(2,156,837) | — | | Net loss | $(3,270,959) | $(1,828,715) | | Net loss attributable to common stockholders | $(3,270,959) | $(2,139,883) | | Net loss per common share (basic and diluted) | $(0.14) | $(1.91) | | Weighted average of common shares outstanding | 22,915,160 | 1,122,529 | Condensed Consolidated Statements of Stockholders' Deficit Stockholders' equity shifted to a deficit of $1.39 million due to the AxoBio disposition and net loss Condensed Consolidated Statements of Stockholders' Deficit | Metric | January 1, 2024 | March 31, 2024 | | :--- | :--- | :--- | | Series A Preferred Stock (Amount) | $1 | $- | | Common Stock (Shares) | 23,090,585 | 19,361,068 | | Common Stock (Amount) | $2,309 | $1,936 | | Additional Paid-in Capital | $83,250,101 | $60,380,765 | | Accumulated Deficit | $(58,503,401) | $(61,774,360) | | Total Stockholders' (Deficit) Equity | $24,749,010 | $(1,391,659) | - Stock received from AxoBio Disposition resulted in a decrease of 3,845,337 common shares and a reduction of $23,455,793 in additional paid-in capital[14] Condensed Consolidated Statements of Cash Flows Net cash decreased by $2.02 million, driven by increased use in operating and investing activities Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,075,778) | $(475,959) | | Net cash used in investing activities | $(748,796) | — | | Net cash (used in) provided by financing activities | $(195,726) | $375,000 | | Net decrease in cash | $(2,020,300) | $(100,959) | | Cash - end of the period | $892,161 | $27,190 | - Non-cash financing activity included $23,456,179 in fair value of shares received in the AxoBio Disposition for the three months ended March 31, 2024[17] NOTE 1 — NATURE OF THE ORGANIZATION AND BUSINESS The company is a bio-aesthetics firm that recently completed a business combination and disposed of AxoBio - Carmell Corporation is a bio-aesthetics company developing cosmetic skincare and haircare products using human platelet secretome, with operations in Pittsburgh, Pennsylvania, and trades on Nasdaq under 'CTCX' and 'CTCXW'[21] - The company completed a business combination on July 14, 2023, with Alpha Healthcare Acquisition Corp III, treated as a reverse recapitalization where Legacy Carmell was the accounting acquirer[22][24] - Carmell acquired Axolotl Biologix (AxoBio) on August 9, 2023, for cash and stock consideration, but subsequently disposed of AxoBio on March 26, 2024, in exchange for the return of stock, cancellation of notes payable, and termination of earnout obligations[30][31][32] NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES This note outlines key accounting policies, including its emerging growth company status and discontinued operations - Carmell Corporation is an 'emerging growth company' and has elected to use the extended transition period for complying with new or revised financial accounting standards, aligning with private company adoption dates[35][36] - The AxoBio Disposition on March 26, 2024, led to AxoBio's assets and liabilities being classified as 'available for sale' and its operations reported as 'discontinued operations' in the financial statements[41] - The company operates as a single segment, focusing on developing and commercializing aesthetic and regenerative care products[42] Fair Value Measurements of Financial Instruments (March 31, 2024 vs. December 31, 2023) | Financial Instrument | Carrying Value (March 31, 2024) | Estimated Fair Value (March 31, 2024) | Carrying Value (Dec 31, 2023) | Estimated Fair Value (Dec 31, 2023) | Input Hierarchy | | :--- | :--- | :--- | :--- | :--- | :--- | | Forward purchase agreement | $3,543,614 | $3,543,614 | $5,700,451 | $5,700,451 | Level 3 | | SBA Loan | — | — | $1,505,070 | $1,498,000 | Level 2 | NOTE 3 — BUSINESS COMBINATION The AxoBio Acquisition involved $43.1 million in consideration and resulted in $19.19 million in goodwill - The AxoBio Acquisition was completed on August 9, 2023, and accounted for under the acquisition method, with AxoBio's assets and liabilities recorded at fair value[73] AxoBio Acquisition Consideration Transferred | Consideration Component | Estimated Value | | :--- | :--- | | Common Stock (3,845,337 shares) | $11,270,683 | | Series A Convertible Voting Preferred Stock (4,243 shares) | $10,382,107 | | Earnout | $13,482,292 | | Deferred Consideration | $8,000,000 | | Total estimated value of consideration transferred | $43,135,082 | AxoBio Acquisition Purchase Price Allocation | Asset/Liability | Allocated Fair Value | | :--- | :--- | | Total estimated value of consideration transferred | $43,135,082 | | Cash and cash equivalents | $662,997 | | Accounts receivable | $18,296,000 | | Inventories | $10,600,000 | | Intangible assets | $23,260,000 | | Total assets | $53,071,447 | | Total liabilities (excluding goodwill) | $23,946,804 | | Goodwill | $19,188,278 | NOTE 4 — GOING CONCERN AND MANAGEMENT'S LIQUIDITY PLANS The company's financial condition raises substantial doubt about its ability to continue as a going concern - As of March 31, 2024, the Company had cash of $892,161 and an accumulated deficit of $61,774,360, raising substantial doubt about its ability to continue as a going concern[85][87] - Management's liquidity plans include a $3 million private placement in April 2024, refocusing on aesthetic products with near-term commercial potential, reprioritizing R&D, ceasing long-term clinical studies, and exploring out-licensing programs[88] NOTE 5 — PROPERTY AND EQUIPMENT Net property and equipment for continuing operations decreased slightly to $170,447 Property and Equipment | Asset Category | March 31, 2024 (Continuing Operations) | December 31, 2023 (Continuing Operations) | December 31, 2023 (Discontinued Operations) | | :--- | :--- | :--- | :--- | | Lab equipment | $696,648 | $696,648 | $216,210 | | Leasehold improvements | $115,333 | $115,333 | — | | Furniture and fixtures | $3,580 | $3,580 | $30,057 | | Less: accumulated depreciation | $(645,114) | $(622,715) | $(182,883) | | Property and equipment, net | $170,447 | $192,846 | $63,384 | - Depreciation expense for continuing operations was $22,399 for the three months ended March 31, 2024, and $22,971 for the same period in 2023[89] NOTE 6 —GOODWILL AND INTANGIBLE ASSETS Goodwill from the AxoBio acquisition was removed from the balance sheet following the disposition - Goodwill of $19,188,278 from the AxoBio Acquisition was classified as assets available for sale at December 31, 2023, and is no longer on the balance sheet as of March 31, 2024, due to the AxoBio Disposition[90] Intangible Assets (Continuing Operations) | Asset Category | Amortization Period | Gross Carrying Value (March 31, 2024) | Accumulated Amortization (March 31, 2024) | Net Book Value (March 31, 2024) | | :--- | :--- | :--- | :--- | :--- | | Patents | 16 years | $70,746 | $47,691 | $23,055 | - Amortization expense for continuing operations was $1,132 for the three months ended March 31, 2024, and $1,128 for the same period in 2023[94] NOTE 7— ACCRUED EXPENSES AND OTHER LIABILITIES Accrued expenses for continuing operations decreased significantly due to lower severance and compensation Accrued Expenses and Other Liabilities | Liability Category | March 31, 2024 (Continuing Operations) | December 31, 2023 (Continuing Operations) | December 31, 2023 (Discontinued Operations) | | :--- | :--- | :--- | :--- | | Accrued severance | $220,683 | $452,579 | — | | Accrued compensation | $56,832 | $790,332 | — | | Accrued stock-based compensation | $48,698 | $48,698 | — | | Other accrued expenses | $242,132 | $303,825 | $468,652 | | Total accrued expenses and other liabilities | $568,345 | $1,595,434 | $468,652 | NOTE 8 —DEBT Debt associated with AxoBio was removed from the balance sheet, while disputes over other notes continue - The SBA Loan and Related Party Loans (Burns Notes) associated with AxoBio were classified as assets available for sale at December 31, 2023, and are no longer on the balance sheet as of March 31, 2024, due to the AxoBio Disposition[99][100] - During Q1 2024, the Company issued 115,820 shares of Common Stock to repay $375,000 of maturing Promissory Notes; $473,500 in principal remains outstanding[101] - The Company has outstanding Insurance Premium Financing with $263,921 remaining principal as of March 31, 2024, incurring $11,566 in interest expense for the quarter[102] - The Company is in dispute with holders of January 2022 Convertible Notes and Warrants, who are demanding additional payments exceeding $4 million, which the Company believes have been satisfied[109] NOTE 9 — LEASES The company holds two office leases expiring in 2028 with a present value of liabilities of $813,002 - The Company has two office leases expiring on December 31, 2028, with a weighted average incremental borrowing rate of 8%[111][112] Net Lease Cost and Cash Paid for Lease Liabilities | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Operating lease cost | $50,423 | $50,423 | | Net lease cost | $50,423 | $52,446 | | Cash paid for operating lease liabilities | $34,839 | $31,413 | Future Minimum Lease Payments | Fiscal Year | Operating Leases | | :--- | :--- | | 2024 (remainder) | $153,698 | | 2025 | $204,930 | | 2026 | $204,930 | | 2027 | $204,930 | | 2028 | $204,930 | | Total future minimum annual lease payments | $973,418 | | Less: Imputed interest | $(160,416) | | Present value of lease liabilities | $813,002 | NOTE 10 — COMMITMENTS AND CONTINGENCIES The company has a licensing agreement with CMU and is involved in litigation with Puritan Partners LLC - The Company has an exclusive, worldwide license agreement with Carnegie Mellon University (CMU) for plasma-based plastics technology, effective until January 30, 2028, or patent expiration[114][115] - Royalties payable to CMU are 2.07% of net sales and 25% of sublicense fees; no royalties were accrued or paid in Q1 2024 or Q1 2023[117] - Puritan Partners LLC filed a complaint against the Company on November 8, 2023, asserting breach of obligations under Convertible Notes and Warrants, seeking damages totaling $2,725,000 plus additional fees and interest[119][120] NOTE 11 — PROFIT-SHARING PLAN No discretionary profit-sharing contributions were made to the company's 401(k) plans in Q1 2024 or 2023 - No discretionary profit-sharing contributions were made to the 401(k) plans during the three months ended March 31, 2024, and 2023[121] NOTE 12 — STOCKHOLDERS' EQUITY (DEFICIT) Common stock outstanding decreased following the AxoBio Disposition, and stock-based compensation was recorded - As of March 31, 2024, 19,361,068 shares of Common Stock were outstanding, a decrease from 23,090,585 shares at December 31, 2023, due to the AxoBio Disposition[122] - All 4,243 shares of Series A Preferred Stock issued in the AxoBio Acquisition were returned and retired in conjunction with the AxoBio Disposition on March 26, 2024[123] - The 2023 Long-Term Incentive Plan was approved in July 2023, authorizing the issuance of stock options, restricted stock, and other awards, with a maximum of 1,046,408 shares initially available[126][127] Stock Option Activity (Three Months Ended March 31, 2024) | Metric | Number of Options | Weighted Average Exercise Price | | :--- | :--- | :--- | | Outstanding, Dec 31, 2023 | 1,689,765 | $2.72 | | Granted | 70,000 | $3.57 | | Expired/Cancelled | (386,254) | $2.90 | | Outstanding, Mar 31, 2024 | 1,373,511 | $2.71 | | Vested/Exercisable, Mar 31, 2024 | 332,737 | $2.16 | - Stock-based compensation expense for options was $211,469 for the three months ended March 31, 2024, and $180,509 for the same period in 2023[133] NOTE 13 – INCOME TAXES No income tax provision was recorded due to a full valuation allowance against net deferred tax assets - No income tax provision or benefit was recorded for the three months ended March 31, 2024, and 2023[134] - A valuation allowance has been established against the net deferred tax asset due to uncertainty regarding the realization of these assets through future taxable income[134][135] NOTE 14 – DISCONTINUED OPERATIONS The AxoBio disposition resulted in a net loss from discontinued operations of $1.25 million for the quarter Assets and Liabilities Available for Sale (AxoBio) | Category | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total assets available for sale | $— | $53,321,372 | | Total liabilities available for sale | $— | $29,874,831 | Discontinued Operations (Three Months Ended March 31, 2024) | Metric | Amount | | :--- | :--- | | Selling and marketing | $100,000 | | Research and development | $89,972 | | General and administrative | $470,686 | | Depreciation and amortization | $636,449 | | Total operating expenses | $1,297,107 | | Loss from operations | $(1,297,107) | | Total other (expense) income | $(111,261) | | Loss before income taxes | $(1,408,368) | | Income tax benefit, deferred | $156,092 | | Discontinued operations, net | $(1,252,276) | NOTE 15 – SUBSEQUENT EVENTS The company closed a private placement in April 2024, raising gross proceeds of approximately $3 million - On April 11, 2024, the Company closed a private placement, selling 1,331,452 shares of Common Stock for gross proceeds of $3,001,235[138] - In connection with the private placement, 89,787 Common Stock warrants were issued with an exercise price of $2.81 and a 5-year term[138] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the strategic shift to bio-aesthetics, the AxoBio disposition, and going concern issues Overview The company develops cosmetic products using its proprietary Carmell Secretome™ technology - Carmell is a bio-aesthetics company utilizing the Carmell Secretome™ (growth factors and proteins from human platelets) for cosmetic skincare and haircare products[142] - The company is launching its cosmetic skincare products in H1 2024 via an omni-channel strategy, including direct e-commerce, retailers, distributors, and professional practices[143] Recent Developments The company completed the disposition of AxoBio and closed a private placement raising over $3 million - The AxoBio Disposition closed on March 26, 2024, involving the sale of AxoBio's interests in exchange for the return of Closing Share Consideration, cancellation of $8 million in notes payable, and termination of earnout obligations[144] - On April 11, 2024, Carmell closed a private placement, selling 1,331,452 shares of Common Stock for gross proceeds of $3,001,235 and issuing 89,787 Common Stock warrants[147] Impact of Macroeconomic Events Global economic uncertainty could adversely affect the company's business and access to capital - Global economic uncertainty, including political instability, conflicts (Ukraine, Israel), and inflation, could materially and adversely affect Carmell's business, financial condition, and access to capital[148] - To date, the company's operations have not been materially impacted, but the extent and duration of future disruptions are unpredictable[148] Critical Accounting Policies and Estimates Financial statements require significant management estimates and assumptions affecting reported amounts - Financial statements require significant management estimates and assumptions, including those for forward purchase assets, earnout liabilities, derivative liabilities, and impairment assessments[37][38][149] Going Concern and Management Plan The company's cash position raises substantial doubt about its ability to continue as a going concern - As of March 31, 2024, Carmell had $892,161 in cash and an accumulated deficit of $61,774,360, indicating substantial doubt about its ability to continue as a going concern[150] - Management's plan to extend cash runway includes a $3 million private placement in April 2024, cost reductions from the AxoBio disposition, refocusing on near-term commercial aesthetic products, and exploring out-licensing R&D programs[151][159] Comparison of Results of Operations for the Three Months Ended March 31, 2024 and 2023 Operating expenses increased by 8%, while net loss before taxes grew 94% due to other expenses Results of Operations (Three Months Ended March 31, 2024 vs. 2023) | Metric | 2024 (unaudited) | 2023 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $429,420 | $740,325 | $(310,905) | -42% | | General and administrative | $927,394 | $510,445 | $416,949 | 82% | | Depreciation and amortization of intangibles | $23,531 | $24,101 | $(570) | -2% | | Total operating expenses | $1,380,345 | $1,274,871 | $105,474 | 8% | | Loss from operations | $(1,380,345) | $(1,274,871) | $(105,474) | 8% | | Other expenses, net | $(2,172,817) | $(553,844) | $(1,618,973) | 292% | | Net loss income before taxes | $(3,553,162) | $(1,828,715) | $(1,724,447) | 94% | - The decrease in R&D expenses was due to strategic realignment, focusing on near-term commercial aesthetic products and ceasing long-term clinical studies, along with employee terminations in non-core areas[154] - The significant increase in 'Other expenses, net' was primarily driven by an unfavorable change in the fair value of the Forward Purchase Agreement of $2,156,837[156] Liquidity, Capital Resources, and Going Concern Liquidity is a significant concern, and the company is implementing cost-saving measures to extend its cash runway - As of March 31, 2024, Carmell had cash of $892,161 and an accumulated deficit of $61,774,360, indicating a going concern risk[158] - Management anticipates revenue from new cosmetic skincare products and cost savings from AxoBio disposition and R&D reprioritization to extend cash runway, but additional capital may be needed[159][160] Cash Flows Net cash used in operating activities increased, while financing activities shifted from providing to using cash Cash Flow Summary (Three Months Ended March 31, 2024 vs. 2023) | Cash Flow Activity | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(1,075,778) | $(475,959) | $(599,819) | | Net cash used in investing activities | $(748,796) | — | $(748,796) | | Net cash (used in) provided by financing activities | $(195,726) | $375,000 | $(570,726) | - The increase in cash used in operating activities was primarily driven by net cash used in AxoBio's operations ($1,033,586) and changes in accounts payable, accrued expenses, and prepaid expenses[164] - Net cash used in financing activities in 2024 was due to $227,264 in repayments of Premium Financing Programs, contrasting with $375,000 in proceeds from Promissory Notes in 2023[166] Contingencies The company is facing a lawsuit from Puritan Partners LLC seeking damages of over $2.7 million - Puritan Partners LLC filed a complaint on November 8, 2023, alleging breaches of Convertible Notes and Warrants and seeking $2,725,000 in damages, plus fees and interest[167][168] - The Company has moved to dismiss the complaint and intends to vigorously defend against the litigation[168] Contractual Obligations and Commitments Commitments include operating leases and royalty payments to Carnegie Mellon University - Contractual obligations include operating leases and royalty payments under the Amended License Agreement with Carnegie Mellon University[169] Emerging Growth Company and Smaller Reporting Company Status The company qualifies as an emerging growth and smaller reporting company, allowing for reduced disclosures - Carmell is 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[170] - As a 'smaller reporting company,' Carmell can present only two years of audited financial statements and has reduced disclosure obligations for executive compensation[171] Item 3. Quantitative and Qualitative Disclosures About Market Risk Quantitative and qualitative disclosures about market risk are not required for the company Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of the quarter-end Evaluation of Disclosure Controls and Procedures The CEO and CFO concluded that the company's disclosure controls and procedures were effective - The CEO and CFO concluded that disclosure controls and procedures were effective as of March 31, 2024[174] Changes in Internal Control Over Financial Reporting No material changes in internal control over financial reporting occurred during the quarter - No material changes in internal control over financial reporting occurred during the most recently completed fiscal quarter[175] PART II. OTHER INFORMATION Item 1. Legal Proceedings Material pending legal proceedings are detailed in the financial statement notes - Material pending legal proceedings are described in Note 8 (Debt) and Note 10 (Commitments and Contingencies) of the financial statements[176] Item 1A. Risk Factors There have been no material changes to the risk factors disclosed in the 2023 Annual Report - No material changes from the risk factors disclosed in the 2023 Annual Report on Form 10-K[177] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities or use of proceeds - No unregistered sales of equity securities and use of proceeds to report[178] Item 3. Defaults Upon Senior Securities The company reports no defaults upon senior securities during the period - No defaults upon senior securities to report[179] Item 4. Mine Safety Disclosures The company reports no mine safety disclosures - No mine safety disclosures to report[180] Item 5. Other Information No directors or officers adopted, terminated, or modified a Rule 10b5-1 trading arrangement - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted, terminated, or modified by directors or officers during Q1 2024[181] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including agreements and certifications - Exhibits include the Membership Interest Purchase Agreement (Exhibit 10.1), certifications of Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2), and Inline XBRL documents[184] Signatures Signatures The report was duly signed by the Chief Executive Officer and Chief Financial Officer on May 15, 2024 - The report was signed by Rajiv Shukla, CEO and Executive Chairman, and Bryan J. Cassaday, CFO, on May 15, 2024[187]