Longevity Health Holdings, Inc 10-Q for FY2024 Q2
Longevity Health Holdings, Inc. (XAGE)
About this 10-Q
Longevity Health Holdings, Inc filed this 10-Q on August 14, 2024, covering the quarter ended June 30, 2024 (FY2024 Q2).
Headline figures
Quarter ended June 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $12.32K
- compared with $0 a year earlier
- Net loss
- $3.3M
- compared with a net loss of $5.31M a year earlier
- Diluted EPS
- -$0.16
- compared with -$5.00 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
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The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 11, 2024, the registrant had
Table of Contents
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PART I. |
FINANCIAL INFORMATION |
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Item 1. |
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Condensed Consolidated Statements of Stockholders’ Deficit |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. |
OTHER INFORMATION |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
CARMELL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, |
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December 31, |
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2024 |
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2023 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash |
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Prepaid expenses |
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Forward purchase agreement |
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Inventory |
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Income taxes receivable |
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Assets available for sale |
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Total current assets |
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Property and equipment, net of accumulated depreciation of $ |
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Operating lease right of use asset |
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Intangible assets, net of accumulated amortization of $ |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued interest |
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Accrued expenses and other liabilities |
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Loans payable, net of debt discount |
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Operating lease liability |
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Liabilities available for sale |
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Total current liabilities |
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Long-term liabilities: |
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Operating lease liability, net of current portion |
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Total liabilities |
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Stockholders’ (deficit) equity: |
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Series A convertible voting preferred stock, $ |
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— |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ (deficit) equity |
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Total liabilities and stockholders’ (deficit) equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
CARMELL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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For the Three Months Ended |
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For the Six Months Ended |
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June 30, |
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June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue, net of discounts |
$ |
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$ |
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$ |
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$ |
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Cost of Goods Sold |
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Gross Profit |
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Operating expenses: |
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Selling and marketing |
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Research and development |
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General and administrative |
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Depreciation and amortization of intangible assets |
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Total operating expenses |
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Loss from operations |
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( |
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Other income (expense): |
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Other income (expense) |
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( |
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Interest expense |
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( |
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( |
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( |
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Amortization of debt discount |
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( |
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( |
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( |
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Loss on forward purchase agreement |
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( |
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Change in fair value of derivative liabilities |
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( |
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Total other income (expense) |
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( |
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Loss from continuing operations before provision for income taxes |
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( |
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Provision for income taxes |
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Loss from continuing operations |
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Loss from discontinued operations attributable to common shareholders |
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( |
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Gain on sale of discontinued operations attributable to common shareholders |
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Net loss |
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( |
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Dividends on Legacy Series A, Legacy Series C-1, and Legacy C-2 preferred stock |
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Net loss attributable to common stockholders |
$ |
( |
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$ |
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$ |
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$ |
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Net (loss) income per common share - basic and diluted: |
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Net loss from continuing operations |
$ |
( |
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$ |
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$ |
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$ |
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Discontinued operations, net of tax |
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Net loss per common share |
$ |
( |
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$ |
( |
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$ |
( |
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$ |
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Weighted average of common shares outstanding - basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
CARMELL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
For the Three and Six Months Ended June 30, 2024 and 2023
(Unaudited)
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Series A Preferred Stock |
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Common Stock |
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Additional |
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Accumulated |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Total |
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Balance at March 31, 2024 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Common Stock issued in connection with Promissory Notes |
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— |
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— |
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— |
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Common Stock issued |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at June 30, 2024 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Balance at March 31, 2023 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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Accrued Legacy Series A preferred stock dividend |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Accrued Legacy Series C-1 preferred stock dividend |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Accrued Legacy Series C-2 preferred stock dividend |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Exercise of common stock warrants |
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— |
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— |
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— |
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Warrants issued in connection with Promissory Notes |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance at June 30, 2023 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Balance at January 1, 2024 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Stock received from AxoBio Disposition |
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( |
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( |
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( |
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( |
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( |
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— |
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( |
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Common Stock issued in connection with Promissory Notes |
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— |
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— |
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— |
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Common Stock issued |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at June 30, 2024 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Balance at January 1, 2023 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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Accrued Legacy Series A preferred stock dividends |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Accrued Legacy Series C-1 preferred stock dividends |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Accrued Legacy Series C-2 preferred stock dividends |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Exercise of common stock options |
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— |
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— |
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Warrants issued in connection with Promissory Notes |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at June 30, 2023 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
CARMELL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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For the Six Months Ended June 30, |
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|||||
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2024 |
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2023 |
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||
Cash flows from operating activities: |
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Net loss from continuing operations |
$ |
( |
) |
|
$ |
( |
) |
Loss from discontinued operations, net of tax |
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( |
) |
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— |
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Gain on sale of discontinued operations |
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— |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Gain on sale of discontinued operations |
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( |
) |
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— |
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Stock-based compensation |
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Depreciation and amortization of intangible assets |
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Amortization of right of use assets |
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Amortization of debt discount |
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||
Change in fair value of forward purchase agreement |
|
|
|
|
— |
|
|
Change in fair value of derivative liabilities |
|
— |
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
||
Prepaid expenses |
|
|
|
|
|
||
Inventory |
|
( |
) |
|
|
— |
|
Assets available for sale |
|
|
|
|
— |
|
|
Other current assets |
|
— |
|
|
|
|
|
Accounts payable |
|
( |
) |
|
|
|
|
Accrued expenses and other liabilities |
|
( |
) |
|
|
|
|
Lease liability |
|
( |
) |
|
|
( |
) |
Accrued interest |
|
— |
|
|
|
|
|
Liabilities available for sale |
|
( |
) |
|
|
— |
|
Net cash used in operating activities |
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
||
Cash flows from investing activities |
|
|
|
|
|
||
Cash paid in AxoBio Disposition |
|
( |
) |
|
|
— |
|
Purchase of property and equipment |
|
— |
|
|
|
( |
) |
Net cash used in investing activities |
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
||
Proceeds from issuance of Common Stock, net of costs |
|
|
|
|
— |
|
|
Proceeds from issuance of loans |
|
|
|
|
|
||
Payment of loans |
|
( |
) |
|
|
— |
|
Proceeds from common stock option exercises |
|
— |
|
|
|
|
|
Net cash provided by financing activities |
|
|
|
|
|
||
|
|
|
|
|
|
||
Net decrease in cash |
|
( |
) |
|
|
( |
) |
Cash - beginning of the period |
|
|
|
|
|
||
Cash - end of the period |
$ |
|
|
$ |
|
||
|
|
|
|
|
|
||
Supplemental cash flow information: |
|
|
|
|
|
||
Interest paid |
$ |
|
|
$ |
— |
|
|
Income taxes paid |
|
— |
|
|
|
— |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
CARMELL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Continued)
(Unaudited)
|
For the Six Months Ended June 30, |
|
|||||
|
2024 |
|
|
2023 |
|
||
Non-cash financing activity: |
|
|
|
|
|
||
Net assets sold in AxoBio Acquisition |
$ |
|
|
$ |
— |
|
|
Fair value of shares received in AxoBio Disposition |
|
|
|
|
— |
|
|
Common Stock issued in connection with conversion of Promissory Notes |
|
|
|
|
— |
|
|
Accrued Legacy Series A preferred stock dividends |
|
— |
|
|
|
|
|
Accrued Legacy Series C-1 preferred stock dividends |
|
— |
|
|
|
|
|
Accrued Legacy Series C-2 preferred stock dividends |
|
— |
|
|
|
|
|
Warrants issued in connection with promissory notes |
|
|
|
|
|
||
Unpaid deferred offering costs |
|
— |
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
CARMELL CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 — NATURE OF THE ORGANIZATION AND BUSINESS
Unless the context requires otherwise, references to “Carmell,” or the “Company” prior to the closing of the Business Combination (as defined below) are intended to refer to Carmell Therapeutics Corporation, a Delaware corporation, (“Legacy Carmell”), and, after the closing of the Business Combination, are intended to refer to Carmell Corporation, a Delaware corporation, and its consolidated subsidiaries.
Carmell Corporation is a bio-aesthetics company developing cosmetic skincare and haircare products that utilize the Carmell Secretome™ to topically deliver proteins and growth factors to support skin and hair health. The Carmell Secretome™ consists of a potent cocktail of proteins, peptides and bio-lipids extracted from allogeneic human platelets sourced from U.S. Food and Drug Administration-approved tissue banks. The Company’s product pipeline also includes innovative bone and wound healing products that are under development. Carmell’s operations are based in Pittsburgh, Pennsylvania. The Company operates as a single segment, and all of its operations are located in the United States. Carmell’s common stock, par value $
Business Combination
On July 14, 2023 (the “Closing Date”), the Company consummated a business combination (the “Business Combination”) pursuant to the terms of the Business Combination Agreement, dated as of January 4, 2023 (the “Business Combination Agreement”), by and among Alpha Healthcare Acquisition Corp. III, a Delaware corporation and the predecessor of Carmell (“Alpha”), Candy Merger Sub, Inc., a Delaware corporation (“Merger Sub”) and Legacy Carmell, pursuant to which Merger Sub merged with and into Legacy Carmell, with Legacy Carmell as the surviving company of the Business Combination. After giving effect to the Business Combination, Legacy Carmell became a wholly owned subsidiary of the Company. Pursuant to the Business Combination Agreement, on the Closing Date, Alpha changed its name to “Carmell Therapeutics Corporation” and Legacy Carmell changed its name to “Carmell Regen Med Corporation.” On August 1, 2023, the Company filed an amendment to its Third Amended and Restated Certificate of Incorporation with the Delaware Secretary of State to change its name to “Carmell Corporation.”
Pursuant to the Business Combination Agreement, at the effective time of the Business Combination (the “Effective Time”), (i) each outstanding share of common stock of Legacy Carmell (the “Legacy Carmell common stock”) was converted into the right to receive a number of shares of Common Stock equal to the applicable Exchange Ratio (as defined in the Business Combination Agreement); (ii) each outstanding share of preferred stock of Legacy Carmell was converted into the right to receive the aggregate number of shares of Common Stock that would be issued upon conversion of the underlying Legacy Carmell common stock, multiplied by the applicable Exchange Ratio; (iii) each outstanding option and warrant to purchase Legacy Carmell common stock was converted into an option or warrant, as applicable, to purchase a number of shares of Common Stock equal to the number of shares of Legacy Carmell common stock subject to such option or warrant multiplied by the applicable Exchange Ratio; and (iv) each outstanding share of Alpha Class A common stock, par value $
On July 11, 2023, the record date for the special meeting of Alpha’s stockholders to approve the Business Combination (the “Special Meeting”), there were (i)
The Business Combination was accounted for as a reverse recapitalization in accordance with accounting principles generally accepted in the United States (“GAAP”). Under this method of accounting, Alpha was treated as the acquired company for financial reporting purposes, and Legacy Carmell was treated as the accounting acquirer. Operations prior to the Business Combination are those of Legacy
6
Carmell. Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related share price information to give effect to the Exchange Ratio established in the Business Combination Agreement.
Axolotl Biologix Acquisition
On August 9, 2023 (the “Merger Closing Date”), the Company completed the acquisition of Axolotl Biologix, Inc. (“AxoBio”) pursuant to an Agreement and Plan of Merger, dated
Axolotl Biologix Disposition
On March 20, 2024, the Company entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) with the former stockholders of AxoBio, including Burns Ventures, LLC, a Texas limited liability company (“BVLLC”), H. Rodney Burns, an individual resident of Texas (“Burns”), AXO XP, LLC, an Arizona limited liability company (“AXPLLC”), and Protein Genomics, LLC, a Delaware corporation (“PGEN” and together with BVLLC, Burns, and AXPLLC, collectively, the “Buyers” and each, a “Buyer”), providing for, upon the terms and subject to the conditions set forth therein, the sale by the Company of all outstanding limited liability company interests of AxoBio (the “AxoBio Disposition”) to the Buyers for aggregate consideration as described below. The AxoBio Disposition closed on
The consideration for the AxoBio Disposition consisted of (i) the Closing Share Consideration, initially issued as consideration to the Buyers under the Merger Agreement, (ii) cancellation of the notes payable to the Buyers in an aggregate principal amount of $
Risks and Uncertainties
Disruption of global financial markets and a recession or market correction, including the ongoing military conflicts between Russia and Ukraine and the related sanctions imposed against Russia, as well as the conflict between Israel and Hamas and the related tensions in the Middle East and other global macroeconomic factors such as inflation and changes in interest rates, could reduce the Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity and could materially affect the Company’s business and the value of its Common Stock.
NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. These financial statements should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023. The accompanying unaudited condensed consolidated financial statements include all adjustments that are of a normal recurring nature and necessary for the fair presentation of the results for the interim periods presented. Results for interim periods are not necessarily indicative of results to be expected for the full year.
Emerging Growth Company Status
The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended (the “Securities Act”), as modified by the Jumpstart our Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain
7
exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.
Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies, but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period, which means that when a standard is issued or revised and has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make a comparison of the Company’s financial statements with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.
Use of Estimates
The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. Significant estimates in these unaudited condensed consolidated financial statements include those related to the forward purchase asset, earnout liabilities, derivative liabilities, long-term assets and goodwill impairment, the provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets, and contingent liabilities. If the underlying estimates and assumptions upon which the unaudited condensed consolidated financial statements are based change in the future, actual amounts may differ from those included in the accompanying unaudited condensed consolidated financial statements.
Business Combinations
The Company allocates the fair value of the purchase consideration of its acquisitions to the tangible assets, liabilities, and intangible assets acquired based on their estimated fair values. The excess of the fair value of purchase consideration over the fair values of these identifiable assets and liabilities is recorded as goodwill. Acquisition-related expenses are expensed as incurred and included in general and administrative expenses.
The allocation of the purchase price requires management to make significant estimates in determining the fair values of assets acquired and liabilities assumed, especially with respect to intangible assets. These estimates are based on information obtained from management of the acquired companies and historical experience. These estimates can include, but are not limited to, the cash flows that an asset is expected to generate in the future and the cost savings expected to be derived from acquiring an asset. These estimates are inherently uncertain and unpredictable, and if different estimates were used, the purchase price for the acquisition could be allocated to the acquired assets and liabilities differently from the allocation that the Company has made.
Discontinued Operations
On March 26, 2024, the Company completed the AxoBio Disposition as described in Note 1 above. In accordance with Financial Accounting Standards Board Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements, Discontinued Operations, Other Presentation Matters (“ASC 205”), the assets and liabilities of AxoBio are classified as available for sale on the accompanying unaudited condensed consolidated balance sheets, and the results of its operations are reported as discontinued operations in the accompanying unaudited condensed consolidated statements of operations.
Segment Reporting
ASC Topic No. 280, Segment Reporting (“ASC 280”), establishes standards for the way that public business enterprises report information about operating segments in their annual consolidated financial statements and requires that those enterprises report selected information about operating segments in interim financial reports. ASC 280 also establishes standards for related disclosures about products and services, geographic areas and major customers. The Company’s business segments are based on the organizational structure used by the chief operating decision maker to make operating and investment decisions and assess performance. Our chief executive officer, who is our chief operating decision maker, views the Company’s operations and manages its business in
Cash and Cash Equivalents
The Company considers all short-term investments with an original maturity of three months or less when purchased to be cash
8
equivalents. Cash and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, the Company’s cash and cash equivalents balance exceeds the federally insured limits, which potentially subject the Company to concentrations of credit risk. For the six months ended June 30, 2024 and 2023, the Company has experienced no losses related to its cash and cash equivalents that exceed federally insured deposit limits. As of June 30, 2024, the Company had cash in excess of federally insured limits of $
Forward Purchase Agreement
On July 9, 2023, Alpha and each of Meteora Special Opportunity Fund I, LP (“MSOF”), Meteora Capital Partners, LP (“MCP”) and Meteora Select Trading Opportunities Master, LP (“MSTO” and together with MCP and MSOF, the “Sellers” or “Meteora”) entered into a forward purchase agreement (the “Forward Purchase Agreement”) providing for an over-the-counter equity forward transaction relating to, prior to the Effective Time, the Class A Common Stock and, after the Effective Time, the Common Stock. Pursuant to the terms of the Forward Purchase Agreement, at the Closing Date, the Sellers purchased directly from the stockholders of Alpha
In accordance with the terms of the Forward Purchase Agreement, at the Closing Date, the Company paid to the Sellers an aggregate cash amount of $
From time to time and on any date following the Business Combination (any such date, an “OET Date”) and subject to the terms and conditions below, Meteora may, in its absolute discretion, and so long as the daily volume-weighted average price (“VWAP Price”) of the Recycled Shares is equal to or exceeds the Reset Price (as defined in the Forward Purchase Agreement), terminate the transaction in whole or in part by providing written notice (an “OET Notice”) in accordance with the terms of the Forward Purchase Agreement. The effect of an OET Notice given shall be to reduce the number of shares by the number of Terminated Shares (as defined in the Forward Purchase Agreement) specified in such OET Notice with effect as of the related OET Date. As of each OET Date, the Company shall be entitled to an amount from Meteora, and Meteora shall pay to the Company an amount equal to the product of (a) the number of Terminated Shares multiplied by (b) the Initial Price in respect of such OET Date.
The Reset Price is initially $
On August 6, 2024, the Company and Meteora entered into an amendment to the Forward Purchase Agreement to change the settlement method from physical settlement to cash settlement. See Note 16 for further information.
Accounts Receivables, Net
Accounts receivable are recorded at the original invoice amount. Receivables are considered past due based on the contractual payment terms. The Company reserves a percentage of its trade receivable balance based on collection history and current economic trends that it expects will impact the level of credit losses over the life of the Company’s receivables. These reserves are re-evaluated on a regular basis and adjusted as needed. Once a receivable is deemed to be uncollectible, such balance is charged against the reserve. The Company had no reserve related to the potential likelihood of not collecting its receivables as of June 30, 2024 and December 31, 2023. All of the Company’s trade receivables were related to AxoBio at December 31, 2023 and are classified as a component of assets available for sale in the accompanying unaudited condensed consolidated balance sheets.
9
Inventories
Inventory is stated at the lower of cost or net realizable value. Cost is calculated by applying the first-in-first-out method. The Company regularly reviews inventory quantities on hand and writes down any inventory that it believes to be impaired to its net realizable value. Management considers forecast demand in relation to the inventory on hand, competitiveness of product offerings, market conditions and product life cycles when determining excess and obsolescence and net realizable value adjustments. At December 31, 2023, all of the Company’s inventory was related to AxoBio and is classified as a component of assets available for sale in the accompanying unaudited condensed consolidated balance sheets. The Company had
Inventory as of June 30, 2024 was comprised of the following:
|
June 30, 2024 |
Raw materials |
$ |
Work-in-process |
|
Finished goods |
|
Total |
$ |
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Maintenance and repair charges are expensed as incurred. Fixed assets are depreciated using the straight-line method using the following estimated useful lives:
Goodwill and Intangible Assets
Goodwill is not amortized but tested for impairment on an annual basis in the fourth quarter and more frequently if events or changes in circumstances indicate that the asset may be impaired. The Company’s impairment tests are based on a single reporting unit structure. The carrying value and ultimate realization of these assets are dependent upon estimates of future earnings and benefits that the Company expects to generate from their use. If the expectations of future results and cash flows are significantly diminished, intangible assets and goodwill may be impaired, and the resulting charge to operations may be material. First, the Company assesses qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform the two-step goodwill impairment test. If, after assessing qualitative factors, the Company determines it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing the two-step impairment test is unnecessary. If deemed necessary, a two-step test is used to identify the potential impairment and to measure the amount of goodwill impairment, if any. The first step is to compare the fair value of the reporting unit with its carrying amount, including goodwill. An impairment charge is recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value. However, the impairment loss recognized should not exceed the total amount of goodwill allocated to that single reporting unit. All of the Company’s goodwill was related to the AxoBio Acquisition and totaled $
Finite-lived intangible assets are carried at cost and amortized based on an economic benefit period, which is seven to twenty years. The Company evaluates finite-lived intangible assets for impairment by assessing the recoverability of these assets whenever adverse events or changes in circumstances or business climate indicate that expected undiscounted future cash flows related to such intangible assets may not be sufficient to support the net book value of such assets. An impairment charge is recognized in the period of identification to the extent the carrying amount of an asset exceeds the fair value of such asset. Costs billed to the Company as reimbursement for third parties’ patent submissions are considered to be license fees and are expensed as incurred. Intangible assets related to AxoBio are classified as a component of assets available for sale in the accompanying unaudited condensed consolidated balance sheets.
Finite-lived intangible assets are amortized using the straight-line method using the following useful lives:
Significant judgments required in assessing the impairment of goodwill and intangible assets include the assumption the Company only
10
has a single reporting unit, identifying whether events or changes in circumstances require an impairment assessment, estimating future cash flows, determining appropriate discount and growth rates and other assumptions. Changes in these estimates and assumptions could materially affect the determination of fair value and whether an impairment exists and, if so, the amount of that impairment. The Company has not recognized any goodwill or intangible asset impairment charges in the six months ended June 30, 2024 and 2023.
Series A Voting Convertible Preferred Stock
In connection with the AxoBio Acquisition, the Company issued
Earnout Liability
In connection with the AxoBio Acquisition, the former stockholders of AxoBio were entitled to receive the Earnout, consisting of up to $
Revenue Recognition
The Company accounts for revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, revenue is recognized when control of promised goods or services is transferred to a customer in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. Revenue is recognized based on the following five-step model:
All of the Company's revenue for the three and six months ended June 30, 2024 was derived from direct-to-consumer sales for which the price is fixed. Such revenue is recognized upon the shipment of the related goods.
Selling and Marketing Expenses
Selling and marketing expenses included in continuing operations principally consist of marketing and advertising expenses. Such costs are expensed as incurred. The Company had
Research and Development Expenses
Research and development expenses are expensed as incurred and consist principally of internal and external costs, which include the cost of patent licenses, contract research services, laboratory supplies and development and manufacture of preclinical compounds and consumables for clinical trials and preclinical testing.
Income Taxes
Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that included the enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.
11
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax expense. There were
Net Loss Per Share
Under ASC 260, Earnings per Share, the Company is required to apply the two-class method to compute earnings per share (“EPS”). Under the two-class method, both basic and diluted EPS are calculated for each class of common stock and participating security, considering both dividends declared (or accumulated) and participation rights in undistributed earnings. The two-class method results in an allocation of all undistributed earnings as if all those earnings were distributed. As the Company has generated losses in each reporting period since its inception, the Company also considered the guidance related to the allocation of the undistributed losses under the two-class method. The contractual rights and obligations of the shares of Legacy Preferred Stock (as defined in Note 11 below) and the Company’s warrants were evaluated to determine if they have an obligation to share in the losses of the Company. As there is no obligation for the holders of Legacy Preferred Stock or the holders of the Company's warrants to fund the losses of the Company, nor is the contractual principal or redemption amount of the shares of Legacy Preferred Stock or the warrants reduced as a result of losses incurred by the Company, under the two-class method, the undistributed losses are allocated entirely to the Common Stock. Earnings per share information has been retrospectively adjusted to reflect the Business Combination ratio applied to Legacy Carmell’s historical number of shares outstanding. Shares of Alpha are considered issued for EPS purposes as of the date of the Business Combination.
The Company computes basic loss per share by dividing the loss attributable to holders of Common Stock for the period by the weighted average number of shares of Common Stock outstanding during the period. The Company’s warrants, options, Legacy Preferred Stock, and convertible notes could, potentially, be exercised or converted into Common Stock and then share in the earnings of the Company. However, these convertible instruments, warrants, and options were excluded when calculating diluted loss per share because such inclusion would be anti-dilutive for the periods presented. As a result, diluted loss per share is the same as basic loss per share for the periods presented.
Potentially dilutive securities as of June 30, 2024, which are not included in diluted weighted average shares outstanding for the three and six months ended June 30, 2024 and 2023, consist of the following (in common stock equivalents):
|
June 30, |
||
|
2024 |
|
2023 |
Stock Options |
|
||
Common Stock Warrants |
|
||
Legacy Series A Preferred Stock (if converted) |
|
||
Legacy Series B Preferred Stock (if converted) |
|
||
Legacy Series C-1 Preferred Stock (if converted) |
|
||
Legacy Series C-2 Preferred Stock (if converted) |
|
||
Legacy Preferred Stock Warrants |
|
||
Convertible Notes (if converted) |
|
||
Total |
|
||
Stock-Based Compensation
The Company applies the provisions of ASC 718, Compensation-Stock Compensation (“ASC 718”), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, including employee stock options, in the unaudited condensed consolidated statements of operations.
For stock options issued to employees and members of the Company’s Board of Directors (the “Board”) for their services, the Company estimates each option’s grant-date fair value using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates, and expected dividend yields of the Common Stock. For awards subject to service-based vesting conditions, including those with a graded vesting schedule, the Company recognizes stock-based compensation expense equal to the grant date fair value of stock options on a straight-line basis over the requisite service period, generally the vesting term. Forfeitures are recorded as incurred instead of estimated at the time of grant and revised.
Under Accounting Standards Update (“ASU”) 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to
12
Non-Employee Share-Based Payment Accounting, the Company accounts for stock options issued to non-employees for their services in accordance with ASC 718. The Company uses valuation methods and assumptions to value the stock options that are in line with the process for valuing employee stock options noted above.
Leases
The Company accounts for its leases pursuant to ASC 842, Leases, as amended. The Company’s leases consist of leaseholds on office space. The Company determines if an arrangement contains a lease at inception as defined by ASC 842. To meet the definition of a lease under ASC 842, the contractual arrangement must convey to the Company the right to control the use of an identifiable asset for a period of time in exchange for consideration. Right of Use (“ROU”) assets represent the right to use an underlying asset for the lease term, and lease liabilities represent the obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the lease commencement date based on the estimated present value of lease payments over the lease term.
Concentrations
Fair Value Measurements and Fair Value of Financial Instruments
The Company categorizes its assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy in accordance with GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy below gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The carrying value of cash and cash equivalents, accounts receivable, accounts payable, accrued expenses, deferred consideration payable and related party loans payable approximate fair value because of the short-term maturity of such instruments.
Other financial assets and liabilities are categorized based on a hierarchy of inputs as follows:
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
Fair Value |
||||||||||
|
|
Carrying Value |
|
|
Estimated Fair Value |
|
|
Carrying Value |
|
|
Estimated Fair Value |
|
|
Input Hierarchy |
||||
Forward purchase agreement |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Level 3 |
||||
SBA Loan |
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 2 |
||||
Changes in the fair value of Level 3 financial assets and liabilities for the six months ended June 30, 2024 are as follows:
Forward Purchase Agreement: |
|
|
|
|
Balance, beginning of year |
|
$ |
|
|
Change in fair value |
|
|
( |
) |
Balance, end of period |
|
$ |
|
|
The Forward Purchase Agreement was accounted for at fair value as a financial instrument in the scope of ASC 480, Distinguishing Liabilities from Equity, and resulted in an asset at the Closing Date. The fair value of the Company’s position under the Forward Purchase Agreement was calculated using the . The assumptions incorporated into the valuation model as of December 31, 2023 included the share price of $
13
NOTE 3 — BUSINESS COMBINATION
AxoBio Acquisition
The AxoBio Acquisition is reflected in the unaudited condensed consolidated financial statements under the acquisition method of accounting in accordance with ASC 805, with the Company treated as the accounting and legal acquirer in the AxoBio Acquisition. It was determined that AxoBio is a variable interest entity, as AxoBio’s total equity at risk is not sufficient to permit AxoBio to finance its activities without additional subordinated financial support, with the Company being the primary beneficiary. In accordance with ASC 805, the Company recorded AxoBio’s assets and liabilities at fair value. For purposes of estimating the fair value, where applicable, of the assets acquired and liabilities assumed as reflected in the unaudited condensed consolidated financial information, the Company has applied the guidance in ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), which establishes a framework for measuring fair value in acquisitions. In accordance with ASC 820, fair value is an exit price and is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Under ASC 805, acquisition-related transaction costs are not included as components of consideration transferred but are accounted for as expenses in the period in which the costs are incurred.
Common Stock - |
$ |
|
|
Series A Convertible Voting Preferred Stock - |
|
|
|
Earnout |
|
|
|
Deferred Consideration |
|
|
|
Total estimated value of consideration transferred |
$ |
|
The fair value of the Series A Preferred Stock was estimated at $
In connection with the AxoBio Acquisition, the former stockholders of AxoBio were entitled to receive payment of the Earnout consisting of up to $
The fair value of the Earnout was estimated as of the Merger Closing Date using (1) the probabilities of success and estimated dates of milestone achievements in relation to the research and development milestones, and (2) probability-adjusted revenue scenarios in relation to the revenue targets.
The total purchase consideration transferred in the AxoBio Acquisition has been allocated to the net assets acquired and liabilities assumed based on their fair values at the acquisition date. The transaction costs related to this acquisition of approximately $
14
The allocation of the purchase price was as follows:
Total estimated value of consideration transferred |
$ |
|
|
Cash and cash equivalents |
|
|
|
Accounts receivable |
|
|
|
Prepaid expenses |
|
|
|
Inventories |
|
|
|
Property and equipment |
|
|
|
Intangible assets |
|
|
|
Total assets |
|
|
|
Accounts payable |
|
|
|
Accrued interest |
|
|
|
Other accrued expenses |
|
|
|
Loan payable |
|
|
|
Related party loans |
|
|
|
Deferred tax liabilities |
|
|
|
Net assets to be acquired |
|
|
|
Goodwill |
$ |
|
The Company estimated the fair value of the acquired inventories based on the selling price less costs to sell and recorded the fair value step-up of approximately $
The acquired loan payable of AxoBio was adjusted down to its fair value by $
The intangible assets include trade names, customer contracts and intellectual property. The intangible assets were valued using a discounted cash flow model. The estimated fair value of the customer contracts as of the acquisition date was determined based on the projected future profits from the contracts, discounted to present value, and the likelihood of contract renewals at the end of each contract term. The estimated fair value of the intellectual property as of the acquisition date was determined based on the estimated license royalty rates, the present value of future cash flows from the intellectual property, and the expected useful life of
The Company determined that the AxoBio Acquisition was deemed significant to the Company in accordance with Rule 3-05 of Regulation S-X. As required by ASC 805, Business Combinations, the following unaudited pro forma statements of operations for the three and six months ended June 30, 2023 give effect to the AxoBio Acquisition as if it had been completed on January 1, 2023. The unaudited pro forma financial information below is presented for illustrative purposes only and is not necessarily indicative of what the operating results actually would have been during the periods presented had the AxoBio Acquisition been completed during the periods presented. In addition, the unaudited pro forma financial information does not purport to project future operating results.
15
|
For the three months ended June 30, 2023 |
|
|
For the six months ended June 30, 2023 |
|
||
Revenue included in discontinued operations in the consolidated statements of operations |
$ |
— |
|
|
$ |
— |
|
Add: AxoBio revenue not reflected in the consolidated statements of operations |
|
|
|
|
|
||
Unaudited pro forma revenue |
$ |
|
|
$ |
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
Net loss from consolidated statements of operations |
$ |
( |
) |
|
$ |
( |
) |
Add: AxoBio net income not reflected in the consolidated statements of |
|
|
|
|
|
||
operations, less pro forma adjustments described below (1) |
|
( |
) |
|
|
( |
) |
Unaudited pro forma net loss |
$ |
( |
) |
|
$ |
( |
) |
NOTE 4 — GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS
Historically, the Company’s liquidity needs have been satisfied through debt and equity financing. As of June 30, 2024, the Company had cash of $
Due to its current liabilities and other potential liabilities, the cash available to the Company may not be sufficient to allow the Company to operate for at least 12 months from the date these unaudited condensed consolidated financial statements are available for issuance. The Company may need to raise additional capital through equity or debt issuances. If the Company is unable to raise additional capital, it may be required to take additional measures to conserve liquidity, which could include, but not necessarily be limited to, curtailing operations and reducing payroll expenses. The Company cannot provide any assurance that new financing will be available to it on commercially acceptable terms, if at all.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern. These unaudited condensed consolidated financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.
The Company has refocused its efforts on cosmetic skincare products with near-term commercial potential, reprioritized its research and development, and ceased clinical studies of product candidates that will take more than a year to commercialize. The Company is also exploring the development and commercialization of haircare products based on the Carmell SecretomeTM and out-licensing of certain research and development programs to generate non-dilutive liquidity.
16
NOTE 5 — PROPERTY AND EQUIPMENT
Property and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|||
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
||||||
|
|
Continuing Operations |
|
|
Continuing Operations |
|
|
Discontinued Operations |
|
|||
Lab equipment |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Leasehold improvements |
|
|
|
|
|
|
|
|
— |
|
||
Furniture and fixtures |
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Less: accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Depreciation expense included in loss from continuing operations in the accompanying unaudited condensed consolidated statements of operations was $
NOTE 6 —GOODWILL AND INTANGIBLE ASSETS
The Company’s goodwill relates to the AxoBio Acquisition. Goodwill represents the excess of the purchase price of the acquired business over the fair value of the underlying net tangible and intangible assets. The Company may record goodwill adjustments pursuant to changes in the preliminary valuations acquired during the measurement period, which is up to one year from the date of acquisition. For the year ended December 31, 2023, the Company recognized $
The Company capitalizes legal costs directly associated with the submission of Company patent applications. Gross patent costs of $
Intangible assets acquired in connection with the AxoBio Acquisition were initially recorded at their estimated fair value as of the acquisition date (see Note 3 - Business Combination). Intangible assets that have finite lives are amortized over their economic useful life. Amortization of intangibles related to AxoBio is included as a component of discontinued operations in the accompanying unaudited condensed consolidated statements of operations.
Intangible assets and the related accumulated amortization consist of the following at June 30, 2024:
|
Amortization Period |
|
Gross Carrying Value |
|
|
Accumulated Amortization |
|
|
Net Book Value |
|
|||
Continuing operations: |
|
|
|
|
|
|
|
|
|
|
|||
Patents |
|
$ |
|
|
$ |
|
|
$ |
|
||||
Intangible assets and the related accumulated amortization consist of the following at December 31, 2023:
|
Amortization Period |
|
Gross Carrying Value |
|
|
Accumulated Amortization |
|
|
Net Book Value |
|
|||
Continuing operations: |
|
|
|
|
|
|
|
|
|
|
|||
Patents |
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|||
Discontinued operations: |
|
|
|
|
|
|
|
|
|
|
|||
Customer contracts |
|
$ |
|
|
$ |
|
|
$ |
|
||||
Trade name |
|
|
|
|
|
|
|
|
|
||||
Intellectual property |
|
|
|
|
|
|
|
|
|
||||
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
17
Amortization expense included in loss from continuing operation in the accompanying unaudited condensed consolidated statements of operations was $
NOTE 7— ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued expenses and other liabilities consist of the following amounts:
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
||||||
|
|
Continuing Operations |
|
|
Continuing Operations |
|
|
Discontinued Operations |
|
|||
Accrued severance |
|
$ |
|
|
$ |
|
|
$ |
— |
|
||
Accrued compensation |
|
|
|
|
|
|
|
|
— |
|
||
Accrued stock-based compensation |
|
|
— |
|
|
|
|
|
|
— |
|
|
Other accrued expenses |
|
|
|
|
|
|
|
|
|
|||
Accrued expenses and other liabilities |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Accrued compensation is a non-interest bearing liability for employee payroll outstanding as of June 30, 2024 and December 31, 2023. This includes compensation earned during the years 2019 to 2023.
NOTE 8 —DEBT
U.S. Small Business Administration (SBA) Loan
As of the Merger Closing Date, AxoBio had an outstanding loan with the SBA with total principal and accrued interest outstanding of $
Related Party Loans
As of the Merger Closing Date, AxoBio had several promissory notes outstanding to Burns Ventures, LLC (the “Burns Notes”) with total principal outstanding of $
2023 Promissory Notes
During the year ended December 31, 2023, the Company received proceeds of $
18
Notes in shares of Common Stock. During the six months ended June 30, 2024, the Company issued
Insurance Premium Financing
In August 2024, the Company entered into an agreement with a third party to finance a $
In April 2024, the Company entered into another agreement with a third party to finance a $
During the three and six months ended June 30, 2024, interest expense totaled $
January 2022 Convertible Notes
On January 19, 2022, the Company issued two senior secured convertible notes (the “Convertible Notes”) of $
The conversion feature within the Convertible Notes met the requirements to be treated as a derivative. Accordingly, the Company estimated the fair value of the Convertible Notes derivative using the Monte Carlo Method as of the date of issuance. The fair value of the derivative was determined to be $
Proceeds from the sales of the Convertible Notes with Convertible Note Warrants were allocated to the two elements based on the relative fair value of the Convertible Notes without the warrants and the warrants themselves at the time of issuance. The total amount allocated to the Convertible Note Warrants was $
On July 19, 2022, Carmell defaulted on the Convertible Notes. Under the terms of the Convertible Notes, upon an event of default, there would be a
An Agreement Subsequent to the Notice of Acceleration
On November 2, 2022, Carmell received a letter (“Notice of Acceleration”) from one of the Holders, notifying it of an Event of Default under the Convertible Notes. Carmell and Alpha entered into an agreement with such Holder, Puritan Partners LLC (“Puritan”), in connection with the Notice of Acceleration on December 19, 2022. Pursuant to this agreement, Alpha and Carmell each represented and
19
warranted to Puritan that (i) it intended to enter into the Business Combination, (ii) there would be no conditions to closing relating to Alpha or its affiliates delivering a certain amount of cash to the Company at closing of the Business Combination, (iii) the only conditions to the closing of the Business Combination were as set forth in Sections 6.1 through Section 6.3 of the Business Combination Agreement, (iv) upon entering into such Business Combination Agreement, such parties would have a commitment letter from a third party to provide capital in an amount sufficient to the surviving company of the Business Combination to, among other things, repay all amounts due and owing at such time to Puritan at the closing, (v) the equity valuation ascribed to Carmell in the Business Combination Agreement was $
Based on the representations, warranties and agreements above and in consideration of Carmell’s agreement to pay Puritan at the closing of the Business Combination (i) the outstanding principal amount, plus accrued interest, late fees and all other amounts then owed as specified in the Convertible Notes and (ii)
On the closing of the Business Combination, the Company repaid $
NOTE 9 — COMMITMENTS AND CONTINGENCIES
Exclusive License Agreement
On January 30, 2008, the Company and Carnegie Mellon University (“CMU”) entered into a License Agreement, as amended by that certain Amendment No. 1 to License Agreement, dated as of July 19, 2011, as further amended by that certain Amendment No. 2 to License Agreement, dated as of February 8, 2016, as further amended by that certain Amendment No. 3 to License Agreement, dated as of February 27, 2020 and as further amended by that certain Amendment No. 4 to License Agreement, dated November 23, 2021 (collectively, the “Amended License Agreement”). The Amended License Agreement provides the Company an exclusive, worldwide right to use certain technology of CMU relating to biocompatible plasma-based plastics to make, have made, use, and otherwise dispose of licensed products and to create derivatives for the field of use. The Company is required to use its best efforts to effect the introduction of the licensed technology into the commercial market as soon as possible and meet certain milestones as stipulated within the Amended License Agreement. CMU retains the right to use any derivative technology developed by the Company due to its use of this technology and retains the intellectual property rights to the licensed technology, including patents, copyrights, and trademarks.
The Amended License Agreement is effective until January 30, 2028, or until the expiration of the last-to-expire patent relating to this technology, whichever comes later, unless otherwise terminated under another provision within the Amended License Agreement. Failure to perform in accordance with the agreed-upon milestones is grounds for CMU to terminate the Amended License Agreement prior to the expiration date. As a partial royalty for the license rights, the Company issued
20
addition, in 2008, the Company issued a warrant which was exercised in full in 2011 for
Royalties payable by the Company to CMU are
The Company is obligated to reimburse CMU for all patent expenses and fees incurred to date by CMU for the licensed technology at the earlier of (1) three years from the effective date of the Amended License Agreement; (2) the closing date of a change in control event; and (3) for international patents, from the start of expenses for patenting outside of the United States of America. There were
Convertible Notes
As detailed in Note 8 - Debt, both Holders have provided notice to the Company demanding additional payment of principal and interest on the Convertible Notes in an approximate amount of $
Puritan Litigation
On
NOTE 10 — PROFIT-SHARING PLAN
NOTE 11 — STOCKHOLDERS’ EQUITY (DEFICIT)
Common Stock
As of June 30, 2024 and December 31, 2023, the Company was authorized to issue
21
On April 4, 2024, the Company entered into a securities purchase agreement with certain investors for the sale of an aggregate of
Series A Voting Convertible Preferred Stock
In connection with the AxoBio Acquisition, the Company issued
Convertible Preferred Stock
Immediately prior to the Business Combination, Legacy Carmell had outstanding Series A convertible preferred stock (“Legacy Series A Preferred Stock”), Series B convertible preferred stock (“Legacy Series B Preferred Stock”), Series C-1 convertible preferred stock (“Legacy Series C-1 Preferred Stock”) and Series C-2 convertible preferred stock (“Legacy Series C-2 Preferred Stock”), which are collectively referred to herein as “Legacy Preferred Stock.”
Legacy Series A Preferred Stock, Legacy Series C-1 Preferred Stock, and Legacy Series C-2 Preferred Stock accrued cumulative dividends at a per annum rate of
In connection with the Business Combination, all previously issued and outstanding shares of Legacy Preferred Stock were converted into an equivalent number of shares of Common Stock on a one-for-one basis, then multiplied by the Exchange Ratio pursuant to the Business Combination Agreement.
2023 Long-Term Incentive Plan
In July 2023, the stockholders of the Company approved the 2023 Long-Term Incentive Plan (the “2023 Plan”), which replaced the Amended and Restated 2009 Stock Incentive Plan of Legacy Carmell (the “2009 Plan”). No new awards are being made under the 2009 Plan. Under the 2023 Plan, the Board may grant awards of stock options, stock appreciation rights, restricted stock, restricted stock units or other stock-based awards to employees and other recipients as determined by the Board. The exercise price per share for an option granted to employees owning stock representing more than
22
However, the total number of shares underlying 2009 Plan awards that may be recycled into the 2023 Plan pursuant to the above-described rules will not exceed the number of shares underlying 2009 Plan awards as of the effective date of the 2023 Plan (as adjusted to reflect the Business Combination). Shares of Common Stock issued through the assumption or substitution of awards in connection with a future acquisition of another entity will not reduce the shares available for issuance under the 2023 Plan.
Warrant and Option Valuation
The Company computes the fair value of warrants and options granted using the Black-Scholes option pricing model. The expected term used for warrants and options issued to non-employees is the contractual life, and the expected term used for options issued to employees and directors is the estimated period that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” grants for stock options. The Company utilizes an expected volatility figure based on a review of the historical volatilities over a period equivalent to the expected life of the instrument valued by similarly positioned public companies within its industry. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued. The Company’s stock price was derived from a 409A valuation prior to the Business Combination and market price for all options and warrants granted thereafter.
Warrants Outstanding
A summary of the Common Stock warrant activity during the six months ended June 30, 2024 is as follows:
|
Number of Warrants |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Remaining Contractual Life in Years |
|
|
Aggregate Intrinsic Value |
|
||||
Outstanding, December 31, 2023 |
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Issued |
|
|
|
|
|
|
|
|
|
|
|
||||
Expired |
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding, June 30, 2024 |
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable, June 30, 2024 |
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Option Activity and Summary
A summary of the option activity during the six months ended June 30, 2024 is as follows:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding, December 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Expired/Cancelled |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding, June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
Vested/Exercisable, June 30, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
The weighted average fair value of the options granted during the six months ended June 30, 2024 was based on a Black Scholes option pricing model using the following assumptions:
Expected volatility |
|
|
Expected term of option |
|
|
Range of risk-free interest rate |
|
|
Dividend yield |
|
The Company recorded stock-based compensation expense related to its options of $
23
of June 30, 2024, there was $
NOTE 12 – INCOME TAXES
The Company did
NOTE 13 – DISCONTINUED OPERATIONS
On March 20, 2024, the Company entered into the Purchase Agreement to sell AxoBio and closed the AxoBio Disposition on March 26, 2024 as detailed in Note 1. The assets and liabilities of AxoBio are classified as available for sale in the accompanying unaudited condensed consolidated balance sheets and consist of the following:
|
June 30, 2024 |
|
|
December 31, 2023 |
|
||
Assets available for sale |
|
|
|
|
|
||
Cash and cash equivalents |
$ |
— |
|
|
$ |
|
|
Accounts receivable, net |
|
— |
|
|
|
|
|
Prepaid expenses |
|
— |
|
|
|
|
|
Inventories |
|
— |
|
|
|
|
|
Property and equipment, net |
|
— |
|
|
|
|
|
Intangible assets, net |
|
— |
|
|
|
|
|
Goodwill |
|
— |
|
|
|
|
|
Total assets available for sale |
$ |
— |
|
|
$ |
|
|
|
|
|
|
|
|
||
Liabilities available for sale |
|
|
|
|
|
||
Accounts payable |
$ |
— |
|
|
$ |
|
|
Accrued interest |
|
— |
|
|
|
|
|
Accrued interest, related party |
|
— |
|
|
|
|
|
Other accrued expenses |
|
— |
|
|
|
|
|
Loans payable, current |
|
— |
|
|
|
|
|
Related party loans, current |
|
— |
|
|
|
|
|
Earnout liability |
|
— |
|
|
|
|
|
Deferred income taxes |
|
— |
|
|
|
|
|
Total liabilities available for sale |
$ |
— |
|
|
$ |
|
|
24
The significant components of discontinued operations in the accompanying unaudited condensed consolidated statements of income are as follows:
|
For the Six Months Ended |
|
|||||
|
June 30, |
|
|||||
|
2024 |
|
|
2023 |
|
||
Revenue |
$ |
— |
|
|
$ |
— |
|
Cost of sales |
|
— |
|
|
|
— |
|
Gross profit |
|
— |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
||
Selling and marketing |
$ |
|
|
$ |
— |
|
|
Research and development |
|
|
|
|
— |
|
|
General and administrative |
|
|
|
|
— |
|
|
Depreciation and amortization |
|
|
|
|
— |
|
|
Total operating expenses |
|
|
|
|
— |
|
|
Loss from operations |
|
( |
) |
|
|
— |
|
Other income (expense): |
|
|
|
|
|
||
Amortization of debt discount |
|
( |
) |
|
|
|
|
Interest expense, related party |
|
( |
) |
|
|
— |
|
Interest expense |
|
( |
) |
|
|
— |
|
Total other (expense) income |
|
( |
) |
|
|
— |
|
Loss before income taxes |
|
( |
) |
|
|
— |
|
Income tax benefit, deferred |
|
|
|
|
— |
|
|
$ |
( |
) |
|
$ |
— |
|
|
NOTE 14 – SUBSEQUENT EVENTS
In July 2024, the Company issued options for
On July 16, 2024, the Company was notified by Meteora of a potential Event of Default under the Forward Purchase Agreement (the “Default Notice”). On August 6, 2024, the Company and Meteora amended the Forward Purchase Agreement (the “FPA Amendment”) to change the settlement method from physical settlement to cash settlement. Pursuant to the FPA Amendment, Meteora waived any potential Event of Default referred to in the Default Notice and agreed to make a cash payment to the Company on the tenth business day immediately following the last day of the Valuation Period (as defined below) in an amount equal to (i)
The Board appointed Kendra Bracken-Ferguson as Chief Executive Officer of the Company effective as of July 30, 2024. In conjunction with Ms. Bracken-Ferguson’s appointment as Chief Executive Officer, Rajiv Shukla resigned from his position as Chief Executive Officer of the Company. Following his resignation, Mr. Shukla continues to serve as Executive Chairman of the Board.
25
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying unaudited condensed consolidated financial statements and the related notes contained in Part I, Item 1 of this Quarterly Report on Form 10-Q (this "Quarterly Report") and our audited consolidated financial statements and the notes thereto, Part I – Item 1A. “Risk Factors” and Part II – Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “2023 Annual Report”). Unless the context requires otherwise, references in this Quarterly Report to “Carmell,” the “Company,” “we,” “us,” or “our,” prior to the closing of the Business Combination (as defined in Note 1 to the accompanying unaudited condensed consolidated financial statements), are intended to refer to Carmell Therapeutics Corporation, a Delaware corporation, (“Legacy Carmell”) and, after the closing of the Business Combination, are intended to refer to Carmell Corporation, a Delaware corporation, and its consolidated subsidiaries.
Cautionary Statement Regarding Forward-Looking Statements
This Quarterly Report includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. We have based these forward- looking statements on our current expectations, assumptions and projections about future events. These forward-looking statements involve known and unknown risks and uncertainties that are difficult to predict and could cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “could,” “would,” “expect,” “plan,” “future,” “intend,” “anticipate,” “likely,” “believe,” “estimate,” “continue,” 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 forward-looking statements include, but are not limited to, statements and expectations regarding the launch and commercialization of our products, our ability to raise financing in the future, our success in retaining or recruiting key members of our management, the benefits of and our expectations related to the AxoBio Disposition and the Private Placement, market acceptance of our products, regulatory developments related to the cosmetics industry, our ability to compete in our industry, our need to grow the size of our organization in the future and the management of such growth, outcomes related to legal proceedings, as well as all other statements other than statements of historical fact included in this Quarterly Report. Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other filings we make with the U.S. Securities and Exchange Commission (the “SEC”), including those described under the section entitled Part II, Item 1A. “Risk Factors” in this Quarterly Report and under Part I, Item 1A, “Risk Factors” in the 2023 Annual Report. These forward-looking statements represent our estimates and assumptions as of the filing date of this Quarterly 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.
Overview
Carmell is a bio-aesthetics company that utilizes the Carmell SecretomeTM to support skin and hair health. The Carmell SecretomeTM consists of a potent cocktail of growth factors and proteins extracted from allogeneic human platelets sourced from U.S. Food and Drug Administration-approved tissue banks. Over the past seven years, Carmell has extensively tested the technology underpinning the Carmell SecretomeTM. In addition, we have developed a novel microemulsion formulation that enables 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. Additionally, Carmell’s microemulsion formulations do not utilize mineral or vegetable oils across its entire product line and are designed to be non-comedogenic. We are also developing a line of men’s products and a line of topical haircare products. 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 that are under development.
We are developing and have started to commercially launch our line of cosmetic skincare products in the first half of 2024. We plan to employ an omni-channel distribution strategy and sell our products online through direct e-commerce channels and through retailers and distributors in the United States. In addition, we plan to sell our doctor dispensed products through dermatology and plastic surgery practices and medical aesthetics centers.
Recent Developments
Appointment of Chief Executive Officer
The Board appointed Kendra Bracken-Ferguson as Chief Executive Officer of the Company effective as of July 30, 2024. Ms. Bracken-Ferguson, age 44, is the Founder and Chief Executive Officer of BrainTrust, which encompasses BrainTrust Agency, BrainTrust Founders Studio and BrainTrust Fund 1. She has vast experience in the digital media space and has excelled at developing revenue-generating partnerships in the beauty and wellness industries. Ms. Bracken-Ferguson has served as Chief Executive Officer of BrainTrust Founders Studio since October 2021 and as the Chief Executive Officer of BrainTrust Fund since 2022. She was previously the interim
26
Chief Executive Officer of rē•spin by Halle Berry from April 2020 until October 2021. From May 2019 to April 2020, she was the Chief Business Officer of Beautycon Media. Ms. Bracken-Ferguson has helped develop more than 200 influencer-driven brands that have collectively generated more than $100 million in revenue. She currently serves on the growth advisory board of Iced Media, and previously served on the board of directors of Cayton Children’s Museum, the board of directors of Influencer Marketing Association and the advisory board of BeautyUnited. Ms. Bracken-Ferguson earned her bachelor’s degree from Purdue University and an MBA from Keller School of Management, Devry University.
In conjunction with Ms. Bracken-Ferguson’s appointment as Chief Executive Officer, Rajiv Shukla resigned from his position as our Chief Executive Officer. Following his resignation, Mr. Shukla continues to serve as Executive Chairman of the Board.
Sale of Common Stock
On April 11, 2024, we closed the Private Placement, in which we sold to certain accredited investors an aggregate of 1,331,452 shares of Common Stock, at a price of $2.25 per share for unaffiliated investors and at a price of $2.88 per share for our former Chief Executive Officer. The purchase price per share paid by our former Chief Executive Officer in the Private Placement reflected the closing sale price of the Common Stock on The Nasdaq Capital Market on April 3, 2024. We received gross proceeds of $3,001,235 from the Private Placement. In connection with the Private Placement, we issued to the placement agent a warrant for 89,787 shares of Common Stock with an exercise price of $2.81 and a term of five years. We also incurred $314,009 in fees and legal costs related to the Private Placement, which was recorded as a reduction of the gross proceeds received. A member of the Board is a managing partner of the placement agent. See Note 11 to the accompanying unaudited condensed consolidated financial statements for additional information regarding the Private Placement.
Axolotl Biologix Disposition
On March 20, 2024, we entered into the Purchase Agreement with the Buyers, the former stockholders of AxoBio, for the AxoBio Disposition. The AxoBio Disposition, as contemplated by the Purchase Agreement, closed on March 26, 2024. In connection with the AxoBio Disposition, upon the terms and subject to the conditions set forth in the Purchase Agreement, we sold all of the outstanding limited liability company interests of AxoBio to the Buyers in exchange for the return of the Closing Share Consideration, the cancellation of the notes payable by the Company to the Buyers in an aggregate principal amount of $8,000,000 issued as the Closing Cash Consideration and termination of the Company’s obligations with respect to the Earnout. See Note 1 to the accompanying unaudited condensed consolidated financial statements for additional information regarding the AxoBio Disposition.
In accordance with ASC 205, the assets and liabilities of AxoBio are classified as available for sale on the accompanying unaudited condensed consolidated balance sheets, and the results of its operations are reported as discontinued operations in the accompanying unaudited condensed consolidated statements of operations.
Impact of Macroeconomic Events
Economic uncertainty in various global markets caused by political instability and conflicts, such as the ongoing conflicts in Ukraine and Israel, rising tensions in the Middle East, and economic challenges have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability, and supply chain interruptions, which have caused record inflation globally. Our business, financial condition, and results of operations could be materially and adversely affected by further negative impacts on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen. Although, to date, our results of operations have not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations may be impacted in the short and long term. The extent and duration of these market disruptions, whether as a result of the military conflict between Russia and Ukraine, the effects of the Russian sanctions, the conflict between Israel and Hamas, geopolitical tensions, inflation, or otherwise, are impossible to predict. Any such disruptions may also magnify the impact of other risks described or incorporated by reference in Part II, Item 1A. "Risk Factors" in this Quarterly Report and Part I, Item 1A, “Risk Factors” in our 2023 Annual Report.
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported revenue expenses and net loss incurred during the reporting periods. Our estimates are based on our historical experience and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
27
Going Concern and Management Plan
The unaudited condensed consolidated financial statements included elsewhere herein were prepared under the assumption that we would continue our operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. However, as of June 30, 2024, we had cash of $2,198,275, an accumulated deficit of $65,078,898 and liabilities of $6,405,627. We have incurred substantial recurring losses from continuing operations, have used, rather than provided, cash from our continuing operations and are dependent on additional financing to fund future operations. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. The unaudited condensed consolidated financial statements included elsewhere herein do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
We closed on the Private Placement in April 2024 and received gross proceeds of $3,001,235. Furthermore, we have refocused our efforts on cosmetic skincare products with near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that will take more than a year to commercialize. We are also exploring the development and commercialization of haircare products based on the Carmell SecretomeTM and out-licensing certain research and development programs to generate non-dilutive liquidity. Collectively, these activities are anticipated to assist us in extending our cash runway.
Comparison of Results of Operations for the Three Months Ended June 30, 2024 and 2023
The following table sets forth our results of operations for the three months ended June 30, 2024 and 2023:
|
|
For the three months ended June 30, |
|
|
|
|
|
% |
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
Change |
|||
Revenue |
|
$ |
12,320 |
|
|
$ |
— |
|
|
$ |
12,320 |
|
|
100% |
Cost of goods sold |
|
|
292 |
|
|
|
— |
|
|
|
292 |
|
|
100% |
Gross profit |
|
|
12,028 |
|
|
|
— |
|
|
|
12,028 |
|
|
100% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Selling and marketing |
|
|
11,045 |
|
|
|
— |
|
|
|
|
|
|
|
Research and development |
|
|
104,066 |
|
|
|
823,657 |
|
|
|
(719,591 |
) |
|
-87% |
General and administrative |
|
|
1,064,874 |
|
|
|
637,453 |
|
|
|
427,421 |
|
|
67% |
Depreciation and amortization of intangibles |
|
|
23,530 |
|
|
|
26,274 |
|
|
|
(2,744 |
) |
|
-10% |
Total operating expenses |
|
|
1,203,515 |
|
|
|
1,487,384 |
|
|
|
(283,869 |
) |
|
-19% |
Loss from operations |
|
|
(1,191,487 |
) |
|
|
(1,487,384 |
) |
|
|
295,897 |
|
|
-20% |
Other expenses, net |
|
|
(2,113,051 |
) |
|
|
(3,821,568 |
) |
|
|
1,708,517 |
|
|
-45% |
Net loss from continuing operations before taxes |
|
$ |
(3,304,538 |
) |
|
$ |
(5,308,952 |
) |
|
$ |
2,004,414 |
|
|
-38% |
Revenue/Gross Profit
Revenue for the three months ended June 30, 2024 was $12,320 and reflects the launch of our first three cosmetic skincare products in the later part of the second quarter of 2024. Our cost of goods and gross profit on these sales were $292 and $12,028, respectively.
Operating Expenses
Selling and marketing expenses totaled $11,045 for the three months ended June 30, 2024 and were driven by the costs related to our initial marketing endeavors related to the launch of our first three cosmetic skincare products in the later part of the second quarter of 2024.
Research and development expenses decreased by $719,591 to $104,066 in the second quarter of 2024 as compared to the same period of 2023. This decrease was driven by our strategic realignment, which refocused our efforts on cosmetic skincare products with near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that will take more than a year to commercialize. Also contributing to the decrease was the termination of employees in non-core or overlapping business areas in the third quarter of 2023 and the first quarter of 2024.
General and administrative expenses were $1,064,874 and $637,453 for the three months ended June 30, 2024 and 2023, respectively. This increase was primarily driven by an increase in insurance costs and salaries and benefits for personnel.
Other Expenses, Net
Other expenses, net, were $2,113,051 for the three months ended June 30, 2024, as compared to $3,821,568 in the corresponding period of 2023. Other expenses, net, for the second quarter of 2024 were driven by an unfavorable change in the fair value of the Forward
28
Purchase Agreement of $2,123,477, partially offset by a decrease of $265,173 in interest expense, reflecting a lower level of average debt outstanding. The corresponding period of 2023 includes an unfavorable change in the fair value of derivative liabilities related to the Convertible Notes of $3,545,073.
Comparison of Results of Operations for the Six Months Ended June 30, 2024 and 2023
The following table sets forth our results of operations for the six months ended June 30, 2024 and 2023:
|
|
For the Six Months Ended June 30, |
|
|
|
|
|
% |
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|
Change |
|||
|
|
(unaudited) |
|
|
|
|
|
|
||||||
Revenue |
|
$ |
12,320 |
|
|
$ |
— |
|
|
$ |
12,320 |
|
|
100% |
Cost of goods sold |
|
|
292 |
|
|
|
— |
|
|
|
292 |
|
|
|
Gross profit |
|
|
12,028 |
|
|
|
— |
|
|
|
12,028 |
|
|
100% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|||
Selling and marketing |
|
|
11,045 |
|
|
|
— |
|
|
|
11,045 |
|
|
100% |
Research and development |
|
|
533,486 |
|
|
|
1,563,982 |
|
|
|
(1,030,496 |
) |
|
-66% |
General and administrative |
|
|
1,992,268 |
|
|
|
1,147,898 |
|
|
|
844,370 |
|
|
74% |
Depreciation and amortization of intangibles |
|
|
47,061 |
|
|
|
50,375 |
|
|
|
(3,314 |
) |
|
-7% |
Total operating expenses |
|
|
2,583,860 |
|
|
|
2,762,255 |
|
|
|
(178,395 |
) |
|
-6% |
Loss from operations |
|
|
(2,571,832 |
) |
|
|
(2,762,255 |
) |
|
|
190,423 |
|
|
-7% |
Other expenses, net |
|
|
(4,285,868 |
) |
|
|
(4,375,412 |
) |
|
|
89,544 |
|
|
-2% |
Net loss income before taxes |
|
$ |
(6,857,700 |
) |
|
$ |
(7,137,667 |
) |
|
$ |
279,967 |
|
|
-4% |
Revenue/Gross Profit
Revenue for the six months ended June 30, 2024 was $12,320 and reflects the launch of our first three cosmetic skincare products in the later part of the second quarter of 2024. Our cost of goods and gross profit on these sales were $292 and $12,028, respectively.
Operating Expenses
Selling and marketing expenses totaled $11,045 for the six months ended June 30, 2024 and were driven by the costs related to our initial marketing endeavors related to the initial launch of our cosmetic skincare products.
Research and development expenses decreased by $1,030,496 to $533,486 in the first six months of 2024 as compared to the same period of 2023. This decrease was driven by our strategic realignment, which refocused our efforts on cosmetic skincare products with near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that will take more than a year to commercialize. Also contributing to the decrease was the termination of employees in non-core or overlapping business areas in the third quarter of 2023 and the first quarter of 2024.
General and administrative expenses were $1,992,268 and $1,147,898 for the six months ended June 30, 2024 and 2023, respectively. This increase was primarily driven by an increase in insurance costs and salaries and benefits for personnel.
Other Expenses, Net
Other expenses, net, were $4,285,868 for the six months ended June 30, 2024, as compared to $4,375,412 in the corresponding period of 2023. For the six months ended June 30, 2024, other expenses, net, was driven by an unfavorable change in the fair value of the Forward Purchase Agreement of $4,280,314, partially offset by a decrease of $516,204 in interest expense, reflecting a lower level of average debt outstanding. The same period of 2023 includes an unfavorable change in the fair value of derivative liabilities related to the Convertible Notes of $3,870,158.
Discontinued Operations, Net
We had a loss from discontinued operations of $1,252,276, net of tax, for the six months ended June 30, 2024, which reflects the results of the AxoBio business through the closing of the AxoBio Disposition on March 26, 2024. There have been no sales of AxoBio’s products since October 2023. The Company recognized a non-cash gain on the sale of AxoBio of $1,534,479 during the six months ended June 30, 2024, due principally to the change in the fair value of the stock consideration between the AxoBio Acquisition and the AxoBio Disposition. See Note 1 to the accompanying unaudited condensed consolidated financial statements.
29
Liquidity, Capital Resources, and Going Concern
As of June 30, 2024, we had cash of $2,198,275 and an accumulated deficit of $65,078,898. In addition, we had a net loss from continuing operations of $6,857,700 and negative cash flows from operations of $2,214,254 for the six months ended June 30, 2024. Since our inception, we have financed operations principally through public and private issuances of equity securities and debt financing. In addition to the cost savings from the elimination of non-core areas or overlapping business functions in both the third quarter of 2023 and the first quarter of 2024 and the reduction of expenses resulting from the AxoBio Disposition, we have refocused our efforts on cosmetic skincare products with near-term commercial potential, reprioritized further research and development, and ceased clinical studies of product candidates that will take more than a year to commercialize.
Late in the second quarter of 2024, we launched our first three cosmetic skincare products based on the Carmell Secretome™. Management anticipates that revenue from the commercialization of its cosmetic skincare products and the anticipated cost savings from the activities detailed above will assist us in extending our cash runway. In addition, we are exploring the development and commercialization of haircare products based on the Carmell Secretome™ and out-licensing of certain research and development programs to generate non-dilutive liquidity.
However, the cash available to us may not be sufficient to allow us to operate for the next 12 months due to our current and potential liabilities. We may need to raise additional capital through equity or debt issuances. If we are unable to raise additional capital, we may be required to take additional measures to conserve liquidity, which could include, but not necessarily be limited to, curtailing operations and reducing overhead expenses. We cannot provide any assurance that new financing will be available on commercially acceptable terms, if at all, or will be completed on a timely basis. These conditions raise substantial doubt about our ability to continue as a going concern.
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with GAAP, which contemplates the continuation of the Company as a going concern, the realization of assets, and the satisfaction of liabilities in the normal course of business. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty or that may be necessary should we be unable to continue as a going concern.
Debt
As of June 30, 2024, we had outstanding debt totaling $21,286 (Note 8 to the accompanying unaudited condensed consolidated financial statements). In the first quarter of 2024, the Board elected to repay all of the maturing Promissory Notes in shares of the Company’s Common Stock in accordance with the terms of the Promissory Notes. During the six months ended June 30, 2024, all of the Promissory Notes with an aggregate principal amount of $848,500 were repaid through the issuance of an aggregate of 328,707 shares of Common Stock. In addition, the Holders of the Convertible Notes have demanded additional payment of principal and interest on the Convertible Notes and certain payments with respect to the Convertible Note Warrants, as more fully described in Note 9 to the accompanying unaudited condensed consolidated financial statements.
Cash Flows
The following table summarizes our cash flows for the six months ended June 30, 2024 and 2023:
|
|
Six Months Ended June 30, |
|
|
|
|
||||||
|
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Net cash used in operating activities |
|
$ |
(2,214,254 |
) |
|
$ |
(956,137 |
) |
|
$ |
(1,258,117 |
) |
Net cash used in investing activities |
|
|
(748,796 |
) |
|
|
(30,470 |
) |
|
|
(718,326 |
) |
Net cash provided by financing activities |
|
|
2,248,864 |
|
|
|
874,378 |
|
|
|
1,374,486 |
|
|
|
|
|
|
|
|
|
|
|
|||
Operating Activities
Net cash used in operating activities for the six months ended June 30, 2024 increased by $1,258,117 as compared to the same period of 2023. This increase was primarily driven by the payment of accounts payable and accrued expenses.
Investing Activities
For the six months ended June 30, 2024, we paid $748,796 of costs in connection with the AxoBio Disposition.
Financing Activities
Net cash provided by financing activities was $2,248,864 for the six months ended June 30, 2024, as compared to $874,378 for the six months ended June 30, 2023. In the six months ended June 30, 2024, we closed the Private Placement, which provided net proceeds of $2,687,225. In addition, we repaid $469,899 of principal related to our insurance financing programs described in Note 8 to the
30
accompanying unaudited condensed consolidated financial statements, while we received $848,500 in proceeds from the issuance of the Promissory Notes in the six months ended June 30, 2023.
Contingencies
On November 8, 2023, Puritan filed a complaint captioned Puritan Partners LLC v. Carmell Regen Med Corporation et al., No. 655566/2023 (New York Supreme Court, New York County) naming the Company as defendant. In the complaint, Puritan asserts that the Company breached its obligations under the Convertible Notes and the Convertible Note Warrants. Puritan also asserts the Company did not comply with its obligations to provide Puritan with 25,000 freely tradeable shares of Common Stock on a timely basis. Puritan asserts claims for declaratory judgment, breach of contract, conversion, foreclosure of its security interest, replevin, unjust enrichment, and indemnification, and seeks remedies including damages totaling $2,725,000 through November 1, 2023, additional fees and interest thereafter, costs and attorney’s fees, an order of foreclosure on its security interest, and other declaratory relief. The Company has moved to dismiss the complaint and intends to defend itself vigorously against this litigation.
Contractual Obligations and Commitments
In addition to financing obligations under our debt agreements, our contractual and commercial commitments include expenditures for operating leases and royalty payments. For further information on our Amended License Agreement with CMU see Note 9 to the accompanying unaudited condensed consolidated financial statements.
Emerging Growth Company and Smaller Reporting Company Status
The JOBS Act permits an “emerging growth company” to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. Although we qualify as an emerging growth company, we have elected not to “opt-out” of this provision and, as a result, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting standard and will do so until such time that we either (i) irrevocably elect to “opt-out” of such extended transition period or (ii) no longer qualify as an emerging growth company.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates is less than $700 million, and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year, and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time that we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
31
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not required.
Item 4. Controls and Procedures.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.
Evaluation of Disclosure Controls and Procedures
As required by Rules 13a-15 and 15d-15 under the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation of the effectiveness of our disclosure controls and procedures as of June 30, 2024. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of such date due to the issue described below.
Changes in Internal Control Over Financial Reporting
Management identified a material weakness in its internal controls over the accounting treatment for a complex transaction during the quarter ended June 30, 2024. They have addressed this weakness by adopting a policy requiring formal documentation to substantiate the accounting treatment of all material transactions, including references to the relevant authoritative guidance.
32
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
For a description of our material pending legal proceedings, see Note 8 and Note 9 to the accompanying unaudited condensed consolidated financial statements, which are incorporated herein by reference.
Item 1A. Risk Factors.
There have been no material changes from the risk factors disclosed under “Risk Factors” in Part I, Item 1A of our 2023 Annual Report. The risks and uncertainties described in our 2023 Annual Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition or results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
None.
Item 5. Other Information.
Executive Compensation
On August 13, 2024, the Company entered into an amended and restated executive employment agreement (the “Employment Agreement”) with Rajiv Shukla, the Executive Chairman of the Board which is effective as of July 30, 2024 (the “Effective Date”). Mr. Shukla will receive, starting with calendar year 2024, a base salary at an annualized rate of $360,000 (the “Base Salary”) inclusive of base salary paid prior to the date of the Employment Agreement, which may be adjusted from time to time by the Compensation Committee of the Board (“Compensation Committee”).” In addition, any fully vested shares of Common Stock granted to Mr. Shukla under his executive employment agreement, dated December 29, 2023 (the “Original Employment Agreement”), as part of his annual base compensation was cancelled as of the Effective Date. Nothing in the Employment Agreement will amend, revoke or otherwise change anything related to Mr. Shukla’s outstanding stock options granted prior to the date of the Employment Agreement.
In addition, Mr. Shukla has the opportunity to earn an annual bonus with a target amount of 50% of his Base Salary in effect at the end of the applicable year. The amount of such annual bonus will be solely determined by the Compensation Committee based on the satisfactory achievement of corporate and/or personal objectives set by the Compensation Committee.
The Employment Agreement also provides Mr. Shukla the opportunity to receive restricted stock units with respect to the Common Stock (“RSUs”) upon the achievement of the milestones detailed in (a) and (b) below, subject to continued employment through the applicable grant date. All RSUs awarded will vest immediately upon achievement of the milestone described below and will provide for share withholding or a broker-assisted share sale to cover any withholding taxes due upon the vesting of the RSUs.
Under the Employment Agreement, Mr. Shukla also has the opportunity to receive cash compensation for the achievement of the following performance milestones subject to continued employment through the applicable closing date:
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If Mr. Shukla is terminated by the Company without “cause” or upon Mr. Shukla’s resignation for “good reason” (each as defined in the Employment Agreement), the Company will pay to him, in addition to any unpaid portion of Mr. Shukla’s Base Salary or unpaid portion of any annual bonus that would have been earned with respect to the fiscal year ended immediately prior to such termination, (a) a pro rata bonus for the year of termination, (b) 12 months Base Salary, and (c) 12 months of COBRA coverage. If such termination occurs within three months preceding or 15 months following a “change in control” (as defined in the Employment Agreement), (a) the Company will pay to Mr. Shukla, in addition to the unpaid portion of any annual bonus that would have been earned with respect to the fiscal year ended immediately prior to such termination, (i) a pro rata bonus for the year of termination, (ii) 18 months Base Salary, (iii) 18 months of COBRA coverage, and (b) all outstanding time-based equity awards of Mr. Shukla will accelerate and vest upon the later of such termination and the change in control.
If Mr. Shukla is terminated by the Company due to death or “disability” (as defined in the Employment Agreement), the Company will pay to him a pro rata bonus for the year of termination. The foregoing severance payments and benefits are subject to Mr. Shukla executing and not revoking a general release of claims against the Company and its affiliates.
The foregoing description of the terms of the Employment Agreement does not purport to be complete and is qualified in its entirety by reference to full text of the Employment Agreement, a copy of which is filed as Exhibit 10.1 hereto and is incorporated by reference herein.
Insider Trading Arrangements
During the three months ended June 30, 2024, none of the Company’s directors or officers (as defined in Rule 16a-1(f) of the Exchange Act)
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Item 6. Exhibits.
Furnish the exhibits required by Item 601 of Regulation S-K (§ 229.601 of this chapter).
Number |
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Description |
10.1* |
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10.2 |
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10.3 |
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31.1* |
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31.2* |
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32.1* |
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32.2* |
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
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Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Carmell Corporation |
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Date: August 14, 2024 |
By: |
/s/ Rajiv Shukla |
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Name: Rajiv Shukla |
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Title: Executive Chairman |
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Carmell Corporation |
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Date: August 14, 2024 |
By: |
/s/ Bryan J. Cassaday |
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Name: Bryan J. Cassaday |
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Title: Chief Financial Officer |
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AMENDED AND RESTATED EXECUTIVE EMPLOYMENT AGREEMENT
This Amended and Restated Executive Employment Agreement (the “Agreement”), dated August 13, 2024, is made and entered into by and between Carmell Corporation, a Delaware corporation (the “Company”) and Rajiv Shukla (the “Executive’’) and will be deemed effective as of July 30, 2024 (the “Effective Date”), each of the Company and the Executive, a “party” and together, the “parties.”
Introduction
WHEREAS, the Executive is currently employed by the Company as its Executive Chairman;
WHEREAS, the Company and the Executive entered into an Executive Employment Agreement, dated December 29, 2023 (the “Prior Agreement”); and
WHEREAS, the parties desire to amend and restate the Prior Agreement, as of the Effective Date.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the parties hereby agree as follows:
[Signature page follows.]
This Agreement has been executed and delivered on the date first above written.
Carmell Corporation
By:
Name: Kathryn Gregory
Title: Independent Director
Executive
By:
Name: Rajiv Shukla
Title: Executive Chairman
Exhibit A
Sole Owner, Constellation Alpha Holdings LLC: holding company for my private investments
Partner, SPAC Research (owns 33%)
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Rajiv Shukla, certify that:
Date: August 14, 2024 |
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By: |
/s/ Rajiv Shukla |
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Rajiv Shukla |
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Executive Chairman |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Bryan J. Cassaday, certify that:
Date: August 14, 2024 |
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By: |
/s/ Bryan J. Cassaday |
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Bryan J. Cassaday |
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Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Carmell Corporation (the “Company”) on Form 10-Q for the period ending June 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: August 14, 2024 |
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By: |
/s/ Rajiv Shukla |
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Rajiv Shukla |
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Executive Chairman |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Carmell Corporation (the “Company”) on Form 10-Q for the period ending June 300, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: August 14, 2024 |
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By: |
/s/ Bryan J. Cassaday |
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Bryan J. Cassaday |
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Chief Financial Officer |