Creative Medical Technology Holdings, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024; unaudited. The company is a commercial-stage biotechnology business. Its CaverStem and FemCelz kits are marketed through physicians; its other described programs remain in development.
Financial performance and position
| Metric | Q1 2024 / March 31, 2024 | Comparable period / December 31, 2023 |
|---|---|---|
| Revenue | $0 | $0 in Q1 2023 |
| Operating expenses | $1.123 million | $1.113 million in Q1 2023 |
| Operating loss | $1.123 million | $1.113 million in Q1 2023 |
| Net loss | $1.042 million; $0.73 per share | $1.052 million; $0.75 per share in Q1 2023 |
| Interest income | $81,603 | $61,197 in Q1 2023 |
| Cash and investments | $9.007 million in cash; no investments reported on the balance sheet | $9.987 million combined |
| Working capital | $8.814 million | $9.900 million at December 31, 2023 |
| Total assets / liabilities | $9.620 million / $391,000 | $10.715 million / $371,000 at December 31, 2023 |
| Operating cash flow | $(897,000) | $(3.842) million in Q1 2023 |
There was no revenue or cost of revenue, so a gross margin is not meaningful. No funded debt is reported; liabilities are primarily accounts payable, accrued expenses, and a $14,194 related-party advance. Deferred revenue was $40,000 at both balance-sheet dates.
Changes and cash flows
- Net loss narrowed by about $10,000 year over year. R&D increased 32% to $422,392, principally from the CELZ-201 CREATE-1 diabetes and CELZ-201 ADAPT back-pain trials. SG&A decreased 13% to $671,484, partly offset by higher compensation.
- Operating cash use fell by $2.945 million year over year, largely because Q1 2023 included a $3.0 million accounts-payable payment.
- Investment redemptions provided $6.520 million of investing cash; the company spent $82,796 repurchasing shares. Cash rose to $9.007 million, largely reflecting investment redemptions rather than operating cash generation.
- During Q1 the company repurchased 19,000 shares for an average $4.36 per share. The board’s program authorizes up to $2 million; $1.646 million remained available at quarter-end.
Outlook, developments, and risks
- No financial guidance or quantified outlook is provided. Management reports eight U.S. physician locations offering CaverStem and FemCelz, and states that subsidiaries ImmCelz and AlloCelz have not begun commercial activities.
- Reported developments include FDA orphan-drug designation in March 2024 for ImmCelz treatment of brittle Type 1 diabetes, and FDA authorization for expanded access to CELZ-201 for a high-risk individual. Recruitment for the CELZ-201 CREATE-1 trial began in September 2023; the filing also describes an FDA-cleared lower-back-pain trial.
- The company cites limited operating history and minimal sales, limited marketing and distribution capacity, dependence on product development and clinical progress, competition, and potential disruption from economic conditions or supply-chain events. Cash balances exceeded FDIC insurance limits at three of four financial institutions.
- Management reported disclosure controls effective and no material change in internal control. No subsequent events were noted through the filing date. The filing describes ordinary-course litigation risk but identifies no specific proceeding.
Important facts to verify
- Reported-results discrepancies: The financial statements show operating loss of $1,123,147 and net loss of $1,041,544; MD&A instead gives $1,119,397 and $1,037,794. Confirm which figures are intended.
- Share counts: The balance sheet reports 1,354,626 shares outstanding at March 31, while the cover reports 1,348,126 as of May 10. Confirm the movement and dates; the quarter included 19,000 repurchased shares.
- Liquidity composition and clinical spending: Verify current cash and investment holdings, and the cash runway required to support ongoing trials and development given the absence of revenue.
- Repurchase disclosure: The monthly issuer-purchase table labels the March period “March 1–31, 2023”; confirm the apparent date error and remaining program authorization.