Creative Medical Technology Holdings, Inc. Quarterly Report on Form 10-Q for the Quarterly Period Ended March 31, 2024

Press release · 05/11 02:48
Creative Medical Technology Holdings, Inc. Quarterly Report on Form 10-Q for the Quarterly Period Ended March 31, 2024

Creative Medical Technology Holdings, Inc. Quarterly Report on Form 10-Q for the Quarterly Period Ended March 31, 2024

Creative Medical Technology Holdings, Inc. has reported a decline in revenue and an increase in net loss for the quarter ended March 31, 2024. The company’s unaudited condensed consolidated balance sheet shows a deficit in stockholder’s equity. The financial report also mentions legal proceedings and unregistered sales of equity securities.

Overview of Company’s Financial Performance

The company is a commercial stage biotechnology company focused on developing novel cell-based therapies. In 2024, the company continued to advance its clinical programs but has not yet generated revenue. The net loss for the first quarter of 2024 was $1.04 million compared to $1.05 million for the same period in 2023. The decreased net loss reflects lower general and administrative expenses, offset by increased research and development costs related to advancing clinical trials. The company maintains a strong cash position, ending the first quarter of 2024 with $9.0 million of cash, certificates of deposit and US Treasuries.

Revenue and Profit Trends

The company has not yet generated revenue and has incurred net losses since inception. The net loss decreased slightly from $1.05 million in Q1 2023 to $1.04 million in Q1 2024. Research and development expenses increased 32% to $0.42 million in Q1 2024, reflecting advancement of the company’s Type 1 Diabetes (CREATE-1) and Chronic Lower Back Pain (ADAPT) clinical trials. General and administrative expenses decreased 13% to $0.67 million in Q1 2024 due to lower marketing, public company and professional fees.

Financial Metric Q1 2024 Q1 2023 Trend
Revenue $0 $0 Flat
Net Loss $1.04 million $1.05 million Decreased Slightly
R&D Expenses $0.42 million $0.32 million Increased due to Clinical Trials
G&A Expenses $0.67 million $0.77 million Decreased due to Cost Controls

Strengths and Weaknesses

Key strengths of the company include:

  • Strong cash position to support clinical development
  • Advancing pipeline of novel cell therapy candidates
  • Orphan drug designation received for diabetes therapy

The company’s weaknesses and challenges:

  • No approved products or revenue
  • History of net losses; depends on financing to fund operations
  • Clinical development involves risks and uncertainties

Future Outlook

The company expects to achieve multiple value-driving milestones over the next 12-18 months:

  • Initiate Phase 12 trials for Type 1 Diabetes and Chronic Lower Back Pain therapies
  • Report initial safety and efficacy data from clinical trials
  • Submit applications for additional orphan drug designations
  • Continue patient recruitment in CREATE-1 diabetes trial
  • Advance collaborative iPSC cell line development

If successful in clinical development, the company’s cell therapy candidates could address significant unmet needs for patients and drive future revenue growth. However, drug development is expensive and uncertain, and the company expects R&D costs and losses to increase significantly as clinical programs progress. The company will require substantial additional capital to achieve key development and commercial milestones.

Critical Accounting Policies and Estimates

The company’s financial statements are prepared according to U.S. GAAP. Some policies require management to apply judgments that affect financial statement results. Key judgments relate to assumptions and estimates about clinical trial expenses and accruals. Actual results could differ materially from initial estimates based on changes in business conditions or other relevant factors.