PHOENIX - Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a biotechnology firm, has reported significant progress in its cell-based therapies, particularly in treatments for Type 1 Diabetes (T1D) and Chronic Lower Back Pain. The company has successfully produced over six billion AlloStem™ clinical-grade cells for ongoing clinical trials and received FDA clearance for two Investigational New Drug (IND) applications, as well as an expanded access therapy, within a month of filing.
For T1D, Creative Medical Technology has been cleared to conduct a Phase I/II clinical trial using AlloStem™ (CELZ-201), which utilizes Perinatal Tissue Derived Cells. This trial has received Institutional Review Board (IRB) approval, and patient recruitment is underway.
Additionally, the company's ImmCelz™ therapy (CELZ-101) received Orphan Drug Designation from the FDA for treating brittle T1D and is in preparation for a Phase I/II clinical trial. Furthermore, FDA authorization was granted for an expanded access therapy using CELZ-201 to manage abnormal glucose tolerance and prevent T1D in high-risk individuals.
In the field of Chronic Lower Back Pain, the FDA has cleared a Phase I/II clinical trial for AlloStemSpine™ (CELZ-201 ADAPT), a minimally invasive procedure using AlloStem™ cells. The trial has received IRB approval, with the trial site selected and patient recruitment initiated.
The company's iPSCelz™ program has also achieved a breakthrough by generating human insulin-producing induced pluripotent stem cells (iPSC), which have potential for both clinical use and standalone human insulin production. Strategic discussions are ongoing to further develop these programs.
Financially, Creative Medical Technology expects to report a cash balance of around $7.5 million with no long-term debt as of June 30, 2024, and anticipates sufficient funds through at least Q2 2025.
The upcoming Annual Meeting of Stockholders on July 19, 2024, will include a vote on increasing the authorized shares of common stock from 5 million to 25 million. CEO Timothy Warbington emphasized the company's commitment to financial prudence and shareholder value, acknowledging the need for flexibility in capital stock for potential future business and financial purposes.
This article is based on a press release statement from Creative Medical Technology Holdings, Inc.
In other recent news, Creative Medical Technology Holdings Inc. maintained its positive outlook from Roth/MKM, which reiterated a Buy rating and a steady price target of $30.00. This optimism is driven by the company's advancement in its iPSCelz program, which has successfully produced a clinical line of human induced pluripotent stem cell (iPSC)-derived islet cells capable of producing human insulin.
The iPSC cell line, currently under evaluation in various U.S. clinical programs, has shown potential to generate other cell types, expanding the scope of the company's clinical programs. The strategic discussions CELZ is engaged in to further these programs were highlighted by the Roth/MKM analyst, indicating a proactive approach to leveraging its scientific advancements.
The iPSCelz program's ability to produce human insulin positions CELZ as a significant entity in the field of regenerative medicine. The company's efforts to enter collaborations for its clinical programs could accelerate development and potentially bring its therapies to market.
InvestingPro Insights
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), while advancing in clinical trials and expanding its therapeutic pipeline, presents a mixed financial landscape as per the latest metrics from InvestingPro. With a market capitalization of just $4.73 million, the company's size is relatively small in the biotech industry. The latest data shows a significant gross profit margin of 60.0% in the last twelve months as of Q1 2024, reflecting the company's ability to maintain profitability on its products despite the challenges faced in the sector.
InvestingPro Tips highlight two critical aspects of the company's financial health. Firstly, management's strategy of aggressively buying back shares could indicate confidence in the firm's future prospects and a commitment to enhancing shareholder value. Secondly, Creative Medical Technology holds more cash than debt on its balance sheet, which is a positive sign of financial stability and may provide the flexibility needed to support ongoing research and development activities.
Despite these strong points, analysts are concerned about the company's short-term revenue trajectory, anticipating a sales decline in the current year. This could be a reflection of the high costs associated with clinical trials and the uncertainty of commercial success. Additionally, the company's stock has experienced significant volatility and a notable decline over the past week, month, and three months, with a 1-month price total return of -17.41% and a 3-month price total return of -37.27%.
For investors seeking a deeper dive into Creative Medical Technology's financials and future outlook, there are 14 additional InvestingPro Tips available at https://www.investing.com/pro/CELZ. To access these insights, readers can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, offering a comprehensive view of the company's performance and potential investment opportunities.
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