Breakeven Date Change • May 11
No longer forecast to breakeven The analyst covering Creative Medical Technology Holdings no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$31.0m in 2028. New forecast suggests the company will make a loss of US$5.94m in 2028. Reported Earnings • May 11
First quarter 2026 earnings released: US$0.38 loss per share (vs US$0.83 loss in 1Q 2025) First quarter 2026 results: US$0.38 loss per share (improved from US$0.83 loss in 1Q 2025). Net loss: US$1.41m (loss narrowed 14% from 1Q 2025). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 39% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. Announcement • Apr 30
Creative Medical Technology Holdings, Inc. Reports Breakthrough Response Rate in Ultrasome Knee Osteoarthritis Program and Expands CELZ-201 Platform Into Scalable Cell-Free Regenerative Therapies Creative Medical Technology Holdings, Inc. announced breakthrough positive results from its pilot study of Ultrasome™, the Company’s proprietary cell-free regenerative therapy for the treatment of osteoarthritis (OA) of the knee. The study achieved its primary endpoint with an industry-leading 93% of patients demonstrating clinically meaningful improvements in mobility and pain reduction, with the therapy well-tolerated and no serious adverse events reported. Ultrasome™ is derived from the Company’s GMP-manufactured cell therapy product CELZ-201 (Olastrocel), which is currently being evaluated in the Company’s FDA-cleared ADAPT clinical trial. This relationship establishes a direct connection between CELZ’s clinical-stage biologic platform and its next-generation cell-free regenerative strategy, expanding the potential applications of CELZ-201 into broader, high-volume indications. Creative Medical is leveraging the biological signaling components of CELZ-201 in a cell-free format, enabling scalable manufacturing, reduced cost of production, off-the-shelf availability, and simplified execution across outpatient settings. Ultrasome™ is designed to address osteoarthritis through targeted modulation of inflammatory signaling, suppression of cartilage degradation, and promotion of regenerative activity. Osteoarthritis affects over 30 million adults in the United States and represents a significant multi-billion-dollar opportunity. Current treatments are limited to symptom management and invasive procedures. Following these positive pilot results, Creative Medical plans to expand clinical execution of the Ultrasome™ program, generate additional clinical data across regenerative platforms, and evaluate strategic pathways toward commercialization and partnerships. Ultrasome™ is Creative Medical’s proprietary cell-free regenerative therapy platform, derived from CELZ-201 (Olastrocel), designed to deliver biologically active regenerative signals through a minimally invasive procedure for the treatment of osteoarthritis and other degenerative conditions. Reported Earnings • Mar 23
Full year 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2025 results: US$2.52 loss per share. Net loss: US$6.00m (loss widened 9.1% from FY 2024). Revenue exceeded analyst estimates by 100%. Earnings per share (EPS) missed analyst estimates by 24%. Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. New Risk • Jan 14
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$5.9m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (100% increase in shares outstanding). Revenue is less than US$1m (US$6.0k revenue). Market cap is less than US$10m (US$6.36m market cap). Announcement • Jan 13
Creative Medical Technology Holdings Reaches Major Clinical Inflection Point with Positive Interim Data from Adapt Trial and Celz-201 (Olastrocel) in the Treatment of Chronic Lower Back Pain Creative Medical Technology Holdings, Inc. announced positive interim 180-day follow-up data from its FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel), the Company's proprietary perinatal tissue-derived cell therapy for chronic lower back pain associated with degenerative disc disease. The study produced statistically significant, clinically meaningful improvements in both functional disability (ODI%) and pain at primary trial end point, confirming durable human efficacy alongside an excellent safety profile. The announcement of this data follows a previously announced study enrollment completion and positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed that CELZ-201(Olastrocel) demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial. Key Clinical Outcomes at Interim Analysis: ODI% (Functional Disability): Mean improvement of 15.3 percentage points at 180 days (p = 0.0003; large effect size). Approximately 79% of patients achieved clinically meaningful functional improvement. Pain (0-10 Scale): Mean reduction of 3.9 points at 180 days (p < 0.00005; large effect size). Approximately79% of patients achieved 2-point pain reduction. Safety: Independent DSMB review confirmed no serious adverse events and no treatment-related safety signals, remaining blinded 4:1 treatment: placebo. Chronic lower back pain affects more than 16 million Americans and represents a multi-billion-dollar annual market. Current standards of care rely heavily on opioids, steroid injections, or invasive spine surgery, with limited durable solutions. CELZ-201 (Olastrocel) is an off-the-shelf, allogeneic regenerative cell therapy designed to deliver scalable, consistent, non-surgical, disease-modifying benefit. Breakeven Date Change • Dec 31
Forecast to breakeven in 2028 The analyst covering Creative Medical Technology Holdings expects the company to break even for the first time. New forecast suggests the company will make a profit of US$31.0m in 2028. Average annual earnings growth of 57% is required to achieve expected profit on schedule. Announcement • Dec 18
Creative Medical Technology Holdings, Inc. Completes Enrollment in FDA-Cleared Adapt Trial for CELZ-201-Olastrocel, Marking Major Clinical Inflection Point Creative Medical Technology Holdings, Inc. announced the successful completion of patient enrollment in its FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel), the Company's proprietary perinatal tissue-derived cell therapy for the treatment of chronic lower back pain associated with degenerative disc disease. Enrollment completion follows a previously announced positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed that CELZ-201 demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial. With enrollment now complete, CELZ has reached a critical execution milestone, transitioning the ADAPT program into its next phase focused on follow-up, and data analysis. Company leadership, investigators, and clinical partners expressed strong enthusiasm as CELZ advances toward what management believes could represent a paradigm shift in the treatment of chronic back pain, a condition impacting more than 16 million Americans and representing a multi-billion-dollar market with limited durable, non-surgical solutions. Chronic lower back pain remains one of the leading causes of disability worldwide, often managed with invasive surgery, repeated steroid injections, or long-term opioid use. CELZ-201 is engineered as an "off-the-shelf," allogenic cell therapy, offering scalability, consistency, and broad clinical applicability--key differentiators versus autologous approaches. Creative Medical Technology's StemSpine®? intellectual property portfolio, which covers both autologous and allogenic applications, further strengthens the Company's strategic position as it advances toward later-stage clinical development and potential commercialization. With enrollment complete, CELZ expects to: Continue scheduled DSMB reviews; Advance toward topline safety and efficacy readouts; Evaluate strategic pathways for late-stage development and commercialization including opioid patients. Management believes these upcoming milestones represent multiple potential value-creation catalysts for shareholders as CELZ continues executing against its clinical and corporate roadmap. With a diversified pipeline spanning orthopedics, immunotherapy, endocrinology, urology, and gynecology, the Company is committed to translating cutting-edge science into transformative, accessible therapies for patients with high unmet medical needs. Announcement • Dec 02
Creative Medical Technology Holdings Announces World Health Organization Approval of "Olastrocel" as Inn for Lead Allogeneic Cell Therapy Celz-201 Creative Medical Technology Holdings, Inc. announced that the World Health Organization (WHO) has approved "olastrocel" as the International Non-Proprietary Name (INN) for the active cellular substance in CELZ-201, the Company's lead allogeneic cell therapy also known as AlloStem. The INN is the globally standardized, unique scientific name used by regulators, clinicians, researchers, and global markets to identify a therapeutic substance throughout its development and commercialization lifecycle. This assignment is a key global milestone that typically occurs as a program advances into later regulatory stages and requires unified international identification. Breakeven Date Change • Nov 09
No longer forecast to breakeven The analyst covering Creative Medical Technology Holdings no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$18.3m in 2027. New forecast suggests the company will make a loss of US$5.51m in 2027. Announcement • Oct 31
Creative Medical Technology Holdings, Inc., Annual General Meeting, Dec 18, 2025 Creative Medical Technology Holdings, Inc., Annual General Meeting, Dec 18, 2025. Location: 440 stevens avenue, suite 200, solana beach, ca 92075, United States Announcement • Aug 14
Creative Medical Technology Holdings Secures FDA Fast Track Designation for CELZ-201-DDT - Advancing Breakthrough Therapy for Chronic Lower Back Pain Creative Medical Technology Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability. This designation positions CEL Z-201-DDT among a select group of therapies recognized for their potential to address serious medical conditions with high unmet need. Fast Track status enables the Company to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review--pot potentially expediting the path to market and patient access. CELZ-201- DDT, part of the Company's proprietary AlloStem®? platform, is an allogeneic perinatal cell therapy administered via minimally invasive, ultrasound-guided intramuscular injections. The Fast Track designation was awarded based on compelling clinical data demonstrating a favorable safety profile and early signs of efficacy, marking a potentially significant step forward in redefining treatment standards for patients suffering from chronic back pain due to DDD. DDD impacts millions of patients globally, with current options often limited to symptom management or invasive surgery. The Company's approach targets the underlying cellular degeneration and inflammation, aiming to restore function and improve quality of life. The global spinal disorders treatment market is projected to surpass $20 billion by 2030, highlighting the significant commercial potential for novel, effective therapies. Reported Earnings • Aug 11
Second quarter 2025 earnings released: US$0.48 loss per share (vs US$1.11 loss in 2Q 2024) Second quarter 2025 results: US$0.48 loss per share (improved from US$1.11 loss in 2Q 2024). Net loss: US$1.23m (loss narrowed 21% from 2Q 2024). Revenue is forecast to grow 67% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 52% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Breakeven Date Change • Aug 10 The analyst covering Creative Medical Technology Holdings previously expected the company to break even in 2027. New forecast suggests the company will make a profit of US$15.5m in 2027. Average annual earnings growth of 66% is required to achieve expected profit on schedule.
New Risk • Jun 01
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$5.63m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (91% increase in shares outstanding). Revenue is less than US$1m (US$14k revenue). Market cap is less than US$10m (US$5.63m market cap). Minor Risk Share price has been volatile over the past 3 months (17% average weekly change). Breakeven Date Change • May 11 The analyst covering Creative Medical Technology Holdings previously expected the company to break even in 2027. New forecast suggests losses will reduce by 1.9% per year to 2026. The company is expected to make a profit of US$18.3m in 2027. Average annual earnings growth of 65% is required to achieve expected profit on schedule.
New Risk • Apr 25
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 91% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$5.5m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Shareholders have been substantially diluted in the past year (91% increase in shares outstanding). Revenue is less than US$1m (US$11k revenue). Market cap is less than US$10m (US$4.99m market cap). Announcement • Apr 12
Creative Medical Technology Holdings Provides Nasdaq Compliance Update On April 4, 2025, Creative Medical Technology Holdings, Inc. (the Company") adopted a Clawback Policy (the Policy") pursuant to Listing Rule 5608(b)(1) of The Nasdaq Stock Market LLC (Nasdaq"), and filed the Policy with the Securities and Exchange Commission as an exhibit to its Amended Annual Report on Form 10-K. Although the Clawback Policy has been adopted with retroactive effect to December 1, 2023, the Clawback Policy will have no impact on compensation previously paid to the Company's executive officers because the Company's executive officers have not received any incentive compensation that could be subject to clawback under the Policy. Notwithstanding the Company's adoption of the Policy and current compliance with Nasdaq Listing Rule 5608, on April 8, 2025, the Company received a letter from Nasdaq stating that because the Company failed to timely adopt the Policy as required by Listing Rule 5608(b)(1), and failed to disclose the Policy in its Form 10-K for the fiscal years ended December 31, 2023 or December 31, 2024 (prior to its amendment), the Company previously did not comply with Listing Rule 5608(b)(2). However, in the letter, Nasdaq further informed the Company that it is currently in compliance with Nasdaq Listing Rules, and the matter raised by Nasdaq in the letter is now closed. Breakeven Date Change • Mar 16
Forecast breakeven date pushed back to 2027 The analyst covering Creative Medical Technology Holdings previously expected the company to break even in 2026. New forecast suggests the company will make a profit of US$17.7m in 2027. Average annual earnings growth of 60% is required to achieve expected profit on schedule. New Risk • Mar 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m (US$11k revenue). Minor Risks Shareholders have been diluted in the past year (27% increase in shares outstanding). Market cap is less than US$100m (US$11.3m market cap). Announcement • Feb 14
Creative Medical Technology Holdings Announces Mid-Term Follow-up Study Data Reporting Significant Reduction in Opioid Use by Chronic Lower Back Pain Patients Undergoing StemSpine® Procedure using AlloStem™ Creative Medical Technology Holdings, Inc. announced compelling mid-term follow-up data from its StemSpine® pilot study utilizing its AlloStem™ cells for the treatment of chronic lower back pain. The pilot study demonstrated a substantial reduction in opioid dependency and significant improvements in pain levels and functional mobility. Notably, over 90% of patients reported no opioid use for pain management three years post-procedure, with an 80% persistent reduction in pain scores and a greater than 60% improvement inOswestry Disability Index scores. Only one patient required reintervention at the three-year follow-up mark, and no serious adverse events were reported, reinforcing the favorable safety profile of the StemSpine® procedure. StemSpine® is a proprietary, patented, non-surgical, ultrasound-guided procedure that leverages AlloStem™, an "off-the-shelf" allogenic (donor-derived) cell therapy developed by the Company. The StemSpine®? patent encompasses the use of both autologous (patient-derived) and allogenic cells, broadening its clinical utility. The StemSpine pilot study data is independent of the Company's ongoing FDA-cleared Phase 1/2 ADAPT clinical trial of CELZ-201-DDT for chronic lower back pain; however, these compelling findings continue to drive strong enrollment in the prospective, randomized, double-blind, dose-escalation ADAPT study, further reinforcing StemSpine® as a advancement in regenerative medicine. Announcement • Feb 11
Creative Medical Technology Reports Positive One-Year Results for Allostem™? Type 2 Diabetes Program Creative Medical Technology Holdings, Inc. announced promising one-year follow-up data from the AlloStem™? (CELZ-201) Type 2 Diabetes pilot study for late-stage patients. CELZ-201 is an off the shelf, ready-to-use universal and proprietary allogenic (donor) cell line developed by the Company. Results demonstrate that CELZ-201 achieved an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported. The study, which included 20 patients--10 receiving CELZ-201 and 10 undergoing optimized medical therapy--validated the safety and efficacy of CELZ-201 through the same infusion procedure used in the Company's U.S. FDA-cleared Type 1 Diabetes clinical trial, which is currently underway. The absence of safety concerns further supports the potential of CELZ-201 as a breakthrough treatment for late-stage Type 2 Diabetes. Given these compelling results, Creative Medical Technology plans to advance the development of AlloStem (CELZ-201). While initially managed through diet, exercise, and oral medications, many patients eventually require insulin therapy as the disease progresses. Diabetes remains the eighth leading cause of death in the U.S., with over 96 million adults classified as prediabetic--more than 80% of whom are unaware of their condition. Announcement • Jan 30
Creative Medical Technology Holdings Announces Positive Initial Safety, Tolerability, and Efficacy Data from First Cohort in Phase 1/2 Trial of CELZ-201-DDT for Chronic Back Pain Creative Medical Technology Holdings, Inc. announced promising initial data from the first cohort of its ongoing Phase 1/2 clinical trial of CELZ-201-DDT, the Company’s proprietary stem cell-based therapeutic for the treatment of chronic back pain caused by degenerative disc disease (DDD). The first cohort of 10 participants (8 receiving CELZ-201-DDT and 2 receiving placebo) completed the study phase without any dose-limiting toxicities or serious adverse events. Blinded preliminary data suggest encouraging therapeutic potential in alleviating back pain and restoring functionality. Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned. Key Milestones Achieved: Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort. Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease. DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design. Next Steps: Enrollment for the second cohort is expected in the current first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans. Advancing Innovation in Regenerative Medicine: Creative Medical Technology Holdings is committed to pioneering regenerative solutions that improve quality of life for patients with chronic and debilitating conditions. CELZ-201-DDT represents the Company’s dedication to leveraging stem cell technology to address the root causes of pain and degenerative conditions, providing patients with a novel, non-opioid therapeutic option. About CELZ-201-DDT: CELZ-201-DDT is a proprietary regenerative stem cell-based therapy designed to address chronic back pain caused by DDD. By targeting the underlying causes of DDD, CELZ-201-DDT has the potential to restore disc integrity and reduce pain, providing a novel therapeutic approach to a condition that affects millions of patients. Using an ultrasound guided, non-surgical procedure CELZ-201-DDT is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation as with other cell-based procedures. The Phase 1 /2 study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain. Board Change • Jan 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 3 highly experienced directors. Independent Director Susan Snow was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Nov 14
Creative Medical Technology Holdings, Inc. Advances FDA Cleared ADAPT Clinical Trial with Positive Independent Review, Validating the Safety and Potential of CELZ-201 for Chronic Lower Back Pain Treatment Creative Medical Technology Holdings, Inc. announced the successful completion of an independent interim safety review by the Data Safety Monitoring Board for its ADAPT clinical trial. The trial evaluated CELZ-201, a novel therapeutic perinatal tissue derived cell product, designed to treat chronic lower back pain associated with degenerative disc disease. The DSMB reviewed safety data from the first five dosed patients concluding that the trial may proceed as planned, underscoring the safety profile of CELZ-201 and supporting the advancement of this innovative therapy. This positive review follows the completion of a rigorous 30-day dose-limiting toxicity assessment per patient, an important milestone as CELZ-201 moves closer to potentially transformative therapeutic outcomes for patients. The ADAPT trial (CELZ-201-ADAPT-2023) is a double-blind, randomized, placebo-controlled, dose-escalation study designed to rigorously evaluate the safety, tolerability, and efficacy of CELZ-201 administered intramuscularly using minimally invasive ultrasound techniques. The trial employs careful, protocol-driven monitoring of adverse events in alignment with Common Terminology Criteria for Adverse Events (CTCAE v.5), safeguarding patients and providing real-time data for DSMB review and study continuity. Regular DSMB reviews are scheduled to ensure ongoing compliance with safety standards, reinforcing CELZ-201’s clinical potential. Creative Medical Technology Holdings continues to pursue cutting-edge therapies within its regenerative medicine and immunotherapy pipeline, pioneering safe, effective treatments for high-need indications. CELZ-201 exemplifies the company’s mission to develop targeted cellular therapies, combining rigorous science with strategic clinical insights to tackle previously unmet medical needs. New Risk • Nov 06
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 26% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m (US$17k revenue). Market cap is less than US$10m (US$5.51m market cap). Minor Risk Shareholders have been diluted in the past year (26% increase in shares outstanding). Announcement • Oct 24
Creative Medical Technology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.85 million. Creative Medical Technology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.85 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 418,552
Price\Range: $4.42
Discount Per Security: $0.35 New Risk • Sep 10
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m (US$17k revenue). Market cap is less than US$10m (US$4.82m market cap). Minor Risk Share price has been volatile over the past 3 months (10% average weekly change). Announcement • Jun 24
Creative Medical Technology Holdings Announces Evolutionary Development of its iPSCelz® Program with the Successful Generation of iPSC Derived Islet Cells that Produce Human Insulin Creative Medical Technology Holdings, Inc. announced that it has successfully generated human induced pluripotent stem cells (iPSC)-derived Islet Cells that produce human insulin. The iPSC clinical line that generated these insulin producing Islet Cells is part of the Company’s iPSCelz® program, which is validated by Greenstone Biosciences Inc. The iPSC clinical line, which is currently utilized in a number of its FDA cleared clinical programs in the U.S., has also been utilized to derive validated mesenchymal cells and T-regulatory cells. Announcement • May 21
Creative Medical Technology Holdings, Inc., Annual General Meeting, Jul 19, 2024 Creative Medical Technology Holdings, Inc., Annual General Meeting, Jul 19, 2024. Location: 440 stevens avenue, suite 200, california 92075, solana beach, United States Reported Earnings • Mar 24
Full year 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2023 results: US$3.76 loss per share (improved from US$9.28 loss in FY 2022). Net loss: US$5.29m (loss narrowed 48% from FY 2022). Revenue exceeded analyst estimates by 50%. Earnings per share (EPS) missed analyst estimates by 2.2%. Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. New Risk • Mar 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.8m free cash flow). Revenue is less than US$1m (US$25k revenue). Market cap is less than US$10m (US$8.71m market cap). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Announcement • Mar 07
Creative Medical Technology Holdings Inc. Announces FDA Authorization for Type 1 Diabetes Prevention Therapy Under Expanded Access Creative Medical Technology Holdings, Inc. announced a major stride in combating Type 1 Diabetes Mellitus (T1D). The company has secured FDA authorization for an expanded access therapy using CELZ-201, a pioneering cell-based program in managing abnormal glucose tolerance and preventing T1D in high-risk individuals. This therapy uses CELZ-201 to potentially prevent T1D onset and is believed to be a first in medical history. This medicine approach, focusing on a single high-risk patient, demonstrates the company's dedication to innovative, tailored healthcare solutions. CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a T1D precursor, at the cellular level. It embodies hope for high-risk individuals, offering a proactive defense against T1D development. This aligns with the company's ethos of addressing diseases before they manifest, leveraging cutting-edge science for preventative care. Announcement • Dec 20
Creative Medical Technology Holdings, Inc. Receives Clearance from the FDA to Conduct a Phase 1/2 Clinical Trial Using Their Innovative StemSpine Treatment Known as AlloStem Creative Medical Technology Holdings, Inc. has received clearance from the FDA to conduct a phase 1/2 clinical trial using their innovative StemSpine®? treatment known as AlloStem™?. This study aims to determine the safety, efficacy and tolerability of CELZ-201-DDT, a proprietary, ready-to-use cell line developed by the company. The trial will focus on individuals with chronic lower back pain, providing them with an AlloStem™? injection surrounding the affected disc(s) using an ultrasound-guided, non-surgical procedure that is radiation-free. This delivery method aims to repair and remodel the surrounding tissue, improving the blood supply to the affected area and potentially alleviating the chronic pain symptoms experienced by the patient. What sets AlloStem™? apart is its unique immunomodulatory formula derived from allogeneic perinatal cells. These cells have shown promise in tissue repair and can influence cytokine profiles, which play a crucial role in the body's immune response and tissue healing processes. Chronic back pain affects around 80% of adults. This long-lasting pain can greatly affect a person's quality of life, causing limited mobility, challenges in performing daily tasks and an increased likelihood of depression and anxiety. The economic consequences of chronic back pain are also substantial, with billions of dollars spent each year on medical treatments, reduced productivity, and disability payments. According to a report by the National Institutes of Health, approximately $200 billion is spent annually on managing back pain. CELZ-201- DDT is unique because it uses a customized immunomodulatory formula made of perinatal cells derived from donors. Initial studies have shown that this formula has the potential for tissue repair and to change cytokine profiles - paving the way for further research in regenerative medicine in areas of immunotherapy, endocrinology, gynecology, urology and orthopedics. The trial seeks to enroll approximately 30 individuals, and the company is hopeful that the study will provide the necessary information to move toward a new, innovative treatment for chronic lower back pain in the future. With the necessary endorsement from the FDA and an ongoing clinical trial, Creative Medical Technology's recent developments potentially set the stage for innovative treatment options that could significantly improve the lives of patients grappling with chronic pain and other diseases. New Risk • Nov 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.8m free cash flow). Revenue is less than US$1m (US$25k revenue). Market cap is less than US$10m (US$6.15m market cap). Announcement • Nov 04
Creative Medical Technology Holdings, Inc., Annual General Meeting, Dec 20, 2023 Creative Medical Technology Holdings, Inc., Annual General Meeting, Dec 20, 2023, at 09:00 Pacific Standard Time. Location: Town & Country Resort 500 Hotel Cir N San Diego California United States Agenda: To elect five directors to the board of directors to serve until the next annual meeting of stockholders or until their successors have been duly elected or appointed and qualified; to approve on a nonbinding advisory basis, the compensation of our named executive officers; and to approve and ratify the appointment of Haynie and company. Announcement • Oct 11
Creative Medical Technology Holdings, Inc. Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of Stemspine(R) Using Allostem(Tm) (Celz-201-Ddt) Novel Cell Therapy to Treat Chronic Lower Back Pain Creative Medical Technology Holdings, Inc. announced that it has received Institutional Review Board approval to proceed with its clinical trial for the treatment of chronic lower back pain with its StemSpine(R) procedure using AlloStem(TM) ("CELZ-201-DDT") cell therapy. The receipt of IRB approval is a necessary step that will allow Creative Medical Technology to move forward with recruitment of its recently FDA approved Phase 1 /2 randomized, double blind, placebo controlled clinical trial to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain caused by Degenerative Disc Disease. An IRB is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects. IRB approval is a critical and necessary prerequisite to commencing human clinical trials and serves an important role in the protection of the rights and welfare of human research subjects. Announcement • Sep 20
Creative Medical Technology Holdings Receives FDA Clearance to Initiate A Phase 1/2 Clinical Trial of Stemspine® Using Allostem™ (Celz-201-Ddt) for the Treatment of Chronic Lower Back Pain Creative Medical Technology Holdings, Inc. announced that the U.S. Food and Drug Administration has cleared the Company to proceed with a Phase 1/2 clinical trial of StemSpine® using AlloStem. The study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain. CELZ-201-DDT is a patented procedure that utilizes an "off the shelf, ready-to-use" universal and proprietary allogenic (donor) cell line developed by the Company and trademarked as AlloStem™. Using an ultrasound guided, non-surgical procedure AlloStem™ is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation as with other cell-based procedures. CELZ-201-DDT distinguishes itself by using a unique immunomodulatory formula derived from allogeneic perinatal cells, which in preliminary studies have shown potential for tissue repair and changing cytokine profiles. Announcement • Jun 30
Creative Medical Technology Holdings Regains Compliance with Nasdaq Listing Requirements Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") announced that on June 27, 2023 it received written notice from The Nasdaq Stock Market LLC informing the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Consequently, the Company is now in compliance with all applicable Nasdaq listing standards. Previously, on July 8, 2022, Creative Medical Technology had been notified by Nasdaq that the Company was not in compliance with the minimum bid price rule because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. In order to regain Nasdaq compliance, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. This requirement was met on June 26, 2023, the tenth consecutive trading day when the closing bid price of the Company's common stock was over $1.00. Announcement • Jun 13
Creative Medical Technology Holdings, Inc. (NasdaqCM:CELZ) announces an Equity Buyback for $2 million worth of its shares. Creative Medical Technology Holdings, Inc. (NasdaqCM:CELZ) announces a share repurchase program. Under the program, the company will repurchase up to $2 million worth of its outstanding common stock. The program has no expiry date. Announcement • Jun 01
Creative Medical Technology Holdings Announces Successful Completion of the First Phase of Its Program with Greenstone Biosciences, Inc. to Develop Next Generation iPSC Pipeline for ImmCelz(R) Immunotherapy Platform Creative Medical Technology Holdings, Inc. announced that it has received confirmation that Greenstone Biosciences Inc. in Palo Alto, CA has successfully developed a human induced pluripotent stem cell (iPSC) pipeline for the Company's ImmCelz(R) platform. In June 2022, the Company announced its collaboration with Greenstone Biosciences, Inc. on this project, called the iPScelz(TM) program, to enable the Company to increase its scalability for the ImmCelz(R") Immunotherapy Platform at a lower cost and continue its drug discovery program using artificial intelligence. Announcement • May 23
Creative Medical Technology Holdings, Inc. Announces Next Milestone Achievements in ImmCelz Platform Development Creative Medical Technology Holdings, Inc. announced significant advances in the ongoing development of its ImmCelz (CELZ-100) platform, the Company's cell-free system which has previously been validated to supercharge a patient's own cells to treat a number of immune disorders. These advances support the Company's prior work in this area and confirm that the use of fewer donor cells can lower production costs while producing a more potent and efficacious final product. In particular, independent studies confirmed: That the ImmCelz ("CELZ-100) platforms required 75% fewer donor patient cells compared to industry standard; That the purity of the final ImmCelz(CELZ-100) product was greater than 95% compared to the industry standard of greater than 80%; That ImmCelz (CELZ -100) demonstrated a greater than 200% reduction in functional suppression of effector T cells, which are a critical concern for patients with autoimmune issues, while still possessing a high number of functional T regulatory cells; and The ability to verify repeated potency of the final ImmCelz-(CELZ-100) product. All experiments were independently conducted and validated on selected human donor patient cells for accuracy and reproducibility. Announcement • May 19
Creative Medical Technology Holdings Announces Positive Top-Line Study Results for Chronic Lower Back Pain Utilizing its StemSpine® Procedure Using AlloStem™ Allogenic Cell Line Creative Medical Technology Holdings, Inc. announced positive top line pilot study results for the StemSpine® procedure using AlloStem™ to treat chronic lower back pain. The data demonstrated significant efficacy and no serious adverse events using the StemSpine® ultrasound guided non-surgical procedure for treating chronic lower back pain. The StemSpine® procedure using AlloStem™ resulted in a greater than 90% reduction in narcotic usage, greater than 80% reduction in pain score, and greater than 50% reduction in the Oswestry Score in the treated patients. No patients required re-dosage or surgical intervention at the primary end point of six months and there were no safety related concerns. StemSpine® using AlloStem™ is a patented procedure that utilizes an "off the shelf, ready-to-use" universal and proprietary allogenic (donor) cell developed by the Company and trademarked as AlloStem™. The patent issued to StemSpine® includes both the use of autologous (from the patient) and allogenic (universal donor) cells. In February 2023, the Company reported positive three-year follow-up data for its StemSpine® pilot study using autologous cells to treat chronic lower back pain. Announcement • Feb 15
Creative Medical Technology Holdings, Inc. Announces Positive Three-Year Follow-Up Data for the Company's Stemspine Pilot Study Creative Medical Technology Holdings, Inc. announced positive three-year follow-up data for the Company's StemSpine pilot study. The three-year data demonstrates continued efficacy of the StemSpine® procedure for treating chronic lower back pain without any serious adverse effects reported. StemSpine® is a patented procedure that primarily utilizes a patient's own bone marrow aspirate for the treatment of chronic lower back pain. The issued patent also covers the use of allogenic (donor) cells for this condition, which provides the Company with additional options for treating millions of potential patients suffering from chronic lower back pain. There were no safety related concerns at up to three years, and the StemSpine® procedure resulted in a continued efficacy rate of 87% of patients that participated in the pilot study. No patients required re-dosage or surgical intervention since the last follow-up at two years. Announcement • Feb 09
Creative Medical Technology Holdings, Inc. Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of Novel Cell Therapy for the Treatment of Type 1 Diabetes Creative Medical Technology Holdings, Inc. announced that it has received Institutional Review Board (IRB) approval to proceed with its Clinical Trial for the treatment of Type 1 Diabetes with its CELZ-201 cell therapy. The U.S. Food and Drug Administration (FDA) had previously cleared the Company's Investigational New Drug (IND) application within 30 days from submission. The Company believes that CELZ-201 leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. The primary objective of the study is to evaluate CELZ-201 as a treatment for patients with newly diagnosed Type 1 Diabetes. The company sponsored trial will be conducted at the University of Miami Health System in conjunction with the Diabetes Research Institute. Board Change • Nov 16
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 4 experienced directors. No highly experienced directors. Senior VP, CFO & Director Donald Dickerson is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Nov 04
Creative Medical Technology Holdings, Inc. Announces Fda Clearance of Investigational New Drug (Ind) Application for Allostem(Tm), A Novel Cell Therapy for the Treatment of Type 1 Diabetes Creative Medical Technology Holdings, Inc. announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug (IND) application, enabling the Company to proceed with initiating a clinical trial for Type 1 Diabetes using AlloStem(TM). AlloStem(TM) leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells(R) (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. The primary objective of the study (CELZ-201) is to evaluate AlloStem(TM) in patients with newly diagnosed Type 1 Diabetes. Patient recruitment is expected to begin in First Quarter 2023 with trial commencement updates to follow. The national principal investigator of the study is Camillo Ricordi, M.D. Dr. Ricordi is the Stacy Joy Goodman Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, and Microbiology and Immunology at the University of Miami in Florida, where he serves as the Director of the Diabetes Research Institute and the Cell Transplant Program.Dr. Ricordi will give an update on the study at the 8th Perinatal Stem Cell Society Congress/Workshop at 9:00am EST. Announcement • Oct 27
Creative Medical Technology Holdings, Inc., Annual General Meeting, Dec 19, 2022 Creative Medical Technology Holdings, Inc., Annual General Meeting, Dec 19, 2022, at 09:30 Pacific Standard Time. Location: 500 Hotel Cir N, San Diego, CA 92108 San Diego United States Agenda: To elect five directors to company board of directors to serve until the next annual meeting of stockholders or until their successors have been duly elected or appointed and qualified; to approve, on a nonbinding advisory basis, the compensation of company named executive officers; to vote, on a nonbinding advisory basis, on the preferred frequency of holding an advisory vote on executive compensation; to ratify the appointment of haynie & company, as our independent registered public accountants for the fiscal year ending December 31, 2022; and to transact such other business that may properly come before the annual meeting or any adjournment or postponement thereof. Announcement • Oct 21
Creative Medical Technology Holdings, Inc. Develops AlloStem Clinical Cell Line Creative Medical Technology Holdings, Inc. announced that through predominantly internal and collaborative development, it has produced an allogenic Cell Line called AlloStem™, which includes a Master Cell Bank and a Drug Master File which shall be submitted for FDA registration. Announcement • Jul 29
Creative Medical Technology Announces Positive Top-Line Results for OvaStem® Pilot Study Creative Medical Technology Holdings, Inc. announced positive three-year follow up data for the Company's OvaStem® pilot study. The data shows significant efficacy of the OvaStem® procedure for the treatment of medical refractory Primary Ovarian Insufficiency (POI) without any serious adverse effects and the successful birth of healthy babies. OvaStem® is a patented outpatient clinic procedure that utilizes a patient's own bone marrow aspirate for treatment of medical refractory POI. Below is a summary of the study's three-year follow up data: There were no safety related concerns at up to three years and the OvaStem® procedure resulted in an efficacy of 90% in the treated patients in terms of improvement in hormonal function and 70% in terms of delivery of healthy babies using their own eggs. Patients with POI usually only have a 5% to 10% chance of spontaneous pregnancy and must rely on donor eggs for conception via in vitro fertilization therapy. The company plans to submit a manuscript for publication in a peer reviewed journal and present the data at future fertility medicine conferences. Announcement • Jul 16
Creative Medical Technology Holdings Receives Non-Compliance Notice from Nasdaq On July 8, 2022, Creative Medical Technology Holdings, Inc. (the Company") received a letter from The Nasdaq Stock Market stating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because theclosing bid price of the Company's common stock was below $1.00 per share for 30 consecutive business days. The notice has no immediate impact on the Company's listing. Pursuant to Nasdaq's Listing Rules, the Company has a 180 day grace period, until January 4, 2023, during which the Company may regain compliance if the bid price of its common stock closes at $1.00 per share or more for a minimum of ten consecutive business days. The Company may be eligible for an additional 180-day grace period if the Company meets Nasdaq's initial listing standards (other than with respect to minimum bid price) for The Nasdaq Capital Market. The Company intends to actively monitor the bid price for its common stock between now and January 4, 2023, and will consider available options to regain compliance with the Nasdaq minimum bid price requirements. Announcement • May 06
Creative Medical Technology Holdings, Inc. announced that it has received $17.000001 million in funding On May 5, 2022, Creative Medical Technology Holdings, Inc. closed the transaction. The transaction included participation from 18 investors. Board Change • Apr 27
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 4 experienced directors. No highly experienced directors. Senior VP, CFO & Director Donald Dickerson is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Apr 21
Creative Medical Technology Holdings, Inc. Announces Progress in Developing a Reproducible Clinical Grade of the Company's ImmCelz® Product Creative Medical Technology Holdings, Inc. announced progress in developing a reproducible clinical grade product of ImmCelz®. Multiple clinical experiments were performed in which the ImmCelz® product was produced in less than 72 hours, utilizing the Company's cell-free supercharging solution. The amount of ImmCelz® produced was significantly greater than the control in numerous replicates of the experiments. There was also the ability to verify repeated potency of the final ImmCelz® product. ImmCelz®, which is protected by trade secrets and published U.S. patents, utilizes adult stem cells derived from qualified donors to endow specific properties to the patient's immune cells. After the patient's harvested cells are incubated with the Company's cell-free reprogramming "cocktail", the cells are re-injected back into the patient. These "supercharged" cells subsequently "educate" other cells of the immune system to stop attacking the body, while preserving the ability to attack foreign pathogens. The Company plans to advance multiple indications for ImmCelz® starting with stroke, which is currently under FDA review. Upon successful approval to proceed with clinical trials for stroke, the Company anticipates accelerating additional therapies under the ImmCelz® umbrella, including for Type I diabetes, heart disease, liver disease, and kidney disease. Reported Earnings • Apr 01
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: EPS: US$7.38 (up from US$62.69 loss in FY 2020). Net income: US$19.2m (up US$55.5m from FY 2020). Revenue exceeded analyst estimates by 192%. Earnings per share (EPS) missed analyst estimates by 32%. Over the next year, revenue is forecast to grow 135%, compared to a 66% growth forecast for the pharmaceuticals industry in the US. Announcement • Mar 04
Creative Medical Technology Appoints Sahil Nock as Chief Commercial Officer Creative Medical Technology Holdings, Inc. announced the appointment of Sahil Nock as the Company's Chief Commercial Officer, effective February 28, 2022. Mr. Nock brings to Creative Medical Technology more than 15 years of healthcare leadership experience in sales, marketing, and business development. He most recently served as Head of US Commercial Marketing at Mentor, the worldwide leader in breast aesthetics and a Johnson & Johnson Medical Device Company. In this role, he was responsible for growing Mentor's market leadership position across both augmentation and reconstruction. Board Change • Jan 02
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 5 experienced directors. No highly experienced directors. Senior VP, CFO & Director Donald Dickerson is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Dec 05
Creative Medical Technology Holdings Deleted from Other OTC Creative Medical Technology Holdings, Inc.'s Common Stock have been deleted from other OTC effective from December 3, 2021 due to Market Center Change Listed on NASDAQ. Board Change • Dec 04
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Chief Scientific Officer & Independent Director Tom Ichim was the last independent director to join the board, commencing their role in 2016. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Aug 13
Creative Medical Technology Holdings, Inc. announced that it has received $3.78775 million in funding On August 11, 2021, Creative Medical Technology Holdings, Inc closed the transaction for an aggregate purchase price of $3,787,750. The transaction was effected pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended and Rule 506(b) promulgated thereunder. Announcement • Aug 10
Creative Medical Technology Holdings, Inc. announced that it expects to receive $3.788 million in funding Creative Medical Technology Holdings, Inc. announced that it has entered into a definitive agreements with accredited institutional investors for a private placement of 15% Original Issue Discount Senior Notes for the gross proceeds of $3,788,000 on August 9, 2021. The principal amount of the Notes will be due on February 11, 2022. The company will also issue to the investors unregistered warrants for the purchase of 157,184,354 shares of common stock. Each warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.02835 for a period of five years from the date of issuance. The transaction is expected to be closed on August 11, 2021, subject to customary closing conditions. Announcement • Jun 10
Creative Medical Technology Holdings Identifies Synergy Between Immcelz® Regenerative Immunotherapy and Myeloid Suppressor Cells in Treatment of Type 1 Diabetes Creative Medical Technology Holdings, announced the filing of a provisional patent application in connection with new data indicating that the Company's ImmCelz® personalized cell therapy product and myeloid suppressor cells suppress autoimmune diabetes. In a series of experiments, administration of ImmCelz® was demonstrated to enhance the ability of BCG and GM-CSF to prevent diabetes, which are known to augment myeloid suppressor cell numbers and activity. ImmCelz® is a cell therapy product generated by reprogramming patient cells through exposure to factors secreted by universal donor stem cells. Preclinical models of stroke, liver failure, kidney failure, cardiac infarct and rheumatoid arthritis indicate a benefit from treatment with ImmCelz®. Mechanistically, ImmCelz® appears to suppress pathological immunity through induction of T regulatory cells while concurrently stimulation production of regenerative cytokines such as HGF-1. Announcement • May 25
Creative Medical Technology Holdings Expands Neurological Application of ImmCelz® into Parkinson's Disease Creative Medical Technology Holdings announced positive preclinical data supporting extension of ImmCelz® applicability to Parkinson's Disease. Using the well established MPTP mouse model of the disease, it was demonstrated that administration of ImmCelz® inhibited onset of Parkinsonism-like behavior and resulted in protection of dopaminergic cells. Importantly, augmentation of brain protective interleukin-10 protein was observed in treated animals. The Company is excited to see that the concept of "regenerative immunotherapy" appears to be applicable to numerous indications, especially in the area of neurological diseases. The ImmCelz® product utilizes the patient's own blood cells that have been "reprogrammed" by culturing with established universal donor stem cells followed by re-infusion into the patient. To date preclinical models of liver failure1, diabetes2, stroke3, rheumatoid arthritis4, and now Parkinson's have been shown responsive to ImmCelz® therapy. Announcement • May 15
FDA Responds to Creative Medical Technology Holdings, Inc. Regarding its ImmCelz® IND for Stroke Treatment Creative Medical Technology Holdings Inc. announced receipt of detailed correspondence from the FDA regarding necessary modifications to IND #27375 for using ImmCelz® regenerative immunotherapy for the treatment of stroke. The company's ImmCelz® product utilizes a patient's own blood cells that have been reprogrammed in the laboratory by culturing with established universal donor stem cells, followed by re-infusion into the patient. Efficacy in animal models has been demonstrated in heart failure, kidney failure, multiple sclerosis, liver failure and type 1 diabetes. Given that this is the first time such a product was brought to the FDA, the Company appreciates the detailed analysis provided by the Agency, and the constructive feedback. Announcement • Mar 17
Creative Medical Technology Holdings, Inc. Announces Fda Acknowledgment of Ind Application for Immcelz® to Treat Stroke Creative Medical Technology Holdings, Inc. announced that the FDA issued IND Number 27375 to the company in connection with its Clinical Trial application to use ImmCelz® to treat stroke victims. The ImmCelz® treatment involves utilization of stem cells outside of the body to reprogram the patient's own immune cells so as to endow the immune cells with regenerative properties. In contrast to other stem cell based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissue and induce regeneration. Announcement • Mar 05
Creative Medical Technology Holdings Publishes Efficacy in Pain Reduction and Mobility in Patients with Disc Degenerative Disc Using Stemspine® Personalized Adult Stem Cell Therapy Creative Medical Technology Holdings announced a publication in the pre-print server SSRN describing data from its first 15 patients treated in a clinical trial evaluation perispinal injection of bone marrow cells in patients with disc degenerative disease. Evaluation of patients at 30, 60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score . The mean pain changed from 8.9 at baseline to 4.3 at 30 days and sustained to 1.8 at 6 months and 1.3 at 12 months with a gradual reduction in overall pain medication utilization guided by their healthcare team. No serious adverse effects were noted with some short-term bruising in two patients at the harvest site and no long term adverse events where reported related to the procedure. The autologous utilization of bone marrow falls under the "minimal manipulation exception" and can be commercialized rapidly, in the same manner that the Company commercialized Caverstem® for treatment of erectile dysfunction. Granted United States Patent #9,598,673 which is owned by the Company covers the use of any mesenchymal stem cells, both from the patient or from donors, for reduction of lower back pain when injected into the major muscles of the lower back. Announcement • Mar 04
Creative Medical Technology Holdings Provides Update on ImmCelz® FDA Application Creative Medical Technology Holdings announced that due to COVID related technical changes in the FDA's submission requirements, the Company's ImmCelz® Investigational New Drug Application (IND) for the treatment of Stroke will be resubmitted to the FDA in electronic form to comply with such requirements. Previously, the FDA had accepted IND applications in hard copy submitted by mail. Due to the complexity of the new requirements, Creative Medical Technology Holdings has retained the services of an FDA consulting firm with the expertise to assist it with the FDA's electronic submission procedures, which include formatting, hyperlinking, and tagging requirements. The Company believes that retaining a third party firm experienced in FDA electronic submissions will better equip the Company to navigate and comply with the FDA's new requirements. Resubmission of the Company's ImmCelz® IND will not change the substance of the Company's application to the FDA. As previously reported, the IND seeks approval from the FDA to initiate the first clinical trial using cellular immunotherapy for treatment of stroke, using the Company's ImmCelz® product. Announcement • Feb 18
Creative Medical Technology Holdings Files Patent on Prevention of Organ Transplant Rejection Using ImmCelz® Creative Medical Technology Holdings, Inc. announced filing of a patent application covering the use of ImmCelz® regenerative cell therapy for preventing rejection of transplanted organs. ImmCelz® is a cellular therapy that prevents pathological immunity and inflammation while at the same time inducing regeneration of damaged tissue. Mechanistically ImmCelz® has been shown to function through stimulation of T regulatory cells and producing the regenerative protein Hepatocyte Growth Factor (HGF). The patent demonstrates that ImmCelz® may have the potential to inhibit chronic graft rejection, which is the major cause of organ loss. Sales of immune suppressants, which are used after transplants to prevent patients from rejecting their organs exceeded 4 billion dollars in 2018. Announcement • Feb 11
Creative Medical Technology Holdings Identifies Cellular Mechanism of Patented Ovastem® Female Infertility/Ovarian Failure Treatment Creative Medical Technology Holdings announced new data explaining mechanisms of action of its patented OvaStem® female infertility/ovarian failure treatment. OvaStem®, which is covered by issued patent #10,792,310, involves injection of stem cells into dysfunctional ovaries and has been demonstrated to induce fertility, as well as restore hormone levels. The data, which are covered in a newly filed patent application, demonstrate that mesenchymal stem cell injection results in generation of T regulatory cells. These cells are a type of immune cell which the Company has previously patented for regeneration of lumbar discs. Importantly, depletion of T regulatory cells resulted in negation of the beneficial effects of stem cells, whereas exogenous administration of T regulatory cells are capable of restoring ovarian function. Although the menopause market is believed to be approximately $600 billion[1], the Company is focusing on the initial indication of premature ovarian failure. Premature ovarian failure occurs in woman under 40 who experience degeneration of ovaries from a variety of conditions. The Company has demonstrated efficacy of autologous (patient's own stem cells) and allogeneic (universal donor) in animal models of this condition. Announcement • Feb 09
Creative Medical Technology Holdings, Inc. Announces the Recruitment of Dr. Caigan Du to the Scientific Advisory Board Creative Medical Technology Holdings, Inc. announced the recruitment of Dr. Caigan Du, Associate Professor at the University of British Columbia to the Company's Scientific Advisory Board. The Advisory Board of Creative Medical Technology Holdings includes internationally renowned neurologist Santosh Kesari MD, Ph.D, the former head of cardiology at Cedar Sinai Medical Center Timothy Henry, MD and the Director Dr. Amit Patel, inventor of the JadiCell and the first physician to have implanted stem cells into the human heart. Announcement • Feb 02
Creative Medical Technology Holdings Identifies and Files Patent on Novel Mechanism of Immcelz® Therapeutic Activity Creative Medical Technology Holdings, Inc. announced new data demonstrating that administration of ImmCelz® to animals with a variety of conditions results is a significant surge of the protein hepatocyte growth factor (HGF-1). When scientists blocked the effects of HGF in ImmCelz® treated animals, the therapeutic effects where significantly inhibited. The data suggests one of the molecular mechanisms of action of ImmCelz® is mediated by production of this therapeutic molecule. To date the Company has reported therapeutic activity of ImmCelz® in models of rheumatoid arthritis, stroke, type 1 diabetes, kidney failure and liver failure. The data disclosed now are supported by independent studies which have shown HGF-1 is capable of inducing T regulatory cells and stimulating neurogenesis. Announcement • Jan 13
Creative Medical Technology Holdings Inc. Files Investigational New Drug Application with FDA for Treatment of Stroke using ImmCelz® Regenerative Immunotherapy Creative Medical Technology Holdings Inc. announced filing of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) requesting clearance to initiate the first clinical trial using cellular immunotherapy for treatment of stroke. The proposed study will involve treatment of 4 groups of 8 patients per group. Treated patients will receive one intravenous injection of ImmCelZ® product at 0.5 X10(6) cells per kilogram; the second arm 1 X10(6) cells per kilogram; the third arm 2X10(6) cells per kilogram; and the fourth arm will serve as a control. Patients will be followed for a total of 6 months with both safety and efficacy being examined. The ImmCelz® treatment involves utilization of stem cells outside of the body to "reprogram" the patient's own immune cells so as to endow upon the immune cells regenerative activities. In contrast to other stem cell based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged brain and induce regeneration. Announcement • Jan 01
Creative Medical Technology Holdings Announces Patent Filing Based on Preclinical Data in Model of Heart Attack Using ImmCelz Regenerative Immunotherapy Creative Medical Technology Holdings Inc. announced positive preclinical data using ImmCelz in treatment of a model of heart attack. Patent application #63/132472, entitled "Treatment of Heart Failure and/or Post Infarct Pathological Remodeling by Ex Vivo Reprogrammed Immune Cells" covers data in which mice with restricted blood flow to the heart had significantly improved survival when treated with ImmCelz as compared to control mice. The ImmCelz® product, based on decades of immunological research by Drs Thomas Ichim and Amit Patel, involves extraction of patient immune cells, "training" the immune cells to exhibit regenerative properties by incubation with regenerative cells outside of the body, followed by re-infusion of the patient's own cells. To date the Company has demonstrated that ImmCelz® has therapeutic activity in stroke and liver failure. Announcement • Dec 18
Creative Medical Technology Holdings Announces Successful Application of ImmCelz® Immunotherapy for Treatment of Stroke Creative Medical Technology Holdings Inc. announced positive preclinical data supporting the utilization of its ImmCelz® cell based immunotherapy for treatment of stroke. In an animal model of ischemia stroke, the middle cerebral artery ligation model, administration of ImmCelz® resulted in 34% reduction in infarct volume, whereas control bone marrow mesenchymal stem cells reduced infarct volume by 21%. Additionally, improvements in functional recovery where observed using the Rotarod test. At 28 days after induction of stroke the animals receiving ImmCelz® had superior running time (92% of non-stroke controls) compared to animals which received bone marrow mesenchymal stem cells (73% of non-stroke control). Animals that received saline had a running time that was 50% of non-stroke controls. Creative Medical Technology Holdings possesses numerous issued patents in the area of cellular therapy including patent no. 10,842,815 covering use of T regulatory cells for spinal disc regeneration, patent no. 9,598,673 covering stem cell therapy for disc regeneration, patent no. 10,792,310 covering regeneration of ovaries using endothelial progenitor cells and mesenchymal stem cells, patent no. 8,372,797 covering use of stem cells for erectile dysfunction, and patent no. 7,569,385 licensed from the University of California covering a novel stem cell type. Announcement • Dec 13
Creative Medical Technology Holdings Files Patent on Induction of Infectious Tolerance by Ex Vivo Reprogrammed Immune Cells Utilizing ImmCelz® Cellular Immunotherapy Creative Medical Technology Holdings announced its patent filing based on data covering utilization of the Company's ImmCelz® product at generating what is termed in the field of immunology as infectious tolerance. Using an animal model of rheumatoid arthritis, investigators demonstrated administration of ImmCel® protected mice from immunologically mediated joint damage. Importantly, cells from treated mice were able to reverse disease when transferred to arthritic mice. Detailed scientific analysis revealed that ImmCelz® administration caused generation of T regulatory cells and tolerogenic dendritic cells. Both of these cell types have previously been described to possess ability to suppress autoimmunity. Announcement • Sep 30
Creative Medical Technology Holdings Reports Positive Preclinical Data on ImmCelz® Immunotherapy Product in Rheumatoid Arthritis Model Creative Medical Technology Holdings announced proof of concept studies demonstrating efficacy of its ImmCelz® immunotherapy product in the collage induced model of rheumatoid arthritis. The studies, which involved exposing mouse immune cells to the Company's patent pending "ex vivo" reprogramming protocol, demonstrated selective suppression of autoimmunity which causes joint damage, while sparing of normal immune functions. Current treatments for rheumatoid arthritis non-specifically depress immune responses leading to increased susceptibility to infections. ImmCelz®, which is protected by trade secrets and published US patent application 15/987739, utilizes adult stem cells derived from qualified donors, to endow specific properties to patient immune cells. After the patient immune cells are incubated with the donor stem cells, the immune cells are extracted and re-injected back into the patient. These "reprogrammed cells" subsequent "educate" other cells of the immune system to stop attacking the body, while preserving ability to attack cancers and foreign pathogens. Harmful immune responses, otherwise known as autoimmunity, are a multibillion dollar market which comprises conditions such as type 1 diabetes, multiple sclerosis, lupus, rheumatoid arthritis, and Grave's Disease.