CREATIVE MEDICAL TECHNOLOGY HOLDINGS, INC.
For the period ended Mar 31, 2025. Filed May 9, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 9, 2025
CELZ$0.62+2.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-08.
0001477932-24-006991
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-09.
0001477932-25-003498
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 53 previous paragraphs and 49 current paragraphs.
21 unchanged; 19 reworded; 9 added; 8 removed; 5 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
In October, 2023 we filed for and received approval from an institutional review board (IRB) to proceed with the Phase I/II clinical trial for the treatment of chronic lower back pain with its AlloStemSpine® procedure using AlloStem™ (CELZ-201-DDT ADAPT) cell therapy. The clinical trial is registered onwww.clinicaltrials.gov. From November 2023 through July 2024, we:
Current report
In November 2024, we announced the successful completion of an independent interim safety review by the Data Safety Monitoring Board (DSMB) of our CELZ-201 ADAPT clinical trial. 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 (DLT) assessment per patient, an important milestone as CELZ-201 moves closer to potentially transformative therapeutic outcomes for patients.
Current report
In January 2025, we announced promising initial data from the first cohort of the CELZ-201 ADAPT clinical trial. 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
Current report
Key Milestones Achieved:
Current report
We began treating the second cohort in this trial in the first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans.
Current report
On March 6, 2025, we entered into warrant exercise inducement offer letters (the "Inducement Letters") with the holders (the "Holders") of warrants to purchase an aggregate of 837,104 shares of our Common Stock originally issued on October 23, 2024 (collectively, the "Existing Warrants"), pursuant to which the Holders agreed to exercise the Existing Warrants at their current exercise price of $4.42 per share, in exchange for our agreement to issue the Holders new warrants to purchase an aggregate of 1,674,208 shares of common stock (the "Inducement Warrants"). The Inducement Warrants have an exercise price of $3.75 per share, will not be considered granted and exercisable until we have obtained stockholder approval for the issuance of the shares of Common Stock underlying the Inducement Warrants, and will then be exercisable for a period of five years following the date we obtain such stockholder approval. The transaction closed on March 6, 2025, resulting in total net proceeds to the Company of approximately $3.7 million after deducting placement agent fees and other costs of the offering. Upon stockholder approval, the Company is expected to record a deemed dividend of approximately $3.9 million representing the difference between the fair market value of the Existing Warrants and Inducement Warrants on the date of the transaction.
Current report
We were incorporated on December 3, 1998, in the State of Nevada under the name Jolley Marketing, Inc. On May 18, 2016, we completed a reverse merger transaction under which Creative Medical Technologies, Inc. became our wholly owned subsidiary. In connection with this merger, we changed our name to Creative Medical Technologies Holdings, Inc. to reflect our current business.
Current report
Our principal executive offices are located at 211 E Osborn Road, Phoenix, AZ 85012.
Current report
Cash received in financing activities for the three-months ended March 31, 2025 was $3,354,000 in proceeds from the exercise of warrants net of issuance costs, in comparison to $82,796 in cash spent from the purchase of treasury stock for the comparable period a year ago.
Removed paragraphs (8)
Previous report
We currently conduct substantially all of our commercial operations through CMT, which markets and sells our CaverStem® and FemCelz®disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively. Our CaverStem® and FemCelz® kits are currently available through physicians at eight locations in the United States.
Previous report
During the second quarter of 2024, the Company selected and contracted with the clinical trial site and Contract Research Organization (CRO), initiated the clinical trial site, launched subject recruitment and started dosing trial subjects on the Phase I/II clinical trial of AlloStemSpine™ Chronic Lower Back Pain (CELZ-201 ADAPT) using AlloStem™ (CELZ-201-DDT) for the treatment of lower back pain.
Previous report
Research and Development Expenses. Research and development expenses for the three-months ended September 30, 2024, totaled $581,796 in comparison to $992,272 for the comparable period a year ago. The decrease of $410,926, or 41% was primarily due to a decrease of $661,403 in general research and development offset by an increase of $262,129 associated with the CELZ-201 ADAPT Chronic Lower Back Pain clinical trial.
Previous report
Gross Revenue**.** There was $8,000 in revenues generated for the nine-months ended September 30, 2024 in comparison with $6,000 in revenues for the comparable period a year ago.
Previous report
Selling, General and Administrative Expenses**.** General and administrative expenses for the nine-months ended September 30, 2024, totaled $1,846,177, in comparison with $2,161,599 for the comparable period a year ago. The decrease of $315,422, or 15% is primarily due to decreases of $140,339 in marketing, $94,299 in public company related expenses, and $157,078 in professional fees, offset by $72,753 in salaries and administrative expenses.
Previous report
Amortization Expenses.* *Amortization expenses for the nine-months ended September 30, 2024 totaled $87,813 in comparison with $69,063 for the comparable period a year ago.
Previous report
Operating Loss**.** For the reasons stated above, our operating loss for the nine-months ended September 30, 2024, was $3,858,127 in comparison with $3,848,293 for the comparable period a year ago.
Previous report
Cash used in financing activities for the nine-months ended September 30, 2024 was $174,864 associated with the repurchase of our common stock under our stock re-purchase program, in comparison to $191,780 associated with same program during the nine-months ended June 30, 2023.
Reworded paragraphs (19)
Previous wording
In February 2023, the Company reported positive three-year follow-up data for its 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.
Current wording
In February 2023, we reported positive three-year follow-up data for its 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.
Previous wording
In March 2023, the Company announced that it filed an application with the FDA to receive Orphan Drug Designation (“ODD”) for the treatment of Brittle Type 1 Diabetes using its ImmCelz™ (CELZ-100) platform. In March 2024, the Company received ODD for the treatment of Brittle Type 1 Diabetes from the FDA. This designation provides multiple important benefits to support the therapy's development including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval.
Current wording
In March 2023, we announced that we had filed an application with the FDA to receive Orphan Drug Designation (“ODD”) for the treatment of Brittle Type 1 Diabetes using its ImmCelz™ (CELZ-100) platform**.**In March 2024 we received the ODD from the FDA. This designation provides multiple important benefits to support the therapy’s development including tax advantages, user fee exemptions, and the opportunity for market exclusivity following approval.
Previous wording
In April 2023, the Company reported positive one-year follow-up data and significant efficacy using CELZ-001 to treat patients with Type 2 Diabetes. There were no safety concerns related to CELZ-001 at one year follow-up utilizing the same infusion procedure as in the currently U.S. FDA cleared Type I Diabetes (CELZ-201 CREATE-1) clinical trial. There were 30 patients in the study, 15 who received CELZ-001 and the rest received optimized medical therapy. At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement.
Current wording
In April 2023, we reported positive one-year follow-up data and significant efficacy using CELZ-001 to treat patients with Type 2 Diabetes. There were no safety concerns related to CELZ-001 at one year follow-up utilizing the same infusion procedure as in the currently U.S. FDA cleared Type I Diabetes (CELZ-201 CREATE-1) clinical trial. There were 30 patients in the study, 15 received CELZ-001 and the rest received optimized medical therapy. At one year, there was an overall efficacy of 93% in the treated patients demonstrating at least a 50% reduction in insulin requirement.
Previous wording
In September 2023, the Company received FDA clearance to initiate a Phase I/II clinical trial of AlloStemSpine™ Chronic Lower Back Pain (CELZ-201 ADAPT) using AlloStem™ (CELZ-201-DDT) for the treatment of lower back pain. The first in country study, which will enroll 30 individuals suffering from chronic lower back pain, is designed to evaluate the safety, efficacy, and tolerability of AlloStem™ (CELZ-201-DDT). The minimally invasive procedure uses ultrasound for the targeted delivery of the cell product, and thus prevents radiation exposure to the patient or the injecting physician. In October, 2023 we filed for and received approval from an institutional review board (IRB) to proceed with this trial. This trial, protected by issued patents, is a huge milestone for the Company and for patients suffering from this debilitating problem and their need for opioids for pain.
Current wording
In September 2023, we received FDA clearance to initiate a Phase I/II clinical trial of AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT) using AlloStem™ (CELZ-201-DDT) for the treatment of lower back pain. The first in country study, which will enroll 30 individuals suffering from chronic lower back pain, is designed to evaluate the safety, efficacy, and tolerability of AlloStem™ (CELZ-201-DDT). The minimally invasive procedure uses ultrasound for the targeted delivery of the cell product, and thus prevents radiation exposure to the patient or the injecting physician. This trial, protected by issued patents, is a huge milestone for the Company and for patients suffering from this debilitating problem and their need for opioids for pain.
Previous wording
In March 2024, the Company secured FDA authorization for an expanded access therapy using CELZ-201, in managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. The therapy uses CELZ-201 to potentially prevent Type I Diabetes onset and is believed to be a first in medical history. This personalized medicine approach, focuses on a single high-risk patient. CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a Type I Diabetes precursor, at the cellular level.
Current wording
In March 2024, we secured FDA authorization for an expanded access therapy using CELZ-201, in managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. The therapy uses CELZ-201 to potentially prevent Type I Diabetes onset and is believed to be a first in medical history. This personalized medicine approach, focuses on a single high-risk patient. CELZ-201 has a multi-target mechanism to address abnormal glucose tolerance, a Type I Diabetes precursor, at the cellular level.
Previous wording
In June 2024, the Company announced that it has successfully generated human induced pluripotent stem cells (iPSC)-derived Islet Cells that produce human insulin. The Company believes this development has the potential for not only clinical translation of the human Islet Cells, but also the stand-alone human insulin which is produced by these cells.
Current wording
In June 2024, we announced that we had successfully generated human induced pluripotent stem cells (iPSCs)-derived islet cells that produce human insulin. We believe this development has the potential for not only clinical translation of the human Islet Cells, but also the stand-alone human insulin which is produced by these cells.
Previous wording
In July 2024, the Company announced that it initiated a program to diagnose and treat patients exposed to biological and chemical weapons by combining Artificial Intelligence (AI) with the Company’s proprietary human induced pluripotent stem cells (“iPSC”). This iPSC clinical derived line is part of the Company’s iPSCelz® program. The program is designed to utilize the predictive capabilities of AI to identify damage to patients exposed to biological or chemical weapons and, based on a clinical diagnosis supported by that assessment, use the Company’s validated iPSCelz, ImmCelz™ (CELZ-100) and/or AlloStem™ (CELZ-201-DDT) to develop optimized therapeutic options. The use of AI strengthens the Company’s research efficiency, precision, and innovation. In drug discovery, AI accelerates the identification of potential targets and optimizes biological screenings, significantly shortening development timelines. This model enables the Company to accelerate development for civilian and military options for biological optimization of on-site and remote therapeutic interventions. Along with Greenstone Biosciences Inc., the Company continues to evaluate other collaborators, partners and business opportunities to accelerate development without taking away from the core clinical programs.
Current wording
In July 2024, we announced the initiation of a program to diagnose and treat patients exposed to biological and chemical weapons by combining artificial intelligence (AI) with our proprietary iPSC”. This iPSC clinically derived line is part of our iPSCelz® program. The program is designed to utilize the predictive capabilities of AI to identify damage to patients exposed to biological or chemical weapons and, based on a clinical diagnosis supported by that assessment, use our validated iPSCelz, ImmCelz™ (CELZ-100) and/or AlloStem™ (CELZ-201-DDT) to develop optimized therapeutic options. The use of AI strengthens the Company’s research efficiency, precision, and innovation. In drug discovery, AI accelerates the identification of potential targets and optimizes biological screenings, significantly shortening development timelines. This model enables the Company to accelerate development for civilian and military options for biological optimization of on-site and remote therapeutic interventions. Along with Greenstone Biosciences Inc., the Company continues to evaluate other collaborators, partners and business opportunities to accelerate development without taking away from the core clinical programs.
Previous wording
Gross Revenue. There were no revenues generated for the three-months ended September 30, 2024 in comparison with $6,000 in revenues for the comparable period a year ago.
Current wording
Gross Revenue. There was $3,000 in revenue generated for the three-months ended March 31, 2025 in comparison with no in revenues for the comparable period a year ago.
Previous wording
Cost of Goods Sold. There was no cost of goods sold for the three-months ended September 30, 2024 in comparison to $2,400 cost of goods sold for the comparable period a year ago.
Current wording
Cost of Goods Sold. There was $1,200 in cost of goods sold for the three-months ended March 31, 2025 in comparison to no cost of goods sold for the comparable period a year ago.
Previous wording
Gross Profit/(Loss). There were no gross profits for the three-months ended September 30, 2024 in comparison to $3,600 gross profit for the comparable period a year ago.
Current wording
Gross Profit/(Loss). There was $1,800 in gross profits for the three-months ended March 31, 2025 in comparison to no gross profit for the comparable period a year ago.
Previous wording
Selling, General and Administrative Expenses. General and administrative expenses for the three-months ended September 30, 2024, totaled $498,607, in comparison with $531,042 for the comparable period a year ago. The decrease of $32,435, or 6% is primarily due to decreases of $18,123 in marketing and $30,736 in Director and Officer (D&O) insurance, offset by $24,219 in increased wages.
Current wording
Selling, General and Administrative Expenses. General and administrative expenses for the three-months ended March 31, 2025, totaled $888,397, in comparison with $671,484 for the comparable period a year ago. The increase of $216,913, or 32% is primarily due to an increase of $130,851 in marketing expenses, timing of a $50,512 general liability insurance payment, and a $19,065 increase in computer and internet expenses.
Previous wording
Amortization Expenses.* *Amortization expenses for the three-months ended September 30, 2024 totaled $29,271 in comparison with $23,021 for the comparable period a year ago.
Current wording
Amortization Expenses.* *Amortization expenses for the three-months ended March 31, 2025 totaled $30,577 in comparison with $29,271 for the comparable period a year ago.
Previous wording
Research and Development Expenses**.** Research and development expenses for the nine-months ended September 30, 2024, totaled $1,928,937 in comparison to $1,621,231 for the comparable period a year ago. The increase of $307,706, or 19% was primarily due to increases of $148,649 associated with the CELZ 201 CREATE-1 Type 1 Diabetes clinical trial, $508,268 associated with the CELZ-201 ADAPT Chronic Lower Back Pain clinical trial, offset by a reduction of $349,210 in general research and development.
Current wording
Research and Development Expenses. Research and development expenses for the three-months ended March 31, 2025, totaled $743,304 in comparison to $422,392 for the comparable period a year ago. The increase of $320,912, or 76% was primarily due to increases of $242,240 in general research and $176,629 associated with the CELZ-201 ADAPT Chronic Lower Back Pain clinical trial offset by a decrease of $42,708 on the CELZ-201 CREATE-1 Type II diabetes trial.
Previous wording
Operating Loss. For the reasons stated above, our operating loss for the three-months ended September 30, 2024, was $1,109,674 in comparison with $1,546,785 for the comparable period a year ago.
Current wording
Operating Loss. For the reasons stated above, our operating loss for the three-months ended March 31, 2025, was $1,660,478 in comparison with $1,123,147 for the comparable period a year ago.
Previous wording
Other Income**.** Other income for the three-months ended September 30, 2024, totaled $69,539 in comparison with $89,233 for the comparable period a year ago. The decreased income of $19,694 is due to lower short-term investment balances.
Current wording
Other Income**.** Other income for the three-months ended March 31, 2025, totaled $22,381 in comparison with $81,603 for the comparable period a year ago. The decreased income of $59,222 is due to lower short-term investment balances.
Previous wording
Net Income/Loss**.** For the reasons stated above, our net loss for the three-months ended September 30, 2024, was $1,040,135 in comparison with a net loss of $1,453,952 for the comparable period a year ago.
Current wording
Net Income/Loss**.** For the reasons stated above, our net loss for the three-months ended March 31, 2025, was $1,638,097 in comparison with a net loss of $1,041,544 for the comparable period a year ago.
Previous wording
As of September 30, 2024, we had $6,260,438 of available cash, certificates of deposit and US Treasuries and positive working capital of approximately $6,000,532. In comparison, as of December 31, 2023, we had $9,987,058 of available cash, certificates of deposit and US Treasuries and positive working capital of $9,899,504.
Current wording
As of March 31, 2025, we had $7,702,867 of available cash, certificates of deposit and US Treasuries and positive working capital of approximately $7,557,624. In comparison, as of December 31, 2024, we had $5,940,402 of available cash, certificates of deposit and US Treasuries and positive working capital of $5,807,659.
Previous wording
***Net Cash used in Operating Activities.***We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was $3,351,756 for the nine-months ended September 30, 2024, in comparison to $6,132,902 for the comparable period a year ago, a decrease of $2,781,146 or 45%. The decrease in cash used in operations was primarily related to a $3,000,000 payment of an outstanding accounts payable balance made in the nine-months ended June 30, 2023.
Current wording
***Net Cash used in Operating Activities.***We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was $1,591,535 for the three-months ended March 31, 2025, in comparison to $896,864 for the comparable period a year ago, an increase of $694,671 or 77%. The increase in cash used in operations was primarily related to an increase in research and development investments and corporate marketing.
Previous wording
Net Cash Received From Investing Activities*.* Cash received in investing activities was $6,320,191 for the nine-months ended September 30, 2024, from the net redemptions of certificates of deposit offset by a $200,000 payment of a patent purchase obligation, in comparison to $2,611,271 of cash received from net redemptions of certificates of deposit offset by a $100,000 payment of a patent purchase obligation for the comparable period a year ago.
Current wording
Net Cash Received From Investing Activities*.* There was no cash received or spent in investing activities during the three-months ended March 31, 2025, in comparison to $6,520,191 of cash received from net redemptions of certificates of deposit for the comparable period a year ago.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
Results of Operations** –** For the Nine-month Periods Ended September 30, 2024, and 2023
Previous report — wording carried elsewhere
Cost of Goods Sold**.** There was $3,200 in cost of goods sold for the nine-months ended September 30, 2024 in comparison to $2,400 in cost of goods sold for the comparable period a year ago.
Previous report — wording carried elsewhere
Gross Profit/(Loss). There was $4,800 in gross profits for the nine-months ended September 30, 2024 in comparison to $3,600 in gross profits for the comparable period a year ago.
Previous report — wording carried elsewhere
Other Income. Other income for the nine-months ended September 30, 2024, totaled $218,720 in comparison with $240,293 for the comparable period a year ago. The decreased income of $21,573 is due to lower short-term investment balances offset by increased interest rates.
Previous report — wording carried elsewhere
Net Income/Loss. For the reasons stated above, our net loss for the nine-months ended September 30, 2024, was $3,639,407 in comparison with a net loss of $3,608,000 for the comparable period a year ago.