FibroBiologics, Inc.
For the period ended Jun 30, 2026. Filed Jul 31, 2026.
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.
Jun 30, 2026 · Filed Jul 31, 2026
FBLG$0.98+2.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-04-30.
0001193125-26-197858
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-07-31.
0001193125-26-328454
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 125 previous paragraphs and 146 current paragraphs.
89 unchanged; 23 reworded; 21 added; 9 removed; 4 previous and 13 current paragraphs rearranged.
Tables are not compared: 2 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 (21)
Current report
We completed site onboarding as outlined in the protocol for the DFU clinical trial in Australia and began screening, enrolling and dosing patients in the second quarter of 2026. To date, recruitment and enrollment of patients is slower than anticipated, partly as a result of protocol eligibility requirements and higher than anticipated pre-screen failures. Additionally, some clinical study sites are experiencing limited patient pools, investigator departures, and limited resources. We are working to improve patient recruitment efforts and activate additional sites to support recruitment objectives and maintain applicable timelines for the trial.
Current report
Nasdaq Delisting Determination
Current report
On July 22, 2026, we received a Staff Determination letter, or the Staff Determination, from Nasdaq notifying us that the Staff had determined to delist our securities from the Nasdaq Capital Market. The Staff Determination stated that the bid price of our listed securities had closed at less than $1.00 per share over the previous 30 consecutive business days, from June 8, 2026 through July 21, 2026, and that, as a result, we are not in compliance with the Bid Price Rule. The Staff Determination further stated that, although companies are normally afforded a 180-calendar day period to demonstrate compliance with the Bid Price Rule, we are not eligible for any such compliance period pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv) due to the fact that we effected a reverse stock split over the prior one-year period. Unless we requested an appeal of this determination by July 29, 2026, Nasdaq staff had determined that our securities would be scheduled for delisting from The Nasdaq Capital Market and would be suspended at the opening of business on July 31, 2026. We timely requested a hearing before a Nasdaq Hearings Panel to appeal the Staff’s determination. The timely hearing request stays any further delisting actions through the hearing process. At the hearing, we expect to present our plan to regain compliance with Nasdaq’s continued listing requirements. There can be no assurance that we will be successful in our appeal, that the Nasdaq Hearings Panel will grant our request for continued listing, or that we will be able to regain or maintain compliance with any applicable Nasdaq listing requirements. Please see “Risk Factors – Risks Related to Ownership of Our Common Stock” in our Annual Report and “Item 1A. Risk Factors – Risks Related to Ownership of Our Common Stock” in this Quarterly Report.
Current report
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for any of our product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales. We cannot predict if, when or to what extent we will generate revenue from the commercialization and sale of any of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates and, even if we do, we may never generate revenue that is significant enough for us to achieve profitability.
Current report
Research and development expenses were $1.7 million and $2.0 million for the three months ended June 30, 2026 and 2025, respectively. The decrease of $0.4 million was primarily due to:
Current report
decreased CRO costs of $0.3 million as clinical validation changed to manufacturing, and certain costs were capitalized to research and development supplies; and
Current report
General, administrative and other expenses were $2.4 million and $2.4 million for the three months ended June 30, 2026 and 2025, respectively. The decrease of $0.1 million was primarily due to:
Current report
decreased facilities expenses of $0.1 million
Current report
increased costs associated with maintaining our Nasdaq listing of $0.1 million
Current report
Other expense
Current report
There is $0.1 million of other expense for the three months ended June 30, 2026 primarily for the loss on the lease termination and $0.6 million of non-cash original discount on convertible debt for the three months ended June 30, 2025.
Current report
Comparison of Six Months Ended June 30, 2026 and 2025
Current report
increased lab facilities expense of $0.1 million; and
Current report
General, administrative and other expenses were $4.5 million and $5.2 million for the six months ended June 30, 2026 and 2025, respectively. The decrease of $0.7 million was primarily due to:
Current report
increased costs associated with maintaining our Nasdaq listing of $0.1 million.
Current report
Other expense
Current report
There is $0.1 million of other expense for the six months ended June 30, 2026 primarily for the loss on the lease termination and $0.6 million of non-cash original discount on convertible debt for the six months ended June 30, 2025.
Current report
Interest income
Current report
Interest expense
Current report
Interest expense was approximately $11,000 and $0 for the six months ended June 30, 2026 and 2025, respectively, primarily related to financing our directors and officers insurance.
Removed paragraphs (9)
Previous report
CYPS317
Previous report
Research and Development Expenses
Previous report
General, Administrative and Other Expenses
Previous report
Research and Development Expenses
Previous report
General, Administrative and Other Expenses
Previous report
General, administrative and other expenses were $2.1 million and $2.8 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $0.6 million was primarily due to:
Previous report
increased costs associated with Nasdaq listing costs of $0.1 million
Previous report
Other income/(expense)
Previous report
There is $2,000 of other expense for the three months ended March 31, 2026 for foreign currency exchange rate and none in other income for the three months ended March 31, 2025.
Reworded paragraphs (23)
Previous wording
We are a clinical-stage biotechnology company focused on developing and commercializing fibroblast-based therapies for patients suffering from chronic diseases with significant unmet medical needs, including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, certain cancers, and potential human longevity applications including thymic involution reversal using a thymic organoid. Our most advanced product candidates are CYWC628, CYPS317, CYMS101 and CybroCell™.
Current wording
We are a clinical-stage biotechnology company focused on developing and commercializing fibroblast-based therapies for patients suffering from chronic diseases with significant unmet medical needs, including wound healing, psoriasis, multiple sclerosis, degenerative disc disease, certain cancers, and potential human longevity applications including thymic involution reversal using a thymic organoid. Our most advanced product candidates are CYWC628, CYPS317, CYMS101 and CybroCell™.
Previous wording
We have completed our IND-enabling pre-clinical studies for the development of CYWC628 as a topically administered allogeneic fibroblast cell-based therapy for wound healing. Our pre-clinical studies focused on utilizing single cell fibroblasts, fibroblast spheroids, and fibroblast-derived materials to treat wounds in diabetic mice. We completed pre-clinical studies investigating (i) multiple administrations of CYWC628 spheroids on a chemically induced chronic wound NONcNZO10/LtJ and BKS.Cg-Dock7m +/+ LepRdb/J mouse model, (ii) dose titration to provide information on the proposed dose range of CYWC628, and (iii) acute and chronic toxicity. The results of our studies have shown statistically significant acceleration in the rate of wound closure, and statistically significant improvement in the quality of the healed wounds in comparison with both a marketed wound care product and control. Based upon our results, we are progressing a twelve-week Phase 1/2 clinical trial in Australia for treatment of diabetic foot ulcers.
Current wording
We have completed our IND-enabling pre-clinical studies for the development of CYWC628 as a topically administered allogeneic fibroblast cell-based therapy for wound healing. Our pre-clinical studies focused on utilizing single cell fibroblasts, fibroblast spheroids, and fibroblast-derived materials to treat wounds in diabetic mice. We completed pre-clinical studies investigating (i) multiple administrations of CYWC628 spheroids on a chemically induced chronic wound NONcNZO10/LtJ and BKS.Cg-Dock7m +/+ LepRdb/J mouse model, (ii) dose titration to provide information on the proposed dose range of CYWC628, and (iii) acute and chronic toxicity. The results of our studies have shown statistically significant acceleration in the rate of wound closure, and statistically significant improvement in the quality of the healed wounds in comparison with both a marketed wound care product and control. We have initiated a twelve-week Phase 1/2 clinical trial in Australia for treatment of diabetic foot ulcers.
Previous wording
CYPS317 is our allogeneic intravenously administered fibroblast spheroid cell-based investigational therapeutic for the treatment of psoriasis. We have completed preliminary IND-enabling pre-clinical studies utilizing chronic and acute psoriasis mouse models to assess the potential use of intravenous administration of fibroblast spheroids for the treatment of psoriasis. We also completed IND-enabling animal model studies to determine the optimal efficacious dose range and the durability of treatment for mild to moderate, and moderate to severe psoriasis. On December 30, 2025, we filed a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317.
Current wording
CYPS317 is our allogeneic, intravenously administered fibroblast spheroid cell-based investigational therapeutic for the treatment of psoriasis. We have completed preliminary IND-enabling pre-clinical studies utilizing chronic and acute psoriasis mouse models to assess the potential use of intravenous administration of fibroblast spheroids for the treatment of psoriasis. We also completed IND-enabling animal model studies to determine the optimal efficacious dose range and the durability of treatment for mild to moderate, and moderate to severe psoriasis. On December 30, 2025, we filed a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317. We are in the process of updating our submission to the FDA based on feedback received.
Previous wording
We are developing CYMS101 as an intravenously administered allogeneic fibroblast single cell, and fibroblast spheroid, cell-based therapy to treat multiple sclerosis ("MS"). After completing animal studies using CYMS101, we received approval from a U.S.-based IRB to conduct clinical investigations in Mexico using the fibroblast cell composition for patients with MS, and completed a Phase 1 study. The study was conducted in five participants. The primary objective of the study was to assess safety, and the secondary objective was to assess efficacy. The primary objective was achieved as we saw no adverse events related to the treatment - no adverse events during intravenous injection of the tolerogenic fibroblasts, no short or long-impact in complete blood count tests during the 16-week monitoring period, and no short or long impact in electrocardiogram results during the 16-week monitoring period. In addition, the study assessed clinical activity using a standard set of neurological assessments routinely used to assess MS. We are currently conducting further research to more fully characterize the mode of action of fibroblasts in oligodendrocyte expansion. We plan to file an IND application for a Phase 1/2 clinical trial relating to MS in the United States in 2026 after we receive FDA clearance for our IND relating to CYPS317. We expect to seek a strategic partner to collaborate with us on the development of CYMS101 either before initiating the Phase 1/2 study, or after its completion, if successful, and prior to commencing a potential Phase 3 clinical trial.
Current wording
We are developing CYMS101 as an intravenously administered allogeneic fibroblast single cell, and fibroblast spheroid, cell-based therapy to treat multiple sclerosis or MS. After completing animal studies using CYMS101, we received approval from a U.S.-based IRB to conduct clinical investigations in Mexico using the fibroblast cell composition for patients with MS, and completed a Phase 1 study. The study was conducted in five participants. The primary objective of the study was to assess safety, and the secondary objective was to assess efficacy. The primary objective was achieved as we saw no adverse events related to the treatment - no adverse events during intravenous injection of the tolerogenic fibroblasts, no short or long-impact in complete blood count tests during the 16-week monitoring period, and no short or long impact in electrocardiogram results during the 16-week monitoring period. In addition, the study assessed clinical activity using a standard set of neurological assessments routinely used to assess MS. We are currently conducting further research to more fully characterize the mode of action of fibroblasts in oligodendrocyte expansion. We plan to file an IND application for a Phase 1/2 clinical trial relating to MS in the United States in 2026 after we receive FDA clearance for our IND relating to CYPS317. We expect to seek a strategic partner to collaborate with us on the development of CYMS101 either before initiating the Phase 1/2 study, or after its completion, if successful, and prior to commencing a potential Phase 3 clinical trial.
Previous wording
We successfully carried out experiments that demonstrated the ability to use the CYWC628 spheroid master cell bank for the manufacturing of a modified CybroCell™ drug product for the treatment of degenerative disc disease. We also supported animal trials confirming that the therapeutic effects of the fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank are significantly better to those of single-cell fibroblasts, which supported our IND clearance with the FDA for the planned Phase I clinical trial for degenerative disc disease. Based on these results, we will work to amend the IND clearance with the FDA to replace single-cell fibroblasts, CybroCell™, with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank. A timeline for the trial will be determined in connection with discussions with the FDA. If any of our product candidates receive marketing approval, we expect to evaluate the feasibility of building our own cGMP manufacturing facility or continuing to outsource manufacturing to a CDMO for clinical testing and commercial supply. We expect to rely on third parties for our cell therapy manufacturing process for the foreseeable future.
Current wording
CybroCell™ is an investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease and is being designed as an alternative method for repairing the cartilage of the intervertebral disc (or any other articular cartilage). We have completed two animal studies in rabbit models. The results from the studies were positive and supported our IND application to run a “first in human” trial. We received IND clearance from the FDA in 2018, conditional upon approval of our master cell bank, to evaluate this candidate in a planned clinical trial. We successfully carried out experiments that demonstrated the ability to use the CYWC628 spheroid master cell bank for the manufacturing of a modified CybroCell™ drug product for the treatment of degenerative disc disease. We also supported animal trials confirming that the therapeutic effects of the fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank are significantly better to those of single-cell fibroblasts, which supported our IND clearance with the FDA for the planned Phase I clinical trial for degenerative disc disease. Based on these results, we plan to work to amend the IND clearance with the FDA to replace single-cell fibroblasts, CybroCell™, with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank. A timeline for the trial will be determined in connection with discussions with the FDA.
Previous wording
The manufacturing of our master cell bank and working cell bank for CYWC628 is now complete and both are certified as released by our CDMO. This CDMO will also manufacture CYWC628 for use in our twelve-week Phase 1/2 clinical trial for treatment of diabetic foot ulcers that we will conduct in Australia.
Current wording
The manufacturing of our master cell bank and working cell bank for CYWC628 is now complete and both are certified as released by our CDMO. This CDMO has also manufactured CYWC628 for use in our twelve-week Phase 1/2 clinical trial for treatment of diabetic foot ulcers that we are conducting in Australia. If any of our product candidates receive marketing approval, we expect to evaluate the feasibility of building our own cGMP manufacturing facility or continuing to outsource manufacturing to a CDMO for clinical testing and commercial supply. We expect to rely on third parties for our cell therapy manufacturing process for the foreseeable future.
Previous wording
As of March 31, 2026, we had cash and cash equivalents of $1.5 million. Since our inception, we have incurred significant operating losses. We incurred net losses of $5.0 million and $5.0 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $59.2 million.
Current wording
As of June 30, 2026, we had cash and cash equivalents of $3.5 million. Since our inception, we have incurred significant operating losses. We incurred net losses of $9.1 million and $9.6 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $63.3 million.
Previous wording
We have manufactured two batches of the CYWC628 drug product in accordance with FDA’s Good Manufacturing Practices (CGMP). The batches will be released after they successfully pass all required safety and quality testing. We expect to begin manufacturing the third batch of CYWC628 in May 2026. We also completed site onboarding as outlined in the protocol for the DFU clinical trial in Australia and will activate additional sites if needed to support recruitment objectives. Based upon our progress to date, we expect to begin screening, enrolling and dosing patients in the second quarter of 2026. We will report six-week interim safety and primary efficacy data of the clinical trial once 28 patients from each of the three arms of the study have completed at least 6 weeks of treatment, which we expect will occur in the third quarter of 2026. We will report the final primary safety and efficacy data of the study once all the continuously enrolled patients that remain in all arms of the study have completed at least 12 weeks of treatment, which we expect will occur in the fourth quarter of 2026. Secondary outcome results of the study, which include monitoring for wound recurrence at the same site, will be reported once all the patients in each arm of the study that remain in the study have been assessed for a 6-month follow-up. For the second period of the clinical trial, patients enrolled in the standard of care arm of the study whose wounds did not heal, and still meet the inclusion/exclusion criteria of the study, will be provided the option of receiving the dose of CYWC628 with the highest efficacy from the first part of the study for up to 12 weeks to generate additional secondary outcome results. We expect to release the final report of the study, which will include all the primary and secondary outcomes outlined in the clinical trial, in the third quarter of 2027. These timelines have been extended as we resolve issues that arise during the manufacturing process. Please see “Risk Factors – Risks Related to Manufacturing” in our Annual Report and “Item 1A. Risk Factors – Risks Related to Manufacturing” in this Quarterly Report.
Current wording
We plan to report six-week interim safety and primary efficacy data of the clinical trial once 28 patients from each of the three arms of the study have completed at least 6 weeks of treatment, which we expect will occur in the second half of 2026. We plan to report the final primary safety and efficacy data of the study once all the continuously enrolled patients that remain in all arms of the study have completed at least 12 weeks of treatment, which we expect will occur in the fourth quarter of 2026. Secondary outcome results of the study, which include monitoring for wound recurrence at the same site, will be reported once all the patients in each arm of the study that remain in the study have been assessed for a 6-month follow-up. For the second period of the clinical trial, patients enrolled in the standard of care arm of the study whose wounds did not heal, and still meet the inclusion/exclusion criteria of the study, will be provided the option of receiving the dose of CYWC628 with the highest efficacy from the first part of the study for up to
Previous wording
decreased supplies expenses of $0.3 million
Current wording
decreased supplies expenses of $0.1 million
Previous wording
Interest income was approximately $20,000 and $0.1 million for the three months ended March 31, 2026 and 2025, respectively. Interest income is comprised of interest income and unrealized gain/losses on cash equivalents.
Current wording
Interest income was approximately $15,000 and $0.1 million for the three months ended June 30, 2026 and 2025, respectively. Interest income is comprised of interest income and unrealized gain/losses on cash equivalents.
Previous wording
Interest expense was approximately $4,000 and $0 for the three months ended March 31, 2026 and 2025, respectively.
Current wording
Interest expense was approximately $7,000 and $0 for the three months ended June 30, 2026 and 2025, respectively.
Previous wording
Research and development expenses were $3.0 million and $1.8 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $1.2 million was primarily due to:
Current wording
Research and development expenses were $4.6 million and $3.8 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $0.8 million was primarily due to:
Previous wording
increased CRO costs of $1.8 million to prepare for a clinical trial;
Current wording
increased CRO costs of $1.1 million for the clinical trial currently underway;
Previous wording
decreased professional fees of $0.4 million such as legal and accounting fees
Current wording
decreased professional fees of $0.3 million such as legal and accounting fees;
Previous wording
decreased travel expenses of $0.1 million
Current wording
decreased travel expenses of $0.1 million; and
Previous wording
The change in fair value of the SEPA put option liability was a gain of $0.1 million during the three months ended March 31, 2026 and resulted primarily from changes in stock price and other assumptions used in the valuation model.
Current wording
The change in fair value of the SEPA put option liability was a gain of $0.1 million during the six months ended June 30, 2026 and resulted primarily from changes in stock price and other assumptions used in the valuation model.
Previous wording
Through March 31, 2026, we have financed our operations primarily with various borrowings and stock offerings. As of March 31, 2026, we had cash and cash equivalents of $1.5 million and an accumulated deficit of $59.2 million.
Current wording
Through June 30, 2026, we have financed our operations primarily with various borrowings and stock offerings. As of June 30, 2026, we had cash and cash equivalents of $3.5 million and an accumulated deficit of $63.3 million.
Previous wording
The following table sets forth a summary of our cash flows for the three months ended March 31, 2026 and 2025.
Current wording
The following table sets forth a summary of our cash flows for the six months ended June 30, 2026 and 2025.
Previous wording
Net cash used in operating activities was $4.4 million and $5.3 million for the three months ended March 31, 2026 and 2025, respectively, and consisted primarily of net losses of $5.0 million and $5.0 million, respectively. Noncash expenses consisting of stock-based compensation expense of $0.7 million, and amortization of operating lease right-of-use asset of $0.2 million partially offset the net loss, while a decrease in prepaid expenses of $0.4 million, a decrease in accounts payable and accrued expenses of $0.1 million, and a decrease in operating lease liability of $0.2 million added to the cash used in operations in the three months ended March 31, 2026. In addition, we issued a note receivable of $0.4 million. For the three months ended March 31, 2025, noncash expenses consisting of change in fair value of convertible debt of $0.3 million, change in fair value of SEPA put option liability of $0.1 million, net loss on issuance of Common Stock in exchange for convertible debt of $0.2 million, stock-based compensation expense of $0.6 million, and amortization of operating lease right-of-use asset of $0.1 million partially offset the net loss, while an increase in prepaid expenses of $0.4 million, a decrease in accounts payable and accrued expenses of $1.0 million, and a decrease in operating lease liability of $0.1 million added to the cash used in operations.
Current wording
Net cash used in operating activities was $7.7 million and $9.3 million for the six months ended June 30, 2026 and 2025, respectively, and consisted primarily of net losses of $9.1 million and $9.6 million, respectively. Noncash expenses consisting of stock-based compensation expense of $1.4 million, and amortization of operating lease right-of-use asset of $0.3 million partially offset the net loss, while an increase in prepaid expenses of $0.9 million, an increase in accounts payable and accrued expenses of $0.9 million, and a decrease in operating lease liability of $0.2 million added to the cash used in operations in the six months ended June 30, 2026. In addition, we issued a note receivable of $0.4 million. For the six months ended June 30, 2025, noncash expenses consisting of change in fair value of convertible debt of $0.3 million, change in fair value of SEPA put option liability of $0.1 million, net loss on issuance of Common Stock in exchange for convertible debt of $0.2 million, stock-based compensation expense of $0.6 million, and amortization of operating lease right-of-use asset of $0.1 million partially offset the net loss, while an increase in prepaid expenses of $0.4 million, a decrease in accounts payable and accrued expenses of $1.0 million, and a decrease in operating lease liability of $0.1 million added to the cash used in operations.
Previous wording
Net cash used in investing activities was $0.0 million and approximately $43,000 for the three months ended March 31, 2026 and 2025, respectively, and consisted primarily of laboratory equipment purchases.
Current wording
Net cash used in investing activities was $0.0 million and approximately $0.3 million for the six months ended June 30, 2026 and 2025, respectively, and consisted primarily of laboratory equipment purchases.
Previous wording
Net cash provided by financing activities was $1.0 million and $0.0 million for the three months ended March 31, 2026 and 2025, respectively. During the three months ended March 31, 2026, the Company issued stock from its SEPA for $0.8 million. In addition, the company received proceeds from a loan for D&O costs of $0.3 million and repaid $0.1 million.
Current wording
Net cash provided by financing activities was $6.3 million and $4.4 million for the six months ended June 30, 2026 and 2025, respectively. During the six months ended June 30, 2026, we issued stock under the SEPA for $0.8 million and stock from our ATM of $0.3 million. We also sold stock in a registered offering for net proceeds of $2.6 million and a private placement for net proceeds of $2.6 million. In addition, we received proceeds from a loan for D&O costs of $0.3 million and repaid $0.2 million.
Previous wording
We have incurred operating losses since our formation and expect such losses to continue in the future as we build infrastructure, develop intellectual property and conduct research and development activities. Moreover, we have incurred, and expect to continue to incur, additional costs associated with operating as a public company. We do not have any products approved for sale, and we have never generated any revenue from product sales. We have primarily relied on a combination of angel investors, private debt placements, convertible debt issuances, and sales of equity to fund our operations. As of March 31, 2026, we had an accumulated deficit of $59.2 million and cash and cash equivalents of $1.5 million. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our current or future product candidates and we do not know when, or if, that will occur. Unless and until such time that revenue and net income are generated, we will need to continue to raise additional capital. These factors raise substantial doubt about our ability to continue as a going concern for one year from the issuance of the financial statements included in this Quarterly Report. The financial statements have been prepared as though we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Current wording
We have incurred operating losses since our formation and expect such losses to continue in the future as we build infrastructure, develop intellectual property and conduct research and development activities. Moreover, we have incurred, and expect to continue to incur, additional costs associated with operating as a public company. We do not have any products approved for sale, and we have never generated any revenue from product sales. We have primarily relied on a combination of angel investors, private debt placements, convertible debt issuances, and sales of equity to fund our operations. As of June 30, 2026, we had an accumulated deficit of $63.3 million and cash and cash equivalents of $3.5 million. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our current or future product candidates and we do not know when, or if, that will occur. Unless and until such time that revenue and net income are generated, we will need to continue to raise additional capital. These factors raise substantial doubt about our ability to continue as a going concern for one year from the issuance of the financial statements included in this Quarterly Report. The financial statements have been prepared as though we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Previous wording
Our ability to continue as a going concern is dependent on our ability to raise additional capital. We believe we will be able to obtain additional capital through equity financings or other arrangements to fund operations; however, there can be no assurance that such additional financing, if available, can be obtained on acceptable terms. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts. During the three months ended March 31, 2026, we have implemented measures to reduce operating expenses including delaying certain research and development project spend while prioritizing near term pipeline projects, limiting finance, legal and administrative costs, and pursuing options to limit spend on office space. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, and other licensing arrangements. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.
Current wording
Our ability to continue as a going concern is dependent on our ability to raise additional capital. We believe we will be able to obtain additional capital through equity financings or other arrangements to fund operations; however, there can be no assurance that such additional financing, if available, can be obtained on acceptable terms. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts. During the six months ended June 30, 2026, we have implemented measures to reduce operating expenses including delaying certain research and development project spend while prioritizing near term pipeline projects, limiting finance, legal and administrative costs, and decreasing spend on office space. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, and other licensing arrangements. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.
Rearranged current paragraphs (13)
Current report — wording carried from elsewhere
We have manufactured three batches of the CYWC628 drug product in accordance with FDA’s Good Manufacturing Practices (cGMP). Two of these batches have been released and the third batch will be released after it successfully passes all required safety and quality testing.
Current report — wording carried from elsewhere
12 weeks to generate additional secondary outcome results. We expect to release the final report of the study, which will include all the primary and secondary outcomes outlined in the clinical trial, in the third quarter of 2027. These timelines have been extended, and may be further extended, as we resolve issues that have arisen and may continue to develop during the manufacturing and development process. Please see “Risk Factors – Risks Related to Manufacturing” and “– Risks Related to Development, Regulatory Approval and Commercialization” in our Annual Report and “Item 1A. Risk Factors – Risks Related to Manufacturing” and “– Risks Related to Development, Regulatory Approval and Commercialization” in this Quarterly Report.
Current report — wording carried from elsewhere
increased professional fees of $0.1 million such as legal and patent filing fees
Current report — wording carried from elsewhere
There was no change in the fair value of the SEPA put option liability during the three months ended June 30, 2026. There was a $0.1 million gain in the change in the fair value of the SEPA put option liability during the three months ended June 30, 2025 resulting primarily from changes in stock price and other assumptions used in the valuation model.
Current report — wording carried from elsewhere
The following tables set forth our results of operations for the six months ended June 30, 2026 and 2025.
Current report — wording carried from elsewhere
decreased supplies expenses of $0.4 million.
Current report — wording carried from elsewhere
Research and development expenses are not tracked by product candidate.
Current report — wording carried from elsewhere
decreased personnel expenses of $0.4 million which consisted of severance and vacation accrual costs in the prior year;
Current report — wording carried from elsewhere
Change in fair value of SEPA put option liability
Current report — wording carried from elsewhere
Change in fair value of convertible debt
Current report — wording carried from elsewhere
We received advances in the form of convertible notes pursuant to the SEPA in December 2024 and June 2025 and elected to account for the short-term convertible notes under the fair value option. Under the fair value option, all costs associated with raising the funds were expensed immediately. The convertible notes were fully paid off in 2025.
Current report — wording carried from elsewhere
Interest income was approximately $35,000 and $0.1 million for the six months ended June 30, 2026 and 2025, respectively. Interest income is comprised of interest income and unrealized gain/losses on cash equivalents.
Current report — wording carried from elsewhere
The effective income tax rate was 0.0% for all periods. Currently, we have recorded a full valuation allowance against our net deferred tax assets.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
CybroCell™ is an investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease and is being designed as an alternative method for repairing the cartilage of the intervertebral disc (or any other articular cartilage). We have completed two animal studies in rabbit models. The results from the studies were positive and supported our IND application to run a “first in human” trial. We received IND clearance from the FDA in 2018, conditional upon approval of our master cell bank, to evaluate this candidate in a planned clinical trial. A timeline for the trial will be determined in connection with discussions with the FDA.
Previous report — wording carried elsewhere
We have completed preliminary IND-enabling pre-clinical studies utilizing chronic and acute psoriasis mouse models to assess the potential use of intravenous administration of fibroblast spheroids for the treatment of psoriasis. We also completed IND-enabling animal model studies to determine the optimal efficacious dose range and the durability of treatment for mild to moderate, and moderate to severe psoriasis. On December 30, 2025, we filed a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317. We are in the process of updating our submission to the FDA based on feedback received.
Previous report — wording carried elsewhere
We have completed preliminary IND-enabling pre-clinical studies utilizing chronic and acute psoriasis mouse models to assess the potential use of intravenous administration of fibroblast spheroids for the treatment of psoriasis. We also completed IND-enabling animal model studies to determine the optimal efficacious dose range and the durability of treatment for mild to moderate, and moderate to severe psoriasis. On December 30, 2025, we filed a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317. We are in the process of updating our submission to the FDA based on feedback received.
Previous report — wording carried elsewhere
decreased contract research costs of $0.3 million; and