FBLG

If we or any of our third-party manufacturers encounter such difficulties, our ability to supply our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented. ● Manufacturing cell therapy products is complex and subject to both human and systemic risks.
Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts. ● Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees. ● In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth. ● If we cannot maintain compliance with the applicable Nasdaq continued listing requirements, our common stock may be delisted from Nasdaq, which could limit stockholders’ ability to trade our common stock. ● An active trading market may not be sustained and the market price of shares of our common stock may be volatile. ● We have 2,500 shares of Series C Preferred Stock with super voting rights which may adversely affect holders of our common stock. ● Our management and principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval. ● Provisions of our amended and restated certificate of incorporation and amended and restated bylaws may delay or prevent a take-over that may be in the best interests of our stockholders. ● Our internal computer systems, or those of any of our CROs, CDMOs, other contractors, consultants, collaborators and third-party service providers, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations. ● We, or the third parties upon whom we depend, may be adversely affected by natural disasters, public health crises or other business interruptions and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
In connection with the preparation of our Annual Report, our management concluded that there is substantial doubt as to whether we can continue as a going concern for the twelve months following the issuance of the Annual Report, and our independent registered public accounting firm included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended December 31, 2025, that raised substantial doubt about our ability to continue as a going concern.
We have prepared our consolidated financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
Our consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
We have incurred significant net losses since our inception, have not generated any revenue from product sales to date and have financed our operations principally through public and private financings.
For the years ended December 31, 2025 and 2024, we incurred net losses of $18.6 million and $11.2 million, respectively.
As of December 31, 2025 and 2024, we had an accumulated deficit of $54.2 million and $35.5 million, respectively.
As of December 31, 2025, we had approximately $4.9 million in cash and cash equivalents.
We are party to a standby equity purchase agreement, or the SEPA, dated December 20, 2024, with YA II PN, LTD., or Yorkville.
Pursuant to the SEPA, Yorkville advanced us the principal amount of $15 million evidenced by convertible promissory notes in three tranches and, subject to the satisfaction of certain conditions, we may elect to issue and sell to Yorkville up to $10 million worth of shares of our common stock for a period ending December 20, 2026.
Additionally, our only clinical trial conducted to date utilized, and our contemplated twelve-week Phase 1/2 clinical trial in Australia for treatment of diabetic foot ulcers will utilize, an “open-label” trial design, and some of our planned clinical trials may be designed similarly.
For additional information, see the section of this report titled, “ Business—Regulatory Environment—Coverage and Reimbursement .” In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information, reports and registration, and will need to continue to comply (or ensure that any third-party providers comply) with cGMPs and good clinical practices, or GCPs, for any clinical trials that we conduct post-approval.
Under the Food and Drug Omnibus Reform Act, or FDORA, the FDA is permitted to require, as appropriate, that a post-approval confirmatory study or studies be underway prior to approval or within a specified time period after the date of approval for a product granted accelerated approval.
For example, our CRO and clinical trial sites for our contemplated twelve-week Phase 1/2 clinical trial in Australia for treatment of diabetic foot ulcers are located outside of the United States and we formed an Australian subsidiary to act as a sponsor for the clinical trial.
If we succeed in obtaining approval of any product candidates, we anticipate marketing them in the European Union and other jurisdictions in addition to the United States.
Doing business internationally involves a number of risks, including but not limited to: ● multiple, conflicting, and changing laws and regulations such as privacy regulations, data transfer restrictions, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits and licenses; ● failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; ● rejection or qualification of foreign clinical trial data by the competent authorities of other countries; ● additional potentially relevant third-party patent and other intellectual property rights that may be necessary to develop and commercialize our products and product candidates; ● complexities and difficulties in obtaining, maintaining, enforcing, and defending our patent and other intellectual property rights; ● difficulties in staffing and managing foreign operations; ● complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; ● limits in our ability to penetrate international markets; ● financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations; ● natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions, and implementation of tariffs; ● certain expenses including, among others, expenses for travel, translation, and insurance; and ● regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.
Any of these factors could harm our contemplated clinical trial in Australia, as well as our current and any future international operations and, consequently, our business, financial condition, prospects, and results of operations.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, substantial changes in leadership and shifting policy priorities as a result of changes in the presidential administration and its appointees tasked to oversee the agency, and statutory, regulatory and policy changes.
Disruptions at the FDA and other agencies, including as a result of reductions in force, significant organizational changes, substantial leadership departures, and policy changes, may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
With the change in the U.S. presidential administration in 2025, there continues to be substantial uncertainty as to the extent and manner in which the Trump administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval.
This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates.
Additionally, the current administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.
Also, state governments may seek to address or react to changes at the federal level with changes to their regulatory frameworks in a manner that could impact our operations We are subject to export and import controls, economic sanctions, and anti-corruption laws and regulations of the United States and other jurisdictions.
Despite our best efforts, we may not be able to produce reliable consolidated financial statements or file such consolidated financial statements as part of a periodic report in a timely manner with the SEC or comply with Nasdaq listing requirements.
Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate consolidated financial statements on a timely basis is a costly and time-consuming effort that needs to be reevaluated frequently.
Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements in accordance with generally accepted accounting principles.
In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our consolidated financial statements or identify other areas for further attention or improvement.
Undetected material weaknesses in our internal controls over financial reporting could lead to restatements of our consolidated financial statements and require us to incur the expense of remediation.
During the preparation of our consolidated financial statements for the fiscal years ended December 31, 2025, 2024, 2023 and 2022, our management identified a material weakness in our internal control over financial reporting due to a lack of segregation of duties.
A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis.
Specifically, our management identified a deficiency in our internal controls within the financial reporting function that resulted from an ineffective design and implementation of controls over proper segregation of duties for the period of time covered by our consolidated financial statements prior to our then Chief Financial Officer joining us in June 2025 when all financial functions were handled by a single individual, and afterward, through December 31, 2025, due to a limited number of individuals.
We will continue to add staff, evaluate segregation of duties, and implement initiatives to improve our internal controls over financial reporting as we grow.
For example, initial timelines for our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia were extended as we worked with our CDMO to resolve process issues with the manufacturing training run and increased the number of test manufacturing runs needed to confirm no sterility issues.
We have contracted with a CDMO for the production of our master cell bank and working cell bank to enable our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia.
If the CDMO is unable to maintain our master cell bank and working cell bank for CYWC628 or produce CYWC628 or any other fibroblast cell-based product candidates to enable clinical trials, we may encounter delays, additional costs, or technical failure of one or more of our product candidates.
For example, timelines for our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia were extended as we worked with our CDMO to resolve process issues encountered with the manufacturing training run and increased the number of test manufacturing runs needed to confirm no sterility issues.
For example, we encountered process issues with the manufacturing training run of CYWC628 and increased the number of test manufacturing runs needed to confirm no sterility issues, which we had to resolve and complete before we could begin the manufacture of CYWC628 for our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia.
These issues required us to extend the initial timelines for the initiation and completion of the clinical trial.
If these issues were not resolved and completed, we would have been unable to manufacture CYWC628 for our clinical trial in a timely manner.

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Gone since FY2024

Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts. ● Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees. ● In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth. ● If we cannot maintain compliance with the applicable Nasdaq continued listing requirements, our common stock may be delisted from Nasdaq, which could limit stockholders’ ability to trade our common stock. ● An active trading market may not be sustained and the market price of shares of our common stock may be volatile. ● We have 2,500 shares of Series C Preferred Stock with super voting rights which may adversely affect holders of our common stock. ● We are a “controlled company” within the meaning of the Nasdaq Stock Market Rules because our insiders beneficially own more than 50% of the voting power of our outstanding voting securities. ● Provisions of our amended and restated certificate of incorporation and amended and restated bylaws may delay or prevent a take-over that may be in the best interests of our stockholders. ● Our internal computer systems, or those of any of our CROs, CDMOs, other contractors, consultants, collaborators and third-party service providers, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations. ● We, or the third parties upon whom we depend, may be adversely affected by natural disasters, public health crises or other business interruptions and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
In connection with the preparation of our Annual Report, our management concluded that there is substantial doubt as to whether we can continue as a going concern for the twelve months following the issuance of the Annual Report, and our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of and for the year ended December 31, 2024, that raised substantial doubt about our ability to continue as a going concern.
We have prepared our condensed consolidated financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
Our financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
We have incurred significant net losses since our inception, have not generated any revenue from product sales to date and have financed our operations principally through private financings.
For the years ended December 31, 2024 and 2023, we incurred net losses of $11.2 million and $16.5 million, respectively.
As of December 31, 2024 and 2023, we had an accumulated deficit of $35.5 million and $24.4 million, respectively.
As of December 31, 2024, we had approximately $14.0 million in cash and cash equivalents.
We are party to a standby equity purchase agreement, or the SEPA, dated December 20, 2024, with YA II PN, LTD.
Pursuant to the SEPA, subject to the satisfaction of certain conditions, YA II PN, LTD., or Yorkville, agreed to advance us the principal amount of $15 million to be evidenced by convertible promissory notes in three tranches and we may elect to issue and sell to Yorkville up to $10 million worth of shares of our common stock for a period ending December 20, 2026.
The first two tranches of the advance were disbursed on December 20, 2024 and December 30, 2024, respectively, and we issued a convertible promissory note to Yorkville in the principal amount of $5.0 million in each of the first two tranches.
Additionally, our only clinical trial conducted to date utilized an “open-label” trial design, and some of our planned clinical trials may be designed similarly.
In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that any third-party providers comply) with cGMPs and good clinical practices, or GCPs, for any clinical trials that we conduct post-approval.
Under FDORA, the FDA is permitted to require, as appropriate, that a post-approval confirmatory study or studies be underway prior to approval or within a specified time period after the date of approval for a product granted accelerated approval.
The law is complex and is still being interpreted and implemented by the FDA.
As a result, its ultimate impact, implementation, and meaning are subject to uncertainty.
For example, our CRO and clinical trial sites for our contemplated twelve-week Phase 1/2 clinical trial in Australia for treatment of diabetic foot ulcers in the second half of 2025 are located outside of the United States.
Furthermore, if we succeed in obtaining approval of any product candidates, we anticipate marketing them in the European Union and other jurisdictions in addition to the United States.
Doing business internationally involves a number of risks, including but not limited to: ● multiple, conflicting, and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits and licenses; ● failure by us to obtain and maintain regulatory approvals for the use of our products in various countries; ● rejection or qualification of foreign clinical trial data by the competent authorities of other countries; ● additional potentially relevant third-party patent and other intellectual property rights that may be necessary to develop and commercialize our products and product candidates; ● complexities and difficulties in obtaining, maintaining, enforcing, and defending our patent and other intellectual property rights; ● difficulties in staffing and managing foreign operations; ● complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; ● limits in our ability to penetrate international markets; ● financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations; ● natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions, and implementation of tariffs; ● certain expenses including, among others, expenses for travel, translation, and insurance; and ● regulatory and compliance risks that relate to anti-corruption compliance and record-keeping that may fall within the purview of the U.S.
Any of these factors could harm our contemplated clinical trial in Australia, as well as any future international operations and, consequently, our business, financial condition, prospects, and results of operations.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, layoffs, and statutory, regulatory and policy changes.
Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
We are subject to export and import controls, economic sanctions, and anti-corruption laws and regulations of the United States and other jurisdictions.
Despite our best efforts, we may not be able to produce reliable financial statements or file such financial statements as part of a periodic report in a timely manner with the SEC or comply with Nasdaq listing requirements.
Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be reevaluated frequently.
Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles.
In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement.
Undetected material weaknesses in our internal controls over financial reporting could lead to restatements of our financial statements and require us to incur the expense of remediation.
During the preparation of our financial statements for the fiscal years ended December 31, 2024, 2023 and 2022, our management identified a material weakness in our internal control over financial reporting due to a lack of segregation of duties.
A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
Specifically, our management identified a deficiency in our internal controls within the financial reporting function that resulted from an ineffective design and implementation of controls over proper segregation of duties for the period of time covered by our financial statements prior to our then Chief Financial Officer joining us in June 2022 when all financial functions were handled by a single individual, and afterward, through December 31, 2024, due to a limited number of individuals.
With the addition of our Interim Chief Financial Officer and the changes made to our accounting and financial reporting processes and internal controls during the last half of fiscal year 2022 and through December 31, 2024, we have strengthened our internal controls and will continue to add staff, evaluate segregation of duties, and implement initiatives to improve our internal controls over financial reporting as we grow.
We have contracted with CDMOs for the production of our master cell banks and working cell banks for our fibroblast cell-based product candidates to enable clinical trials.
If the CDMO is unable to produce our master cell banks, working cell banks and our fibroblast cell-based product candidates to enable clinical trials, we may encounter delays, additional costs, or technical failure of one or more of our product candidates.
In addition to our operations in the United States, which may be subject to healthcare and other laws relating to the privacy and security of health information and other personal information, we may seek to conduct clinical trials in the United Kingdom or the European Economic Area, or the EEA, and may become subject to additional European data privacy laws, regulations and guidelines, including the GDPR.
We currently have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product candidates, if approved.
We face potential liability related to the privacy of health information we obtain from clinical trials sponsored by us.
To date, we have only completed one clinical trial, in Mexico, and we may choose to conduct international clinical trials in the future.
These changes include aggregate reductions to Medicare payments and may result in additional reductions in Medicare and other healthcare funding, all of which could have a material adverse effect on customers for our product candidates, if approved, and accordingly, our financial operations.
There have also been several changes and challenges to the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities.

and 25 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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