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CLOSED · 06:35 ET
Market ClerkRecap
Sun Oct 25 · markets closed1 signal on Oct 2494 insider buys this week · $48.3MCIRO short report next: Oct 31The week ahead

CELU

Celularity Inc
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
0.98
−0.07 −6.86%
USD · close Oct 23
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nobody we score has called it yet
MKT CAP $28.3MP/E —DIV YIELD —FCF YIELD —REV TTM $26.6M −51.0%NET INCOME −$91.7MNET DEBT $10.9M52W 0.60 – 2.10SEC XBRL · TTM TO Invalid Date

How CELU rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
71%
of sentences unchanged
Added
128
new sentences
Dropped
163
sentences removed
Length
−750
words, now 30,078

New in FY2025

  • Our business is subject to significant risks and uncertainties that make an investment in us speculative and risky.
  • Below we summarize what we believe are the principal risk factors, but these risks are not the only ones we face, and you should carefully review and consider the full discussion of our risk factors in the section titled “Risk Factors,” together with the other information included in this Form 10-K.
  • If any of the following risks occurs (or if any of those listed elsewhere in this prospectus occur), our business, reputation, financial condition, results of operations, revenue, and future prospects could be seriously harmed.
  • Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business.
  • Risks Related to Business and Industry We have minimal cash on hand, and we do not generate sufficient cash from operations to operate our business for the next twelve months.
  • We need to raise additional cash through equity or debt sales to provide cash to continue operations.
  • If we are not successful raising cash we will not be able to continue as a going concern. ● We have incurred net losses in every period since our inception, have no cellular therapeutics approved for commercial sales and anticipate that we will incur substantial net losses in the future.
  • In the first quarter of 2026 we reduced headcount and salaries to restructure our business in order to conserve cash and focus on our core sales strategies. ● Our historical operating results indicate substantial doubt exists related to our ability to continue as a going concern. ● We will need substantial additional financing to develop our therapeutics and implement our operating plans.
  • If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our therapeutic candidates. ● Our placental-derived cellular therapy candidates represent a novel approach to cancer, infectious and degenerative disease treatments that create significant challenges.
  • In addition, the gene-editing technology we use is relatively new, and if we are unable to use this technology in our intended therapeutic candidates, our revenue opportunities will be materially limited.
  • Moreover, our therapeutic candidates are based on novel technologies, which makes it difficult to predict the time and cost of therapeutic candidate development and to obtain regulatory approval. ● We may not be able to submit INDs to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit such trials to proceed. ● Clinical trials are expensive, time-consuming and difficult to design and implement. ● Our organizational changes and cost cutting measures may not be successful. ● We operate our own manufacturing and storage facility, which requires significant resources; manufacturing or other failures could adversely affect our clinical trials and the commercial viability of our therapeutic candidates and our biobanking and degenerative diseases businesses. ● Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new therapeutics and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business. ● If we do not obtain and maintain federal and state licenses and registrations required for our current and future operations, our ability to generate revenue will be limited. ● Failure to maintain effective internal controls could cause our investors to lose confidence in us and adversely affect the market price of our Class A common stock.
  • If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of, or commercialize, our therapeutic candidates. ● Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.
  • Risks Related to Government Regulation ● The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our future therapeutic candidates. ● Obtaining and maintaining regulatory approval of our therapeutic candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our therapeutic candidates in other jurisdictions. ● Our commercial biomaterials business may be impacted if The Centers for Medicare & Medicaid Services and Medicare Administrative Contractors do not reverse their LCD for skin substitute grafts and CTPs.
  • In addition, we may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties. ● We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses. ● We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Ownership of Our Class A Common Stock ● Our Class A common stock is currently listed on Nasdaq.
  • If we are not successful raising cash we will not be able to continue as a going concern.
  • As of December 31, 2025, we had limited cash and cash equivalents and continue to incur significant operating losses and negative operating cash flows.
  • Our current revenues, which are primarily derived from our biomaterials and biobanking businesses, are not sufficient to fund our operating expenses, debt service obligations, and working capital needs for the next twelve months.
  • As a result, we expect to require additional capital to continue operations, fund planned activities, and meet our obligations as they become due.
  • Our ability to continue as a going concern is dependent on our ability to raise additional capital in the near term through equity financings, debt financings, strategic transactions, asset sales, licensing arrangements, or other sources of financing.
  • There can be no assurance that such financing will be available when needed or on terms acceptable to us, if at all.
  • Market conditions, our stock price, existing debt obligations, operating performance, and broader macroeconomic factors may further limit our ability to access capital.
  • If we are unable to obtain sufficient additional capital, we may be required to significantly curtail or suspend our operations, further reduce workforce and operating expenses, delay or terminate development or commercialization efforts, sell assets, seek strategic alternatives, or pursue protection under the U.S.
  • Any of these outcomes would materially and adversely affect our business, financial condition, results of operations, and stockholder value, and could result in our inability to continue as a going concern.
  • We have incurred net losses in every period since our inception, and anticipate that we will incur substantial net losses in the future.
  • In the first quarter of 2026 we reduced headcount and salaries to restructure our business in order to conserve cash and focus on our core sales strategies.
  • We will continue to incur research and development and other expenses related to our ongoing operations.
  • We reported a net loss of $91.7 million for the year ended December 31, 2025 and we had an accumulated deficit of $991.5 million, our cash and cash equivalents were $6.2 million at December 31, 2025, which is less than will be required to fund operations for a period of 12 months beyond the issuance date.
  • We expect to incur significant expenditures for the foreseeable future.
  • Accordingly, there is substantial doubt about our ability to continue as a going concern, which may affect our ability to obtain future financing and may require us to further curtail our operations.
  • We will need to raise additional capital to support our operations.
  • Due to the significant resources required for the development of our product candidates, we must focus on specific treatment pathways and decide which product candidates to pursue and the resources to allocate to each product candidate.
  • Specifically, we are focused on the development of cellular therapeutic candidates.
  • Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward products may not lead to the development of any viable product and may divert resources away from better opportunities.
  • Our placental-derived cellular therapy candidates represent a novel approach to degenerative disease treatments that creates significant challenges.
  • Advancing these novel therapeutic candidates creates significant challenges, including: ● manufacturing cellular therapeutic candidates to our and regulatory specifications and in a timely manner to support our clinical trials, and, if approved, commercialization; ● biosourcing placentas and other materials and supplies for the manufacture of our therapeutic candidates; ● any variability in placental-derived cells, or a higher-rejection rate, which could ultimately affect our ability to produce therapeutics in a reliable and consistent manner and treat certain patients; ● educating medical personnel regarding the potential advantages and potential disadvantages such as the side effect profile of our therapeutics, if approved, such as the potential adverse side effects related to graft-versus-host disease , or GvHD, cytokine release syndrome, or CRS, neurotoxicity, prolonged cytopenia and neutropenic sepsis; ● using medicines to manage adverse side effects of our therapeutic candidates that may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment; ● obtaining regulatory approval, as the FDA, and other regulatory authorities have limited experience with development of allogeneic cell therapies for cancer, infectious and degenerative diseases; and ● establishing sales and marketing capabilities for our therapeutic portfolio upon obtaining any regulatory approval to gain market acceptance of novel therapies.
  • We may rely on licensed gene editing technology for future cell therapy product candidates. may be dependent on patents, know-how and proprietary technology, both our own and licensed from others.
  • In addition, our expectations about our scalability and costs of manufacturing may vary significantly as we develop our therapeutic candidates and understand these critical factors.
  • In addition, under guidelines issued by the National Institutes of Health, or NIH, gene therapy clinical trials are also subject to review and oversight by an institutional biosafety committees, or IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution.
  • As we continue to evolve our placental-derived therapeutic programs, we may need to halt or modify development of certain candidates because of adverse events.

and 88 more.

Gone since FY2024

  • Risks Related to Business and Industry We have incurred net losses in every period since our inception, have no cellular therapeutics approved for commercial sale and anticipate that we will incur substantial net losses in the future.
  • We are a clinical-stage biopharmaceutical company, have no cellular therapeutics approved for commercial sale, have not generated any revenue from cellular therapeutic sales to date, and will continue to incur research and development and other expenses related to our ongoing operations.
  • We reported a net loss of $57.9 million and $196.3 million for the years ended December 31, 2024 and 2023, respectively.
  • We had an accumulated deficit of $899.7 million at December 31, 2024 and $0.7 million of cash and cash equivalents at such date.
  • Even after significant reductions in headcount in 2023, our strategic review to refocus our pipeline, and capital raises in 2024, we expect to incur significant expenditures for the foreseeable future, and we expect these expenditures to increase as we continue production of our commercial products that have seen strong demand.
  • We will continue to incur research and development and other expenditures to develop and market therapeutic candidates.
  • We have incurred net losses and used significant cash in operating activities since inception, have no cellular therapeutic candidates approved for commercial sale and we anticipate that we will incur substantial net losses in the future.
  • We had an accumulated deficit of $899.7 million and have cash and cash equivalents of $0.7 million as of December 31, 2024, and as of the date of this filing, had no available additional sources of outside capital to sustain our operations for a period of six months beyond the issuance date.
  • Accordingly, there is substantial doubt about our ability to continue as a going concern, which may affect our ability to obtain future financing and may require us to further curtail our operations and our independent registered public accounting firm included in its opinion for the year ended December 31, 2024 an explanatory paragraph referring to our recurring losses, and net cash outflows from operations and outstanding debt and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available.
  • For additional details, see the discussion under “ Management’s Discussion and Analysis of Financial Condition and Results of Operations – Overview - Going Concern. ” We will need to raise additional capital to support our operations.
  • As of December 31, 2024 and 2023, we had $0.7 million and $0.2 million in cash and cash equivalents, respectively.
  • We will need to raise additional capital to implement our plans.
  • Further, changing circumstances may cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control.
  • We may also need to raise a large amount of capital sooner than currently anticipated if we choose to expand more rapidly than our present plans.
  • In any event, we will require additional capital for the further development and commercialization of our therapeutic candidates, including funding our internal manufacturing capabilities and growth of our degenerative disease business.
  • We cannot be certain that additional funding will be available on acceptable terms, or at all.
  • We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our therapeutic candidates or other research and development initiatives.
  • We could be required to seek collaborators for our therapeutic candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to our therapeutic candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.
  • Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our securities to decline.
  • Due to the significant resources required for the development of our product candidates, we must focus on specific treatment pathways and decide which product candidates to pursue and the amount of resources to allocate to each such product candidate.
  • Specifically, we are focused on the development of cellular therapeutic candidates, targeting indications across cancer, infectious and degenerative diseases.
  • Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular product candidates may not lead to the development of any viable product and may divert resources away from better opportunities.
  • Our placental-derived cellular therapy candidates represent a novel approach to cancer, infectious and degenerative disease treatments that creates significant challenges.
  • Advancing these novel therapeutic candidates creates significant challenges, including: ● manufacturing cellular therapeutic candidates to our and regulatory specifications and in a timely manner to support our clinical trials, and, if approved, commercialization; ● biosourcing placentas and other materials and supplies for the manufacture of our therapeutic candidates; ● any variability in placental-derived cells, or a higher-rejection rate, which could ultimately affect our ability to produce therapeutics in a reliable and consistent manner and treat certain patients; ● educating medical personnel regarding the potential advantages and potential disadvantages such as the side effect profile of our therapeutics, if approved, such as the potential adverse side effects related to GvHD, cytokine release syndrome, or CRS, neurotoxicity, prolonged cytopenia and neutropenic sepsis; ● using medicines to manage adverse side effects of our therapeutic candidates that may not adequately control the side effects and/or may have a detrimental impact on the efficacy of the treatment; ● obtaining regulatory approval, as the FDA, and other regulatory authorities have limited experience with development of allogeneic cell therapies for cancer, infectious and degenerative diseases; and ● establishing sales and marketing capabilities for our therapeutic portfolio upon obtaining any regulatory approval to gain market acceptance of a novel therapy.
  • The gene-editing technology we use is relatively new, and if we are unable to use this technology in our intended therapeutic candidates, our revenue opportunities will be materially limited.
  • We use gene editing techniques to modify certain of the placental-derived cell types.
  • We use these technologies to either reduce the risk of toxicity or improve the potential for efficacy.
  • These technologies are relatively new and may not be shown to be effective at achieving the expected effect in clinical studies, or may be associated with safety issues, either in our clinical development programs or those of others using these novel technologies.
  • Any issues with the novel gene editing technologies, even if not experienced by us, could negatively affect our development programs.
  • Genetic modifications may create unintended changes to the DNA of the edited cell, such as a non-target site gene-editing, a large deletion, or a DNA translocation, any of which could lead to unwanted side-effects.
  • The gene-editing of our therapeutic candidates may also not be successful in limiting the risk of GvHD or thrombosis or in increasing affinity.
  • Some competitors in the allogeneic cell therapy space and more broadly in the gene therapy space have had clinical trials put on hold by the FDA.
  • Based on findings in those clinical trials, the FDA may request additional testing, request different types of testing or even substantially revise the methodology used to evaluate clinical trials for other companies pursuing similar therapeutic avenues.
  • We cannot control the actions of our competitors, cannot influence the results of their clinical trials and cannot know how FDA may react to a specific fact pattern arising in another clinical trial.
  • Additional testing, different types of testing or a revised regulatory approach may delay our future clinical trials, increase costs in our future trials or otherwise preclude our trial from being given permission to proceed absent substantial time, effort and resources on our part.
  • The gene-editing industry is rapidly developing, and our competitors may introduce new technologies that render the technologies that we employ for our therapeutic candidates obsolete or less attractive.
  • New technology could emerge at any point in the development cycle of our therapeutic candidates.
  • As competitors use or develop new technologies, any failures of such technology could adversely impact our programs.
  • We also may be placed at a competitive disadvantage, and competitive pressures may force us to implement new technologies at a substantial cost.
  • In addition, our competitors may have greater financial, technical and personnel resources that allow them to enjoy technological advantages and may in the future allow them to implement new technologies before we can.

and 123 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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