Annuncio • May 19
FibroBiologics, Inc. Files Patent Application for Oral Administration of Fibroblast Therapeutics FibroBiologics, Inc. announced the filing of a new provisional patent application with the U.S. Patent and Trademark Office titled “Oral Fibroblasts and Fibroblast-Derived Therapeutics and Delivery Systems for Same” covering oral delivery systems designed to protect fibroblast-based therapeutics through the stomach and enable targeted release in the gastrointestinal tract. The provisional patent application describes an oral administration platform intended to deliver fibroblasts and fibroblast-derived therapeutics, including whole cells, spheroids, extracellular vesicles, fragments, conditioned media, and genetically modified variants, to the GI tract using encapsulation materials and enteric coatings engineered to preserve viability and bioactivity during transit. The disclosed platform contemplates multilayer delivery architectures incorporating hydrogels, nanoparticles, protective intermediate layers, and pH-sensitive outer coatings designed to bypass gastric acid and digestive enzymes before releasing therapeutic payloads in targeted regions of the intestine. The application describes potential oral administration modality across chronic gastrointestinal disorders including inflammatory bowel disease, irritable bowel syndrome, peptic ulcer disease, celiac disease, gastritis, Crohn's disease, ulcerative colitis, and gastrointestinal cancers. The application covers not only fibroblasts, but also fibroblast-derived materials, engineered variants, multilayer encapsulation approaches, and programmable release concepts intended to maintain viability and function through oral delivery. From a scientific perspective, this gives a versatile framework for exploring how fibroblast-based therapeutics may help restore barrier function, modulate inflammation, and support tissue repair in gastrointestinal disease settings. Annuncio • May 12
Fibrobiologics Inc Expands Fibroblast Platform to Target Hantavirus FibroBiologics, Inc. announced a strategic expansion of its fibroblast-based platform to target Hantavirus. Building on existing preclinical work in treating acute respiratory distress syndrome (ARDS), the major cause of lethality in COVID-19 patients, FibroBiologics is expanding its therapeutic platform to encompass Hantavirus pulmonary syndrome (HPS), which causes similar terminal lung damage and inflammatory cascade as severe COVID-related ARDS. HPS is a rare but severe respiratory illness generally transmitted through contact with infected rodents. The disease progresses rapidly, causing severe pulmonary edema and multi-organ failure, with mortality rates exceeding 35-40%, even in clinical settings. Currently, there are no approved antiviral therapies or disease-modifying treatments for HPS, leaving patients dependent on supportive care. The pathophysiology of HPS involves uncontrolled inflammatory responses, endothelial barrier dysfunction, and progressive pulmonary fibrosis, mechanisms that FibroBiologics' fibroblast platform is specifically designed to modulate. Patients surviving acute HPS frequently develop chronic complications including pulmonary fibrosis, reduced lung capacity, and long-term respiratory impairment. Preclinical studies in ARDS models have demonstrated that fibroblasts can reduce excessive inflammatory signaling, restore endothelial barrier integrity, and promote tissue repair, precisely the pathogenic processes that characterize severe Hantavirus disease. The terminal lung damage observed in critical HPS cases mirrors the acute respiratory failure seen in ARDS, making FibroBiologics' fibroblast platform uniquely positioned to address this unmet need. The company is now evaluating its fibroblast platform in Hantavirus disease models, with particular emphasis on inflammatory cytokine modulation and endothelial permeability reduction. The company plans to initiate exploratory discussions with regulatory authorities to establish a development pathway toward clinical evaluation in HPS patients. New Risk • May 05
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings are forecast to decline by an average of 5.8% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (172% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$7.19m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Annuncio • May 02
FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $6.15 million. FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $6.15 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annuncio • Apr 23
FibroBiologics, Inc., Annual General Meeting, Jun 22, 2026 FibroBiologics, Inc., Annual General Meeting, Jun 22, 2026. Annuncio • Apr 11
Fibrobiologics Inc Presents Novel Thymus Organoid Platform to Combat Age-Related Immune Decline FibroBiologics, Inc. announced preclinical data supporting the potential of its proprietary thymic organoid platform to reverse age-related immune decline by restoring thymic function lost over time. The thymus is the primary site of T cell development, responsible for producing and educating the immune cells that underpin adaptive immunity, the body's ability to recognize and respond to specific threats including cancer, pathogens, and aberrant self-cells. Thymic function begins declining early in life and accelerates with age, a process known as thymic involution. By midlife, the organ has lost the majority of its productive capacity, resulting in reduced T cell output, diminished immune diversity, and impaired immune surveillance. These changes are associated with increased susceptibility to infection, cancer, autoimmune disease, and reduced vaccine efficacy. FibroBiologics developed a transplantable thymic micro-organoid system using selectively screened fibroblasts combined with thymic stromal cells. The organoids are produced through a rapid, three-day, matrix-free culture process and are cryopreservable and injectable, features designed with clinical scalability in mind. In immunodeficient mouse models, transplanted thymic organoids successfully generated multiple T cell lineages, including alpha-beta (aß) T cells, gamma-delta (?d) T cells, natural killer T (NKT) cells, and FoxP3+ regulatory T cells. The organoid-derived T cells displayed a diverse T cell receptor (TCR) repertoire in vivo and demonstrated functional responses to multiple immune stimuli, indicating that the cells were not only present but biologically active. Gene expression analysis confirmed that the organoids maintained expression of key factors required to sustain T cell development and maturation in both culture and in vivo settings, suggesting the platform can authentically recapitulate core aspects of thymic biology. In a targeted cancer model, organoids derived from pmel-1 thymocytes, cells pre-programmed to recognize a melanoma-associated antigen, generated antigen-specific T cells that slowed tumor growth in mice. The anti-tumor response extended beyond T cells, with enhanced activation of natural killer (NK) cells also observed. Results were consistent across tumor site and draining lymph node analyses, pointing to a systemic immune response rather than a localized effect. Annuncio • Apr 03
FibroBiologics, Inc. has completed a Follow-on Equity Offering. FibroBiologics, Inc. has completed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,028,788
Price\Range: $1.32
Discount Per Security: $0.0924
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 2,272,728
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,243,940
Price\Range: $1.31999
Discount Per Security: $0.0924 Annuncio • Apr 01
FibroBiologics, Inc. Announces Successful Manufacturing Of CYWC628 Drug Product To Support Upcoming Diabetic Foot Ulcer Clinical Trial FibroBiologics, Inc. announced the successful completion of manufacturing of the first batch of FibroBiologics’ proprietary CYWC628 drug product that will support upcoming first-in-human clinical trials. Manufactured in accordance with Food and Drug Administration’s (FDA’s) Good Manufacturing Practices (CGMP), the drug product will be released after it successfully passes all required safety and quality testing. The CYWC628 fibroblast-based therapy targets diabetic foot ulcers, a condition that affects millions of patients worldwide and currently lacks effective long-term treatment solutions. Annuncio • Mar 28
FibroBiologics, Inc. has filed a Follow-on Equity Offering. FibroBiologics, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,136,363
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,136,363
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 1,136,363 Annuncio • Mar 13
Fibrobiologics Announces Advances in Burn Treatment Using Proprietary Fibroblast Spheroid Technology FibroBiologics, Inc. announced the expansion of its wound care platform into the treatment of patients with acute and chronic burn injuries. Building on its investigational fibroblast spheroid-based programs in chronic wound healing, FibroBiologics is applying the same core technology to address the significant unmet medical needs in burn care, where current standards of care often result in prolonged healing, multiple procedures, and substantial scarring. In preclinical burn models, treatment with proprietary fibroblast spheroids (CYWC628) was associated with nearly a four-fold increase in tissue-level IL-10, a cytokine known to support tissue repair and wound healing in skin. Additionally, CYWC628 drove a significant reduction in IL-1B, a key driver of inflammation in burn wounds, further supporting the potential of the platform to promote better, faster healing in patients with severe burns. These findings suggest that CYWC628 may both accelerate wound closure and improve the quality of healed tissue by simultaneously promoting regeneration and dialing down harmful inflammation. These tissue-level biomarker changes align with the type of regenerative, pro-healing environment we are aiming to create in complex wounds and give us confidence as we advance CYWC628 toward clinical development in burn patients. Burns remain a major global health concern with significant unmet needs, with the worldwide burn care market estimated to be $2.55B worldwide and growing to $3.35B by the year 2030 (Markets & Makers 2025), driven by rising incidence and continued demand for advanced wound care solutions. FibroBiologics intends to integrate its burn program within its broader wound care strategy as it evaluates next steps toward clinical development. Annuncio • Mar 06
FibroBiologics, Inc. Completes Site Onboarding for Phase 1/2 Clinical Trial for Cywc628 for the Treatment of Refractory Diabetic Foot Ulcers FibroBiologics, Inc. announced that onboarding of the clinical sites has been completed for its Phase 1/2 clinical trial evaluating the safety and efficacy of CYWC628 for the treatment of refractory diabetic foot ulcers (DFUs). The clinical trial is a prospective, multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of FibroBiologics’ investigational topically administered allogeneic fibroblast spheroid-based therapy, CYWC628, for the treatment of refractory DFUs. Participants will receive up to 12 weeks of treatment using either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone. FibroBiologics has completed site onboarding as outlined in the protocol for the clinical trial but will activate additional sites if needed to support recruitment objectives. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints. Southern Star Research, a full-service Australian CRO with APAC coverage, is managing all aspects of the CYWC628 trial from start to finish. CYWC628 is an investigational topically administered allogeneic fibroblast cell-based therapy for wound healing. Preclinical data suggest CYWC628 may significantly accelerate wound healing compared to currently available treatments. FibroBiologics is planning a prospective, multicenter, open-label clinical trial evaluating the safety, tolerability, and efficacy of CYWC628 in treating refractory diabetic foot ulcers with up to 12 weeks of treatment using either standard of care plus a low or high-dose of CYWC628, or standard of care only. New Risk • Feb 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$17m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$17m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (79% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$46m net loss in 3 years). Market cap is less than US$100m (US$17.8m market cap). Annuncio • Feb 07
FibroBiologics, Inc. Receives Notice of Nasdaq Delisting Due to Continued Listing Rule Non-Compliance As previously reported, on August 4, 2025, FibroBiologics, Inc. (the “Company”) received a letter from the Listing Qualifications Staff (the "Staff") of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that its market value of listed securities (“MVLS”) had closed below the minimum $35 million threshold required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (the “MVLS Rule”) for the previous 30 consecutive trading day period. In accordance with Listing Rule 5810(c)(3)(C), the Company was provided with a 180-calendar day period to regain compliance with the MVLS Rule, through February 2, 2026. On February 3, 2026, the Company received formal notice from the Staff that, based upon the Company’s continued non-compliance with the MVLS Rule, the deficiency serves as an additional basis for the delisting of the Company’s securities from Nasdaq (the “Notice”). The Notice indicated that, in addition to the previously-reported bid price deficiency under Listing Rule 5550(a)(2) (the “Bid Price Rule”), the Nasdaq Hearings Panel (the “Panel”) will consider the Company’s plan to regain compliance with the MVLS Rule in their decision regarding the Company’s request for continued listing on The Nasdaq Capital Market. At the Company’s hearing before the Panel, the Company presented its plan to regain compliance with both the Bid Price Rule and the MVLS Rule. The Company awaits the Panel’s formal decision in response to its request for continued listing on The Nasdaq Capital Market and will remain listed and trading on The Nasdaq Capital Market at least pending the issuance of the Panel’s decision and the expiration of any extension that may be granted to the Company by the Panel. The Company intends to actively monitor the closing bid price of its common stock and MVLS and evaluate all available options to regain compliance with the applicable rules. To that end, on December 29, 2025, the Company filed definitive proxy materials with the Securities and Exchange Commission, which, among other matters, seeks shareholder approval for the implementation of a reverse split of the Company’s outstanding common stock, at a ratio ranging from any whole number between and including 1 for 5 and 1 for 30 shares, with the ratio to be determined by the Company’s board of directors. Although the Company is taking definitive steps to regain compliance with the applicable rules, there can be no assurance that the Company will be granted an extension to do so or that any actions taken by the Company will be successful in its effort to regain compliance with the listing rules. Annuncio • Jan 06
FibroBiologics, Inc. Announces Positive Preclinical Results for a Fibroblast Spheroid-Derived Chondrocyte (FSdC) Spheroid Therapy for Degenerative Disc Disease FibroBiologics, Inc. announced positive preclinical results for FSdC, an investigational FSdC spheroid-based therapy, demonstrating superior improvement in recovering intervertebral disc integrity and preventing degeneration in animal models of degenerative disc disease. These preclinical findings represent a major advancement for FibroBiologics' regenerative medicine pipeline and highlight the potential of FSdC spheroids to address unmet needs in spinal health. Key results from thedegenerative disc disease animal model study include: Significantly Improved Disc Height Recovery: FSdC spheroids exhibited the highest level of intervertebral disc height recovery at 12 weeks after treatment as compared to 2D fibroblasts and fibroblast spheroids, demonstrating superior long-term structural integrity. FibroBiologics is pursuing a development program for FSdC spheroids with the goal of advancing to clinical trials. The data includes comprehensive preclinical pharmacology and efficacy assessments supporting the therapy's mechanism of action, durability of effect, and potential for regenerative outcomes. Annuncio • Jan 04
FibroBiologics Receives Notice of Nasdaq Delisting Due to Continued Bid Price Non-Compliance As previously reported, on July 1, 2025, FibroBiologics, Inc. (the “Company”) received a letter from the Listing Qualifications Staff (the "Staff") of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the bid price for the Company’s shares of common stock had closed below the minimum threshold of $1.00 per share, as required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Rule”), for the previous 30 consecutive trading day period. In accordance with Listing Rule 5810(c)(3)(A), the Company was provided with a 180-calendar day period to regain compliance with the Rule, through December 29, 2025. On December 30, 2025, the Company received a second notification indicating that the Staff planned to delist the Company’s securities due to the Company’s continued non-compliance with the Rule as of December 29, 2025, unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company plans to timely request a hearing before the Panel, which request will stay any further suspension or delisting action by the Staff at least pending the outcome of the hearing and the expiration of any extension that may be granted to the Company by the Panel. The Company intends to actively monitor the closing bid price of its common stock and evaluate all available options to regain compliance with the Rule. In that regard, the Company filed definitive proxy materials on December 29, 2025, which, among other matters, requests that our stockholders vote to approve a reverse split of our outstanding common stock, at a ratio ranging from any whole number between and including 1 for 5 and 1 for 30 shares, with the ratio to be determined by the board of directors. Although the Company is taking definitive steps to regain compliance with the Rule, there can be no assurance that the Company will be granted an extension to do so or that any actions taken by the Company will be successful in the Company’s effort to regain compliance with the Rule. Annuncio • Jan 01
FibroBiologics, Inc. Files IND Application with the U.S. FDA to Advance Clinical Development of CYPS317 in Patients with Psoriasis FibroBiologics, Inc. announced the filing of 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, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis. This IND filing represents a major advancement for FibroBiologics' chronic inflammatory disease pipeline and follows a series of positive IND-enabling preclinical results demonstrating the potential of fibroblast spheroids to significantly reduce psoriasis disease severity and relapse in preclinical models. In animal studies, a single dose of CYPS317 matched or exceeded the therapeutic effects of multiple doses of anti-IL-23 monoclonal antibodies and yielded significant reductions in disease recurrence, underscoring both the durability and immunomodulatory capacity of this approach. FibroBiologics is pursuing a development program for CYPS317 with the goal of advancing first-in-human clinical trials following FDA review of the IND filing. The IND submission includes comprehensive preclinical pharmacology, safety, and manufacturing data supporting the therapeutic's mechanism of action, durability of effect, and safety profile. Despite advances in biologic treatments, unmet needs remain, particularly in achieving durable responses with favorable safety profiles. FibroBiologics continues to develop additional fibroblast-based therapies across a range of chronic disease indications, leveraging its differentiated platform of engineered organoids and native fibroblast spheroids and a broad intellectual property estate. Annuncio • Dec 17
FibroBiologics, Inc. has completed a Follow-on Equity Offering in the amount of $1.725001 million. FibroBiologics, Inc. has completed a Follow-on Equity Offering in the amount of $1.725001 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,227,275
Price\Range: $0.33
Discount Per Security: $0.0231
Transaction Features: Registered Direct Offering New Risk • Dec 16
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (77% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Market cap is less than US$100m (US$16.1m market cap). Annuncio • Dec 15
FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $1.725001 million. FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $1.725001 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,227,275
Price\Range: $0.33
Discount Per Security: $0.0231
Transaction Features: Registered Direct Offering Annuncio • Nov 24
FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $1.500001 million. FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $1.500001 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,477,614
Price\Range: $0.335
Discount Per Security: $0.02345
Transaction Features: Registered Direct Offering Annuncio • Nov 22
FibroBiologics, Inc. Receives HREC Approval for Phase 1/2 Clinical Trial for CYWC628 for Treatment of Refractory Diabetic Foot Ulcers FibroBiologics, Inc. announced that it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers (DFU). This approval enables enrollment of 120 patients at 10 sites across Australia. With the HREC approval and Therapeutics Goods Administration (TGA) filing now complete, FibroBiologics has secured all necessary regulatory approvals and submitted all required filings to proceed with the clinical trial. Southern Star Research, a leading full-service Australian CRO with APAC coverage, will manage all aspects of the CYWC628 trial from start to finish. The approved clinical trial is a prospective, multicenter, randomized study designed to evaluate the safety, tolerability, and efficacy of FibroBiologics' investigational topically administered allogeneic fibroblast cell-based therapy, CYWC628, for the treatment of refractory DFU. Participants will receive up to 12 weeks of treatment using either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone. The trial will assess wound healing outcomes, efficacy of response, and safety parameters through regular clinical and imaging evaluations. In addition to confirming safety and therapeutic potential, the study is expected to provide key clinical data supporting CYWC628 as a novel, fibroblast-based cell therapy aimed at addressing a significant unmet need in chronic wound management. Annuncio • Nov 20
FibroBiologics, Inc. has completed a Follow-on Equity Offering in the amount of $3.999914 million. FibroBiologics, Inc. has completed a Follow-on Equity Offering in the amount of $3.999914 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,540,000
Price\Range: $0.3303
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 8,570,203
Price\Range: $0.33029
Transaction Features: Registered Direct Offering Annuncio • Nov 19
FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $3.999914 million. FibroBiologics, Inc. has filed a Follow-on Equity Offering in the amount of $3.999914 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,540,000
Price\Range: $0.3303
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 8,570,203
Price\Range: $0.33029
Transaction Features: Registered Direct Offering Price Target Changed • Nov 05
Price target decreased by 15% to US$8.75 Down from US$10.25, the current price target is an average from 4 analysts. New target price is 2,263% above last closing price of US$0.37. Stock is down 90% over the past year. The company is forecast to post a net loss per share of US$0.47 next year compared to a net loss per share of US$0.34 last year. New Risk • Oct 03
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$15m free cash flow). Earnings are forecast to decline by an average of 26% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (US$22.6m market cap). Annuncio • Sep 13
FibroBiologics, Inc. Announces Positive IND-Enabling Updates Demonstrating Potential of Fibroblast Spheroids in Chronic-Relapse Psoriasis Treatment FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis. Psoriasis is a serious autoimmune condition affecting over eight million adults in the United States. In many cases, it progresses to psoriatic arthritis, significantly impacting quality of life. FibroBiologics is focused on harnessing fibroblast science to develop therapies that are not just incremental improvements, but durable, scalable solutions for patients. The company is continuing to expand its research, including exploring repeated dosing regimens, systemic and local cytokine profiling, and histopathological assessments of skin lesions. These efforts are designed to deepen understanding of the mechanisms at work and strengthen the foundation for clinical advancement. FibroBiologics is now evaluating whether a single HDF spheroid treatment can be developed to deliver long-term protection against psoriasis relapse, an outcome that would represent not just progress, but a step-change in how chronic inflammatory diseases are treated. Annuncio • Sep 12
FibroBiologics, Inc. Announces Significant Advancements in Bone Marrow Organoid Platform Enabling Development for Cancer and Immune-Related Therapies FibroBiologics, Inc. announced significant advancements in its Bone Marrow Organoid platform, which may offer promising new treatment options for hematopoietic cancers and age-related immune decline. The company's proprietary Bone Marrow Organoid have demonstrated potential in multiple therapeutic applications: Pre-IND animal trials show that Transplantation of Bone Marrow Organoids into xenografted melanoma mouse model significantly reduced tumor size. The organoids enable efficient ex vivo gene editing, allowing for swift and targeted therapeutic interventions before transplantation. FibroBiologics' Bone Marrow Organoids can be cryopreserved, offering a scalable and readily available treatment option for bone marrow transplantation. Annuncio • Aug 09
FibroBiologics Receives Notice from Nasdaq Regarding the Market Value of Listed Securities Compliance On August 4, 2025, FibroBiologics, Inc. received a notification letter from the Listing Qualifications Staff (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that it does not meet the requirement in Nasdaq Listing Rule 5550(b)(2) to maintain a minimum Market Value of Listed Securities (‘MVLS’) of $35.0 million that is required for continued listing on The Nasdaq Capital Market (the ‘Notice’). The Notice has no immediate impact on the listing of the Company’s common stock, which will continue to be listed and traded on The Nasdaq Capital Market subject to the Company’s continued compliance with the other listing requirements. In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has a period of 180 calendar days, or until February 2, 2026, to regain compliance with this requirement. To regain compliance, the Company’s MVLS must close at $35.0 million or more for a minimum of ten consecutive business days at any time before February 2, 2026. If the Company does not regain compliance with Rule 5550(b)(2) by February 2, 2026, Nasdaq will notify the Company that its securities are subject to delisting. In the event of such notification, the Company may appeal the Staff’s determination to delist its securities, but there can be no assurance the Staff will grant the Company’s request for continued listing. The Company will continue to monitor its MVLS and may, as appropriate, consider available options to regain compliance. New Risk • Aug 04
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 17% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$15m free cash flow). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$35m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (US$27.2m market cap). Annuncio • Jul 30
FibroBiologics, Inc. Files Patent for Methods of Generating Multipotency Cells from Donor Tissue for Clinical Applications FibroBiologics, Inc. announced the filing of a patent application with the United States Patent and Trademark Office covering methods of generating multipotent cells from fibroblasts found in donor tissue for clinical applications. Multipotency refers to a flexible cellular state in which a cell has the potential to differentiate into multiple specialized cell types, depending on the environmental conditions or stimuli it encounters. While stem cells have garnered the most attention on being multipotent, fibroblasts are also considered multipotent and can be directly differentiated into many cell types including chondrocytes, osteocytes, hepatocytes and cardiomyocytes. This patent application broadly relates to methods for generating multipotent cells directly from fibroblasts find in human donor tissues. Annuncio • Jul 10
Fibrobiologics Confirms Ability to Manufacture Cybrocell for Degenerative Disc Disease and Cartilage Repair Programs from Existing Cywc628 Master Cell Bank FibroBiologics, Inc. announced an advancement in its cartilage repair program. FibroBiologics has confirmed, through both immunohistochemistry and transcriptomic analysis, that the CYWC628 spheroids used in its wound healing program can be directly differentiated into chondrocytes, the specialized cells responsible for cartilage formation. This confirmation means that FibroBiologics can use its current CYWC628 master cell bank to produce a working cell bank and manufacture CybroCell™?, the company's investigational cell therapy for the treatment of regenerative disc disease (DDD). This development allows FibroBiologics to move forward with amending its IND clearance with the FDA for the planned Phase I clinical trial for DDD and represents a major milestone in platform scalability. Annuncio • Jul 04
FibroBiologics Receives Non-Compliance Letter from Nasdaq Regarding Minimum Closing Bid Price On July 1, 2025, FibroBiologics, Inc. received a notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC notifying the Company that the closing bid price of the Company’s shares of common stock was below the minimum closing bid price of $1.00 per share during the last 30 consecutive trading days (the “Notice”), as required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The Notice has no immediate impact on the listing of the Company’s common stock, which will continue to be listed and traded on The Nasdaq Capital Market subject to the Company’s continued compliance with the other listing requirements. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until December 29, 2025, to regain compliance with this requirement. To regain compliance, the closing bid price of the Company’s common stock must be $1.00 per share or more for a minimum of 10 consecutive business days at any time before December 29, 2025. If the Company does not regain compliance with Rule 5550(a)(2) by December 29, 2025, the Company may be eligible for an additional 180 calendar day compliance period. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except the bid price requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period. If it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will notify the Company that its securities will be subject to delisting. In the event of such notification, the Company may appeal the Staff’s determination to delist its securities, but there can be no assurance the Staff will grant the Company’s request for continued listing. The Company will continue to monitor the closing bid price of its common stock and may, as appropriate, consider available options to regain compliance. Annuncio • Jun 17
FibroBiologics, Inc. announced that it has received $15 million in funding from Yorkville Advisors Global LP On June 16, 2025, FibroBiologics, Inc., closed the transaction. The company issued convertible promissory notes in the principal amount $5,000,000 in its third and final tranche closing. Annuncio • Jun 09
FibroBiologics, Inc. Appoints Jason D. Davis as Chief Financial Officer, Effective June 9, 2025 FibroBiologics, Inc. announced the appointment of Jason D. Davis, CPA, as Chief Financial Officer, effective June 9, 2025. Mr. Davis brings extensive experience in corporate finance, capital markets, and SEC reporting, with a proven track record of successfully leading companies through critical growth phases, including IPOs and capital raising initiatives. His appointment comes as FibroBiologics advances toward its Phase 1/2 clinical trial for diabetic foot ulcers in the second half of 2025 and continues to expand its fibroblast-based therapeutic platform. Mr. Davis most recently served as Chief Financial Officer of Virax Biolabs, where he helped navigate the company through its successful IPO in July 2022. During his tenure, he led multiple capital raises with favorable terms, managed all periodic reports and other filings with the SEC, and implemented public company governance best practices. Prior to Virax, Mr. Davis served in various finance roles for several public companies, including HyperDynamics Corp, where he increased the company's market cap from $20 million to over $700 million and raised over $200 million in multiple transactions from U.S. and European capital markets. He received his B.B.A. in Accounting from the University of Houston and is a CPA certified in Texas. New Risk • May 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$32m net loss in 3 years). Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (US$42.9m market cap). Annuncio • Apr 02
FibroBiologics, Inc. Auditor Raises 'Going Concern' Doubt FibroBiologics, Inc. filed its 10-K on Mar 31, 2025 for the period ending Dec 31, 2024. In this report its auditor, WithumSmith+Brown, PC , gave an unqualified opinion expressing doubt that the company can continue as a going concern. Board Change • Apr 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. No highly experienced directors. Independent Director Stacy Coen was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Mar 28
FibroBiologics, Inc., Annual General Meeting, Jun 12, 2025 FibroBiologics, Inc., Annual General Meeting, Jun 12, 2025. Annuncio • Feb 28
FibroBiologics, Inc. and Charles River Laboratories Announce Completion and Release of CYWC628 Master Cell Bank for the Manufacturing of Fibroblast Cell-Based Wound Healing Therapeutic FibroBiologics, Inc. and Charles River Laboratories announced the completion of FibroBiologics' proprietary master cell bank that will support upcoming clinical trials. Manufactured in accordance with FDA Good Manufacturing Practices (cGMP), the cell bank has successfully passed all required safety testing. FibroBiologics, a clinical-stage biotechnology company with 160+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, is investigating the potential treatment of chronic diseases using the immunomodulatory and regenerative capabilities of fibroblasts and Fibroblast-derived materials. Indications being studied include wound healing, multiple sclerosis, degenerative disc disease, psoriasis, human longevity, and cancer. CYWC628 fibroblast-based therapy targets diabetic foot ulcers, a condition that affects millions of patients worldwide and currently lacks effective long-term treatment solutions. Charles River's cGMP manufacturing facilities will serve as the production site for the CYWC628 cell banks and drug product for upcoming phase I/II diabetic foot ulcer clinical trial slated to begin later this year. Annuncio • Jan 01
FibroBiologics, Inc. announced that it expects to receive $25 million in funding from Yorkville Advisors Global LP FibroBiologics, Inc. entered into a Standby Equity Purchase Agreement with YA II PN LTD.an investment fund managed by Yorkville Advisors Global, LP. The agreement allows FibroBiologics, subject to customary conditions, to sell up to $25 million in the aggregate of its common stock to Yorkville over the course of two years on December 30, 2024. Annuncio • Nov 20
FibroBiologics, Inc Files Patent Application for a Cell-based Therapeutic for the Treatment Of Splenomegaly FibroBiologics, Inc. announced the filing of a patent application covering methods for treatment of splenomegaly using a cell-based therapeutic approach. Splenomegaly, or an enlarged spleen, often occurs in connection with immune-related conditions and is seen in a variety of diseases, including autoimmune disorders and chronic infections. Additionally, it can also be caused by multiple rounds of chemotherapy, and depression treatment drugs. The spleen is essential for filtering blood, supporting immune function, and managing red blood cells. However, in cases of immune disorders, it can become overactive, leading to enlargement. Conditions like psoriasis, lupus, HIV, tuberculosis, and blood cancers such as lymphoma and leukemia are common causes of this issue. When the spleen enlarges to handle excess immune cells and inflammation, it can lead to discomfort, anemia, and a weakened immune system, increasing vulnerability to further infections. Annuncio • Nov 14
Fibrobiologics Files Patent Application Covering Reduction of Blood Clots Associated with Instant Blood-Mediated Inflammatory Reaction in Cell-Based Therapeutics FibroBiologics, Inc. announced the filing of a patent application with the United States Patent and Trademark Office covering methods employing fibroblasts or other Tissue Factor (TF)-expressing cells to prevent IBMIR-mediated blood clotting. This patent application addresses a critical challenge in cell therapy: the risk of instant IBMIR, which can lead to complications such as complement activation, immune cell infiltration, platelet adhesion and coagulation (clotting) that endanger the effectiveness and safety of cell-based treatment. Reducing inflammatory and coagulative responses has the potential to transform therapeutic protocols for intravascular, subcutaneous, and intraperitoneal cell administration and could provide safer and more effective treatments for patients worldwide. Annuncio • Oct 29
FibroBiologics, Inc. Announces Updates for Novel Artificial Thymus Organoid Technology FibroBiologics, Inc. announced promising new findings from its artificial thymus organoid program. Recent results from the artificial thymus organoid programs showed that fibroblasts and thymus-derived cell organoids can persist and function for over 50 days post-transplantation, with vascularization and the generation of a diverse array of mature T cells in animal models. The artificial thymus organoid has shown an ability to support distinct vascularization, critical for sustained functionality in vivo, while producing fully mature T cells expressing T cell receptors (TCR). Fully mature T cells differentiate into various types of cells, including CD4, CD8, T-regulatory, and gamma delta T cells, and contribute to a well-rounded immune response. The artificial thymus Organoid also produces T cells with diverse TCR-beta chains that enable the recognition of a broad spectrum of antigens. Annuncio • Aug 20
FibroBiologics, Inc. Announces Filing of Patent Application for Wound Healing Using an Adhesive Bandage with Fibroblast Cell-Based Technology FibroBiologics, Inc. announced the filing of a patent application with the United States Patent Office covering the use of fibroblast cell-based technology in an adhesive bandage for wound healing. Annuncio • Jun 25
Fibrobiologics Announces Preliminary Proof of Concept for Novel Artificial Thymus Organoid Technology FibroBiologics, Inc. announced the development of a novel artificial thymus organoid that can restore immune function in a severe combined immunodeficiency (SCID) mouse model. The organoid, composed of fibroblasts and thymus derived cells, is capable of generating mature and diverse T cells, including CD4, CD8, and regulatory T cells, in vitro and in vivo. FibroBiologics intends to develop this technology as a subcutaneous injection of an allogeneic fibroblast-based organoid to restore thymus function lost due to age-related natural thymus involution, and for a rapid restoration of the immune system in patients who have gone through chemotherapy. Annuncio • May 19
FibroBiologics, Inc., Annual General Meeting, Aug 27, 2024 FibroBiologics, Inc., Annual General Meeting, Aug 27, 2024. New Risk • May 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.1m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Negative equity (-US$3.9m). Earnings have declined by 64% per year over the past 5 years. Revenue is less than US$1m. Annuncio • Apr 05
Fibrobiologics Presents Data from Dermal Fibroblast Spheroid-Based Treatment of Chronic Wounds in A Diabetes Mouse Model At Advanced Wound Care Summit USA FibroBiologics, Inc. announced data from its latest study in a diabetes mouse model on the potential therapeutic efficacy of dermal fibroblast spheroids in treating chronic wounds. These findings will be presented via an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, MA, April 16-17. Diabetic foot ulcers (DFUs) are prevalent in individuals with diabetes, with approximately 33 million people impacted globally. DFUs pose significant challenges for patients and the healthcare system due to impaired healing mechanisms associated with hyperglycemia, cellular senescence, and other comorbidities associated with diabetes. FibroBiologics' research aims to address this issue by investigating the potential of using human dermal fibroblast (HDF) spheroids in promoting and accelerating the wound healing process in diabetic patients. The study, led by a team of researchers including FibroBiologics’ Chief Scientific Officer, Hamid Khoja, Ph.D., utilized a diabetic mouse model to evaluate the therapeutic effects of HDF spheroids on mice with wounds resembling DFUs. Key findings from the study include: Acceleration of wound healing with a 60% decrease in relative wound area within 4 days post-treatment with a single administration of HDF spheroids compared to standard of care treatment control. Upregulation of pro-inflammatory cytokines such as interferon-gamma (IFN-?), interleukins IL-1), and tumor necrosis factor-alpha (TNF-a), along with anti-inflammatory cytokines IL-6 and IL-10, indicating modulation of the wound microenvironment conducive to healing.Increased levels of vascular endothelial growth factors (VEGF) and endothelial growth factor receptors (EGFR), suggesting enhanced revascularization and re-epithelialization in HDF-treated wounds. Immunohistochemical analysis revealing the presence of markers indicative of fibroblast and endothelial proliferation, active cell proliferation, angiogenesis, and macrophage proliferation in HDF-treated wounds. Annuncio • Mar 07
FibroBiologics, Inc. Appoints Ruben A. Garcia as General Counsel FibroBiologics, Inc. announced the appointment of Ruben A. Garcia as General Counsel. He will report to Pete O'Heeron, FibroBiologics' Founder, Chairman and Chief Executive Officer, and be an integral member of the executive leadership team. Mr. Garcia brings more than 20 years of experience and an extensive background in legal leadership positions in the pharmaceutical industry. He most recently served as Senior Vice President, General Counsel and Corporate Secretary at AcelRx Pharmaceuticals, Inc. (n/k/a Talphera, Inc.). In that role, he was responsible for all legal and compliance matters. Prior to his role at AcelRx, Mr. Garcia served as Senior Corporate Counsel and Assistant Secretary for Ultragenyx Pharmaceutical Inc. Mr. Garcia began his legal career at Vinson & Elkins L.L.P. in Houston before joining Jones Day in Silicon Valley. He earned his Juris Doctor from Stanford Law School and his B.A. from Georgetown University. Mr. Garcia is a member of the State Bars of California and Texas. Board Change • Feb 01
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 5 experienced directors. No highly experienced directors. Independent Director Victoria Niklas is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. 
